Effects of soil compaction on soil, environment and plant growth.
\\n\\n
More than half of the publishers listed alongside IntechOpen (18 out of 30) are Social Science and Humanities publishers. IntechOpen is an exception to this as a leader in not only Open Access content but Open Access content across all scientific disciplines, including Physical Sciences, Engineering and Technology, Health Sciences, Life Science, and Social Sciences and Humanities.
\\n\\nOur breakdown of titles published demonstrates this with 47% PET, 31% HS, 18% LS, and 4% SSH books published.
\\n\\n“Even though ItechOpen has shown the potential of sci-tech books using an OA approach,” other publishers “have shown little interest in OA books.”
\\n\\nAdditionally, each book published by IntechOpen contains original content and research findings.
\\n\\nWe are honored to be among such prestigious publishers and we hope to continue to spearhead that growth in our quest to promote Open Access as a true pioneer in OA book publishing.
\\n\\n\\n\\n
\\n"}]',published:!0,mainMedia:{caption:"IntechOpen Maintains",originalUrl:"/media/original/113"}},components:[{type:"htmlEditorComponent",content:'
Simba Information has released its Open Access Book Publishing 2020 - 2024 report and has again identified IntechOpen as the world’s largest Open Access book publisher by title count.
\n\nSimba Information is a leading provider for market intelligence and forecasts in the media and publishing industry. The report, published every year, provides an overview and financial outlook for the global professional e-book publishing market.
\n\nIntechOpen, De Gruyter, and Frontiers are the largest OA book publishers by title count, with IntechOpen coming in at first place with 5,101 OA books published, a good 1,782 titles ahead of the nearest competitor.
\n\nSince the first Open Access Book Publishing report published in 2016, IntechOpen has held the top stop each year.
\n\n\n\nMore than half of the publishers listed alongside IntechOpen (18 out of 30) are Social Science and Humanities publishers. IntechOpen is an exception to this as a leader in not only Open Access content but Open Access content across all scientific disciplines, including Physical Sciences, Engineering and Technology, Health Sciences, Life Science, and Social Sciences and Humanities.
\n\nOur breakdown of titles published demonstrates this with 47% PET, 31% HS, 18% LS, and 4% SSH books published.
\n\n“Even though ItechOpen has shown the potential of sci-tech books using an OA approach,” other publishers “have shown little interest in OA books.”
\n\nAdditionally, each book published by IntechOpen contains original content and research findings.
\n\nWe are honored to be among such prestigious publishers and we hope to continue to spearhead that growth in our quest to promote Open Access as a true pioneer in OA book publishing.
\n\n\n\n
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\r\n\tThe global population will be nearly 10 billion by 2050, which means there will be about 2 billion more mouths to feed than in 2021. Rice is one of the most important staple foods in the world, where more than half of the population relies on it for more than 20% of their daily caloric intake. It is projected that global rice production will need to increase by 70% by 2050 to meet the food demands of the world’s growing population. Satisfying future rice demands will mainly depend on our ability to improve rice productivity rather than on the area enlargement of rice paddies because of space limitations caused by urban expansion. At the same time, we also require efforts to improve the rice quality because the demand and consumption of high-quality rice will increase as living standards improve. In addition, we urgently need to develop new technologies and strategies to overcome the constraints (e.g., climate change, soil degradation, and biodiversity loss) confronting the sustainable development of rice production. This book will aim to collect original research and review articles focused on but not limited to, the topics of rice productivity, quality, and sustainability.
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For example, the European Union has identified soil compaction as one of the main threats to soil that may cause the degradation of soils [2].
In simple terms, soil compaction can be described as the increase of bulk density or decrease in porosity of soil due to externally or internally applied loads. In agricultural production, soil compaction is considered as a complex problem in which soil, crops, weather and machinery interactions have an important role and which may result in dramatic economic and environmental problems. Wheel traffic from the use of heavy machinery and inappropriate soil management can cause the compaction of soil, creating impermeable layers within the soil that restrict water and nutrient cycles. This situation can result in reduced crop growth, yield and quality as well as a decline in the physical, chemical and biological indicators of soil quality such as destroyed soil structure, increased surface water run-off, soil erosion, greenhouse gas emissions, decreased hydraulic conductivity, reduced groundwater recharge and a loss of biodiversity [3, 4].
Mainly, there are two types of soil compaction defined as surface soil compaction and subsurface compaction. Surface soil compaction is also called as soil crusting. This type of soil compaction happens when the surface soil aggregates are broken down through the impact of falling raindrops, runoff, standing water during irrigation, or tillage. Therefore, it restricts water and air entry into soil by causing runoff and erosion of soil and impedes seedling emergence. The subsurface compaction can defined as tillage-induced compaction and wheel traffic-induced compaction depending on where it occurs. Tillage implements such as discs, moldboard plows and sweep type tools cause the tillage-induced compaction. This soil compaction type is mostly called as “hardpan,” or “plow pan” and occurs in the layer of soil just below the depth of tillage when soils are cultivated repeatedly at the same depth. Wheel traffic-induced compaction lies beneath the tillage zone and is caused by axle weight load to the soil. This type of soil compaction is the most difficult to eliminate, so prevention is important [4, 5, 6, 7].
Until today, many scientists [3, 4, 8, 9, 10, 11, 12, 13] have discussed the potential causes of compaction, its main consequences, and strategies to prevent and reduce soil compaction. Also, many field and laboratory studies have been conducted to better understand the mechanics of soil compaction, the factors affecting it and its effects on soil properties and crop growth in many parts of the world. Nawaz et al. [13] reviewed the main causes of the soil compaction, and its effects on soil physical, chemical, biogeochemical processes and biodiversity properties at both macro- and microscales. The authors also discussed the existing models for the soil compaction and proposed new directions for modeling the effects of the compaction on the soil properties. They emphasized that soil productivity was very important for human survival but any form of soil degradation can reduce the soil fertility and ultimately, it lowers the soil productivity. Also, it was underlined in the paper that in spite of hundreds of articles appearing during the last 10 years on the soil compaction, there was an urgent need to apply multidisciplinary approach in the soil compaction studies, addressing diverse effects in different soil compartments. Soane and van Ouwerkerk [14] summarized the studies carried out the impacts of soil compaction on the environment, including its effects on soil water dynamics, erosion, soil nitrogen and carbon cycling, cultivation energy requirement and effectiveness, pesticide leaching, and crop growth. They reported that compaction-induced changes could lead to soil degradation, pollution of the atmosphere and of ground and surface waters, and might increase the mechanical resistance of the soil, resulting in an increase in soil cutting force, fuel consumption, working hours, and abrasion of agricultural instruments. Also, several researchers [15, 16, 17, 18] reported that soil compaction negatively influenced the water dynamics, pesticide diffusion, soil erosion, carbon and nitrogen cycle, plant growth, and mechanical operations cost. Although overall effect of the soil compaction on environment, soil properties and the plant yield is mostly reported as negative, moderate compaction can sometimes result in yield increase by increasing the contact between the roots and soil particles which may lead to the rapid exchange of ions between the soil matrix and roots [13]. Batey and McKenzie [19] stated that the effects of soil compaction on crops and soil properties are very complex and should be well documented. Therefore, it is very important to understand what is the causes and harmful level of soil compaction, how soil compaction affects soil properties and plant growth, and to know how to avoid soil compaction as much as possible in agricultural production.
This chapter includes identification of compaction, the main causes of soil compaction in agricultural fields, its effects on soil properties, environment and plant growth, and strategies for preventing compaction in agricultural production.
Soil compaction is defined as the increase of bulk density or decrease in porosity of soil due to externally or internally applied loads. Soil compaction can be identified either in the field, the laboratory or via remote sensing. In field, soil compaction can be detected by observing or measuring the changes in soil structure, soil moisture and soil color, penetrometer resistance, permeability to air or water, waterlogging on the surface or in subsurface layers, and crop or root growth properties [20]. In Laboratory, soil bulk density, pore-size distribution, water permeability and the relative apparent gas diffusion coefficient is measured to determine the permeability of soils to air and water and therefore on the degree of compaction. Also, remote sensing techniques helps to recognize alterations of soil structure, root growth, water storage capacities and biological activity [21].
Soil compaction in agricultural fields is commonly known to be caused by several forces (natural and man-induced) such as raindrop or tillage equipment during soil cultivation, or trampling of livestock animal or from the heavy weight of field equipment such as mostly tractors, heavy cultivation machinery, harvesting equipment [3, 18]. In this case, we can say that high mechanical load, less crop diversification, intensive grazing, low organic matter and tillage at high moisture contents can lead to soil compaction. Shah et al. [12] summarized the main causes of soil compaction as shown in Figure 1. Similarly, Ziyaee and Roshan [22] conducted a survey to study the causes of soil compaction problems. They defined common causes of soil compaction as natural processes, earlier planting schedules, overgrazing and animal trampling which directly affect the penetration resistance, besides, increased machinery weight and intensity, and especially excessive tillage at high soil moisture content.
A summary of the main causes of soil compaction in agriculture fields [
Raindrop is one of the natural causes of surface compaction, and it causes a soil crust (usually less than 1/2 inch thick at the soil surface) that may prevent seedling emergence. This soil crusts reduces water infiltration and increases surface runoff, and thereby sediment and nutrient losses [6, 23].
Using tillage implements at the same depth can cause serious tillage pans or hardpans just below the depth of tillage. This tillage pan, which is generally relatively thin (2,5 to 5 cm), can reduce yield potential by restricting root growth and nutrient uptake of plant in soil [24].
Trafficking by the tyres of heavy farm machines is known to be the major cause of soil compaction in agricultural fields. Soil compaction by wheels is characterized by a decrease in soil porosity localized in the zone beneath the wheel and rut formation at the soil surface [18]. The degree of soil compaction by farm machines depends on not only the characteristics of the agricultural machinery but also the soil properties such as soil moisture, soil type, texture, structure, and moisture [3, 8, 25]. Several researchers [26, 27, 28] showed that the compaction rate depended on the soil characteristics, and the weight, the pressure and the vibrations of the agricultural machinery. Different machines, or even the same machines with different tyres, differ in their loading and pressure on the soil [25, 26]. Nawaz et al. [13] reported that the soil compaction by a machine depended on the soil strength which is influenced by the organic matter, water content, soil structure, and texture, and machine properties expressed by axle load, number of tyres, tyre dimensions, tyre velocity, and soil-tyre interaction. Botta et al. [29] reported that tyre sizes and rut depth/tyre width ratio had significant effect on soil compaction. The researchers emphasized that the farmer should pay attention to the axle load, the tyre size and the soil water content at the traffic moment. Also, the size, the inflation and the shape of tire in addition of the tyre’s load have significant effects on the ground pressure, indicating traffic-induced soil compaction [30, 31]. Håkansson and Reeder [32] found that the vehicles with high axle loads generally caused deep subsoil compaction when trafficked on soils with high moisture contents, and this deep subsoil compaction caused persistent and possibly permanent reductions in crop yields. Soil moisture and axle load causes soil compaction at various depth as shown in Figure 2. It is seen in Figure 2 that high axle load could result in soil compaction to deeper depth. Also, at a given load and tire size, increasing soil moisture content causes much deeper compaction than dry [33]. Da Silva et al. [34] stated that high contact pressures applied to soil, which is described as the ratio of mass of each machine’s axle and the contact area of the run, resulted in a greater degree of compaction, in addition to promoting other negative effects. The researchers underlined that it was possible to minimize the effects of soil compaction through the appropriate contact pressure of agricultural machines. They suggested that the use of new technologies and suitable management practices should develop and adopt to characterize machine size and solve the machine-soil problems, especially about the distribution of pressures caused by the wheels in the soil, thus avoiding the negative effects of compression. Similarly, Porterfield and Carpenter [35] stated that high-pressure tire-ground contact caused an increase in the density of the soil. so, the researchers recommended to keep contact pressure low to avoid compaction. The intensity of trafficking, also referred to as the number of passes of agricultural machinery on the soil throughout the life of the crop in addition to the wheel ground contact pressure and absolute wheel load, has a significate effect on the degree of compaction and the depth to which wheel pressure affects the soil [36]. Zhang et al. [37] stated that the increased frequency of passes associated with the small four-wheel tractors, which is smaller mass and lower ground pressure than the medium power tractor, potentially was more detrimental than those associated with the medium power tractor. Rusanov [38], who reported official standard values of maximum permissible normal stress at a depth of 0.5 m, observed traffic intensity mostly resulted in higher soil stress than the allowable stress in subsoil. Similarly, Botta et al. [39] observed that high traffic frequency (10 and 12 tractor passes in the same tracks) of a light tractor on typical Argiudol soil produced a significant increase in cone index and dry bulk density in the topsoil and subsoil levels. However, Hamza and Anderson [18] reported that the first pass of a wheel was known to cause a major portion of the total soil compaction and subsoil compaction may be induced by repeated traffic with low axle load and the effects can persist for a very long time. In summary, we can say that repeated passes of agricultural machinery at the same locations will increase soil compaction. Also, Shah et al. [12] emphasized that in intensive agriculture, high axle load of heavy tractors and field machines resulted in compacted soil layer, damaging the structure of tilled soil and subsoil and reducing crop and soil productivity. Keller et al. [40], who analyzed the effect of the increase in weight of agricultural vehicles on soil stress and soil bulk density, showed that the increase in machinery weight has resulted in an increase in subsoil compaction levels, and highlighted that future agricultural operations should consider the inherent mechanical limit of soil.
