23160-Article Text-115680-1-10-20180130
23160-Article Text-115680-1-10-20180130
23160-Article Text-115680-1-10-20180130
ABSTRACT
The pharmaceutical industry is a vital component of health-care systems all over the world engaged in discovery, development, manufacture, and
marketing of medicines for human as well as animal health. Pharmaceutical industries also have many environmental problems, like the other
chemical industries. The pharmaceutical industry is based primarily on the scientific formulation, research, and development of drugs, that is, helpful
in the prevention or treatment of diseases and disorders. The manufacturing of APIs and formulation processes involves the use of various chemicals
which includes various corrosive and irritant agents such as acids, bases, oxidizing and reducing agents, solvents, and many more which can be
found sometimes at very high concentrations and are hazardous to health of persons performing the various processes during manufacturing and
formulation of API and medicines. The effective management of the chemical risks linked to the handling of these agents is mandatory for the safety of
the workers in the industry, ethically and also legally as per the rules and guidelines of various acts regulating the functioning of the pharma industry.
This article provides a comprehensive review of various chemical hazards generally encountered by the pharmaceutical industry, its management
and regulation in India.
Keywords: Chemical hazards, Industrial hazard, Organic solvent, Hazardous gases, Organic synthesis, Management of hazard, Regulations for
chemical hazard, Regulatory agencies for hazards, Workplace safety, Threshold limit value.
© 2018 The Authors. Published by Innovare Academic Sciences Pvt Ltd. This is an open access article under the CC BY license (http://creativecommons.
org/licenses/by/4. 0/) DOI: http://dx.doi.org/10.22159/ajpcr.2018.v11i2.23160
6. A chemical is any element, chemical compound, or mixture of Some clinical symptoms of the affected organs with the relative hazard
elements and/or compounds. causing agents are enlisted in the Table 1 [4,8].
• Element - the simplest form of matter that cannot be further
subdivided by chemical substances. Examples of elements are SOURCES OF CHEMICAL HAZARDS
aluminum, carbon, chlorine, hydrogen, mercury, and oxygen.
The production and use of chemicals are fundamental factors in the
• Chemical compound - A substance consisting of two or more economic development of all countries, whether they are industrialized
elements combined or linked so that their constituent elements or developing. In one way or another, chemicals affect directly or
are always present in the same proportions. indirectly to all humans and are essentials to our feeding (fertilizers,
• Mixture - any combination of two or more chemicals if the pesticides, food additives, packing), our health care (pharmaceuticals,
combination is not, in whole or in part, the result of a chemical cleaning materials), or our well-being (appliances, fuels). Some of the
reaction (occupational safety and health administration [OSHA], chemicals could be hazardous [9].
2007).
7. Chemical hazards can be defined as those where potentially Chemical hazards are toxic, corrosive, irritant, carcinogenic, flammable,
hazardous energy is released through the breakdown of the and mutagenic. Workplace hazardous materials information
molecular bond as a result of a chemical reaction (usually a reactive classification of chemical hazards is represented in Table 2 [9].
chemical hazard).
8. On the other hand, toxic chemicals are defined in terms of effect; THE HAZARDS OF ORGANIC SYNTHESIS
for example, The National Transport Commission has defined toxic
Organic chemical synthesis presents industrial hazards of three main
chemicals as “substances that can cause death or serious injury or
types:
damage to human health if ingested or inhaled or in contact with the
• First, the active agents used to attack and modify the structure of
skin.”
organic compounds are, by their very nature, exceptionally able to
9. Hazardous substances can be defined in operational mode such as
attack and modify the organic compounds of the human body, thus
“those that, after the exposure have negative effects on worker’s producing highly poisonous effects.
health [6].” • Second, the intermediate compounds in most organic synthesis are
often characterized by the readiness with which they enter into
ROUTES OF EXPOSURE TO CHEMICALS chemical combination with other organic matter; they are active.
To cause health problems, chemicals must get entry in the body. There This often confers toxic properties of great variety on them.
are five main “forms of exposure” or ways in which a chemical can enter • Third, the final products, though they are medicines designed to be
the body: introduced into the human body, may nevertheless produce severe
poisoning under conditions of industrial exposure [10].
