According to theFactories Act,1948, a 'factory' means "any premises including the precincts thereof - (i) whereon ten or more workers are working, or were working on any day of the preceding twelve months, and in any part of which a manufacturing process is being carried on with the aid of power, or is ordinarily so carried on, or (ii) whereon twenty or more workers are working, or were working on any day of the preceding twelve months, and in any part of which a manufacturing process is being carried on without the aid of power, or is ordinarily so carried on; but this does not include a mine subject to the operation of theMines Act, 1952, or a mobile unit belonging to the armed forces of the union, a railway running shed or a hotel, restaurant or eating place."The Act is administered by theMinistry of Labour and Employmentthrough itsDirectorate General Factory Advice Service & Labour Institutes (DGFASLI)and by the State Governments through their factory inspectorates. DGFASLI was set up with the objective of advising the Central and State Governments on administration of the Factories Act and coordinating the factory inspection services in the States. It serves as a technical arm to assist the Ministry in formulating national policies on occupational safety and health in factories and docks. It also advises factories on various problems concerning safety, health, efficiency and well-being of the persons at work places. No adult worker shall be required or allowed to work in a factory:- (i) for more than forty-eight hours in any week; and/ or (ii) for more than nine hours in any day.

Where a worker works in a factory for more than nine hours in any day or for more than forty-eight hours in any week, he shall, in respect of overtime work, be entitled to wages at the rate of twice his ordinary rate of wages. The 'ordinary rate of wages' means the basic wages plus such allowances, including the cash equivalent of the advantage accruing through the concessional sale to workers of foodgrains and other articles, as the worker is for the time being entitled to, but does not include a bonus and wages for overtime work.

Where a worker is deprived of any of the weekly holidays, he shall be allowed, within the month in which the holidays were due to him or within the two months immediately following that month, compensatory holidays of equal number to the holidays so lost.

The periods of work of adult workers in a factory each day shall be so fixed that no period shall exceed five hours and that no worker shall work for more than five hours before he has had an interval for rest of at least half an hour.

Every worker who has worked for a period of 240 days or more in a factory during a calendar year shall be allowed during the subsequent calendar year, leave with wages for a number of days calculated at the rate of - (i) if an adult, one day for every twenty days of work performed by him during the previous calendar year; (ii) if a child, one day for every fifteen days of work formed by him during the previous calendar year. In the case of a female worker, maternity leave for any number of days not exceeding twelve weeks.

In order to safeguard the health of the workers:- Every factory shall be kept clean and free from effluvia arising from any drain, privy or other nuisance and in particular accumulations of dirt.

Effective arrangements shall be made in every factory for the treatment of wastes and effluents due to the manufacturing process carried on therein, so as to render them innocuous and for their disposal.

Effective and suitable provision shall be made in every factory for securing and maintaining in every workroom adequate ventilation by the circulation of fresh air; and such a temperature that will secure to workers reasonable conditions of comfort and prevent injury to health.

No room in any factory shall be overcrowded to an extent injurious to the health of the workers employed therein.

Every part of a factory, where workers are working or passing, shall be provided with sufficient and suitable lighting, natural or artificial, or both.

In every factory effective arrangements shall be made to provide, at suitable points conveniently situated for all workers employed therein, a sufficient supply of wholesome drinking water.

In order to ensure safety of the workers:- Every dangerous part of any machinery shall be securely fenced and constantly maintained to keep it in position.

No young person shall be required or allowed to work at any dangerous machine unless he has been fully instructed as to the dangers arising from it and the precautions to be observed as well as has received sufficient training in work at the machine.

No woman or child shall be employed in any part of a factory for pressing cotton in which a cotton-opener is at work (subject to the given conditions).

In every factory every hoist and lift shall be - (i) of good mechanical construction, sound material and adequate strength; (ii) properly maintained, and thoroughly examined by a competent person at least once in every period of six months.

No person shall be required or allowed to enter any chamber, tank, vat, pit, pipe, flue or other confined space in any factory in which any gas, fume, vapour or dust is likely to be present to such an extent as to involve risk to the workers, unless it is provided with a manhole of adequate size or other effective means of egress.

Certain facilities to be provided to the workers:- Every factory shall provide and maintain readily accessible first-aid boxes or cupboards equipped with the prescribed contents, and the number of such boxes or cupboards shall not be less than one for every one hundred and fifty workers ordinarily employed at any one time in the factory.

In any factory wherein more than two hundred and fifty workers are ordinarily employed, a canteen or canteens shall be provided and maintained by the occupier for the use of the workers.

In every factory wherein more than one hundred and fifty workers are ordinarily employed, adequate and suitable shelters, rest rooms and lunch room, with provision for drinking water, where workers can eat meals brought by them, shall be provided and maintained for the use of the workers.