(A) The effect of axle load on soil compaction depth, (B) The effect of soil moisture content on compaction depth [
Soil properties (soil texture, soil aggregate properties, moisture content, organic matter content) and frequent use of chemical fertilizers has significant effect on soil compaction [8, 18]. It is mostly stated that the depth to which compressive forces are transmitted depends on the moisture content in soil profile. Batey [3] described the relationship between soil moisture content and compressibility as following: When the soil was dry and firm throughout the profile, there might be no significant compaction effect. However, when the surface layers were moist and soft lying over dry soil, the upper layers might be strongly compressed, and when the surface layers were dry and firm with moist soil below, the compression might be transmitted some way downwards to compress the moister vulnerable soil. Gysi et al. [41] determined that soil moisture content and wheel load significantly influenced the bulk density at a depth of 0.12–0.17 m. The researchers stated that a soil with very low moisture content was less vulnerable to compaction than a soil with high moisture content. The texture, organic matter content, aggregation stability and mineralogy of the soil also have a significant effect on compressibility of a soil by agricultural vehicles. Several researchers [13, 18] stated that soil texture was one of the most important factors in determining the susceptibility of a soil to compaction. Horn and Lebert [42] reported that coarse-textured soils were less susceptible to compaction than those with a fine texture. Moreover, Horn et al. [15] found that the silt loam soils with low colloid contents were more susceptible than medium or fine textured loamy and clayey soils at low water contents while the sandy soils were slightly susceptible to the soil compaction. Soil aggregation and organic matter content are also the most influencing factors that makes soil resistance to compaction [13, 43]. Ellies Sch et al. [44] reported that soils with poor structure and aggregation were extremely vulnerable to the impacts of wheel traffic, while susceptibility to compaction could be reduced with an increase in soil aggregation. Also, soil organic matter is a very important soil property, which can determine the magnitude of soil compaction. The amount of organic matter in soil significantly influence the compressibility degree under axle load of vehicles [13]. Previous works [45, 46, 47] has shown that increasing organic matter in soil may reduce compatibility by increasing resistance to deformation and/or by increasing elasticity.
Soil compaction alters the soil structure and hydrology by changing many aspects of the soil such as strength, gas, water and heat, which affect chemical and biological balances. In turns, all these alterations in the soil influence root and shoot growth and consequently crop production and environmental quality Table 1 [58]. presents a summary of studies related to the effects of soil compaction on soil, environment and plant growth. In most of these studies, the subsoil compaction negatively affected soil physical conditions, which substantially decreased crop yield. However, some studies [50, 56] showed that moderate compaction had no effect on crop yield or can increase yield. Also, Gürsoy and Türk [59] stated that moderate soil compaction in agriculture production was needed to get good seed/root-soil contact, suitable soil density, timely emergence of seed, root growth and the ability of the plant to absorb the moisture and nutrients from soil.
Land vehicles traffic | Place | Soil texture | Major findings | Reference |
---|---|---|---|---|
Different passes of a tractor pulling a trailer, during harvest operations | Argentina | A fine clay | The first pass of the tractor (4200 kg) resulted in a reduction of grass yield (40.3%) in comparison with the control (no traffic) treatment | [48] |
Weighted tractor compaction and a control of no compaction. | Scotland England | An imperfectly drained silty clay loam and a well drained sandy loam | Damage to soil structure through compaction reduced the yields of grassland swards by mechanical (tractor) compaction (14.5% reduction)after three years of these treatments. The soil type had significant effect on yield losses | [49] |
Most trafficked rows and least trafficked rows | USA | Loamy soils, fine sandy loam soils and fine sands | Different crops grown in a no till field were not very much influenced by wheel traffic | [50] |
Additional load (4.40, 6.40 and 8.40 kg) on the tractor rear wheel and 1, 6, 11 and 16 passes | India | Sandy loam soil | Yields of wheat decreased with an increase in the number of passes/trips at all load and pass combinations. | [51] |
Wheel loads (3, 8 and 12 Mg) and single and multiple (4–5) wheel passes | Denmark | Sandy loam soil | High wheel loads caused significant subsoil compaction at>50 cm depth and heavy traffic in dense soils created a potentially restrictive subsoil structure for plant growth | [52] |
Axle loads of sugarbeet harvesters and the number of passes | Sweden | Loam soil Sandy loam soil Sand soil | Heavy traffic during harvest of sugarbeet implied a major risk for compaction of the subsoil, which can be seen as a long-term threat to soil productivity. | [53] |
The number of passes of 7.0 t roller having length of 1.5 m and diameter of 1.22 m | Pakistan | Well-drained alluvial silt loam | The subsoil compaction adversely affected soil physical conditions, which substantially decreased the yield of wheat. | [54] |
Axle load (0, 7 and 17 tons) | Jordan | Clay loam soil | The yield was significantly reduced as a result of compacting loads. | [55] |
No-tillage system, the tractor traffic, harvester traffic and soil chiseling management | Brazil | Oxisol soil | Soybean grain yield was reduced due to both soil chiseling and heavy traffic by harvester | [56] |
Harvester traffic intensities under direct sowing | Argentina | Fine clay soil | A higher axle load than 79.70 kN caused the cone index peaked in the subsoil to depths below 35 cm and significantly reduced soybean yields. | [57] |
Effects of soil compaction on soil, environment and plant growth.
In Global Land Outlook Working Paper expressed by [60], the consequences regarding the effects of soil compaction on soil properties, environment and crop plant’s morphological and physiological growth have been presented as seen in Figure 3. Also, Horn et al. [15], who summarize the works carried out about effects of soil compaction on the structure of arable soils, stated that soil compaction caused by traffic of heavy vehicles and machinery resulted in soil structure deterioration, both in the topsoil and in the subsoil. They reported that owing to dynamic loading, soil physical properties such as pore size distribution and pore continuity were negatively affected, which entails decrease in air and water permeability and resulted in increased soil strength. The researchers emphasized that these changes in soil structure may have a negative effect on the soil biota, on physical–chemical equilibria and redox potential, on the soil’s filtering and buffering capacity, on ground water recharge and, finally, on crop yield.
The consequences of soil compaction regarded with soil, environment and plant growth [
The major effect of soil compaction on soil properties is known as increase in soil bulk density and decrease in total porosity as soil aggregates are pressed closer together, resulting in a greater mass per unit volume and less space for air and water in the soil [15]. Changes in the soil pore system due to compaction can adversely affect key soil hydraulic properties and aeration such as saturated hydraulic conductivity and air movement in soil [58]. Ziyaee and Roshan [22] stated that pore space provided a room for air and water to circulate around the mineral particles, providing a healthy environment for plant roots and beneficial microorganisms, however, in compacted soils, the particles were pressed together so tightly that the space for air and water was greatly reduced. The researchers emphasized that lack of pore space resulted in the lack of oxygen, which is very important for plant growth, decomposing organic matter, recycling nutrients and aerating the soil. In addition to soil bulk density and porosity, penetration resistance significantly affects plant root growth and crop yield. The previous works [61, 62, 63, 64] showed that plant root growth could be slowed down or completely impeded at penetration resistance values of 2 and 3 MPa, respectively. Also, the soil physical properties changed due to soil compaction can alter elements mobility, change nitrogen and carbon cycles and soil biodiversity [13].
Effects of soil compaction on plant growth are complex and depended on many factors. Mainly, it is known that high soil penetration resistance and low oxygen concentration in a compacted soil can reduce crop yield due to decreased root elongation rates and thus limited accessibility to water and nutrients [65]. Also, plants in compacted soils can also suffer from water stress due to reducing water infiltration and increasing runoff [15]. Keller et al. [40] discussed in detail how soil compaction changed soil properties, and how the soil properties changed by soil compaction affected plant growth and environment. They heighted that soil compaction was one of the main causes of the yield decrease observed for major crops in many European countries. In an experiment with barley, Willatt [61] observed that root length density in the upper 0.30 m of soil and rooting depth decreased as the number of tractor passes increased from zero to six. Ishaq et al. [66], who study subsoil compaction effects on root growth, nutrient uptake and chemical composition of wheat and sorghum, determined that root length density of wheat below 0.15 m depth was significantly reduced with increased soil bulk density. They recommended that appropriate measures such as periodic chiseling, controlled traffic, conservation tillage, and incorporating of crops with deep tap root system in rotation cycle should be applied to minimize the risks of subsoil compaction. de Moraes [56], who study the impact of soil compaction on soybean root growth, investigated three soil compaction levels (no-tillage system, areas trafficked by a tractor, and trafficked by a harvester) and soil chiseling management (performed in an area previously cultivated under no-tillage) on soil properties and plant root growth. The researchers observed that root growth was influenced by soil physical conditions during the cropping season and soybean grain yield was reduced due to both compaction (caused by harvester traffic) and excessive loosening (promoted by chiseling) compared the no-tillage system. Obour and Ugarte [67] used a meta-analytical approach to summarize the results from 51 published articles on the impacts of soil compaction attributed to machinery axle load, wheel passes, compaction events and tire inflation pressure on soil bulk density, degree of compactness, penetration resistance, volume of water filled pores at field capacity, air permeability at field capacity, saturated hydraulic conductivity, and grain yield of corn, wheat, barley and soybean. Results from this meta-analysis showed that compaction increased the soil mechanical strength affected by increased soil bulk density, degree of compactness, penetration resistance. Also, compaction decreased hydraulic conductivity characterized by air permeability and saturated hydraulic conductivity from the topsoil down to the subsoil (>40 cm depth), and grain yield of corn, wheat, barley, and soybean. The researchers suggested that soil hydraulic properties might be more sensitive indicators to reflect the impact of soil compaction on soil structure and pore system functions in the soil profile. Also, negative effects of soil compaction on plant root growth and crop yield have been recognized by several researchers [26, 38, 64].
Soil compaction can affect crop yield depending on soil texture and growing season precipitation. Voorhees [5], who presents relative barley grain yield as a function of the degree of compactness of a clay soil in Sweden, reported the effect of soil compaction on grain yield depending on climate change as fallowing: 1) During relatively dry climatic conditions, grain yields were increased by almost 40% with the initial increases in degree of compactness. However, when the degree of compactness approached 90, yields decreased significantly. 2) Similar results were obtained during a normal year but less pronounced. 3) During a wet year, yields decreased with any increase in degree of compactness above 75. The researcher stated that plants could tolerate (might even need) a more highly compacted soil during dry conditions than during wet conditions.
In summary, soil compaction can significantly change the physical, chemical and biological properties of soil depending on climate and initial soil properties such as soil texture, structure, moisture content, organic matter content. These changes in soil properties can have significant effect on the penetration of plant roots, their growth, soil–plant-water relations, the ability of plants to take up nutrients from soil and consciously crop yield. In another sense, the effect of the same compaction degree on plant root growth and yield depends on the crop grown, soil structure, and weather conditions. All literature data shows that the effects of soil compaction on root and plant growth have a complex interaction including many soil, climate and plant properties. This complex interaction requires complex hypotheses to explain the effects of soil, climate and plant properties on root and plant growth.
Many strategies have been used to avoid soil compaction in agricultural fields and to ameliorate compacted soil or alleviate its associated stresses. Strategies can be roughly divided into three groups: measurements to avoid further compaction, remedial treatments, and methods to alleviate soil compaction [33, 68].
