eChapters

Even though we are now in the atomic age, the idea of the atom is not new. More than 2,000 years ago, the Greek philosopher Democritus suggested that any matter is composed of tiny indestructible particles called Atoms. The word atom is derived from the Greek word Atoms meaning something that can not be cut further. However not much attention was paid to this concept till 1808, when Dalton proposed the famous “Atomic theory”. According to this theory, “all matter is composed of tiny indivisible particles called ‘Atom’. Combining the ideas of Lavoisier, Boyle and his own, Dalton proposed that atoms of elements combine together to make molecules of a compound. This was a great step in the concept of the atom and compounds, since this gave a clear picture of how the supposedly smallest particles of matter called atoms could be put together to form the various familiar substances found in nature.

2.1 Isotopes

In 1913, J.J. Thomson and Aston introduced atmospheric neon into the positive ray apparatus and got two parabolas corresponding to masses 20 and 22, with the intensities of the tracks corresponding to the ratio of 9:1, irrespective of the condition of discharge and pressure. This indicated that neon existed in two forms having atomic weights 20 and 22, and at the same time it could not be distinguished chemically. These two types are known as isotopes of neon (iso = same, topas = place in the periodic table). When the average atomic weight of the ordinary neon was calculated based on the abundance of these two forms in the ordinary neon, it was found to be 20.2 which agreed the chemical methods. Thus the existence of isotopes of a given element was discovered.

Formerly isotopes were defined chemical properties but with different atomic weights, the same atomic number and occupying the same position in the periodic classification. Later this definition was slightly modified and now isotopes are defined as nuclides with the same number of protons but differing in the number of neutrons, for example, ordinary hydrogen (also called protium ; proton =1 and neutron =0), deuterium (heavy hydrogen ; proton =1 and neutron = 1), and tritum super heavy hydrogen (proton =1 and neutron =2). Investigations using mass spectrographs have revealed more than 280 isotopes which are stable artificially radioactive isotopes.

Radioactivity

The discovery of radioactivity, in general, actually came about on a few different fonts. First was the discovery of x-ray radiation that was artificially generated in a laboratory, followed by the discovery of several elements that naturally emit radiation when the nucleus of the atoms disintegrates or decay. These are the elements that today are called radioactive elements and are said to have unstable nuclei.

4.1 Selection of Isotopes for Tracer Studies

In radioisotopes we have all the essentials of a powerful research tool, a non-destructive means by which atoms could be followed and detected in the organism. Application mainly depends on the fact that chemical properties of the isotope of an element are essentially identical.

The basic requirement of a tracer is that it be

1.Chemically and physically, virtually equivalent to the substance it represents or displaces and that it, in no appreciable way, affect the system differing from its normal counterpart.

2.Radioactivity could be detected directly and

3.Unaffected by the physical or chemical treatments that are given. Hence, this has been used widely in the investigations of the various problems in biology, chemistry, physics and other fields like agriculture.

Carbon dating uses the half-life of Carbon-14 to find the approximate age of an object that is 40,000 years old or younger.

5.1 What is radiocarbon dating ?

Radiocarbon dating is a method of estimating the age of organic material. It was developed right after World War II by Willard F. Libby and coworkers, and it has provided a way to determine the ages of different materials in archeology, geology, geophysics, and other branches of science. Some examples of the types of material that radiocarbon can determine the ages are wood, charcoal, marine and freshwater shell, bone and antler, and peat and organic-bearing sediments. Age determinations can also be obtained from carbonate deposits such as calcite, dissolved carbon dioxide, and carbonates in ocean, lake, and groundwater sources.

Although a number of radioactive isotopes are found in nature, most of the isotopes used as radioactive tracers are produced artificially. Methods for producing radioactive isotopes include nuclear fission and the bombardment of selected materials by neutrons or positively charged particles.

6.1 Production of Radioactive Nuclides

Nuclear Reactors

In a nuclear reactor, a fissionable nuclear fuel such as ²³⁵U or ²³⁹Pu is placed in a defined geometry within the reactor core. Fast moving neutrons released as the ²³⁵U or ²³⁹Pu nuclei fission are slowed to thermal energy (0.025 eV) by a low-Z moderator such as water, heavy water, beryllium, or graphite surrounding or mixed intimately with the nuclear fuel. The slowly moving neutrons are absorbed by addition of ²³⁵U or ²³⁹Pu nuclei, and a chain reaction is maintained. The rate of absorption of slow neutrons by fissionable nuclei determines the fission rate for the reactor and is controlled by placing inert neutron absorbers in the reactor core. Typical neutron absorbers, usually termed control roads include boron and calcium. Heat generated in the reactor is removed by a coolant such as water or one of a variety of gases or liquid materials.

7.1 Measurement of Radiation Dose

Radiation dosimetry involves the measurement of the energy actually absorbed in a substrate exposed to ionizing radiation. The radiation may be either electromagnetic or corpuscular in nature. The passage of electromagnetic radiation through a substrate causes ionization by virtue of the secondary electrons released. Particle radiations on the other hand, ionize directly because they are charged, or indirectly through the charged particle resulting from a collision with a substrate. Alpha, beta particles, and protons yield primary ionization. Gamma rays and neutrons produce ionizing radiation by their interaction with the substrate in passage through it.