Inhalation
Hazardous chemicals in the air may be inhaled and may cause damage Some common hazards of organic synthesis with their examples,
the hazards they cause, and their management are summarized in
to the body.
Table 3 [10].
Skin contact
ORGANIC SOLVENT HAZARD
Some hazardous chemicals may damage the skin directly or may be
absorbed into the body through the skin. A large number of organic compounds, namely, alcohols (e.g. methanol,
ethanol); ketones (e.g. acetone); aromatic compounds (e.g. benzene,
Eye contact toluene); nitrates and halogenated hydrocarbons; and many others are
Contact with some hazardous chemicals may cause serious eye injuries. widely used as solvents in both laboratories and chemical industries.
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Table 1: Clinical symptoms in affected body part and their causative chemicals
Table 2: WHMIS classification of chemical hazards Carcinogenic classification of solvents by the international agency for
research on cancer is presented in Table 4 [12].
Class Examples
Class A Compressed gas HAZARDOUS GASES
Dissolved gas or liquefied gas Various volatile and flammable liquids used in the chemical industry,
Class B Flammable gases vaporize when exposed to room temperature or above, causing
Flammable and combustible liquids atmospheric pollution. The steam turns on causing fire accidents
Flammable solids and explosions which tend to spread rapidly in the surrounding
Flammable aerosols environment, causing loss of lives and property. Therefore, the storage
Reactive flammable material and handling of these hazardous gases require special attention to
Class C Oxidizing materials ‑ oxidizer and organic peroxide
avoid risks [13].
Oxidizer: Chlorates, nitric oxide, peroxides,
permanganates, per chlorates, nitrites, nitrates, easily
These can be classified as follows:
oxidize metal powder
Organic peroxide: Tetrahydrofuran, diethyl ether, dioxane, Combustible gas
methyl isobutyl ether Includes gases such as methane (CH4), pentane (C5H12), propane (C3H8),
Class D Poisonous and infectious materials: cyanides, tea salts,
butane (C4H10), and hydrogen (H2) when released in an installation
asbestos
naturally as a by-product or leaked, gets ignited when comes in contact
Class E Corrosive materials: Inorganic acids and bases, hydrogen
with oxygen. This represents the danger of combustion within a
fluoride
facility if the concentration reaches a certain optimum level. Fuel gas
Class F Dangerous reactive materials: Ethylene dioxide, organic
detectors are needed when there is a risk of life or property due to the
azides, Na, Li, Ca
accumulation of combustible gases.
Pyrophosphoric materials: White phosphorous, diethyl
aluminum chloride, lithium
Each type of fuel gas has three important ranges, and each of these
WHMI: Workplace hazardous materials information, ranges differs for specific gases but uses the same definitions.
• Fuel gas concentration is too low for combustion below the lower
• Highly flammable: Flashpoint 23°C. explosion limit (LEL) or lower flammable limit. This is the range in
• Flammable: Flammability point 23–61°C. which more fuel gas detectors work.
• Combustible: Flammability point 61–150°C [11]. • The upper explosive limit (UEL) or upper flammability limit is the
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Table 3: Common hazards of organic synthesis with examples, causes, and management
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detection. Mount the sensors in the breathing zone (4–6 feet above and siren and ventilation for gas concentration dilution) and a high
the level) to protect the staff. alarm (emergency and siren light and process action). The action of the
process involves stopping or isolating the gas source and stopping the
When the oxygen concentration drops, suffocation occurs. OSHA process equipment.
established 19.5% oxygen in the air as the lower limit of a safe
environment [15,16]. Recording
It is an important element of the alarm response. The sensor status
Gas Sensor placement reports provide a valuable reference to assess the severity and
magnitude of the gas hazard. It can generate real-time and post-event
• Place the sensors near a possible source of gas.
analysis. It is the transfer of information provided by the system to the
• Place the sensors in the areas where the gas accumulates.
staff of the plant, which enables effective gas risk management [15].
• Insert oxygen and toxic gas exhaust sensors into the “respiratory
zone.”
CONCENTRATIONS PERMITTED IN THE AIR
• Consider accessibility and maintenance issues [13].
