eChapters

It 9001:2000 Means customer satisfaction and continuous improvement

ISO (International Organization for Standardization) is a worldwide federation of national Standards bodies from each country. The object of ISO is to promote the development of Standardization and related activities in the world with a view to facilitating international exchange of goods and services, and to developing cooperation in the spheres of intellectual, scientific, technological and economic activity. The results of ISO technical work are published as International Standards.

Quality management Systems (QMS) certification as per ISO 9001 : 2000 is an important opportunity that can enable the companies acquire the label of an enterprise caring for the customer needs and improve their economic performance at the same time. QMS provides an organization a systematic structured documented and effective approach to consistently maintain the product quality meeting customer requirements.

Environmental management systems (EMSs) such as ISO 14000 are seen as mechanisms for achieving improvements in environmental performance and for supporting the trade prospects of “clean” firms. The potential advantages of EMSs are clear, but the adoption of ISO 14000 is very recent, and practical issues are emerging, among them the need for an emphasis on performance improvement and for simplification of certification; the potential for regulatory streamlining; and the trade consequences. This chapter outlines the key elements of an EMS and discusses these issues.

The Benefits of an EMS

An environmental management system (EMS) is a structured program of continuous environmental improvement that follows procedures drawn from established business management practices. The concept is straightforward, and the principles can be easily applied, given the necessary support. There has been increasing interest in the potential value of EMS approaches, ofwhich the recently released ISO 14000 series is the most widely known.

The first steps in the control of industrial pollution have been the creation of the necessary regulatory framework and the specification and design of control equipment to reduce emissions. These efforts have been broadly successful in improving the performance of many polluters, but in other cases, investments in pollution equipment are wasted because the equipment is not operated properly. Attention, in the World Bank and elsewhere, is turning to support of regulatory and end-of-pipe approaches through incentives, production efficiencies, and management improvements a range of measures often grouped under the broad banner of cleaner production and eco-efficiency.

1. GMP

Good manufacturing practices and requirements of premises, plant and equipment for pharmaceutical products

To achieve the objectives listed below, each licensee shall evolve appropriate methodology, systems and procedures which shall be documented and maintained for inspection and reference; and the manufacturing premises shall be used exclusively for production of drugs and no other manufacturing activity shall be undertaken therein.

Introduction

In the 1997 WHO guidance document: “WHO/VSQ/97.01: (A WHO guide to good manufacturing practice (GMP) requirements. Part 1: Standard operating procedures and master formulae)” some basic explanations and instructions were given for preparing various documents required by Good Manufacturing Practice guidelines from WHO and from several regulatory authorities.

GMP guidelines include the requirements for documents (individual), documentation (the systems and formats for documents), and documenting (recording) of production and control activities. Most GMP guidelines provide the same or very similar information as the principles of Good Manufacturing Practice are now international in scope.

In this guidance document, the requirement for master manufacturing instructions and the requirements as given in different GMP documents, different names for these documents and various forms that they can take will be described. This is to guide vaccine manufacturers who are applying for pre-qualification or re-qualification of their product(s) in the preparation or improvement of current documents for manufacturing operations.

Principle

Good documentation constitutes an essential part of the quality assurance system. Clearly written documentation prevents errors from spoken communication and permits tracing of batch history. Specifications, Manufacturing Formulae and instructions, procedures, and records must be free from errors and available in writing. The legibility of documents is of paramount importance.

General

Specifications describe in detail the requirements with which the products or materials used or obtained during manufacture have to conform. They serve as a basis for quality evaluation. Manufacturing Formulae, Processing and Packaging Instructions state all the starting materials used and lay down all processing and packaging operations.

Procedures give directions for performing certain operations e.g. cleaning, clothing, environmental control, sampling, testing, and equipment operations.

Records provide a history of each batch of product, including its distribution, and also of all other relevant circumstances pertinent for the quality of the final product.

Validation in the pharmaceutical and medical device industry is defined as the documented act ofdemonstrating that a procedure, process, and activity will consistently lead to the expected results. It often includes the qualification of systems and equipment. It is a requirement for Good Manufacturing Practices and other regulatory requirements. Since a wide variety ofprocedures, processes, and activities need to be validated, the field of validation is divided into a number of subsections including the following:

This chapter focuses on the statistical methods used for method development. These are categories as follow :

1.SUPAC- Scale-Up and Post-Approval Changes

2.PAT -Process Analytical Technique

1. SUPAC - The acronym “ SUPAC “stands for “Scale-Up and Post- Approval Changes” . It refers to the FDA-recommended testing and filing actions to be taken by a pharmaceutical firm when it changes the manufacturing processes of a drug product that has been approved via a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), or an Abbreviated Antibiotic Drug Application (AADA). FDA has provided its recommendations to industry in the form of SUPAC Guidances or supac guidelines.

Analytical methods development and validation play important roles in the discovery, development, and manufacture of pharmaceuticals.

Pharmaceutical products formulated with more than one drug, typically referred to as combination products, are intended to meet previously unmet patients need by combining the therapeutic effects of two or more drugs in one product. These combination products can present daunting challenges to the analytical chemist responsible for the development and validation of analytical methods. This presentation will discuss the development and validation of analytical method (Spectrophotometric, High performance liquid chromatography (HPLC), & High performance thin layer chromatography (HPTLC)) for drug products containing more than one active ingredient. The official test methods that result from these processes are used by quality control laboratories to ensure the identity, purity, potency, and performance of drug products.

1 Introduction

The purpose of these Guidelines on Audit Quality is to assist Supreme Audit Institutions assure the high quality of their work and the resulting products. This Section describes the background of the document, provides key definitions applicable to these guidelines, discusses the types of SAIs and audits to which the guidelines apply, lays out the form in which the guidelines are presented and identifies some other sources of useful guidance for assuring quality. Section 2 then deals with quality control as the “hot review” ofthe audit process. Subsections 2.1 — 2.6 set forth some basic premises for establishing effective quality controls, discuss the nature of the controls required to assure quality in the areas of selection and timing of audits, planning specific audits, executing audits, reporting the results of audits, and following up on audits, respectively. Section 3 describes the procedures necessary to assure that needed quality controls are in place and operating effectively, that is it presents the characteristics of post-audit quality assurance. Finally, Section 4 focuses on institutional measures to enhance quality, especially management of human resources (recruitment, training, staff development and ethical standards), institutional risks and external relations. The Annexes provide other information that was considered potentially useful, including reference material, checklists and excerpts regarding quality controls from other guidance documents. The list of reference documents is contained in Annex A.