In every factory wherein more than thirty women workers are ordinarily employed, there shall be a suitable room or rooms for the use of children under the age of six years of such women. Such rooms shall provide adequate accommodation, lighting and ventilation with clean and sanitary condition.

Pollution prevention in pharma industryAs pollution in pharma factories is increasing now, it's become obvious that environmental problems should be closely interwoven and treated in concert.Monisha Narke, Director, Klenzaids GMP Academy gives a few suggestionsNear the end of the first decade of this millennium we are too late to realise that our concentration on conformance, regulatory mandates, legislation, command-control methods was inane, not the way, not the noble way our care-providing, life-giving industry needed to operate. Only now we realise that only the more simplistic pollution problems have been addressed. Only a limited number of obvious sources have been mitigated. Only a few readily definable pollutants from their emissions have been eliminated. While the health hazards of a host of additional toxic pollutants are released to the environment. Inexplicably, air, water, and waste are treated as separate problem areas to be governed by their own statutes and regulations evolved in the last century. Only now it's become obvious that environmental problems are closely interwoven and should be treated in concert. The traditional type of regulation command and control has severely restricted compliance options.Societal responsibility of pharma companies is an overriding criterion. This presentation sets forth the means and methods to fulfill that obligation over and above and well beyond meeting environmental regulations.Multimedia analysisTo properly design and then implement a pollution prevention program, sources of all wastes must be fully understood and evaluated. A multimedia analysis involves a multifaceted approach. It must not only consider one waste stream but all potentially contaminant media e.g., air, water, solids. Earlier waste-management practices have been concerned primarily with treatment. All too often, such methods solve one waste problem by transferring a contaminant from one medium to another like air stripping. Such waste shifting is neither pollution prevention nor waste reduction.Pollution prevention techniques need to be evaluated through a thorough consideration of all media. This approach is a clear departure from previous pollution treatment or control techniques, where it was acceptable to transfer a pollutant from one source to another in order to solve a waste problem. Such strategies merely provide short-term solutions to an ever-increasing problem. As an example, air pollution control equipment prevents or reduces the discharge of waste into the air but at the same time can produce a hazardous environmental problem.