Employers should identify and assess the respiratory risks in their
Hazardous gas management workplaces. Several types of occupational exposure limits (OELs)
Compressed gases are filled in cylinders and transported to the place of have been established by several organizations and are listed in many
use. Important precautions to be taken include the following: of the OSHAs Guidelines for Chemical and Toxic Substances. A brief
1. The cylinders must not be released or allowed to hit the other. explanation of some of the different levels is listed in Table 5 [17].
2. The safety devices installed on the cylinders must not be tampered
Common terminology used in discussing OELs includes
with.
3. Use special valves and standard tools. Normally, these are supplied Level of action
by the manufacturers. An airborne level, typically half the permissible exposure limits
4. The cylinders must be protected against extremes of weather, designated in the OSHA substance-specific standards, 29 CFR 1910,
especially against excessive rise in the temperature. subheading Z, calculated as an 8-h weighted average, which initiates
5. The cylinders (receipts) must bear a standard label indicating some necessary activities such as exposure monitoring and medical
the type of gas. The color of the label indicates whether the gas is surveillance.
flammable, corrosive, or inert.
6. Full cylinders must be separated from the empty ones [4,13]. Ceiling limit
The exposure limit that a worker’s exposure may never exceed.
Components of a gas hazard management system
A gas monitoring system should provide information to ensure Sampling and analytical error
that effective and complete decisions are made promptly. To be
A statistical estimate of the uncertainty associated with a given
more effective in the management of gas exposure risks, sufficient
exposure measurement.
information is needed to obtain a thorough assessment of the situation
to make good decisions. Data management is a key element of a gas
hazard management system. Short-term exposure limit (STEL)
The average exposure to a contaminant to which a worker can be
Risk assessment exposed for a short period of time (typically 15–30 min).
It is the first step in system design. Field studies can help determine
when and where are the hazardous situation and possible exposure. Time-weighted Average (TWA)
The hazard characteristics can be determined in terms of ignition,
Average exposure to a pollutant in a given period of time, typically
reactivity, corrosivity, and toxicity. The risk to human health is reflected
8 h [17].
in the standards set by the resource conservation and recovery act,
OSHA and environmental protection agency (EPA). The information
TLV CONCEPT
obtained in a risk assessment provides a basis for better addressing the
risk of identified gas. A list of threshold limits (TLV) for about 800 substances has been
prepared. Workers should not be exposed to substances beyond these
System specifications and designs limits. The following three TLV categories are specified:
It is the key outcome of the risk management planning process. The
design begins with the selection and position of the sensor type. Sensor TLV-time weighted average (TWA)
performance should be determined in terms of response speeds, The TWA for concentration for a normal daily work of 8 h and 40 h
concentration range, and resolution drift, ease of calibration and work/week, to which almost all workers can be exposed several times
interference gas and must meet the performance criteria set out in the day after day with no adverse effects.
plan.
TLV-STEL
Daily operation Defined as a weighted average of 15 min, this must not be exceeded
The daily operation of a gas monitoring system focuses on data revision at any time during a working day, even if the weighted average of 8 h
procedures and system reliability. Automatic self-diagnosis of unit is within the TLV. This is the highest concentration where staff can be
functions improves reliability by providing a continuous indication exposed for short periods of time without expressing symptoms of
of the operation. Regular maintenance should confirm the internal irritation, chronic or irreversible tissue damage or narcosis sufficiently
diagnosis. to increase the risk of accident or essentially reduced efficiency of work.
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only guidelines and are not intended to be absolute limits between safe General ventilation
and hazardous concentrations. Every occupational health professional When it is difficult or impossible to avoid hazardous chemicals, fumes,
must have a copy of the current TLVs and biological exposure indices dusts, fogs, or particles entering the laboratory air at the source, general
[4,13]. dilution ventilation can be installed so that the maximum concentration
of pollutants in the air does not exceed the TLV of the substance. At
CHEMICAL HAZARD CONTROL: TECHNICAL MEASURES the best, it should consist of a clean air supply and a forced exhaust
outlet in the right place. It can also be used in conjunction with other
Technical measures that can be used to prevent chemical dangers at the
preventative measures.
source and/or reduce staff exposure:
Housekeeping
Substitution
When working with hazardous chemicals, proper maintenance is
It is an effective control method. A hazardous chemical substance is
required. The storage/stack/cabinet areas should be well organized
replaced by a less hazardous thing. It is particularly preferable if highly
and kept in order and along with the maintenance of premises and
hazardous substances, such as carcinogens, can severely affect human
equipment should be planned. These tasks should be dedicated to
physiological systems. However, it must be ensured that the substitution
individuals/laboratory workgroups. In addition, periodically check
substance eliminates the danger of the above substance.
and repair the defective equipment. Cleaning efficiency should be
monitored with adequate periodicity; this should involve the professors
Engineering control (closed system)
in charge/students/staff associated with a laboratory [18].