Although some forms of electromagnetic energy, such as light and heat, can be detected by the human senses. One of the greatest draw backs to high energy radiation is the inability to detect it. We cannot see, feel, taste, smell, or hear the various forms of ionizing radiation. Fortunately, ionizing radiation interacts with matter which makes detection and measurement possible by utilizing specialized equipment. In this section we want to introduce you to the various ways and means of detecting and measuring ionizing radiation.

As mentioned previously, Becquerel discovered radioactivity because it left marks on photographic film as a means of detecting radiation. However, there are more definitive means commonly used by scientists and technicians who study and work with radiation. The equipment utilized for the detection and measurement of radiation commonly employs some type of a substance or material that responds to radiation. Many common methods use either an ionization process or molecular excitation process as a basis. Remember that we stated earlier that radiation interacts with matter. For detection and measurement purposes the process of ionization is the most commonly employed technique, based on the principle of charged particles producing ion pairs by direct interaction. These charged particles may collide with electrons, which remove them from their parent atoms, or transfer energy to an electron by interaction of electric fields.

9.1 Potential Tracer Difficulties and their Corrections

In radioactive measurements, the observed counting rate is not equal to the true disintegrations rate of the sample since a number of factors like nature of detectors tend to increase it or, in a majority of cases, decrease the actual counts. Some of the important factors responsible for this are

1.Background,

2.Backscattering

3.Absorption

4.Self absorption

6.Geometry

7.Instrument efficiency

Radionuclides are used in two major ways: for their chemical properties and as sources of radiation.

Radionuclides of familiar elements such as carbon can serve as tracers because they are chemically very similar to the non-radioactive nuclides, so most chemical, biological, and ecological processes treat them in a near identical way. One can then examine the result with a radiation detector, such as a Geiger counter, to determine where the provided atoms ended up. For example, one might culture plants in an environment in which the carbon dioxide contained radioactive carbon; then the parts of the plant that had laid down atmospheric carbon would be radioactive.

In medicine, radioisotopes are used for diagnosis, treatment, and research. Radioactive chemical tracers emitting gamma rays that can provide diagnostic information about a person’s internal anatomy and the functioning of specific organs. This is used in some forms of tomography single emission computed tomography and positron emission tomography scanning. Radioisotopes are also a promising method of treatment in hemopoietic forms of tumors, while the success for treatment of solid tumors has been limited so far. More powerful gamma sources are used to sterilize syringes and other medical equipment. About one in two people in Western countries are likely to experience the benefits of nuclear medicine in their lifetime.

In biochemistry and genetics, radionuclides are used to label molecules and allow tracing chemical and physiological processes occurring in living organisms, such as DNA replication or amino acid transport.

In the Radiochemical Laboratory

The following are some illustrative recommendation which may be used selected as a guide for setting up working rules :

General

No unnecessary materials should be brought into the laboratory. No unnecessary work should be done there.

Eating, drinking, and the use of cosmetics in the laboratory should be forbidden. Radioactive materials should not be place in milk bottles, soft drink bottles, or other vessels that might be inadvertently used for food purposes.

Record should be kept of radioactivity brought into the building and of its disposition.

Accuracy

The degree of closeness of the determined value to the nominal or known true value under prescribed conditions. This is sometimes termed trueness.

Analyte

A specific chemical moiety being measured, which can be intact drug, bio molecule or its derivative, metabolite, and/or degradation product in a biologic matrix.

Analytical run (or batch)

A complete set of analytical and study samples with appropriate number of standards and QCs for their validation. Several runs (or batches) may be completed in one day, or one run (or batch) may take several days to complete.

Biological matrix

A discrete material of biological origin that can be sampled and processed in a reproducible manner. Examples are blood, serum, plasma, urine, faces, saliva, sputum, and various discrete tissues.

TQM is an integrative philosophy of management for continuously improving the quality of products and processes. It is used around the world.

TQM functions on the premise that the quality of products and processes is the responsibility of everyone who is involved with the creation or consumption of the products or services offered by an organization. In other words, TQM capitalizes on the involvement of management, workforce, suppliers, and even customers, in order to meet or exceed customer expectations. Considering the practices of TQM as discussed in six empirical studies, Cua, McKone, and Schroeder (2001) identified the nine common TQM practices as cross-functional product design, process management, supplier quality management, customer involvement, information and feedback, committed leadership, strategic planning, cross-functional training, and employee involvement.

TQM and Six Sigma

The Six Sigma management strategy originated in 1986 from Motorola’s drive towards reducing defects by minimizing variation in processes. The main difference between TQM and Six Sigma is the approach Six Sigma is a business management strategy originally developed by Motorola, USA in 1986. As of 2010, it is widely used in many sectors of industry, although its use is not without controversy.

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.