Life-cycle analysisThe approach to evaluating a pharma product's waste streams aims to ensure that the treatment of one waste stream does not result in the generation or increase in a secondary waste output. Environmental impacts resulting during the production of a product or service must be evaluated over its entire history or life-cycle.This life-cycle analysis or total systems approach is crucial to identifying opportunities for improvement. This type of evaluation identifies energy use, material inputs, and waste generated during a product's life from extraction and processing of raw materials to manufacture and transport of a product to the marketplace and finally to use and disposal of the product.Assessment proceduresThe first step in establishing a pollution prevention program is the obtainment of management commitment. This is necessary given the inherent need for project structure and control. Management will determine the amount of funding allotted for the program as well as specific program goals.The data collected during the actual evaluation is then used to develop options for reducing the types and amounts of waste generated.After a particular waste stream or area of concern is identified, feasibility studies are performed involving both economic and technical considerations. Finally, preferred alternatives are implemented. The four phases of mitigation ie planning and organisation, assessment, feasibility and implementation are:Planning and organisationBoth managers and facility staff play important roles in providing the necessary commitment and familiarity with the facility, its processes, and current waste-management operations. It is the benefits of the program, including economic advantages, liability reduction, regulatory compliance, and improved public image that often leads to management support.Assessment phaseThe assessment phase aims to collect data needed to identify and analyse pollution-prevention opportunities. Assessment of the facility's waste-reduction needs include the examination of hazardous waste streams, process operations, and the identification of techniques that often promise the reduction of waste generation. Information is often derived from observations made during a facility walk-through, interviews with employees eg operators, line workers and review of site or regulatory records.The use of process flow diagrams and material balances are worthwhile methods to quantify losses or emissions and provide essential data to estimate the size and cost of additional equipment, other data to evaluate economic performance, and a baseline for tracking the progress of minimisation efforts.The data collected is then used to prioritise waste stream and operations for assessment. Each waste stream is assigned a priority based on corporate pollution-prevention objectives. One of the key element of the assessment phase of a pollution-prevention program involves mass balance equations. Mass in - mass out + mass generated = mass accumulated. This equation can be applied to the total mass involved in a process or to a particular species, on either a mole or mass basis. The conservation law for mass can be applied to steady-state or unsteady-state processes and to batch or continuous system. A steady-state system is once in which there is no change in conditions eg temperature, pressure or rates of flow with time at any given point in the system; the accumulation term then becomes zero. If there is no chemical reaction, the generation term is zero. All other processes are classified as unsteady state.Feasibility analysis phaseMass balance calculations are particularly useful for quantifying fugitive emissions such as evaporative losses. Waste stream data and mass balances will enable one to track flow and characteristics of the waste streams over time. Since in most cases the accumulation equals zero, it can then be assumed that any build-up is actually leaving the process through fugitive emissions or other means. This will be useful in identifying trends in waste/pollutant generation and will also be critical in the task of measuring the performance of implemented pollution prevention options.Primary production ie API processes per se are environmentally polluting. Both air and wastewater management require significant organisational and operational interventions to promote the goals of sustainable life-cycle designs that address cost, performance, societal and legal factors.Let's first take air pollution. In reality gaseous pollution, this may be classified as inorganic or organic, inorganic or paparticulate. [ 1 ]Inorganic pollutants: Sulfur gases: Sulfur dioxide, sulfur trioxide, hydrogen sulfide Oxides of carbon: Carbon monoxide, carbon dioxide Nitrogen gases: Nitrous oxide, nitric oxide, nitrogen dioxide and other nitrous oxides Halogens: Halides, Hydrogen fluoride, hydrogen chloride, chlorine, fluorine, silicon tetra fluoride Photochemical products: Ozone, oxidants Cyanides: Hydrogen cyanide Ammonium compounds: AmmoniaChlorofluorocarbonsOrganic pollutants:Hydrocarbonsa. Paraffins: Methane, ethane, octaneb. Acetylenec. Olefins: Ethylene, butadiened. Aromatics: Benzene, toluene, benzpyrene, xylene, styreneAliphatic oxygenated compoundsa. Aldehydes: Formaldehydeb. Ketones: Acetone, methylethylketonec. Organic acidsd. Alcohols: Methanol, ethanol, isopropanole. Organic halides: Cyanogen, chloride bromobenzyle cyanidef. Organic sulfides: Dimethyl sulfideg. Organic hydroperoxides: Peroxyacetyl nitrate or nitrateParticulate pollutantsParticulates are solid or liquid matter whose effective diameter is larger than a molecule but smaller than approximately 100 m. Particulates dispersed in a gaseous medium are collectively termed as aerosol. Dust is typically formed by the pulverisation or mechanical disintegration of solid matter into particles of smaller size by processes such as for example, electrostatic powder coating is being performed and particulates become entrained in the space surrounding the workstation. Such airborne particulates pose a health hazard to the workers and the release of those same particles to ambient cause a significant environmental problem.[ 1 ] To mitigate these pollutants, Klenzaids has developed a composite air-filtration system, which has found favour with pharma manufacturers, big and small, and has become a universal solution. The system exploits multi-technologies and is detailed elsewhere in this issue.Implementation phaseThe driving force behind any pollution-prevention plan is the promise of economic opportunities. Pollution prevention is now recognised as one of the lowest-cost options for waste pollutant management. Hence, an understanding of the economics involved in pollution prevention program options is quite important in making decisions at both the engineering and management levels.Before the true cost or profit of a pollution-prevention program can be evaluated, the factors contributing to the economics must be recognised. There are two traditional contributing factors; capital costs and operating costs, but there are also other important costs and benefits associated with pollution prevention that need to be quantified, if a meaningful economic analysis is going to be performed.Each company and organisation has its own economic criteria, for selecting projects for implementation. For example, a project can be judged on its payback period. For some companies, if the payback period is more than three years, it is a dead issue. For smaller facilities with only a few and perhaps simple processes, the entire pollution-prevention assessment procedure will tend to be much less formal. In this situation, several obvious pollution-prevention options such as the installation of flow controls and good operating practices may be implemented.Lead-outGiven the evolutionary nature of pollution prevention, it is evident that as technology changes and continued progress is achieved, society's opinion of both what is possible and desirable will also change. Government officials, scientists, and engineers will face new challenges to fulfill society's needs while concurrently meeting the requirements of changing environmental regulations. It is now apparent that attention should also be given to ethical considerations and their application to pollution prevention policy.If one chooses today not to implement a waste-reduction program in order to meet a short-term goal of increased productivity, this might be considered a good decision since it benefits the company and its employees. Should a major release occur that results in the contamination of a local sole-source of drinking water, what then?Toxicological studies have indicated that test animals exposed to small quantities of toxic chemicals had better health than control groups that were not exposed. A theory has been developed that says that a low-level exposure to the toxic chemical results in a challenge to the animal to maintain homeostasis; this challenge increases the animal's vigour and, correspondingly, its health. However, larger doses seem to cause an inability to adjust, resulting in negative health effects. Based on this theory, some individuals would believe that absolute pollution reduction might not be necessary.