In the absence of effective replacement, personnel must be safeguarded
against any exposure. Steam and gas exposures should also be
MAINTENANCE OF OVEREXPOSURE TO CHEMICALS
monitored and minimized if risks are involved in their use. A generally
effective measure is to encircle the hazardous process or chemical. Although thousands of chemicals are commonly used in industry, the
For example, sealed pipes should be used to transfer toxic or highly medical management of acute overexposure is not specific and includes
flammable solvents and other liquids (especially volatile) rather than four basic steps (with some exceptions).
pouring them outdoors.
1. Removal from exposure
Local ventilation systems • Immediate removal of the person from the display site is the first step.
If it is not possible to isolate experimental activities involving hazardous • If a disabled victim is to be rescued; the rescue workers must protect
materials, then a properly designed local ventilation solution should themselves from contaminated atmosphere first.
be found, which generally helps remove contaminants at the source. • Respirators and rescue lines are compulsory first aid.
A ventilation system consists of a hood, duct or pipe drain, a collecting • Sometimes chemically impervious suits are also worn.
system and contaminants are separated from clean and efficient air to
create the fan suction force required. However, hazardous gases, fumes, 2. Resuscitation
and dusts from the ventilated air collection must be handled or treated • Resuscitation means restoring the life of someone apparently dead
before disposal. Inspection, proper maintenance, regular cleaning, (collapsed or shocked).
and changing filters are essential for the protection against hazardous • If the victim is apneic, resuscitation should start as soon as it is
pollutants. removed from the area.
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• Sustainable care must be provided as with any other medical SMS in confirmation to requirements. The results are used to make
emergency. necessary improvements for meaningful implementation of the work.
• The SMS requires periodic critical inspection of both workplace and
3. Decontamination workers to control and prevent the possible occurrences of injuries,
• A victim whose skin or clothing has been contaminated requires accidents, and related problems for the necessary corrective action.
immediate removal of clothing and shoes. Then, a vigorous shower • Periodical workplace inspection by a qualified inspection team
with soap and water is recommended, including attention to nails to know the real problems, if any, of the workers and workplace
and scalp. managers/supervisors. This help to identify jobs and tasks of the
workers, the potential hazards that the workers are exposed to, and
4. Symptomatic treatment the possible reasons for occurrences of hazards [19].
• Acute overexposure can cause a series of signs and symptoms
that require general medical support, regardless of the specific REGULATIONS FOR CHEMICAL HAZARDS
agent. Examples include convulsive seizure control, bronchospasm
treatment, dehydration, and arrhythmias. The chemical management relies on a mix of national, regional, and
international mechanisms, a range of multilateral environmental
There are some situations where specific antidotes or management agreement, as well as voluntary initiatives including a globally
strategies are available. The industry should prepare a list of medical harmonized system of classification and labeling of chemicals, the
management strategies for hazardous chemicals that it manages so that strategic approach to international chemicals management and
it can take corrective action and can attempt immediate rescue [4,13]. responsible care. In many countries, legislative and administrative
measures have been introduced to deal with chemical hazards.
WORKPLACE SAFETY
In 1992, the United Nations Conference on Environment and
Workplace safety is a joint responsibility of all individuals to create a Development (the Rio Earth Conference) gave rise to the Agenda 21
healthy and safe workplace: Report 2. This report outlined the responsibilities of States toward the
• Hazards of chemical substances exist and occur everywhere in the achievement of sustainable development and was adopted by heads of
workplace. Students and professional workers must act by keeping Government in over 150 countries. Chapter 19 of Agenda 21 addresses
safety in the mind all day, every day. the environmentally sound management of toxic chemicals for all
• Establish and clarify the rights and responsibilities of security in all countries, including basic programs for:
workplaces. 1. Adequate legislation.