Audit quality is obtained by a process of identifying and administering the activities needed to achieve the quality objectives of an SAI. All types of SAI need to understand the benefits that can be realised once audit quality is made a priority. Improving audit quality requires a systematic SAI- wide approach. Piecemeal efforts by individuals and individual audit teams are not enough and will not work. There are no quick fixes to be obtained where audit quality is concerned. SAIs needs to proceed methodically in an organised way to fix each quality issue and problem in turn. As new problems will always emerge, this should be a continuous process for the SAI. It is also evident that most audit quality related problems are mainly the result ofpoor management of the audit process or the SAI itself.

1. Pharmaceutical Quality System

1.1 Introduction

This document establishes a new ICH tripartite guideline describing a model for an effective quality management system for the pharmaceutical industry, referredto as the Pharmaceutical Quality System. Throughout this guideline, the term “pharmaceutical quality system” refers to the ICH Q10 model.

ICH Q10 describes one comprehensive model for an effective pharmaceutical quality system that is based on International Standards Organisation (ISO) quality concepts, includes applicable Good Manufacturing Practice (GMP) regulations and complements ICH Q8 “Pharmaceutical Development” and ICH Q9 “Quality Risk Management”. ICH Q10 is a model for a pharmaceutical quality system that can be implemented throughout the different stages of a product lifecycle. Much of the content of ICH Q10 applicable to manufacturing sites is currently specified by regional GMP requirements. ICH Q10 is not intended to create any new expectations beyond current regulatory requirements. Consequently, the content ofICH Q10 that is additional to current regional GMP requirements is optional.

ICH Q10 demonstrates industry and regulatory authorities’ support of an effective pharmaceutical quality system to enhance the quality and availability of medicines around the world in the interest of public health. Implementation of ICH Q10 throughout the product lifecycle should facilitate innovation and continual improvement and strengthen the link between pharmaceutical development and manufacturing activities.

Water is an important element for life on the earth. It is an essential recurrent natural resource for environmental sustenance, agricultural productivity, industrial growth, power production, enrichment and renewal of land and air. For easy assess to the water, the first human settlements occurred along the banks of rivers and ensuing civilizations flourished in river valleys. For example, the Indian civilization of Mohanjodaro and Harappa developed in the Indus valley, the Egyptian civilization in the Nile valley, the Chinese civilization in the Yangtze valley, the Babylonian civilization between the Tigris and the Euphrates rivers, Aztec, Maya and Incas civilization in the basin of Amazon river.

The industrial revolution, which, began in the early 18th century in some European and Asian countries, set in the motion for new forces in the society and greatly changed the pattern of social life on the earth. Rapid industrialization and urbanization subsequently brought many changes in the environment and ecosystems in the world. India also witnessed a phenomenon of industrial development in the post independent era. The last four to five decades have witnessed population explosion and increase in the per capita consumption of food, consumer goods and utilization of natural resources. These have lead to the proportionate increase in the domestic and industrial effluent generation in India. The water pollution is continuously increasing at an alarming rate in Europe and Asia. By the end of this century. India's Population is projected to double itself from its present level. Similarly the per capita consumption of food has been estimated to increase by 40% resulting in 50 % production of industrial and domestic effluents in near future.

Apart from the quantity, there will be qualitative changes in the effluent generation which are likely to contain greater amount of oil, toxic chemicals, detergents and dyes. A large number of these compounds are non-biodegradable and are cumulative, thus rendering toxic product. Certain group of animals and plants are selective in their functions and can executive certain toxic chemicals and heavy metals. These biomes are helping more effectively on recycling of industrial effluent as well as domestic effluent management system.

In nature, there exists a balance between abiotic and biotic communities like animals and plants population, raw materials and total biomass present at any time. This balance ensures natural recycling and optimum production in naturally balanced ecosystems. The plant growth is slow, but it ensures optimum utilization of waste products and a healthy environment. The increased population and its human desire to possess all comforts and pleasures had lead to over exploitation of natural resources. The high demand of natural resources lead to the beginning of waste accumulation due to the creation of man made imbalances in the environment. The environment is to provide up to date information about important concepts in surrounding. Information is presented from an analytical, observational and multidisciplinary perspective from which we must view environmental issues in order to the study successfully.

The science is a process of refining our understanding of nature by continual questioning and active investigation on questions. Students can approach science in this manner, rather than as a collection of facts to be memorized. The Environment is to provide up-to-date information to the important concepts in the study of environment. Information is presented from an analytical, observation and multidisciplinary perspective from which we must view environmental issues in order to deal successfully with them. The environment may be defined as response of a human being influenced by various factors such as abiotic and biotic, which are present in the ecosystems.

2.1 Multidisciplinary Approach

The approach of environment science is multidisciplinary in nature like botany, zoology, physics, hydrology, hydraulics, chemistry, biophysics, biochemistry and biology. It integrates various subjects and includes few of the most important topics of modern civilization as well as oldest philosophical concerns. Applied and basic aspects of environment requires a solid function in the nature of our relationship with nature, in addition to fields like economics, anthropology, history, sociology and philosophy of the environment.

3.1 Introduction

India, when gained independence in 1947, was predominantly an agrarian economy, with a stagnant national income. The country inherited a weak industrial base, restricted to only a few industries. Agricultural growth was virtually negligible, the country had a stagnant cropped area where by only a very small proportion of agricultural land was irrigated. On the eve of the country’s independence, on 15^th August 1947, Jawaharlal Nehru, India’s Prime Minister, reminded the country that the task ahead included ending poverty, ignorance, and disease and inequality of opportunity. India began the process of planning with the launching of the 1^st five-year plan in April 1951. The central purpose of planning was to ‘initiate a process of development which would raise living standards and open out to the people new opportunities for a richer and more varied life’. Afterwards, the five-year plans were formulated seeking development in a sustainable manner.