The best way to manage soil compaction is to prevent it from happening. This includes reducing axle load, proper inflation and size of tires, minimizing soil tillage, increasing stability of soil structure and conducting field operations at appropriate soil moisture content [6]. The capacity of the soil to resist stress (i.e. the strength against compression) and loading of machine is considered to be the major factors affecting the soil compaction by farm machineries [11]. The soil strength against compression is influenced by the organic matter, water content, soil structure, and texture. Therefore, improving soil structural stability and aggregate can reduce the risk of soil compaction [13]. Soil structural stability and aggregate can improved by increasing soil organic matter content and reducing stress on the soil due to machinery traffic. This can be achieved by using conservation tillage systems [11]. Similarly, several researchers reported that long-term use of conservation tillage systems resulted in lower soil compaction threat because it increased surface organic matter contents, more stable soil structure, and increased hydraulic conductivity due to worm holes and stable biochannels [63, 69]. Loading of machine on soil is expressed by axle load, number of tyres, tyre dimensions, tyre velocity, and soil tyre interaction [13]. The axles load and the contact pressure of tires is known to be the most important parameters affecting soil compaction. A high wheel load may lead to compaction of soil in both the top and deep sublayers, whereas low axle loads will cause compaction in the topsoil and the upper part of the subsoil only. An axle loads or wheel loads describe the weight distribution of machines, depending on the degree of the loading of tank or weight transfer during plowing. Therefore, the weight distribution may vary markedly between wheels on the same axle. In their literature review, Alakkuku et al. [11] recommended single axle load of 4–6 Mg for moist mineral soils to avoid soil compaction below normal primary tillage depth (0.2–0.3 m) and a limit of 8–10 Mg for tandem axle loads on moist soils. The researchers stated that to reduce axle loads, machine weight may be reduced by using new, lighter materials or multiple axles can be used to spread the load. Also, they reported that wheel load should be linked with soil contact pressure recommendations because the wheel load alone does not give any information about the stress level transferred to the soil and the corresponding stress distribution in the soil. Contact area between the wheel and soil and the basic dimensions of wheel such as width and length has significant effect on soil contact pressure of wheel [11]. Also, ten Damme et al. [70] stated that the stress distribution in the contact area between the tyre and the soil is of primary importance for the propagation of stress in the soil. The researchers indicated that tyre design might further help reduce the risk of soil compaction at a specific load if it allows for further reductions of the tyre inflation pressure. This literature findings shows that soil compaction can be avoided by adjusting tire size and tire inflation pressure, or using rubber-belt tracks [11, 71]. Alakkuku et al. [11] stated that low tyre inflation pressure usually provided low ground contact pressure and allowed even pressure distribution, which are advantageous to both soil compaction caused by wheel traffic and to wheel tractive efficiency.
According to our review conclusion, we can say that the wheel load and the soil contact pressure is the major engineering tools for the control of subsoil compaction and to avoid permanent subsoil compaction, the machines and equipment used on the critical field conditions should not be cause higher stress than the bearing capacity (strength) of soils. Also, the compaction risk in given vehicle–soil interactions might be quantitatively estimated by using pre-consolidation stress as an indicator of the bearing capacity of a soil. Alakkuku et al. [11], who reviewed technical choices to minimize the risk of subsoil compaction, presented a framework of machinery–soil system in connection with subsoil compaction as shown in Figure 4. The researchers stated that to prevent subsoil compaction, recommendations for wheel load–ground contact pressure combinations should be made available for different soil conditions. Chamen et al. [69], who discussed the machinery usage during field practices to avoid subsoil compaction, stated that the bearing capacity of soils would be improved by increasing their structural stability, such as may be achieved with reduced or no tillage systems. The researchers summarized the preventative strategies suggested for the avoidance of subsoil compaction as follows: (1) no repeated soil loosening as a routine cultivation technique, (2) increased soil stability and reduced soil stress, (3) the selection of machines and field practices with a low risk potential, (4) the assimilation of new, low risk technologies. Also, Kumar et al. [72] stated that the management of soil compaction might be achieved through suitable application of some or all of the following techniques: (1) decreasing the pressure on soil either by reducing axle load or increasing the contact area of wheels, (2) conducting field operations at optimal soil moisture content, (3) decreasing the number of passes of farm machinery and the intensity, (4) restraining traffic to certain areas of the field or controlled traffic, (5) improving soil organic matter through retaining of crop and pasture residues, (6) eliminating soil compaction by deep ripping in the presence of an aggregating agent, (7) including the plants with deep, strong taproots in crop rotations.
A framework of machinery–soil system in connection with subsoil compaction [
In this case, we can suggest the following solutions to prevent and alleviate soil compaction and its detrimental effects:
Maintaining an adequate amount of organic matter such as stubble retention, green and brown manure or addition of plant or animal organic matter from external sources in the soil stabilizes soil structure and makes it more resistant to compaction because it acts a buffer preventing or lessening transmission of compaction to subsoil from external loads acting on the earth [18].
Controlled traffic farming, which confines all machinery loads to the least possible area of permanent traffic lanes, was recommended by many researchers [73] to reduce the damage to soils caused by heavy or repeated agricultural machinery passes on the land. By controlling traffic, the tracked area will have a slightly deeper compaction but the soil between the tracks will not be compacted. Controlled traffic systems has been stated to have fundamental advantages in maintaining ‘good’ soil structural conditions of non-trafficked crop beds.
Another strategy for managing compaction is properly to decrease the contact pressure of tires and axle loads. Therefore, the machines and equipment used on the field in critical conditions should be adjusted to actual strength of the subsoil by controlling wheel/track loads and using low tyre inflation pressures [11]. Other methods to reduce compaction include the use of dual wheels, rubber tracks and flotation tyres.
The conservation agriculture techniques can be practiced to reduce traffic on the soil. A conservation tillage system can reduce the need for vehicle traffic in the field because there are fewer needs for tillage or cultivation operations [74].
Subsoiling/chiseling can be used for eliminating soil compaction, destroying hard pans and ameliorating hard setting soils developed due to traffic and puddling. Deep ripping of compacted soil may also improve soil health and ability of plants to resist disease [75].
Incorporating crops and pasture plants with strong tap roots able to penetrate and break down compacted soils in the rotation is desirable to minimize the risks of subsoil compaction [56].
Field operations should not be performed under wet soil conditions. Soil is more compressible at wet soil conditions. Traffic during high moisture conditions may compact soil, whereas the same traffic under dry conditions will not [18].
In recent years, the structural and technological development of modern agriculture caused a significant increase in the power, size and the weight of vehicles and machinery used on agricultural fields. This dramatic increase in the weight of agricultural machinery and the necessity to use heavy machines in unfavorable soil conditions have caused a significant increase in the subsoil compaction, which is considered as a serious form of soil degradation and may have serious economics and environmental consequences in world agriculture. The main results of our literature evaluation showed that severe soil compaction might result in a decreased root growth and plant development, and consequently, a reduction in crop yield because it adversely affect key soil hydraulic and aeration properties such as saturated hydraulic conductivity and air movement in soil. Soil compaction is also an environmental problem because it is one of the causes of erosion and flooding. In addition, it directly or indirectly increases nutrient and pesticide leaching to the groundwater and nitrous oxide emissions to the atmosphere. Therefore, prevention of soil compaction and alleviation of existing compaction is one of the most important issues in agricultural production in order to sustain or improve soil fertility and productivity.
Quality is not a matter of discussion. Quality is necessary for any manufactured product. Failures mean losses in terms of money, logistics, and prestige, and no industry can withstand these damages. Pharmaceutical products share this situation, but, besides, their lack of quality turns out to be a public health problem. This is why the authorities require that medicines meet their specifications and manufacturers have the responsibility of exclusively commercializing products possessing their purported quality.
The production of medicines is in fact composed of two different types of manufacture. Firstly, there are facilities that produce the ingredients, or active pharmaceutical ingredients (APIs), used in the preparation of the medicines. Secondly, we have those facilities, which combine the ingredients to obtain pharmaceutical forms. These latter are packed to get what we know as a drug, medicine, or pharmaceutical. This chapter focuses on this second type of manufacture, although we consider biotechnology too (in spite of producing substances, which are used as ingredients).
Taking for granted that medicines should always meet their specifications, we should find a reliable method for ensuring this. Unfortunately, guaranteeing quality is not an easy task, and this explains why over time different strategies have been applied.
The oldest one, which we might term as “analytical quality,” proposed the analysis of the finished products as the tool for determining their appropriateness. This approach has many flaws, just to mention one, the quality problem is just detected when the product is already finished (and this makes corrective measures very difficult).
Then, in the middle of the twentieth century, “manufactured quality” was introduced. This new methodology, which led to the publication of the well-known GMP (good manufacturing practices), is based on the assumption that quality should be considered as another ingredient of the product (this was termed as “built-in quality”).
More recently, already in the twenty-first century, the International Council for Harmonization (ICH) has extended this latter approach to the development stages of the product in order to attain a complete control of its life cycle. The logic underlying this method is very simple. How can you manufacture a quality that you have not designed previously? This is why we came to the present situation, which considers that quality is something that you should design (quality by design), construct (built-in quality), and supervise (process and product monitoring). In order to attain these goals, it is necessary to define and implement a policy of quality, which requires the establishment of a quality system. Although different systems are possible, in 2008, the ICH proposed a pharmaceutical quality system (PQS), specially developed for the pharmaceutical industry [1].
Even though the PQS focuses on pharmaceuticals, it is evident that if we are bound to produce quality products, the unit where we manufacture them should share this same approach for quality and here, the PQS provides very useful hints regarding the quality of pharmaceutical projects.
A pharmaceutical project can be defined as a temporary effort undertaken with the aim of creating facilities that allow manufacturing medicines with the required quality and assurance. This effort is usually a quite difficult one, because it has to be carried out by different partners, which should work together, even if pertaining to different technical areas.
The partners who take part in a project belong normally to two groupings. On one side, the “client” (that is, the pharmaceutical laboratory or, maybe, laboratories) desires to possess new manufacturing premises or modify old existing ones. On the other side, the “supplier” usually consists of an engineering company that in fact coordinates different suppliers, extending from the providers of construction materials and associated services to the sellers of pharmaceutical equipment. These two parts, which to simplify matters we are going to name from now on as “laboratory” and “engineering,” are usually sharply asymmetric. The laboratory in these matters, generally speaking, has a much more limited experience than the engineering, whereas the knowledge regarding pharmaceutical norms is often less developed in the engineering. The amount and importance of these differences can vary a lot, but here we have a possible source of problems that should not be overlooked and that makes very advisable tight control on a project.
The paradigm of quality described by the ICH guidelines, Q8 to Q12 [1, 2, 3, 4, 5], should also be applied to pharmaceutical projects, but taking into account the existing differences between manufacturing and managing a project. This is why not all the elements of a quality system devised for products can be applied into a pharmaceutical project. Let us analyze this (Figure 1).
Structure of the PQS (ICH Q10).
The development and implementation of a PQS is the result of the definition of a quality policy by a laboratory. In order to put this policy into practice, the company writes a quality manual and associated documents that develop it in more detail. A quality manual should address the following topics:
The PQS is devised to ensure the application of GMP by the laboratory. As shown in Figure 1, the PQS covers the whole life cycle of a medicine, excluding the stage of development (this is the consequence of an old tradition of working in development centers and of the difficulty of applying the strict controls of GMP to a development laboratory).
Management responsibilities should be clearly stated. Practice shows that this is very important. As in old battles, the army can only win the war if there is a (good) chief leading it.
ICH Q10 describes two capacitors, intended to help in the task of reaching the objectives. The first one is risk management and we will discuss it in detail further on, as the main topic of this chapter. The second one is knowledge management and its intent is fighting the very pernicious practice that rules in more than one company: that is, people who get some knowledge on products or processes do not inform the others, but keep it for them and, consequently, there is a continual loss of information.
The PQS contains four elements (Figure 1). All of them, albeit not in this form, are very important in a project.
A life cycle approach is an important element for ensuring the global quality of a process. As mentioned before, quality has to be designed in order to be controlled. The term “designed quality,” applied to a pharmaceutical project, means that objectives are well defined and that critical variables have been identified and quantified. This allows for a monitoring and evaluation of the project: if the critical variables are kept under control, then objectives will be met. Thus, the life cycle has to be considered as a chain of events that progressively increase the amount of information and build quality gradually.