2. Information gathering and dissemination.
However, it is the responsibility of the administration to: 3. Capacity for risk assessment and interpretation.
• Educate workers and employers in the construction and maintenance 4. Establishment of risk management policy.
of safe and healthy workplaces. 5. Capacity for implementation and enforcement.
• Intervene when security responsibilities are not executed. 6. Capacity for rehabilitation of contaminated sites and poisoned persons.
• Provide information and resources on a variety of security issues 7. Effective education programs.
and to prevent injuries and workplace illnesses. 8. Capacity to respond to emergencies.
Any safety management system (SMS) is a constituent part of the overall Some international treaties related to chemical management and
management system of an organization/industry/establishment which India’s participation in them is represented in Table 6 [20].
reflects the overall management philosophy and system to achieve the
goal. An SMS includes several important inputs such as: The Indian Chemical Industry is poised for growth, and a clearly
• The purpose of inspections. defined vision has been developed to enable it. The vision for Indian
• Importance of workplace inspections. chemical industry is “To facilitate the growth and development of the
• Plan of inspection. chemical industry in an environmental friendly manner; with focus on
• Types of hazards to be looked for in a workplace. innovation to meet local needs, sustainability, and green technologies
• Information needed to complete an inspection report. and processes; so as to enable it to become a globally competitive
• Time taken for an inspection. major-player.”
• Frequency of inspections.
• The periodic audits, with routine monitoring of performance, The non-regulatory mechanisms adopted by industries in India,
should be carried out to determine the overall performance of the in addition to legislative control, play a very important role in the
S. No. International treaties related to chemical management Responsible government agencies in India
1 Agenda 21 ‑ commission for sustainable development Ministry of external affairs, ministry of environmental, forests and climate
change
2 UNEP London guidelines Ministry of environmental, forests and climate change
3 FAO code of conduct Ministry of agriculture, ministry of environmental, forests and climate
change
4 The Rotterdam convention ‑ PIC procedure for certain Ministry of chemicals and fertilizers, ministry of agriculture, ministry of
hazardous chemicals and pesticides in international trade environmental, forests and climate change
5 Montreal protocol Ministry of environmental, forests and climate change
6 ILO 170 Ministry of labour
7 Basel convention Ministry of environmental, forests and climate change
8 London convention (Stockholm dumping guidelines) Ministry of shipping, road transport and highways, ministry of
environmental, forests and climate change
9 Chemical weapon convention Cabinet secretariat
10 Stockholm convention on POPs Ministry of environmental, forests and climate change
11 Bilateral Agreements Indo‑GTZ project, ministry of environmental, forests and climate change
FAO: Food and agriculture organization, PIC: Prior informed consent, ILO: International labour organization, UNEP: United nations environment programme
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management of chemicals. Indian industries take several initiatives change all of these negative aspects and impacts and through design,
for environmental protection and chemical management, such as innovation, and green practices to restore the sustainable development.
responsible care, corporate responsibility in environmental planning, The ultimate goal is to develop and design non-conventional synthetic
ISO 14001, OHSAS 18001, ISI Marking (Indian Standards Institution), methodologies for important industrial chemicals to prevent/reduce
and eco-mark. Several awards related to chemical and environmental environmental pollution [21].
management are initiated on voluntary basis by industrial associations,
who play an important role in encouraging industries to go for CONFLICT OF INTEREST: None
non-regulatory mechanisms for chemical management. Important
AUTHOR CONTRIBUTION
industrial associations include Indian Chemical Council (formerly,
the – Indian Chemical Manufacturer’s Association), Confederation of Princy Agarwal: Conceptualization of work, wrote the manuscript,
Indian Industry, and Federation of Indian Chambers of Commerce and compilation of literature sources.
Industry [20].
Rajat Vaishnav: Wrote the parts of the manuscript, checked the
GLOBAL REGULATORY AGENCIES manuscript and references and contributed in enhancing the standard
of the manuscript.
These are specially related to chemicals, drugs, and petrochemicals are
many and in brief include the following (besides many more):
Anju Goyal: Reviewing and checking of the manuscript and contributed
• US Food and Drug Administration.
in enhancing the standard of the manuscript.
• US EPA.
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