The country, over the past has travelled a long way indeed in its drive towards economic growth, modernization of the economy, feudal economy at the time of independence has been transformed into one based on a fairly developed and diversified industrial structure and a sound agricultural base with a large potential for further industrialization and development. The income and consumption levels of people, on an average, have increased and the consumption basket has diversified. A noteworthy achievement indeed has been the elimination of famines with which the country continued to be afflicted right until independence. That achievement is far from negligible since many other countries in Asia and Africa are yet to free themselves of this malady. There is also other achievement, varying from the successful functioning of a democratic system to the emergence of a strong and large scientific community (Dreze Sen, 1995). The figure 3.1 shows the per capita income during 1997-1998. It shows that the maximum income from Northern India compared to Southern India. However, having adapted the pattern of economic development that brought prosperity to the Western, India has also seen widespread environmental damage and degradation in the pursuit of economic growth. The concern for preserving the environment against the onslaught of industrial expansion, intensification of agricultural, and adoption of a resource-intensive lifestyle has not been given the attention it deserved, and the costs of environmental degradation have not been internalized in the development process. While the Indian economy study made by two World Bank staffers shows that the country is paying an enormous price for this onward march, which has brought in its wake ecological devastation and numerous health problems.

4.1 Introduction

India is a land of many rivers, lakes, ponds, coastal, marines and mountains. Its geographical area of about 329 million hectare is crises crossed by a large number of small and medium, large rivers, some of them figuring amongst the mighty rivers of the world. The rivers and mountains have a greater significance in the history of Indian civilizations, development, religious and spiritual life. It may not be an exaggeration to say that the rivers are the heart and soul of the Indian civilizations

India is a union of States with a federal set up. Politically, the country is divided into 26 States and 7 Union Territories. A major part of India’s population of 869 millions (1991 census) is rural and agriculturally oriented for whom the rivers are the source of their life. India is a land of many religions, diversity of cultures and languages. The different regions of the country have different cultural, linguistic and other ethnic groups. The land and people present a vast panorama of diversity in unity. Physiographically, India may be divided into seven well-defined regions.

5.1 Introduction

The source of pollution are many and varied. The most critical are domestic sewage and industrial effluent discharging into rivers, lakes, ponds etc. Treatment facilities for domestic sewage in class 1 cities having population of more than 1,00,0000 and class 2 cities having population between 50,000 and 99,999 can process hardly 10% of the wastewater generated. Wastewater treatment facilities are difficult to quantify due to lack of continuous data. On an average, the treatment capacity in class 1 cities can handle only 60% of the wastewater collected and less than 15% of the total volume of wastewater generated.

The Indian industry has grown annually at an average rate of 5.5% during the last 50 years. Among different industrial sectors, water pollution is concentrated with in a few industrial sub-sectors mainly in the form of toxic wastes and organic pollutants. Out of the total pollution contributed by the industrial sub-sectors, 40% to 45% of the total pollutants can be traced to the processing of industrial chemicals and nearly 40% of the total organic pollution to the food products industry alone. Food products and agro-based industries together contribute 65% to 70% of the total industrial wastewater in terms of organic load. Blair T Bower, consultant, the Urban Institute, USA, remarks: "… If substantial further growth of Asia’s cities cannot be avoided and if the environmental disasters that could be associated with that growth are to be prevented, there is only one alternative: urban environmental quality management must be substantially improved throughout the region".

The total quantity of water used by the domestic and industrial sectors is much less than that consumed for irrigation. However, the wastewater released from the above sectors has a great concentration of pollutants, and is discharged at specific disposal points. Thus, the wastewater generated from domestic and industrial projects causes much more water pollution as compared to any other source.

6.1 Introduction

The state of India’s forests is important in many ways, whether it be as a source of fuel and fodder for rural citizens, of industrial inputs for a growing economy, as a habitat for thousands of plant and animal species, a sink for carbon dioxide emissions, or as a protective cover for its soils.

The forest resources forms an ecological system consisting of tree dominated vegetative associations. Forests not only provide timber, fuel wood, pulpwood fodder and fiber grasses, and non wood forest produce and support industrial and commercial activities but also maintain the ecological balance and life support systems essential for food production, health, and all round human development. The innate complexity and inherent diversity of forest ecosystems make it difficult to establish clear cause-and effect relationship or to predict the outcomes of a given intervention accurately. Figure 6.1 shows that the percentage of land mass with forest covered and non forest area in India

7.1 Introduction

The rapid population and industrial growth experienced beginning in the middle part of this century has led to spiraling increases in the demand for forest wood. Historical data reveal that there was a 159.6% increase in overall wood production between 1970 and 1993. Wood is defined simply as wood in the rough, and includes trees felled for any purpose. The majority of total wood production has been for use as fuel wood and charcoal, much of which is harvested by villagers, and to some degree urban squatters.

Since 1970, there has been a 160% increase in fuel wood and charcoal production. The largest portion (104%) occurred between 1970 and 1980, which may be attributed to the introduction of fuel wood species earlier, during the Second Five Year Plan period. Looking at the decades to come, the demand for fuel wood is likely to continue growing in pace with future increases in population, which is growing at the rate of 24 % per decade. It is estimated that by the year 2010, demand for fuel wood and charcoal will exceed 33 million cubic meters (FAO, 1993). Since there is expected to be little further change in the area under potential productive forests, there will be an increasing probability of a shortage of wood production in India (Planning Commission, 1992).

8.1 Introduction

Contamination of drinking water supplies from industrial waste is a result of various types of industrial processes and disposal practices. Industries that use large amounts of fresh water for processing have the potential to pollute waterways through the discharge of their waste into streams and rivers, or by run-off and seepage of stored wastes into nearby water sources. Other disposal practices, which cause water contamination, include deep well injection and improper disposal of wastes in surface impoundments.

Industrial wastes consists of both organic and inorganic substances. Organic wastes include pesticide residues, solvents and cleaning fluids, dissolved residues from fruits and vegetables, and lignin from pulp and paper to name a few. Effluents can also contain inorganic wastes such as brine salts and metals. This is an incentive for industry to pre-treat their water by neutralizing the chemically active components, recycling, dilution or extraction and collection for proper disposal.

The waste disposal practices, which presently pose a threat to drinking water supplies, include deep well injection of wastes and wastes that are dumped and retained in surface impoundments or evaporation ponds. (Ministry of Industries, 1994).

In keeping with the functions delegated to the Central Pollution Control Board under the Water (Prevention & Control of Pollution) Act, 1974, they covered a number of industries, their production and location with details of receiving water besides details on the raw material they used, the process they adopted to process them, inplant control systems, pollution control system provided and the future requirement with cost implications, monitoring system etc.

These documents are also aimed at developing standards for effluents and emissions as Minimal National Standards that can be adopted uniformly throughout the country. The State Pollution Control Boards (SPCBs) can tighten the standards, wherever the local situation demands.