As it can be seen (Figure 2), the life cycle of a project is composed of four phases, although only the first two (design and realization) concern what we have been calling pharmaceutical project and are managed by the two partners. The latter two phases (manufacture and discontinuation) are just the consequence of the former two and they belong exclusively to the laboratory. In fact, instead of “manufacture,” we can talk of “routine production,” where quality is the result of the quality of the project plus all the measures applied to build quality into the products and to monitor that this is correctly realized. The last phase, discontinuation, is simply mentioned to remind us that when facilities have to stop production to be closed, this has to be done in an organized way (i.e., market cannot be left undersupplied by a unilateral decision; the environment has to be protected by recycling or disposing of materials in an ecological way, etc.).
The pharmaceutical project within the project life cycle.
Figure 3 summarizes the basic definitions related with risk management, as described in guideline ICH Q9 [3]. In any activity, there are hazards, which are significant because they can turn into harms. It is evident that hazards matter because there is a chance that they materialize into harms, and it is obvious that the importance of the harm determines how much attention they deserve. Thus, it is easy to understand the definition of the risk.
Main definitions concerning risk management.
There is no human activity free from hazards (and, unfortunately, from harms) and, consequently, risk is always extant. This is why we came to speak of risk management. As we always face risk, it is meaningful to understand it and try to diminish it. When we remove a dish from an (hot) oven, there is a hazard: we can burn our fingers. To diminish the risk, we use an oven glove. By donning a glove, we diminish the probability of the harm and, thus, the risk. And what about the severity of the harm? In general, it is considered that we cannot act against it, as the severity of a harm is an attribute of it. Anyway, we might also think that the simple fact of wearing a glove would diminish the severity of the burn. Yes, in the interpretation of risk, there is always some amount of personal understanding, but this is not very relevant if we come to appreciate the situation well and we apply the same criteria over time. Just to finish with these considerations, we should keep in mind that the exact assessment of risk is second to the accurate understanding of the hazard. This is why in many cases we need not determine risk but just assess the hazards (Which hazards exist? Which are their causes? Are they likely? After all, should we worry? Should we take any measure? etc.).
Figure 4 summarizes the different levels of risk or of hazard assessment (to express it in a different way). As we can see, the objective is always reducing the level of risk as much as possible. This reduction, however, should be consistent with the efforts, which we apply for attaining this effect. Sometimes, a high risk might be accepted if there is no better alternative.
Risk.
There are several tools, which we can use for risk analysis [3]. They can be used and combined according to particular needs. In fact, the application of a standard method is necessary when high levels of formality are required (e.g., in comparative studies or in scientific papers), but for the routine risk assessment within a company, it is possible to be less formal and adapt the tools to better fit our needs. Tools just organize information. They do not improve our information (if our raw data are poor or inaccurate, the application of the best of tools will not mend them). Thus, the quality of a risk analysis depends mainly on how worth our information is and on the knowledge and experience of the person who performs the study.
Figure 5 lists the most common methodologies used in risk analysis. Among the specific ones, the most popular is, without any doubt, FMECA, an excellent tool when the process under study is well known. Then, it is possible to evaluate risk and use its value as an indicator for process improvement. Anyway, in most cases, when the amount of knowledge is more modest, it is better to start with PHA. HACCP is a very good tool for the control of processes; in fact, the WHO recommends it for the control of pharmaceutical manufacturing processes [6]. It is not necessary to add that HACCP requires a deep knowledge on the process. FTA is useful to identify the root causes of a problem. HAZOP can help to identify possible problems related to equipment and operation involved in a process. RRF is the choice tool for the comparison of items composed of different elements.
Risk analysis tools.
Next to the specific methodologies, we can talk of unspecific ones. Properly speaking they are not risk analysis tools but provide information, which is critical to perform an analysis. Here, we should emphasize flowcharts, which are a key element to start a risk analysis of a process.
For the risk management of pharmaceutical projects, we select, besides flowcharts, RRF and PHA. This is why, we consider useful to provide some guidance on them.
Flowcharts are very useful to get a clear idea of a process and to perform a hazard assessment. In fact, the layout of a pharmaceutical unit is the translation of the flowchart steps into premises. The example of flowchart, which we present here in Figure 6, covers in a simplified way the operational stages of a pharmaceutical unit. It is evident that in practice there can be different types of processes.
Flowchart summarizing the steps of pharmaceutical manufacture.
RRF (Figure 7) is a tool conceived for the comparison of different items, possessing different types of hazards and risk levels, by reducing them to a common denominator. The application of RRF starts by identifying the items to be compared and identifying their components and subcomponents. Then, the risk factors are determined and their integration allows for the establishment of the global risk of the item. As shown in Figure 7, all Rf are given the same weight and, thus, the load of each component depends more on the number of Rf considered than on the importance of the component itself. This can be corrected, for example, by giving a higher classification of risk to single Rf or to all the Rf of a given component.
Summary of steps for the realization of RRF.
PHA is very practical for the analysis of situations where there is still limited information. PHA uses charts like the one shown in Table 1 (although, often, the column describing the effect can be omitted, because it does not provide any useful information).
Stage/subject | Possible hazard | Hazard cause | Possible effect (harm) | Is hazard significant? | Control measures |
---|---|---|---|---|---|
□ Yes/□ No | |||||
□ Yes/□ No |
Example of chart used to develop PHA.
Practice shows that, while performing risk analysis, one of the points that creates more confusion is the clear distinction among hazard, cause of the hazard, and effect of the hazard (harm). To simplify this matter, we propose the following approach.
We establish six types of hazards as the base of our analysis (Figure 8), then we apply them to the item that we study and we determine if this hazard might exist. If it really exists, then it is easier to establish possible causes and their derived effects and to propose control measures.
Summary of hazards to be considered in PHA charts.
It is not necessary to insist on the fact that the selection of the partner with whom a laboratory will realize a project is very important. Following, we provide a simplified example of application of RRF.
Rf 1.1 = quality system; Rf 1.2 = training program; Rf 1.3 = realization of commissioning; Rf 1.4 = support for qualification; etc.
Rf 2.1 = experience in projects; Rf 2.2 = amount and completeness of documentation; Rf 2.3 = fulfillment of scheduled requirements; etc.
Rf 3.1 = number of people in the company; Rf 3.2 = distance of the nearest point of service of the company to the project site; Rf 3.3 = knowledge of the language of the site; Rf 3.4 = after sale service; etc.
Rf 4.1 = price; Rf 4.2 = payment conditions; Rf 4.3 = bonuses; etc.
After determining the risk factors for each component, they are used to calculate its comprehensive risk.
Then, the global risk of each item is evaluated adding the risks of their components.
Finally, the items are ranked according to their respective risk. Thus, they can be compared. They can also be “filtered,” that is, selected (Figure 6).
As shown in Figure 9, a pharmaceutical plan is the practical translation of the requirements set up in the URS.
The pharmaceutical project: URS and their translation.
The conditions penned in the URS depend on the particular wishes of each laboratory, whereas the plan to be developed and constructed by the engineering is encoded, by GMP [7, 8, 9, 10] and good engineering practice (GEP). GEP is not codified as such. It is understood as the generally admitted good approach.
Let us analyze, using a risk management approach, the requirements that should meet a project. We use an adapted form of PHA.
In Table 2 are described the main causes of (external) contamination and the control measures to keep them at bay.
Cause | Control measures |
---|---|
Inadequate siting of the building | Pharmaceutical units should not be located in contaminated areas |
Insufficient tightness of the premises | Ensure isolation of premises from the outside (sealed panels, floors, and windows) |
Access to premises by airlocks/changing rooms | |
Protection of premises from the entrance of insects, birds, and animals | |
Anticipate the placement of traps and baits | |
Inadequate separations | Rest rooms and refectories should be separated from areas of production and quality control (QC) laboratory |
Toilets should not have direct communication with the areas of production or storage | |
Maintenance workshops should be separated from the production areas | |
Parts and tools used for production should be kept in separate rooms or in lockers | |
Animal houses should be separated from the other areas | |
Dirty incoming materials | Receiving and dispatch bays should be designed and prepared to allow the cleaning of the incoming containers |
Access through drains | Drains should be designed and built to prevent backflow |
Inadequate air-handling | Ventilation air should be HEPA-filtered |
Animal houses should have separate air-handling systems | |
Premises should have overpressure (see the exceptions in Sections 7.3 and 7.4) to prevent the entrance of unfiltered air from outside | |
Defective parts of equipment | Parts of equipment coming into contact with materials and product should not affect them, neither be affected by them |
(External) contamination.
In Table 3 are described the main causes of cross-contamination and the control measures to hold them at bay.
Cause | Control measures |
---|---|
Inadequate facility design | Premises should be designed to allow for adequate cleaning and sanitization |
Premises should be designed to avoid the build-up of dust and dirt | |
Repair and maintenance operations should not affect the quality of the products (e.g., performed from outside the clean rooms). Thus, there should be technical areas for equipment and a technical space over the working areas for ducting, lightning, etc. | |
The layout of the premises should allow the production to take place in areas connected in the logical sequence of the required levels of cleanliness (e.g., of classification) | |
Materials and products should only be exposed to the environment in clean rooms possessing sanitary design | |
Packaging areas should be designed and laid out to avoid cross-contamination | |
The QC laboratory should be designed to suit the operations | |
Inadequate tightness of the premises | Clean rooms should be tight to ensure adequate isolation (sealed panels, floors, and windows) |
Inadequate separations | Access to classified areas by specific airlocks/changing rooms |
There should be an area for the sampling of starting materials | |
There should be an area for the weighing of starting materials | |
Risk of cross-contamination by highly active, toxic substances or biological agents should be controlled. See Section 7.3 | |
The QC laboratory should be separated from the production areas | |
The QC laboratory areas where microbiological, biological, and radioisotope tests are performed should be separated from each other | |
Inadequate cleaning | There should be an adequate cleaning area with adequate separations for equipment to be cleaned, cleaning area, drying area, and storage of clean equipment |
Inadequate air-handling | When operations are likely to generate dust (e.g., sampling, weighing, mixing, etc.), there should be measures to control it |
Starting materials should be weighed in a special area provided with unidirectional flow and exhausting | |
Materials and products should only be exposed to the environment in clean rooms possessing appropriate air-handling | |
Recycled air should be HEPA-filtered | |
Pressure differentials should control the flows of air among clean rooms | |
The QC laboratory should possess an adequate separate air-handling system | |
The QC laboratory areas where microbiological, biological, and radioisotope tests are performed should possess separate air-handling systems | |
Inadequate equipment | Equipment should be installed to avoid contamination |
Washing, cleaning, and drying equipment should not be source of contamination | |
Whenever possible, closed equipment should be preferred |
Cross-contamination.
Table 4 evaluates the main causes of error/mix-up and provides control measures. Although error/mix-up appears because of the inefficiency of personnel (and this means that their prevention is based on training), an improved design of the premises diminishes their probability. Adequate flows and sufficient working space should always be considered in a project.
Cause | Control measures |
---|---|
Inadequate facility design | Layout and design must aim to minimize the possibility of errors |
Premises should be designed to be able to follow the logical flows of personnel and materials | |
The storage areas should allow for the orderly and sure storage of the different sorts of materials and products (“traditional warehouse”) or possess a computerized management system providing the same level of security (“chaotic warehouse”) | |
The layout of the premises should allow the production to take place in areas connected in the logical sequence of the operations | |
The areas should permit the orderly and local positioning of equipment and materials | |
In the production areas, there should be in-process storage rooms permitting to keep materials and equipment in an orderly way | |
Packaging areas should be designed and laid out to avoid mix-ups | |
The QC laboratory should have sufficient space | |
Inadequate separation | The storage areas should ensure the segregation for items under quarantine, returned, rejected, and recalled. This separation can be assured by separated and closed areas or by a computerized management system providing the same level of segregation |
The receiving and dispatch bays of the warehouse should be separated | |
Printed materials should be stored in a separate area with restricted access | |
Free access | Personnel access to critical areas should be controlled and restricted |
Inadequate marking | Fixed pipework should be labeled to indicate contents and direction of flow (if this is necessary) |
Rooms and equipment should be adequately identified | |
Inadequate illumination | Working areas should be well lit |
Inadequate placement of equipment | Equipment should be installed to avoid error and mix-up |
Error/mix-up.
Materials and products are damaged when exposed to inadequate conditions. Table 5 summarizes control measures.
