According to the Factories 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 the Ministry of Labour and
Employment through 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 industry

As 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
suggestions
Near the end of the first decade of this millennium we are too late to realise that
our concentration on conformance, regulatory mandates, legislation, commandcontrol 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 analysis

To 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 wastemanagement 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 analysis
The 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 procedures
The 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 organisation
Both 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 phase
The 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 steadystate or unsteady-state processes and to batch or continuous system. A steadystate 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 phase
Mass 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: Ammonia Chlorofluorocarbons

Organic pollutants:
Hydrocarbons

a.
Paraffins:
Methane,
ethane,
b.
c.
Olefins:
Ethylene,
d. Aromatics: Benzene, toluene, benzpyrene, xylene, styrene

octane
Acetylene
butadiene

Aliphatic oxygenated compounds

a.
Aldehydes:
Formaldehyde
b.
Ketones:
Acetone,
methylethylketone
c.
Organic
acids
d.
Alcohols:
Methanol,
ethanol,
isopropanol
e.
Organic
halides:
Cyanogen,
chloride
bromobenzyle
cyanide
f.
Organic
sulfides:
Dimethyl
sulfide
g. Organic hydroperoxides: Peroxyacetyl nitrate or nitrate
Particulate pollutants
Particulates 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 airfiltration system, which has found favour with pharma manufacturers, big and
small, and has become a universal solution. The system exploits multitechnologies and is detailed elsewhere in this issue.
Implementation phase
The 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-out
Given 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.