While implementing these standards, the status of technologies adopted by the industries and further requirements to meet the overall objective of pollution control have been assessed. The technology requirement for pollution control industry wise has been presented in the following groups of industry categories.

9.1 Introduction

The sources and types of chemical pollution to which freshwater systems can be exposed are many and varied. The origins of pollutants entering these systems range from those that are predominantly point sources (i.e., industrial effluents) to those that are mainly diffuse, such as agricultural run-off and acid deposition. Some of these are effectively continuous, whereas others are intermittent or episodic.

Pollutants can also be characterized by their quality: general organic loading, specific organic toxicants, inorganic toxicants, and acids. While most of the sources listed above produce mixtures of these characteristics, particular components are enhanced. Industrial effluents generally are the source of specific toxicants, but might also lead to general organic loading.

Some consideration should also be given to the types of system exposed to these pollutants. Most freshwater systems flow, but some more rapidly than others; that is, lakes and ponds have a slow throughput, the so called lentic systems whereas that for rivers and streams is rapid. Because they flow rapidly, the so-called lotic systems have been used for the transport of materials, such as removing industrial pollutants from factories and organic effluents from sewage works.

A view exists that lotic systems that depend substantially on organic inputs from terrestrial ecosystems as a basis for their economy should have the capacity for self-cleansing of at least organic pollutants. However, this perception has been challenged recently (Royal Commission on Environmental Pollution, 1992). Of course, “still” or so-called lentic waters may also be important repositories of pollutants, and are certainly exposed to diffuse inputs from agricultural land leading to eutrophication.

Thus, the challenge for aquatic ecotoxicology is to develop methods that can not only assess but also estimate the ecological impact of chemicals on a variety of complex ecosystems under diverse and complicated circumstances (e.g., periodic perturbations or steady trickles, and mixtures of varying complexity). The predictive approach is important in risk assessment used in the regulation of chemical pollutants. Assessment, at times referred to as a “retrospective approach,” is used to determine whether particular contaminants have an impact on specified natural ecosystems. This chapter reviews current methods, first predictive and then retrospective approaches, to address such problems. Initially, one must define what is to be measured, for it has relevance to both approaches.

10.1 Introduction

Industrial effluents, which are deteriorate their quality, and push them to the brink of extinction in the process of unplanned discharge, giving rise to the need for suitable conservation strategies for the receiving water body. Unfortunately, over the years, less attention has been given to industrial effluents world over. The degradation of the industrial effluents has altered their functions, affecting the ecological balance. The objectives of carrying out the physico-chemical and biological analyses of water bodies are as follows:

1. Generally, industrial effluent functions directly relate to their physical, chemical and biological integrity. Water quality evaluation for industrial effluent leads to information about their misuse by indicating the pollution status. 1st define water quality objectives as the overall direction and purpose of the industrial effluent and furthermore define goals as milestones to be met during the course of a book. Since the quality of aquatic life depends on the water quality, a thorough assessment of the water quality is an integral part of industrial effluent toxicity evaluation. The assessment of the chemical criteria of the industrial effluent helps in

11.1 Introduction

Generally, except particular cases, the typical civil wastewater do not present substantial differences according to the town where they are produced, therefore the type and the sequence of water treatment are nearly the same.

Conversely, the industrial wastewater characteristics are extremely varying according to the type of activity. For example, the oil industry wastewater will contain high concentrations of oily substances and hydrocarbons, the galvanic industry will produce heavy metal polluted wastewater, a food industry will produce wastewater containing biodegradable substances and so on. Consequently also the whole cycle of treatment, being aimed at the removal of particular pollutants, will be different according to kind of industry. The individual treatments of a wastewater treatment plant can be classified in different ways. According to the functioning principle it is possible to distinguish biological, physical and chemical treatments.

Biological plants are more commonly used to treat domestic or combined domestic and industrial wastewater from a municipality. They use basically the same processes that would occur naturally in the receiving water, but give them a place to happen under controlled conditions, so that the cleansing reactions are completed before the water is discharged into the environment.

Physico-chemical plants are more often used to treat industrial wastewaters directly, because they often contain pollutants which cannot be removed efficiently by microorganisms— although industries that deal with biodegradable materials, such as food processing, dairies, breweries, and even paper, plastics and petrochemicals, may use biological treatment. And biological plants generally use some physical and chemical processes, too.

12.1 Introduction

Volatile Organic Compounds (VOCs) are chemicals that evaporate easily at room temperature. The term “organic” indicates that the compounds contain carbon. VOC exposures are often associated with an odor while other times there is no odor. Both can be harmful. There are thousands of different VOCs produced and used in our daily lives.

13.1 Introduction

The World Bank Standards for water quality parameters show important because the acute and chronic impact on aquatic ecosystem causes very dangerous to the animals and human beings. It describes about the level of toxic concentration would be allowed to the aquatic ecosystem to survive living beings. The Indian standards also describes about the limit of toxic constituent, which are harmful to the aquatic living beings.

14.1 Introduction

The observation of phytosociology deals with the germination of growth on tree species in the industrial effluents. It shall be calculated germination potential based on germination capablility of the seeds. The growth parameters are measured then calculated leaf weight ratio, stem weight ratio, root weight ratio, top dry weight, sturdiness quatient, volume index and quality index. The following sub chapters dealing with formulae used to calculate the above parameters. The data so collected is then analyzed. The usual methods, which are employed in analysing the data, are averages, dispersion, skew ness, correlation, etc. The leaf weight ratio, stem weight ratio and root weight ratio are calculated by using the following formulae made by Kumaran (1991).

15.1 Introduction

Statistics is mostly used as a tool for assessing the capability of the system. Statistics refers to facts shown in numbers. Modern statistical methods and data are being found increasingly useful in research in different fields such as hydrology, biology, water quality and forestry etc. Statistics when used effectively becomes so intertwined in the whole fabric of the subjects to which it is applied. Statistics assists in planning the initial observations, organizing them and formulating hypothesis from them and in judging whether the new observations agree sufficiently well with the predictions from the hypothesis. In statistical methods, there is an operation of multiple causes and the investigator has only limited control over there. But statistical methods are found extremely useful in predicting the consequences of a situation. It requires skill for acquiring and handling data. There is a methodology to deal with the data and analysis of data is based on scientific and engineering strategies (Ramakrishnan, 1995).

In a huge rainfall data over a period of 300 years, it is not possible to observe all the items. Statistical methods are developed to estimate the error or deflection from the true or real value when we are taking inference from a sample for a hydrological data.