Cause | Control measures |
---|---|
Inadequate facility design | Receiving and dispatch bays should protect the products from the weather |
Inadequate conditions | Acquire adequate information on the product requirements |
Temperature and, if necessary, humidity in the production areas should be adequate and monitored | |
Electrical supply, lighting, temperature, humidity, and ventilation should not adversely affect the products | |
Storage areas should provide adequate conditions of temperature (and if necessary humidity) for the materials and products |
Degradation.
During routine production, equipment is submitted to a maintenance plan to avoid malfunction. During the project, however, equipment has to be well sited and mounted, as summarized in Table 6.
Cause | Control measures |
---|---|
Inadequate installation | Perform commissioning/qualification |
Equipment must be located to suit the operations | |
Inadequate separation | Consider in the QC laboratory separate rooms for instrumentation, in accordance with their particular requirements |
Equipment malfunction.
The denomination health, safety, and environment (HSE) covers all the aspects that can affect the health and security of personnel and the environment. Table 7 describes actions to control them.
Cause | Control measures |
---|---|
Inadequate installation | Perform commissioning/qualification |
Equipment must be located to suit the operations | |
Dangerous products | Highly active, toxic substances or biological agents should be controlled (see Section 7.3) |
There should be special storage areas, safe and secure, for: highly active, radioactive, narcotics, abuse, explosive, flammable, etc. | |
Dangerous biological agents | Biological agents should be handled adequately (see Section 7.4) |
There should be adequate equipment (freezers, refrigerators, etc.) for the maintenance of the biological agents | |
Inaccessibility/unhandiness | Premises should be designed to suit the operations to be carried out |
Changing rooms and toilets should be easily accessible and adapted to the number of users | |
Pipework, light fittings, ventilation points, and other services should be designed and placed to avoid the creation of recesses difficult to clean. And, as far as possible, they should be accessible from technical areas | |
Open channels should be avoided where possible, but if they are necessary, they should be shallow to facilitate cleaning | |
The QC laboratory should be designed to suit the operations | |
In the QC laboratory, there should be adequate space for the storage of samples, standards, solvents, reagents, and records | |
Current drawings of critical equipment and utilities should be maintained | |
Uncontrolled solid waste | There should be adequate places for the storage of solid waste |
There should be a place for the classification of solid waste | |
Uncontrolled effluents | There should be a place for the treatment of liquid effluents (decontamination) prior to its release or transportation to a handling center |
Dangerous gaseous effluents should be either filtered or incinerated |
HSE.
Sometimes commercial/logistic aspects determine from the outset the characteristics of a pharmaceutical plant: typically, multiproduct facilities (when APIs are not particularly active and general GMP precautions suffice for ensuring that significant cross-contamination will be excluded) or, less frequently, dedicated facilities, when logistic reasons recommend limiting the number of products in order to increase output. A quite different situation may arise when APIs can be deemed “toxic.” This term is used in a practical way to provide a general denomination for substances that possess high activity or potency (e.g., tiny amounts are needed to produce a pharmacological effect) or harmful effects (e.g., sensitization, genotoxicity, etc.).
When designing premises where toxic APIs will be handled, there has always existed a key question: is it correct if they are multiproduct or we should opt for dedicated ones? The response to this question cannot be general, because substances are diverse. The traditional approach was considering, roughly speaking, three cases. Firstly, we had the APIs, which could be deemed nontoxic and which, as we said before, could be produced in multiproduct facilities. Secondly, we had the APIs possessing high activity (e.g., hormones, cytostatics, certain antibiotics, etc.), which required dedicated facilities. And finally, we had two cases, which required strict segregation. This last group included live microorganisms and products possessing sensitizing or toxic effects (their action, properly speaking, cannot be quantified and should be considered as “on/off”), such as beta-lactam antibiotics [11].
In order to better clarify this group, it was proposed a scientific approach, which is summarized in Figure 10. The flowchart combines an EMA guideline on this matter [12] (upper part with a darker shade) with logistic criteria (lower part).
Decision tree for facilities.
When it is spoken of single product or multiproduct facilities, their meaning appears evident, but what about dedicated facilities? This implies separation, but what kind of separation. Only risk management can provide an adequate answer to this question. Figure 11 describes the rationale of this approach. The rectangle represents the risk level (on the left lower part, the lighter color indicates low risk, whereas, on the right upper part, the darker color shows high risk). Thus, multiproduct facilities are adequate when risk is low, and segregated facilities are necessary when risk is high. Then, in the middle, where risk can be deemed medium, it is possible to think of intermediate solutions (e.g., instead of separation of facilities, separation of products) or campaign production (e.g., separation is not physical but temporal). The severity of the hazard depends on the API, whereas the probability of occurrence is related to the way of manufacturing. In other words, once the “toxicity” of the API is known, the practical level of risk will depend on the production techniques used for the manufacture of the products. Dedicated facilities mean more expensive projects, but at the same time lower risk of cross-contamination and, for instance, easier and surer cleaning validations [13].
Risk analysis rationale for defining the type of facilities.
Biotechnology implies the use of biological systems. Under this term, we design both cells and microorganisms. Most of them (in principle, the cells, and many microorganisms) do not pose any particular thread to personnel. In fact, the contrary is true. They are labile and very susceptible to contamination and require strict measures of control to keep them viable. There are, however, microorganisms, which suppose a thread for the personnel if they infect them during operations. These “biological agents” are internationally classified into four groups (Table 8) in function of the level of biosecurity (BSL) or protection level (PL) that they require [14, 15].
Characteristic | BSL/PL | |||
---|---|---|---|---|
1 | 2 | 3 | 4 | |
Personal risk | Minimal | Low | High | Very high |
Epidemic risk | No | No | Low | High |
Therapy/prevention | Unnecessary | Available | Available | Unavailable |
Manipulation | Workbench | Open hood | Biological safety cabin (BSC) | Isolator or BSC + personal protective equipment (PPE) |
The four groups of biological agents.
The project of a laboratory handling biological agents has to take into account its two types of requirements: on the one hand, those regarding in general a pharmaceutical laboratory and on the other, the particular necessities of facilities containing live microorganisms. We have already considered the former; thus, here we will exclusively discuss the latter.
In a laboratory where biological agents are cultured, these microorganisms suppose the “hazard”; the “cause” is the inadequacy of the measures taken to ensure that these agents will remain contained; and the “effect” is the infection of people by released agents. Thus, our risk analysis will focus on the control measures (Table 9).
Control measures for biological hazard in the laboratory.
In Table 9, we mention a series of elements that should be taken into account when designing a laboratory manipulating biological agents. The characteristics of these elements depend on the BSL/PL. This means that they might be unnecessary for level 1, just recommended for an intermediate level and required for a high level. It has to be studied case by case, using a risk management approach, which should analyze the level of risk and the level of protection provided for the systems in place.
Society requires medicines possessing the purported quality, and this is only possible if we design, manufacture, monitor, and control them adequately. These undertakings, however, involve appropriately devised, built, and qualified premises and facilities, which are the outcome of a project. A pharmaceutical project is a very complex subject because it involves at least two parts, with different visions and experience, and because it implies scores of suppositions and projections into the future. The risk of straying away from the expected roadmap is quite real. Thus, risk management becomes necessary. In a project, the amount of information is limited and thus, while using risk analysis tools, it is essential to bear in mind that what really matters is to understand which problems are at stake and to get a clear picture of their respective relevance. Once this is achieved, it is easier to provide adequate solutions. Risk is controllable, if we know and understand it!
A frequent problem, when trying to evaluate risk, is that information is so varied and multiform that it becomes difficult to ascertain, which are the hazards and distinguish them from, say, causes and effects, let alone the logical organization of the information. To overcome these difficulties, we propose two tiers of solutions: on one side, to use simple risk analysis tools focusing more on hazard and control measures than on risk quantification and on the other, to use defined simple quality hazards as the point of departure for the analysis.
None.
"Open access contributes to scientific excellence and integrity. It opens up research results to wider analysis. It allows research results to be reused for new discoveries. And it enables the multi-disciplinary research that is needed to solve global 21st century problems. Open access connects science with society. It allows the public to engage with research. To go behind the headlines. And look at the scientific evidence. And it enables policy makers to draw on innovative solutions to societal challenges".
\n\nCarlos Moedas, the European Commissioner for Research Science and Innovation at the STM Annual Frankfurt Conference, October 2016.
",metaTitle:"About Open Access",metaDescription:"Open access contributes to scientific excellence and integrity. It opens up research results to wider analysis. It allows research results to be reused for new discoveries. And it enables the multi-disciplinary research that is needed to solve global 21st century problems. Open access connects science with society. It allows the public to engage with research. To go behind the headlines. And look at the scientific evidence. And it enables policy makers to draw on innovative solutions to societal challenges.\n\nCarlos Moedas, the European Commissioner for Research Science and Innovation at the STM Annual Frankfurt Conference, October 2016.",metaKeywords:null,canonicalURL:"about-open-access",contentRaw:'[{"type":"htmlEditorComponent","content":"The Open Access publishing movement started in the early 2000s when academic leaders from around the world participated in the formation of the Budapest Initiative. They developed recommendations for an Open Access publishing process, “which has worked for the past decade to provide the public with unrestricted, free access to scholarly research—much of which is publicly funded. Making the research publicly available to everyone—free of charge and without most copyright and licensing restrictions—will accelerate scientific research efforts and allow authors to reach a larger number of readers” (reference: http://www.budapestopenaccessinitiative.org)
\\n\\nIntechOpen’s co-founders, both scientists themselves, created the company while undertaking research in robotics at Vienna University. Their goal was to spread research freely “for scientists, by scientists’ to the rest of the world via the Open Access publishing model. The company soon became a signatory of the Budapest Initiative, which currently has more than 1000 supporting organizations worldwide, ranging from universities to funders.
\\n\\nAt IntechOpen today, we are still as committed to working with organizations and people who care about scientific discovery, to putting the academic needs of the scientific community first, and to providing an Open Access environment where scientists can maximize their contribution to scientific advancement. By opening up access to the world’s scientific research articles and book chapters, we aim to facilitate greater opportunity for collaboration, scientific discovery and progress. We subscribe wholeheartedly to the Open Access definition:
\\n\\n“By “open access” to [peer-reviewed research literature], we mean its free availability on the public internet, permitting any users to read, download, copy, distribute, print, search, or link to the full texts of these articles, crawl them for indexing, pass them as data to software, or use them for any other lawful purpose, without financial, legal, or technical barriers other than those inseparable from gaining access to the internet itself. The only constraint on reproduction and distribution, and the only role for copyright in this domain, should be to give authors control over the integrity of their work and the right to be properly acknowledged and cited” (reference: http://www.budapestopenaccessinitiative.org)
\\n\\nOAI-PMH
\\n\\nAs a firm believer in the wider dissemination of knowledge, IntechOpen supports the Open Access Initiative Protocol for Metadata Harvesting (OAI-PMH Version 2.0). Read more
\\n\\nLicense
\\n\\nBook chapters published in edited volumes are distributed under the Creative Commons Attribution 3.0 Unported License (CC BY 3.0). IntechOpen upholds a very flexible Copyright Policy. There is no copyright transfer to the publisher and Authors retain exclusive copyright to their work. All Monographs/Compacts are distributed under the Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0). Read more
\\n\\nPeer Review Policies
\\n\\nAll scientific works are Peer Reviewed prior to publishing. Read more
\\n\\nOA Publishing Fees
\\n\\nThe Open Access publishing model employed by IntechOpen eliminates subscription charges and pay-per-view fees, enabling readers to access research at no cost. In order to sustain operations and keep our publications freely accessible we levy an Open Access Publishing Fee for manuscripts, which helps us cover the costs of editorial work and the production of books. Read more
\\n\\nDigital Archiving Policy
\\n\\nIntechOpen is committed to ensuring the long-term preservation and the availability of all scholarly research we publish. We employ a variety of means to enable us to deliver on our commitments to the scientific community. Apart from preservation by the Croatian National Library (for publications prior to April 18, 2018) and the British Library (for publications after April 18, 2018), our entire catalogue is preserved in the CLOCKSS archive.
\\n\\nOpen Science is transparent and accessible knowledge that is shared and developed through collaborative networks.
\\n\\nOpen Science is about increased rigour, accountability, and reproducibility for research. It is based on the principles of inclusion, fairness, equity, and sharing, and ultimately seeks to change the way research is done, who is involved and how it is valued. It aims to make research more open to participation, review/refutation, improvement and (re)use for the world to benefit.