In the modern world where life sciences is getting more and more importance. To meet our environmental problems and energy requirements due to rapid industrialization and population growth, scop of life science has taken its new shape. Based on statistical analysis, new field like environmental sciences, hydrology, genetic engineering, biotechnology and biosociology have been evolved. Experiments about crop yields with different types of fertilizers and different types of soils or the growth of animal life and plant life under different environmental conditions and diets are very often designed and analyzed according to statistical method. Even in the field of medicine and public health, statistical methods are used for testing the efficacy of new medicine and method of treatments. As a matter of fact, for a research worker in any field, which is concern with numerical results, a study of statistical method is not only useful but also necessary. Hence it can be rightly by remarked “Science without statistics bears no fruit, statistics without science have no root”.

16.1 Conservative Technology

Recycling technology being practiced by ancient times by the people who used for municipal industrial effluent. In India the people in rural area, they collected cow dung in a pit. They applied a layer of soil on the cow dung to composting. After three to four months period, they used as manure for the agricultural fields. In a household waste, they collected as organic waste from a kitchen, store a pit allow it for decompose for conversion of compost. People who are residing in house constructed in a plot, they used to generate industrial effluent in a pit and cultivate a kitchen garden like vegetable crops and banana trees etc. in ancient times, the amount organic waste is limited and self purification is taken in small amount of organic waste therefore no organic pollution occurs in rural India.

17.1 Introduction

Bioenergy is an array of energy produced by biomass (organic matter) including liquid, solid, and gaseous fuels, electricity, heat, steam, biochemicals and materials. Biofuel is any plant derived organic matter available on a renewable basis, including dedicated energy crops and trees, agricultural food and feed crops, agricultural crop wastes and residues, wood wastes and residues, aquatic plants, animal wastes, municipal wastes, and other waste materials. An organic matter such as wood, plants, residues from agriculture or forestry, and the organic component of municipal and industrial wastes that can now be used as an energy source. Today, many bioenergy resources are replenished through the cultivation of energy crops, such as fast-growing trees and grasses, called bioenergy feedstocks.

18.1 Introduction

Recycling of industrial wastewater is not only environmentally beneficial, but it is typically more cost effective than conventional treatment and discharge. Through application of stream segregation and appropriate treatment technologies, high purity water is produced for continuous reuse where by metals are recovered and solid wastes reduced. Recycling of industrial effluent by chemical treatment includes many separation methods for getting pure waters. It is very essential to discuss about reverse osmosis, filtration, adsorption evaporation etc. This chapter includes the discussion about the methodology of chemical treatments.

18.2 Conventional Treatments

The oldest and most widely applied method of wastewater treatment involves the addition of chemicals and applications of aerators etc. to alter the make-up constituents of a waste. Although generally downsized, the process continues to play an important role in newer systems used today. Automated controls and advanced instrumentation have improved this technology in recent years. (Tomer et.al., 1997)

19.1 Introduction

The combination of two separate processes whereby water is lost on the one hand from the soil surface by evaporation and on the other hand from the tree by transpiration is referred to as evapotranspiration (ET).

19.2 Evaporation

Evaporation is the process whereby liquid water is converted into water vapour (vaporization) and removed from the evaporating surface (vapour removal). Water evaporates from a variety of surfaces, such as lakes, rivers, pavements, soils and wet vegetation. (Penman, 1963).

Energy is required to change the state of the molecules of water from liquid to vapour. Direct solar radiation and, to a lesser extent, the ambient temperature of the air provide this energy. The driving force to remove water vapour from the evaporating surface is the difference between the water vapour pressure at the evaporating surface and that of the surrounding atmosphere. As evaporation proceeds, the surrounding air becomes gradually saturated and the process will slow down and might stop if the wet air is not transferred to the atmosphere. The replacement of the saturated air with drier air depends greatly on wind speed. Hence, solar radiation, air temperature, air humidity and wind speed are climatological parameters to consider when assessing the evaporation process.

Where the evaporating surface is the soil surface, the degree of shading of the tree canopy and the amount of water available at the evaporating surface are other factors that affect the evaporation process. Frequent rains, irrigation and water transported upwards in a soil from a shallow water table wet the soil surface. Where the soil is able to supply water fast enough to satisfy the evaporation demand, the evaporation from the soil is determined only by the meteorological conditions. However, where the interval between rains and irrigation becomes large and the ability of the soil to conduct moisture to pear the surface is small, the water content in the topsoil drops and the soil surface dries out. Under these circumstances the limited availability of water exerts a controlling influence on soil evaporation. In the absence of any supply of water to the soil surface, evaporation decreases rapidly and may cease almost completely within a few days.

20.1 Introduction

High levels of energy and materials consumption in industrial countries are the driving force behind the decline in virtually all major life support systems on Planet Earth. Over the last decade an increasing number of scientists and other thoughtful people have come to conclude that modern levels of materials and energy consumption are having a destabilizing influence on the world’s ecosystems.

Energy consumption contributes directly to climate change by adding carbon-based molecules to the atmosphere in excess of naturally occurring amounts. Carbon molecules, primarily carbon dioxide from burning petroleum products, trap radiant heat and keep it from escaping from the Earth’s atmosphere. The resulting warming of the air is changing our global climate.

Materials consumption contributes indirectly to climate change because it requires energy to mine, extract, harvest, process, and transport raw materials, and more energy to manufacture, transport and, after use, dispose of products.

All the materials used in products, only 1% is used in products ‘durable’ enough to still be in use six months later, according to industrial ecologist Robert Ayres. This wasteful consumption of materials wreaks havoc on our land, water resources and their ecosystems. What’s seldom appreciated is that it also wreaks havoc on our atmosphere and contributes to climate change. Waste prevention and recycling are critical to stopping climate change.

21.1 Introduction

The industrial revolution, which began in the early 18th century in some countries of Europe, set in motion new forces in the environment and greatly changed the pattern of social life. Rapid industrialization and urbanization subsequently brought many changes in the environment and ecosystem. India also witnessed a phenomenon of industrial growth in the post independent era. Progress in the industrial development in Tamil Nadu during recent past is appreciable. New industries developed, existing industries expanded and new technologies are introduced.

In India, the past decades have witnessed population explosion and increase in per capita consumption of food and consumer goods. These have led to the proportionate increase in the domestic and industrial wastes. The waste is continuously increasing at an alarming rate. By the end of this century, India’s population is likely to increase from the present level of 700 million to about billion. Similarly the per capita consumption of food has been estimated to increase by 40% resulting in double production and disposal of industrial and domestic wastes (Manivanan, 2004).

Apart from the quantitative increase there will be also a qualitative change in the waste product, which are likely to contain greater amount of oil, toxic chemicals, detergents and dyes. A large number of these compounds are non-degradable and are cumulative, thus rendering the toxic products. Certain group of plants like algae and bacteria are selective in their functions and can executive certain toxic chemicals and heavy metals. The microorganism communities are helping in effective recycling of industrial effluents.

The government is taking serious efforts to keep the production of toxic substances under strict control at production centers. It carefully watches the efforts that are made to discharge the toxic waste from industries within the permissible limits and usages of toxic chemicals within the prescribed limits. The majority of rural population being uneducated is prone to excessive use of water which has become pollutant. The pollutant ultimately is drained into the natural aquatic environment, the rivers and the oceans. A part of these wastes are recycled and they again enter the food chain and cause detrimental effects to human health. Thus in nature, long and short term chain reactions are continuously in progress and these are required to be understood. Even when the best available yardsticks are applied to conserve the environment. It is a stupendous task to enforce these regulations.

In addition to production of more waste the coming years will see a qualitative change in the composition of waste. These wastes are likely to contain greater amount of toxic chemicals, detergents, non-degradable products based on hydrocarbons, and its derivatives. Large amount of wastes which are non degradable and cumulative in nature produce a series of new and complex problems. Therefore, alternative methods should develop for treatment and disposal of cumulative and nondegradable chemicals and pollutants.

1.1 Introduction to Numerical Method

There are three types by which problem / system can be solved and are analytical methods, graphical methods and numerical methods.

Analytical methods: This approach or methods are used to find the exact solution of simple problems / systems rather than complex systems. It provides the behavior and characteristic features of a particular system, but can only be used for systems which can be approximated through use of linear models. Another limitation is in the case of practical problems, consisting of complex and nonlinear equations / processes, as analytical methods cannot handle properly.

Graphical methods: This approach or methods are used to find the approximate solution of problems / systems through drawing of graphs for each of the equation and then check for the intersection of graphs. Intersection of graphs represents solution to system of equations, and no interaction or parallel lines of graphs represents no solution. This is not useful because of non-precise nature due to graphs drawing through hands, which also makes the process tedious. Another limitation is its viability for problems involving three or lesser dimensions.

Numerical methods: This approach or methods are used to find the approximate solution of problems / systems in a simpler way involving a large quantity of long arithmetic calculations, as compared to analytical methods. Numerical methods are the techniques by which mathematical problems are formulated to find the solution through arithmetic operations.

2.1 Introduction

Consider two linear equations in two variables i.e., x and y, such that equations are

4.1 Introduction

Numerical differentiation is the process of computing the function’s derivative values from the given set of numerical values when the actual form of the function is not known.

Similar to the numerical interpolation, a number of formulae for differentiation are derived in this chapter and are

1. Derivatives Based on Newton’s Forward Interpolation Formula: This is used to compute the derivative for some given x lying near the beginning of the data table.
2. Derivatives Based on Newton’s Backward Interpolation Formula: This is used to compute the derivative for a point near the end of the data table.
3. Derivatives Based on Stirling’s and Bessel’s Interpolation Formula: This is used to compute the derivative for some point lying in the middle of the data table.
4. Derivatives Based on Newton’s Divided Difference Formula: This is used to compute the derivative for some point when the data table is not equi- spaced.

5.1 Introduction

In applied mathematics the solution of problem generally consists of numbers which satisfy some kind of equation which are generally specified by numbers. But in practice it is found that these equations not always possible to express numerically or in exact decimal representative of the solution. Numerical methods are very important tools to provide practical methods for calculating the solutions of applied mathematics to a desired degree of accuracy. The wide use of electronic computers for solving problems in the fields of engineering, scientific, industry etc that further enhanced the scope of numerical methods.

The calculus of finite differences deals with the changes in the values of the function (dependent variable) due to changes in the independent variables. Again through this the relation of the values of the function is studied whenever the independent variable changes by finite jumps whether equal or unequal.

6.1 Introduction

Scientists and engineers have an experimental data of various variables in an experiment. To know the facts and to formulate related theories, they need exact relationship between such variables. So, they require the exact function which defines the outputs with introducing the inputs. For example,

Ohm’s law: which states that voltage of a circuit is proportional to the current flowing in it i.e.

7.1 Introduction

A Scottish mathematician David Gibb was firstly introduced a term ‘Numerical Integration’ in 1915. Like numerical differentiation, numerical integration is also a very useful tool for scientists and engineers especially when they have an experimental data for different variables without knowing any mathematical relationship between them. Beside it, there are also many other situations where it plays an important role for integrating the functions like:

8.1 Introduction

In the fields like Physics, Chemistry, Biology, Engineering and Economics; their laws and principles contains various parameters and their derivatives. The mathematical relationships of such parameters with their derivatives constitute the differential equations. In calculus, differential equations were firstly introduced by Newton and Leibnitz. Newton listed the three kinds of differential equations:

Stem cell research is one of the most important and promising areas of research in biological science in recent times. The stem cell technology has revolutionized modern biology. It is playing a major role for improving human as well as animal health by controlling number of incurable degenerative diseases and restoration of damage to organs via transplantation therapy. Stem cells are a specific group of cells that remain in an undifferentiated state and can be found in embryos, fetuses and adult individuals. Stem cells are primitive, undifferentiated cells present in almost every tissue that have the ability to differentiate into different types of tissue like bone, tendon, ligament, cartilage etc. Bone marrow stem cell is the ideal stem cell that is unspecialized and can undergo lineage specific differentiation into bone or blood cells under different signals or environment with new special function. Several verities of stem cells have been isolated and identified in vivo and in vitro. The two broad types of mammalian stem cells are embryonic stem cells that are found in blastocyst, and adult stem cells that are found in adult tissue, bone marrow.

Mesenchymal stem cells are multipotential cells capable of proliferation and differentiation into osteogenic, chondrogenic and adipogenic lineages both in vitro and in vivo. Minimal criteria for defining MSC according to International Society of Cell Therapy (ISCT) are (a) they must be plastic-adherent when maintained in a standard culture conditions, (b) MSC must express some surface antigen such as CD105, CD73, CD90, CD44 and must not express CD34, CD45, CD 14, CD19, and HLA-DR, and (c) MSC must differentiate in vitro into osteoblast, adipocytes and chondrocytes under specific differentiating condition.