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The Open Access publishing movement started in the early 2000s when academic leaders from around the world participated in the formation of the Budapest Initiative. They developed recommendations for an Open Access publishing process, “which has worked for the past decade to provide the public with unrestricted, free access to scholarly research—much of which is publicly funded. Making the research publicly available to everyone—free of charge and without most copyright and licensing restrictions—will accelerate scientific research efforts and allow authors to reach a larger number of readers” (reference: http://www.budapestopenaccessinitiative.org)
\n\nIntechOpen’s co-founders, both scientists themselves, created the company while undertaking research in robotics at Vienna University. Their goal was to spread research freely “for scientists, by scientists’ to the rest of the world via the Open Access publishing model. The company soon became a signatory of the Budapest Initiative, which currently has more than 1000 supporting organizations worldwide, ranging from universities to funders.
\n\nAt IntechOpen today, we are still as committed to working with organizations and people who care about scientific discovery, to putting the academic needs of the scientific community first, and to providing an Open Access environment where scientists can maximize their contribution to scientific advancement. By opening up access to the world’s scientific research articles and book chapters, we aim to facilitate greater opportunity for collaboration, scientific discovery and progress. We subscribe wholeheartedly to the Open Access definition:
\n\n“By “open access” to [peer-reviewed research literature], we mean its free availability on the public internet, permitting any users to read, download, copy, distribute, print, search, or link to the full texts of these articles, crawl them for indexing, pass them as data to software, or use them for any other lawful purpose, without financial, legal, or technical barriers other than those inseparable from gaining access to the internet itself. The only constraint on reproduction and distribution, and the only role for copyright in this domain, should be to give authors control over the integrity of their work and the right to be properly acknowledged and cited” (reference: http://www.budapestopenaccessinitiative.org)
\n\nOAI-PMH
\n\nAs a firm believer in the wider dissemination of knowledge, IntechOpen supports the Open Access Initiative Protocol for Metadata Harvesting (OAI-PMH Version 2.0). Read more
\n\nLicense
\n\nBook chapters published in edited volumes are distributed under the Creative Commons Attribution 3.0 Unported License (CC BY 3.0). IntechOpen upholds a very flexible Copyright Policy. There is no copyright transfer to the publisher and Authors retain exclusive copyright to their work. All Monographs/Compacts are distributed under the Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0). Read more
\n\nPeer Review Policies
\n\nAll scientific works are Peer Reviewed prior to publishing. Read more
\n\nOA Publishing Fees
\n\nThe Open Access publishing model employed by IntechOpen eliminates subscription charges and pay-per-view fees, enabling readers to access research at no cost. In order to sustain operations and keep our publications freely accessible we levy an Open Access Publishing Fee for manuscripts, which helps us cover the costs of editorial work and the production of books. Read more
\n\nDigital Archiving Policy
\n\nIntechOpen is committed to ensuring the long-term preservation and the availability of all scholarly research we publish. We employ a variety of means to enable us to deliver on our commitments to the scientific community. Apart from preservation by the Croatian National Library (for publications prior to April 18, 2018) and the British Library (for publications after April 18, 2018), our entire catalogue is preserved in the CLOCKSS archive.
\n\nOpen Science is transparent and accessible knowledge that is shared and developed through collaborative networks.
\n\nOpen Science is about increased rigour, accountability, and reproducibility for research. It is based on the principles of inclusion, fairness, equity, and sharing, and ultimately seeks to change the way research is done, who is involved and how it is valued. It aims to make research more open to participation, review/refutation, improvement and (re)use for the world to benefit.
\n\nOpen Science refers to doing traditional science with more transparency involved at various stages, for example by openly sharing code and data. It implies a growing set of practices - within different disciplines - aiming at:
\n\nWe aim at improving the quality and availability of scholarly communication by promoting and practicing:
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On September, 29th 2006 he has won a post PhD fellowship from the university of Bologna (from October 2006 to October 2008), at the competitive examination he was ranked first in the industrial engineering area. He extensively served as referee for several international journals. He is author/coauthor of more than 100 research papers. He has been involved in some projects supported by MURST and European Community. 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Delac received his B.Sc.E.E. degree in 2003 and is currentlypursuing a Ph.D. degree at the University of Zagreb, Faculty of Electrical Engineering andComputing. His current research interests are digital image analysis, pattern recognition andbiometrics.",institutionString:null,institution:{name:"University of Zagreb",country:{name:"Croatia"}}},{id:"557",title:"Dr.",name:"Andon",middleName:"Venelinov",surname:"Topalov",slug:"andon-topalov",fullName:"Andon Topalov",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/557/images/1927_n.jpg",biography:"Dr. Andon V. Topalov received the MSc degree in Control Engineering from the Faculty of Information Systems, Technologies, and Automation at Moscow State University of Civil Engineering (MGGU) in 1979. He then received his PhD degree in Control Engineering from the Department of Automation and Remote Control at Moscow State Mining University (MGSU), Moscow, in 1984. 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This chapter examines many questions that need to be considered and the role of the key individual with oversight of the GME, the designated institutional official (DIO). Topics examined are the leadership theories, practices and strategies for the DIO, dealing with change when the DIO starts, using authority versus power, effective problem-solving and decision-making, adaptive leadership style, the historical function of the DIO, as well as the many tools available to the DIO including networking. The chapter concludes with several pearls of wisdom to positively help the DIO meet the many challenges of this very important role in GME.",book:{id:"8645",slug:"contemporary-topics-in-graduate-medical-education",title:"Contemporary Topics in Graduate Medical Education",fullTitle:"Contemporary Topics in Graduate Medical Education"},signatures:"Jay M. 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The whole process of submitting an article and editing of the submitted article goes extremely smooth and fast, the number of reads and downloads of chapters is high, and the contributions are also frequently cited.",author:{id:"55578",name:"Antonio",surname:"Jurado-Navas",institutionString:null,profilePictureURL:"https://s3.us-east-1.amazonaws.com/intech-files/0030O00002bRisIQAS/Profile_Picture_1626166543950",slug:"antonio-jurado-navas",institution:{id:"720",name:"University of Malaga",country:{id:null,name:"Spain"}}}},{id:"6",text:"It is great to work with the IntechOpen to produce a worthwhile collection of research that also becomes a great educational resource and guide for future research endeavors.",author:{id:"259298",name:"Edward",surname:"Narayan",institutionString:null,profilePictureURL:"https://mts.intechopen.com/storage/users/259298/images/system/259298.jpeg",slug:"edward-narayan",institution:{id:"3",name:"University of Queensland",country:{id:null,name:"Australia"}}}}]},series:{item:{id:"14",title:"Artificial Intelligence",doi:"10.5772/intechopen.79920",issn:"2633-1403",scope:"Artificial Intelligence (AI) is a rapidly developing multidisciplinary research area that aims to solve increasingly complex problems. 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He is a full professor of signal processing and pattern recognition and is head of the Signals and Communications Department at ULPGC, teaching from 2001 on subjects on signal processing and learning theory. His research lines are biometrics, biomedical signals and images, data mining, classification system, signal and image processing, machine learning, and environmental intelligence. He has researched in 52 international and Spanish research projects, some of them as head researcher. He is co-author of 4 books, co-editor of 27 proceedings books, guest editor for 8 JCR-ISI international journals, and up to 24 book chapters. He has over 450 papers published in international journals and conferences (81 of them indexed on JCR – ISI - Web of Science). He has published seven patents in the Spanish Patent and Trademark Office. He has been a supervisor on 8 Ph.D. theses (11 more are under supervision), and 130 master theses. 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His research interests include computer/machine vision, machine learning, pattern recognition, computational intelligence. \nDr. Papakostas served as a reviewer in numerous journals, as a program\ncommittee member in international conferences and he is a member of the IAENG, MIR Labs, EUCogIII, INSTICC and the Technical Chamber of Greece (TEE).",institutionString:null,institution:{name:"International Hellenic University",institutionURL:null,country:{name:"Greece"}}},editorTwo:null,editorThree:null},{id:"25",title:"Evolutionary Computation",coverUrl:"https://cdn.intechopen.com/series_topics/covers/25.jpg",isOpenForSubmission:!0,editor:{id:"136112",title:"Dr.",name:"Sebastian",middleName:null,surname:"Ventura Soto",slug:"sebastian-ventura-soto",fullName:"Sebastian Ventura Soto",profilePictureURL:"https://mts.intechopen.com/storage/users/136112/images/system/136112.png",biography:"Sebastian Ventura is a Spanish researcher, a full professor with the Department of Computer Science and Numerical Analysis, University of Córdoba. 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He is currently a principal researcher in data analytics and optimisation at TECNALIA (Spain), a visiting fellow at the Basque Center for Applied Mathematics (BCAM) and a part-time lecturer at the University of the Basque Country (UPV/EHU). His research interests gravitate on the use of descriptive, prescriptive and predictive algorithms for data mining and optimization in a diverse range of application fields such as Energy, Transport, Telecommunications, Health and Industry, among others. In these fields he has published more than 240 articles, co-supervised 8 Ph.D. theses, edited 6 books, coauthored 7 patents and participated/led more than 40 research projects. 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He is currently a full professor in\nthe Department of Automation and Applied Informatics at the\nsame university. Dr. Voloşencu is the author of ten books, seven\nbook chapters, and more than 160 papers published in journals\nand conference proceedings. He has also edited twelve books and\nhas twenty-seven patents to his name. He is a manager of research grants, editor in\nchief and member of international journal editorial boards, a former plenary speaker, a member of scientific committees, and chair at international conferences. His\nresearch is in the fields of control systems, control of electric drives, fuzzy control\nsystems, neural network applications, fault detection and diagnosis, sensor network\napplications, monitoring of distributed parameter systems, and power ultrasound\napplications. 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Dr. Gaiceanu is a member of the National Council for Attesting Titles, Diplomas and Certificates, an expert of the Executive Agency for Higher Education, Research Funding, and a member of the Senate of the Dunarea de Jos University of Galati. He has been the head of the Integrated Energy Conversion Systems and Advanced Control of Complex Processes Research Center, Romania, since 2016. He has conducted several projects in power converter systems for electrical drives, power quality, PEM and SOFC fuel cell power converters for utilities, electric vehicles, and marine applications with the Department of Regulation and Control, SIEI S.pA. (2002–2004) and the Polytechnic University of Turin, Italy (2002–2004, 2006–2007). He is a member of the Institute of Electrical and Electronics Engineers (IEEE) and cofounder-member of the IEEE Power Electronics Romanian Chapter. He is a guest editor at Energies and an academic book editor for IntechOpen. He is also a member of the editorial boards of the Journal of Electrical Engineering, Electronics, Control and Computer Science and Sustainability. Dr. Gaiceanu has been General Chairman of the IEEE International Symposium on Electrical and Electronics Engineering in the last six editions.",institutionString:'"Dunarea de Jos" University of Galati',institution:{name:'"Dunarea de Jos" University of Galati',country:{name:"Romania"}}},{id:"4519",title:"Prof.",name:"Jaydip",middleName:null,surname:"Sen",slug:"jaydip-sen",fullName:"Jaydip Sen",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/4519/images/system/4519.jpeg",biography:"Jaydip Sen is associated with Praxis Business School, Kolkata, India, as a professor in the Department of Data Science. His research areas include security and privacy issues in computing and communication, intrusion detection systems, machine learning, deep learning, and artificial intelligence in the financial domain. He has more than 200 publications in reputed international journals, refereed conference proceedings, and 20 book chapters in books published by internationally renowned publishing houses, such as Springer, CRC press, IGI Global, etc. Currently, he is serving on the editorial board of the prestigious journal Frontiers in Communications and Networks and in the technical program committees of a number of high-ranked international conferences organized by the IEEE, USA, and the ACM, USA. He has been listed among the top 2% of scientists in the world for the last three consecutive years, 2019 to 2021 as per studies conducted by the Stanford University, USA.",institutionString:"Praxis Business School",institution:null},{id:"320071",title:"Dr.",name:"Sidra",middleName:null,surname:"Mehtab",slug:"sidra-mehtab",fullName:"Sidra Mehtab",position:null,profilePictureURL:"https://s3.us-east-1.amazonaws.com/intech-files/0033Y00002v6KHoQAM/Profile_Picture_1584512086360",biography:"Sidra Mehtab has completed her BS with honors in Physics from Calcutta University, India in 2018. She has done MS in Data Science and Analytics from Maulana Abul Kalam Azad University of Technology (MAKAUT), Kolkata, India in 2020. Her research areas include Econometrics, Time Series Analysis, Machine Learning, Deep Learning, Artificial Intelligence, and Computer and Network Security with a particular focus on Cyber Security Analytics. Ms. Mehtab has published seven papers in international conferences and one of her papers has been accepted for publication in a reputable international journal. She has won the best paper awards in two prestigious international conferences – BAICONF 2019, and ICADCML 2021, organized in the Indian Institute of Management, Bangalore, India in December 2019, and SOA University, Bhubaneswar, India in January 2021. Besides, Ms. Mehtab has also published two book chapters in two books. Seven of her book chapters will be published in a volume shortly in 2021 by Cambridge Scholars’ Press, UK. Currently, she is working as the joint editor of two edited volumes on Time Series Analysis and Forecasting to be published in the first half of 2021 by an international house. Currently, she is working as a Data Scientist with an MNC in Delhi, India.",institutionString:"NSHM College of Management and Technology",institution:{name:"Association for Computing Machinery",country:{name:"United States of America"}}},{id:"226240",title:"Dr.",name:"Andri Irfan",middleName:null,surname:"Rifai",slug:"andri-irfan-rifai",fullName:"Andri Irfan Rifai",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/226240/images/7412_n.jpg",biography:"Andri IRFAN is a Senior Lecturer of Civil Engineering and Planning. He completed the PhD at the Universitas Indonesia & Universidade do Minho with Sandwich Program Scholarship from the Directorate General of Higher Education and LPDP scholarship. He has been teaching for more than 19 years and much active to applied his knowledge in the project construction in Indonesia. His research interest ranges from pavement management system to advanced data mining techniques for transportation engineering. He has published more than 50 papers in journals and 2 books.",institutionString:null,institution:{name:"Universitas Internasional Batam",country:{name:"Indonesia"}}},{id:"314576",title:"Dr.",name:"Ibai",middleName:null,surname:"Laña",slug:"ibai-lana",fullName:"Ibai Laña",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/314576/images/system/314576.jpg",biography:"Dr. Ibai Laña works at TECNALIA as a data analyst. He received his Ph.D. in Artificial Intelligence from the University of the Basque Country (UPV/EHU), Spain, in 2018. He is currently a senior researcher at TECNALIA. His research interests fall within the intersection of intelligent transportation systems, machine learning, traffic data analysis, and data science. He has dealt with urban traffic forecasting problems, applying machine learning models and evolutionary algorithms. He has experience in origin-destination matrix estimation or point of interest and trajectory detection. Working with large volumes of data has given him a good command of big data processing tools and NoSQL databases. He has also been a visiting scholar at the Knowledge Engineering and Discovery Research Institute, Auckland University of Technology.",institutionString:"TECNALIA Research & Innovation",institution:{name:"Tecnalia",country:{name:"Spain"}}},{id:"314575",title:"Dr.",name:"Jesus",middleName:null,surname:"L. Lobo",slug:"jesus-l.-lobo",fullName:"Jesus L. Lobo",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/314575/images/system/314575.png",biography:"Dr. Jesús López is currently based in Bilbao (Spain) working at TECNALIA as Artificial Intelligence Research Scientist. In most cases, a project idea or a new research line needs to be investigated to see if it is good enough to take into production or to focus on it. That is exactly what he does, diving into Machine Learning algorithms and technologies to help TECNALIA to decide whether something is great in theory or will actually impact on the product or processes of its projects. So, he is expert at framing experiments, developing hypotheses, and proving whether they’re true or not, in order to investigate fundamental problems with a longer time horizon. He is also able to design and develop PoCs and system prototypes in simulation. He has participated in several national and internacional R&D projects.\n\nAs another relevant part of his everyday research work, he usually publishes his findings in reputed scientific refereed journals and international conferences, occasionally acting as reviewer and Programme Commitee member. Concretely, since 2018 he has published 9 JCR (8 Q1) journal papers, 9 conference papers (e.g. ECML PKDD 2021), and he has co-edited a book. He is also active in popular science writing data science stories for reputed blogs (KDNuggets, TowardsDataScience, Naukas). Besides, he has recently embarked on mentoring programmes as mentor, and has also worked as data science trainer.",institutionString:"TECNALIA Research & Innovation",institution:{name:"Tecnalia",country:{name:"Spain"}}},{id:"103779",title:"Prof.",name:"Yalcin",middleName:null,surname:"Isler",slug:"yalcin-isler",fullName:"Yalcin Isler",position:null,profilePictureURL:"https://s3.us-east-1.amazonaws.com/intech-files/0030O00002bRyQ8QAK/Profile_Picture_1628834958734",biography:"Yalcin Isler (1971 - Burdur / Turkey) received the B.Sc. degree in the Department of Electrical and Electronics Engineering from Anadolu University, Eskisehir, Turkey, in 1993, the M.Sc. degree from the Department of Electronics and Communication Engineering, Suleyman Demirel University, Isparta, Turkey, in 1996, the Ph.D. degree from the Department of Electrical and Electronics Engineering, Dokuz Eylul University, Izmir, Turkey, in 2009, and the Competence of Associate Professorship from the Turkish Interuniversity Council in 2019.\n\nHe was Lecturer at Burdur Vocational School in Suleyman Demirel University (1993-2000, Burdur / Turkey), Software Engineer (2000-2002, Izmir / Turkey), Research Assistant in Bulent Ecevit University (2002-2003, Zonguldak / Turkey), Research Assistant in Dokuz Eylul University (2003-2010, Izmir / Turkey), Assistant Professor at the Department of Electrical and Electronics Engineering in Bulent Ecevit University (2010-2012, Zonguldak / Turkey), Assistant Professor at the Department of Biomedical Engineering in Izmir Katip Celebi University (2012-2019, Izmir / Turkey). He is an Associate Professor at the Department of Biomedical Engineering at Izmir Katip Celebi University, Izmir / Turkey, since 2019. In addition to academics, he has also founded Islerya Medical and Information Technologies Company, Izmir / Turkey, since 2017.\n\nHis main research interests cover biomedical signal processing, pattern recognition, medical device design, programming, and embedded systems. He has many scientific papers and participated in several projects in these study fields. He was an IEEE Student Member (2009-2011) and IEEE Member (2011-2014) and has been IEEE Senior Member since 2014.",institutionString:null,institution:{name:"Izmir Kâtip Çelebi University",country:{name:"Turkey"}}},{id:"339677",title:"Dr.",name:"Mrinmoy",middleName:null,surname:"Roy",slug:"mrinmoy-roy",fullName:"Mrinmoy Roy",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/339677/images/16768_n.jpg",biography:"An accomplished Sales & Marketing professional with 12 years of cross-functional experience in well-known organisations such as CIPLA, LUPIN, GLENMARK, ASTRAZENECA across different segment of Sales & Marketing, International Business, Institutional Business, Product Management, Strategic Marketing of HIV, Oncology, Derma, Respiratory, Anti-Diabetic, Nutraceutical & Stomatological Product Portfolio and Generic as well as Chronic Critical Care Portfolio. A First Class MBA in International Business & Strategic Marketing, B.Pharm, D.Pharm, Google Certified Digital Marketing Professional. Qualified PhD Candidate in Operations and Management with special focus on Artificial Intelligence and Machine Learning adoption, analysis and use in Healthcare, Hospital & Pharma Domain. Seasoned with diverse therapy area of Pharmaceutical Sales & Marketing ranging from generating revenue through generating prescriptions, launching new products, and making them big brands with continuous strategy execution at the Physician and Patients level. Moved from Sales to Marketing and Business Development for 3.5 years in South East Asian Market operating from Manila, Philippines. Came back to India and handled and developed Brands such as Gluconorm, Lupisulin, Supracal, Absolut Woman, Hemozink, Fabiflu (For COVID 19), and many more. In my previous assignment I used to develop and execute strategies on Sales & Marketing, Commercialization & Business Development for Institution and Corporate Hospital Business portfolio of Oncology Therapy Area for AstraZeneca Pharma India Ltd. Being a Research Scholar and Student of ‘Operations Research & Management: Artificial Intelligence’ I published several pioneer research papers and book chapters on the same in Internationally reputed journals and Books indexed in Scopus, Springer and Ei Compendex, Google Scholar etc. Currently, I am launching PGDM Pharmaceutical Management Program in IIHMR Bangalore and spearheading the course curriculum and structure of the same. I am interested in Collaboration for Healthcare Innovation, Pharma AI Innovation, Future trend in Marketing and Management with incubation on Healthcare, Healthcare IT startups, AI-ML Modelling and Healthcare Algorithm based training module development. I am also an affiliated member of the Institute of Management Consultant of India, looking forward to Healthcare, Healthcare IT and Innovation, Pharma and Hospital Management Consulting works.",institutionString:null,institution:{name:"Lovely Professional University",country:{name:"India"}}},{id:"1063",title:"Prof.",name:"Constantin",middleName:null,surname:"Volosencu",slug:"constantin-volosencu",fullName:"Constantin Volosencu",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/1063/images/system/1063.png",biography:"Prof. Dr. Constantin Voloşencu graduated as an engineer from\nPolitehnica University of Timișoara, Romania, where he also\nobtained a doctorate degree. He is currently a full professor in\nthe Department of Automation and Applied Informatics at the\nsame university. Dr. Voloşencu is the author of ten books, seven\nbook chapters, and more than 160 papers published in journals\nand conference proceedings. He has also edited twelve books and\nhas twenty-seven patents to his name. He is a manager of research grants, editor in\nchief and member of international journal editorial boards, a former plenary speaker, a member of scientific committees, and chair at international conferences. His\nresearch is in the fields of control systems, control of electric drives, fuzzy control\nsystems, neural network applications, fault detection and diagnosis, sensor network\napplications, monitoring of distributed parameter systems, and power ultrasound\napplications. He has developed automation equipment for machine tools, spooling\nmachines, high-power ultrasound processes, and more.",institutionString:'"Politechnica" University Timişoara',institution:null},{id:"221364",title:"Dr.",name:"Eneko",middleName:null,surname:"Osaba",slug:"eneko-osaba",fullName:"Eneko Osaba",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/221364/images/system/221364.jpg",biography:"Dr. Eneko Osaba works at TECNALIA as a senior researcher. He obtained his Ph.D. in Artificial Intelligence in 2015. He has participated in more than twenty-five local and European research projects, and in the publication of more than 130 papers. He has performed several stays at universities in the United Kingdom, Italy, and Malta. Dr. Osaba has served as a program committee member in more than forty international conferences and participated in organizing activities in more than ten international conferences. He is a member of the editorial board of the International Journal of Artificial Intelligence, Data in Brief, and Journal of Advanced Transportation. He is also a guest editor for the Journal of Computational Science, Neurocomputing, Swarm, and Evolutionary Computation and IEEE ITS Magazine.",institutionString:"TECNALIA Research & Innovation",institution:{name:"Tecnalia",country:{name:"Spain"}}},{id:"275829",title:"Dr.",name:"Esther",middleName:null,surname:"Villar-Rodriguez",slug:"esther-villar-rodriguez",fullName:"Esther Villar-Rodriguez",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/275829/images/system/275829.jpg",biography:"Dr. Esther Villar obtained