Although traditionally MSC isolated from bone marrow, more recent reports have detailed the isolation of cells with MSC characteristics from a variety of tissues including umbilical cord blood, chorionic villi of the placenta, Wharton’s jelly, peripheral blood, fetal liver and lung, adipose tissue, skeletal muscle, periosteum, deciduous teeth, amniotic fluid, dental pulp, testis, synovium and the circulatory system. Bone marrow and periosteum sources are richest in young animals with their numbers diminishing, but still present in old age. It is estimated that MSCs represent approximately only 0.01 to 0.001% of the total nucleated cells within isolated bone marrow aspirate. The yield of MSCs from bone marrow varies from species to species. e.g., Canine =1 in 2.5 × 10⁴; Feline =1 in 3.8 × 10⁵; Murine =1 in 10.8 ×10³ to 1 in 3.45×10⁴ and Horses =1 in 4.2 × 10³. Despite this low number, they are remains a great interest, as they can be easily isolated from a small aspirate and culture-expanded through as many as 40 population doublings to significant numbers in about 8 to 10 weeks.

Bone marrow contains variety of tissues including hematopoietic lineage cells and mesenchymal stem cells (MSCs). The hematopoietic cells are the major source of the blood cells in the adult body which are regulated within the microenvironment of the stromal cells of the bone marrow. MSCs are multipotent cells and can be differentiate into various cell lineage depend upon their environment and culture condition in which they are kept. Rat bone marrow derived stem cells (rBM-MSCs) have long term self renewing and capabilities of pluripotency including osteoblast, adipocytes, chondrocytes, tenocytes, muscle cells and neurogenic cells, which make them ideal source of stem cells for regeneration of injured tissue.

Bone marrow derived mesenchymal stem cells have been isolated from different species. Each species is having different culturing and growing capacity. For example human bone marrow derived stem cells are easy to harvest and maintain in culture condition whereas rat MSCs it is more difficult compared to other species. Technical difficulties in isolation limited the number of animal experiment and its required animal transplantation model for pre clinical studies. Density gradient centrifugation, plastic adherence and immunomagnetic selection like various methods are available for isolation of MSCs from bone marrow. No appropriate methods are available for selection of suitable cells. Each method has their own pros and cons. Therefore, in this chapter, combined density gradient centrifugation and plastic adherence as easy and reliable method for isolation, culture and characterization of rat bone marrow derived mesenchymal stem cell is described.

Mesenchymal stem cells are multipotential cells capable of proliferation and differentiation into chondrogenic, osteogenic and adipogenic lineages. Minimal criteria for defining MSC according to International Society of Cell Therapy (ISCT) are (a) they must be plastic-adherent when maintained in standard culture conditions, (b) MSC must express some surface antigens such asCD105, CD73, CD90, CD44 and must not express CD34, CD45, CD 14, CD19, and HLA-DR, and (c) MSC must differentiate in vitro into osteoblast, adipocytes and chondrocytes under specific differentiating condition. 
Although MSC is traditionally isolated from bone marrow, more recent reports have detailed the isolation of cells with MSC characteristics from a variety of tissues including umbilical cord blood, chorionic villi of the placenta, Wharton’s jelly, peripheral blood, fetal liver and lung, adipose tissue, skeletal muscle, periosteum, deciduous teeth, amniotic fluid and synovium. Bone marrow and periosteum sources are richest in young animals with their numbers diminishing, but still present in old age. One of the attractive advantage of bone marrow derived mesenchymal stem cells (BM-MSCs) as a source of cell transplantation is their low immunogenecity. Recently, several studies have reported that BM-MSCs may be immune-privileged cells that do not elicit immune response due to an absence of their immunologically relevant cell surface markers. BM-MSCs also are known to inhibit proliferation of T lymphocytes, B lymphocytes, dendritic cells and natural killer cells.

The knowledge and principles from interconnected disciplines of bioengineering, material science and life sciences are combined in tissue engineering with the aim of developing a construct that can wholly or partly restore/maintain/augment the function of a damaged tissue or organ. Tissue engineering construct generally comprises cells on a suitable scaffold. The ultimate functionality of a tissue engineering construct is mainly dependent on the cell behavior on scaffolds. The proliferation and cell viability on scaffolds varies from one cell type to another and from one species to another. So it is important to investigate individual cell-scaffold combinations.

The similarity in structure and composition to bone mineral, osteoconductive properties, ability to integrate with the bony tissue and absence of immune response makes hydroxyapatite [Ca10 (PO4)6(OH)2] the choice of calcium phosphate biomaterial with only disadvantage of slow rate of resorption. On contrary, silica–calcium phosphate composite in comparison to calcium phosphate is rich biomaterials having a faster resorption rate. Studies have shown that coating of hydroxyapatite with a calcium silicate containing layer encourages cell proliferation and osteogenic differentiation of human bone marrow-derived stromal cells.

In this chapter a composite scaffold (calcium silicate, hydroxyapatite and tricalcium phosphate), namely HASi with elements in the following percentages: 66.36 % - calcium, 25.35 % - phosphorus and silicon - 8.29 % and porosity of 50 – 500 µm is undertaken to evaluate the rBMSC proliferation and differentiation properties in vitro with the aim of assessing cytocompatibility of HASi and rBMSC in terms of cell attachment, cell morphology, cell proliferation and osteogenic differentiation.

Fracture healing is a complex process in which damaged bone restores its original architecture through a cascade of molecular and cellular events. The process of fracture healing is unique, in that it does not form a poorly organized replacement matrix, otherwise known as scar tissue, but rather regenerates the original matrix and retains its mechanical properties. Normal fracture and bone repair follows a known sequence of events includes: haematoma formation, inflammation, angiogenesis, osteogenesis, and bone remodeling.

For the repair of bone defects, a tissue engineering approach would be to combine cells capable of osteogenic (i.e. bone-forming) activity with an appropriate scaffolding material to stimulate bone regeneration and repair. An ideal tissue-engineered bone substitute should possess 3 elements: osteoprogenitor cells, osteoinductive factors, and an osteoconductive scaffold, and is considered as a potential substitute for autologous bone transplantation. Tissue engineering approaches have proven very effective in bone regeneration recently, and the successful repair of bone defects has been demonstrated in larger animals like canine, goat and sheep.