a Ph.D. in Information and Communication Technologies from the University of Alcalá, Spain, in 2015. She obtained a degree in Computer Science from the University of Deusto, Spain, in 2010, and an MSc in Computer Languages and Systems from the National University of Distance Education, Spain, in 2012. Her areas of interest and knowledge include natural language processing (NLP), detection of impersonation in social networks, semantic web, and machine learning. Dr. Esther Villar made several contributions at conferences and publishing in various journals in those fields. Currently, she is working within the OPTIMA (Optimization Modeling & Analytics) business of TECNALIA’s ICT Division as a data scientist in projects related to the prediction and optimization of management and industrial processes (resource planning, energy efficiency, etc).",institutionString:"TECNALIA Research & Innovation",institution:{name:"Tecnalia",country:{name:"Spain"}}},{id:"49813",title:"Dr.",name:"Javier",middleName:null,surname:"Del Ser",slug:"javier-del-ser",fullName:"Javier Del Ser",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/49813/images/system/49813.png",biography:"Prof. Dr. Javier Del Ser received his first PhD in Telecommunication Engineering (Cum Laude) from the University of Navarra, Spain, in 2006, and a second PhD in Computational Intelligence (Summa Cum Laude) from the University of Alcala, Spain, in 2013. He is currently a principal researcher in data analytics and optimisation at TECNALIA (Spain), a visiting fellow at the Basque Center for Applied Mathematics (BCAM) and a part-time lecturer at the University of the Basque Country (UPV/EHU). His research interests gravitate on the use of descriptive, prescriptive and predictive algorithms for data mining and optimization in a diverse range of application fields such as Energy, Transport, Telecommunications, Health and Industry, among others. In these fields he has published more than 240 articles, co-supervised 8 Ph.D. theses, edited 6 books, coauthored 7 patents and participated/led more than 40 research projects. He is a Senior Member of the IEEE, and a recipient of the Biscay Talent prize for his academic career.",institutionString:"Tecnalia Research & Innovation",institution:{name:"Tecnalia",country:{name:"Spain"}}},{id:"278948",title:"Dr.",name:"Carlos Pedro",middleName:null,surname:"Gonçalves",slug:"carlos-pedro-goncalves",fullName:"Carlos Pedro Gonçalves",position:null,profilePictureURL:"https://s3.us-east-1.amazonaws.com/intech-files/0030O00002bRcmyQAC/Profile_Picture_1564224512145",biography:'Carlos Pedro Gonçalves (PhD) is an Associate Professor at Lusophone University of Humanities and Technologies and a researcher on Complexity Sciences, Quantum Technologies, Artificial Intelligence, Strategic Studies, Studies in Intelligence and Security, FinTech and Financial Risk Modeling. He is also a progammer with programming experience in:\n\nA) Quantum Computing using Qiskit Python module and IBM Quantum Experience Platform, with software developed on the simulation of Quantum Artificial Neural Networks and Quantum Cybersecurity;\n\nB) Artificial Intelligence and Machine learning programming in Python;\n\nC) Artificial Intelligence, Multiagent Systems Modeling and System Dynamics Modeling in Netlogo, with models developed in the areas of Chaos Theory, Econophysics, Artificial Intelligence, Classical and Quantum Complex Systems Science, with the Econophysics models having been cited worldwide and incorporated in PhD programs by different Universities.\n\nReceived an Arctic Code Vault Contributor status by GitHub, due to having developed open source software preserved in the \\"Arctic Code Vault\\" for future generations (https://archiveprogram.github.com/arctic-vault/), with the Strategy Analyzer A.I. module for decision making support (based on his PhD thesis, used in his Classes on Decision Making and in Strategic Intelligence Consulting Activities) and QNeural Python Quantum Neural Network simulator also preserved in the \\"Arctic Code Vault\\", for access to these software modules see: https://github.com/cpgoncalves. He is also a peer reviewer with outsanding review status from Elsevier journals, including Physica A, Neurocomputing and Engineering Applications of Artificial Intelligence. Science CV available at: https://www.cienciavitae.pt//pt/8E1C-A8B3-78C5 and ORCID: https://orcid.org/0000-0002-0298-3974',institutionString:"University of Lisbon",institution:{name:"Universidade Lusófona",country:{name:"Portugal"}}},{id:"310576",title:"Prof.",name:"Erick Giovani",middleName:null,surname:"Sperandio Nascimento",slug:"erick-giovani-sperandio-nascimento",fullName:"Erick Giovani Sperandio Nascimento",position:null,profilePictureURL:"https://intech-files.s3.amazonaws.com/0033Y00002pDKxDQAW/ProfilePicture%202022-06-20%2019%3A57%3A24.788",biography:"Prof. Erick Sperandio is the Lead Researcher and professor of Artificial Intelligence (AI) at SENAI CIMATEC, Bahia, Brazil, also working with Computational Modeling (CM) and HPC. He holds a PhD in Environmental Engineering in the area of Atmospheric Computational Modeling, a Master in Informatics in the field of Computational Intelligence and Graduated in Computer Science from UFES. He currently coordinates, leads and participates in R&D projects in the areas of AI, computational modeling and supercomputing applied to different areas such as Oil and Gas, Health, Advanced Manufacturing, Renewable Energies and Atmospheric Sciences, advising undergraduate, master's and doctoral students. He is the Lead Researcher at SENAI CIMATEC's Reference Center on Artificial Intelligence. In addition, he is a Certified Instructor and University Ambassador of the NVIDIA Deep Learning Institute (DLI) in the areas of Deep Learning, Computer Vision, Natural Language Processing and Recommender Systems, and Principal Investigator of the NVIDIA/CIMATEC AI Joint Lab, the first in Latin America within the NVIDIA AI Technology Center (NVAITC) worldwide program. He also works as a researcher at the Supercomputing Center for Industrial Innovation (CS2i) and at the SENAI Institute of Innovation for Automation (ISI Automação), both from SENAI CIMATEC. He is a member and vice-coordinator of the Basic Board of Scientific-Technological Advice and Evaluation, in the area of Innovation, of the Foundation for Research Support of the State of Bahia (FAPESB). He serves as Technology Transfer Coordinator and one of the Principal Investigators at the National Applied Research Center in Artificial Intelligence (CPA-IA) of SENAI CIMATEC, focusing on Industry, being one of the six CPA-IA in Brazil approved by MCTI / FAPESP / CGI.br. He also participates as one of the representatives of Brazil in the BRICS Innovation Collaboration Working Group on HPC, ICT and AI. He is the coordinator of the Work Group of the Axis 5 - Workforce and Training - of the Brazilian Strategy for Artificial Intelligence (EBIA), and member of the MCTI/EMBRAPII AI Innovation Network Training Committee. He is the coordinator, by SENAI CIMATEC, of the Artificial Intelligence Reference Network of the State of Bahia (REDE BAH.IA). He leads the working group of experts representing Brazil in the Global Partnership on Artificial Intelligence (GPAI), on the theme \"AI and the Pandemic Response\".",institutionString:null,institution:null},{id:"241400",title:"Prof.",name:"Mohammed",middleName:null,surname:"Bsiss",slug:"mohammed-bsiss",fullName:"Mohammed Bsiss",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/241400/images/8062_n.jpg",biography:null,institutionString:null,institution:null},{id:"276128",title:"Dr.",name:"Hira",middleName:null,surname:"Fatima",slug:"hira-fatima",fullName:"Hira Fatima",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/276128/images/14420_n.jpg",biography:"Dr. Hira Fatima\nAssistant Professor\nDepartment of Mathematics\nInstitute of Applied Science\nMangalayatan University, Aligarh\nMobile: no : 8532041179\nhirafatima2014@gmal.com\n\nDr. Hira Fatima has received his Ph.D. degree in pure Mathematics from Aligarh Muslim University, Aligarh India. Currently working as an Assistant Professor in the Department of Mathematics, Institute of Applied Science, Mangalayatan University, Aligarh. She taught so many courses of Mathematics of UG and PG level. Her research Area of Expertise is Functional Analysis & Sequence Spaces. She has been working on Ideal Convergence of double sequence. She has published 17 research papers in National and International Journals including Cogent Mathematics, Filomat, Journal of Intelligent and Fuzzy Systems, Advances in Difference Equations, Journal of Mathematical Analysis, Journal of Mathematical & Computer Science etc. She has also reviewed few research papers for the and international journals. She is a member of Indian Mathematical Society.",institutionString:null,institution:null},{id:"417317",title:"Mrs.",name:"Chiedza",middleName:null,surname:"Elvina Mashiri",slug:"chiedza-elvina-mashiri",fullName:"Chiedza Elvina Mashiri",position:null,profilePictureURL:"//cdnintech.com/web/frontend/www/assets/author.svg",biography:null,institutionString:null,institution:{name:"Midlands State University",country:{name:"Zimbabwe"}}},{id:"352140",title:"Dr.",name:"Edina",middleName:null,surname:"Chandiwana",slug:"edina-chandiwana",fullName:"Edina Chandiwana",position:null,profilePictureURL:"//cdnintech.com/web/frontend/www/assets/author.svg",biography:null,institutionString:null,institution:{name:"Midlands State University",country:{name:"Zimbabwe"}}},{id:"342259",title:"B.Sc.",name:"Leonard",middleName:null,surname:"Mushunje",slug:"leonard-mushunje",fullName:"Leonard Mushunje",position:null,profilePictureURL:"//cdnintech.com/web/frontend/www/assets/author.svg",biography:null,institutionString:null,institution:{name:"Midlands State University",country:{name:"Zimbabwe"}}},{id:"347042",title:"Mr.",name:"Maxwell",middleName:null,surname:"Mashasha",slug:"maxwell-mashasha",fullName:"Maxwell Mashasha",position:null,profilePictureURL:"//cdnintech.com/web/frontend/www/assets/author.svg",biography:null,institutionString:null,institution:{name:"Midlands State University",country:{name:"Zimbabwe"}}},{id:"2941",title:"Dr.",name:"Alberto J.",middleName:"Jorge",surname:"Rosales-Silva",slug:"alberto-j.-rosales-silva",fullName:"Alberto J. Rosales-Silva",position:null,profilePictureURL:"//cdnintech.com/web/frontend/www/assets/author.svg",biography:null,institutionString:null,institution:{name:"Instituto Politécnico Nacional",country:{name:"Mexico"}}},{id:"437913",title:"Dr.",name:"Guillermo",middleName:null,surname:"Urriolagoitia-Sosa",slug:"guillermo-urriolagoitia-sosa",fullName:"Guillermo Urriolagoitia-Sosa",position:null,profilePictureURL:"//cdnintech.com/web/frontend/www/assets/author.svg",biography:null,institutionString:null,institution:{name:"Instituto Politécnico Nacional",country:{name:"Mexico"}}},{id:"435126",title:"Prof.",name:"Joaquim",middleName:null,surname:"José de Castro Ferreira",slug:"joaquim-jose-de-castro-ferreira",fullName:"Joaquim José de Castro Ferreira",position:null,profilePictureURL:"//cdnintech.com/web/frontend/www/assets/author.svg",biography:null,institutionString:null,institution:{name:"University of Aveiro",country:{name:"Portugal"}}},{id:"437899",title:"MSc.",name:"Miguel Angel",middleName:null,surname:"Ángel Castillo-Martínez",slug:"miguel-angel-angel-castillo-martinez",fullName:"Miguel Angel Ángel Castillo-Martínez",position:null,profilePictureURL:"//cdnintech.com/web/frontend/www/assets/author.svg",biography:null,institutionString:null,institution:{name:"Instituto Politécnico Nacional",country:{name:"Mexico"}}},{id:"289955",title:"Dr.",name:"Raja",middleName:null,surname:"Kishor Duggirala",slug:"raja-kishor-duggirala",fullName:"Raja Kishor Duggirala",position:null,profilePictureURL:"//cdnintech.com/web/frontend/www/assets/author.svg",biography:null,institutionString:null,institution:{name:"Jawaharlal Nehru Technological University, Hyderabad",country:{name:"India"}}}]}},subseries:{item:{id:"12",type:"subseries",title:"Human Physiology",keywords:"Anatomy, Cells, Organs, Systems, Homeostasis, Functions",scope:"Human physiology is the scientific exploration of the various functions (physical, biochemical, and mechanical properties) of humans, their organs, and their constituent cells. The endocrine and nervous systems play important roles in maintaining homeostasis in the human body. Integration, which is the biological basis of physiology, is achieved through communication between the many overlapping functions of the human body's systems, which takes place through electrical and chemical means. Much of the basis of our knowledge of human physiology has been provided by animal experiments. Because of the close relationship between structure and function, studies in human physiology and anatomy seek to understand the mechanisms that help the human body function. The series on human physiology deals with the various mechanisms of interaction between the various organs, nerves, and cells in the human body.",coverUrl:"https://cdn.intechopen.com/series_topics/covers/12.jpg",hasOnlineFirst:!1,hasPublishedBooks:!0,annualVolume:11408,editor:{id:"195829",title:"Prof.",name:"Kunihiro",middleName:null,surname:"Sakuma",slug:"kunihiro-sakuma",fullName:"Kunihiro Sakuma",profilePictureURL:"https://mts.intechopen.com/storage/users/195829/images/system/195829.jpg",biography:"Professor Kunihiro Sakuma, Ph.D., currently works in the Institute for Liberal Arts at the Tokyo Institute of Technology. He is a physiologist working in the field of skeletal muscle. He was awarded his sports science diploma in 1995 by the University of Tsukuba and began his scientific work at the Department of Physiology, Aichi Human Service Center, focusing on the molecular mechanism of congenital muscular dystrophy and normal muscle regeneration. 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