Stem cells from adult tissues are attractive materials for cell therapy, gene therapy, and tissue engineering. These cells generally have restricted lineage potential when compared to embryonic stem cells, and this may be advantageous in certain therapeutic applications. Till and McCulloch in 1961 describes the presence of hematopoietic progenitor cells in bone marrow. After this, the concept of MSCs is brought to light by Friedenstein and co-workers who demonstrated the osteogenic potential of BM cells by heterotrophic transplantation.

Despite the benefits that minimally invasive surgery and osteosynthesis have brought to fracture management and bone healing, there are still many circumstances where bone healing remains challenging. Large bone defects are serious complications that are most commonly caused by extensive trauma, tumour, infection, or congenital musculoskeletal disorders. In nonunion cases repairing of bone defects with composite biomaterials as defect filler can promote bone regeneration. Currently, the gold standard for bone regeneration is use of autogenous bone graft. In order to avoid morbidity at the donor site or if large amount of autogenous bone is needed, bone substitution materials can be used.

Bone substitution materials can be combined with cells such as mesenchymal stem cells (MSCs) to increase bone formation. Bone-marrow derived mesenchymal stem cells (BMSCs) represent an attractive cell population for tissue regeneration. Bone marrow stem cells are pluripotent cells that have been used to facilitate bone repair because of their capability of differentiating into osteoblasts. Several studies on the regeneration of bone have shown that cultured BMSCs, seeded on different bioabsorbable implants are able to induce bone formation in vivo and lead to improved healing of critical-size defects.

Disruption of the cellular or anatomical continuity of the normal organ structure is known as wound. Healing involves migration, infiltration, proliferation and differentiation of several cell types like keratinocytes, fibroblasts, endothelial cells, macrophages, and platelets which are culminate as an inflammatory response, new tissue formation and wound closure. Healing of the wound starts from the moment of the injury and can continue for varying periods of time depending on the extent of wound. The process of wound healing involves coagulation, inflammation, formation of granulation tissue, matrix formation, remodeling of connective tissue, collagenization and acquisition of wound strength.

Chitosan is a -1, 4-linked polymer of glucosamine (2-amino-2-deoxy—D-glucose) and lesser amounts of N-acetylglucosamine. It is a derivative of chitin (poly-Nacetylglucosamine) which is the second most abundant biopolymer after cellulose. Chitosan is first discovered in 1811 by Henri Braconnota, a French chemist and pharmacist. Later in the century, chitin is found in crustaceans (such as crabs, lobsters, shellfish and shrimp). Chitosan is a biodegradable polymer and it accelerates wound healing. It has been reported that chitosan permits regeneration of tissue elements in skin wounds and has positive application effects on wound healing.

The cornea is the anterior transparent part of the fibrous tunic of the globe which has both mechanical and optical function. It functions to support the intraocular contents and transmit and refract light. Histologically, the cornea is composed of an outer stratified squamous corneal epithelium and its basement membrane, an underlying collagenous stroma, a thin acellular membrane, and an inner monolayer of cells, the corneal endothelium. In dogs, the central cornea is thinner than the peripheral cornea, whereas regional differences in thickness may not exist in cats. The active pumping mechanism of corneal endothelium and the barrier function of anterior epithelium keep the cornea in a state of relative dehydration. Compromise of either of these mechanisms will allow corneal edema to develop, with a concomitant increase in corneal thickness. Corneal ulceration is one of the most common ophthalmic disorders in veterinary medicine. Corneal ulcers are classified based on depth and ease of healing. There are several phases during the corneal epithelial wound healing process, including a lag phase where cells alter their metabolic status; a migration phase to cover the bare surface; a proliferation phase and a differentiation phase, where cells stratify and re-establish multiple layers of distinct cells. Methods of surgical treatment for canine corneal ulcers include temporary tarsorrhaphy, third eyelid flap, conjunctival pedicle graft, tissue adhesive, corneo-scleral graft and transplantation of natural or synthetic material.

Full thickness burn wound will not heal spontaneously which need early excision and adequate coverage to prevent fluid loss and risk of infection. Major portion of the skin is lost during burn injury which is the active layer for protecting the entry of micro organism from outside environment. So far, meshed autologous skin graft is regarded as the gold standard for treating extensive full thickness burns. However, their frequent use may be hampered by several impediments such as limited availability, donor site morbidity, associated with additional scarring. Severe burn patients invariably lack additional skin donor site. Moreover, creation of donor site in burned patient is equivalent to second degree burn and which further increase the total body surface area affected (TBSA). In past decades, numerous biomaterials have been investigated for the use as a dermal skin substitute for burn patients but none give promising results. The innovative tissue engineered bioactive materials offer potential tissue regeneration and prevent the tissue deterioration.

The extracellular matrix (ECM) derived naturally from mammalian tissue have been successfully used as scaffold for tissue reconstruction and wound management in clinical applications. ECM can be derived from various tissue or organs of different species but most commonly, porcine small intestinal submucosa and urinary bladder have been successfully used as scaffold for reconstruction. ECM is obtained by process of decellularization that involves the use of various ionic and non ionic detergents, acids, enzymatic solutions and mechanical/physical methods.

Burn wounds are considered to be one of the most devastating kinds of trauma that affect the physical, physiological and psychological well being of an individual. Based on the depth of the affected area, burn wound is divided into three categories: first degree (superficial), second degree (partial) and third degree (full thickness). Extensive and deep burns result in scar formation and subsequent deformation of the affected part. Healing of burn wound involves several interrelated and overlapping stages such as inflammatory, proliferative and remodeling phases. The interaction of a variety of mediators, cells and extracellular matrix proteins are involved in this three phases of healing.

Burn wound therapy has been performed in various ways such as bioengineered skin grafts and administration of growth factors. Small intestinal sub-mucosa (SIS) is a resorbable xenogenic bioscaffold that has induced constructive remodeling in variety of animal models. It is unique from other acellular matrices as it contains few growth factors such as fibroblast growth factor (FGF) and transforming growth factor (TGF) that play a role in the regenerative process. Chitosan is currently proposed to be one of the most promising polymers in wound dressing development and it accelerates wound healing. Epidermal growth factor is known to stimulate growth of keratinocytes in vitro, thus it might be expected to promote wound healing.

In this chapter efficacy of Chitosan and porcine acellular small intestinal sub-mucosal (SIS) matrix seeded with bone marrow derived mesenchymal stem cells (BM-MSCs) and recombinant murine epidermal growth factor (m-EGF) on healing of full thickness burn wound in rat model is described.