Pharmaceutical industrial safety

PHARMACEUTICAL INDUSTRIAL
SAFETY
Compiled and delivered
by,
Mr. Namdeo G. Shinde
M. Pharm.
Assistant professor
Satara College of Pharmacy, Satara.
Shivaji University, Kolhapur.
Maharashtra INDIA 415004.
25-Aug-15 1SATARA COLLEGE OF PHARMACY, SATARA.

CONTENTS
1.INTRODUCTION
2.TYPES OF HAZARDS IN AN INDUSTRY
3.SAFETY ASPECTS IN THE PHARMA INDUSTRY
4.CONCLUSION

• Don’t wait for a major accident to identify need to improve
major hazard management.
• Need to learn lessons from accidents (Hindsight) but don’t
rely on this approach
• Manage risks via Foresight rather than Hindsight ie be
proactive rather than reactive.
Why Do we need Safety?

BP Texas Refinery
• BP AMOCO Refinery is on
1,200 acres with 30 refinery
units and is 71 years old.
• 1800 people work at the
refinery plus contractors
• It is BP’s largest plant, and the
USA’s third largest refinery,
processing 460,000 barrels of
crude oil/day, around 3% of
US gasolene supplies

BP Texas Refinery – The Aftermath

Bruncefield, UK

Piper Alpha

Piper Alpha – After the fire

Texas City Explosion – 23 March 2005
 Direct Root Cause: Level Indicator Failure and
High Level Alarm failure
Buncefield UK Explosion – 11December 2005
 Direct Root Cause: Level Indicator Failure and
High Level Alarm failure
It cant happen to us!!!

• Finding out what people are doing that leads to incidents
and stopping them doing it. Or…
• Finding out what people are doing to avoid incidents and
getting everyone to do it
• Behaviour (unlike attitude) is visible, measurable and can
be directly influenced
Behaviour Safety is based on:

• Planning Stage
• Design stage
• Construction
• Pre commissioning / Commissioning
• Operations stage
• Decommissioning and abandonment.
Safety at various Stages

December 3rd 1984

Bhopal Gas Disaster
 The Union Carbide Pesticide Plant in Bhopal, released 40
tons of Methyl Isocyanate (MIC) gas, killing between
2,500 to 5,000 people in the early hours of the morning.
 The World’s worst Industrial Disaster

 The gas being heavier than air, started entering into the
homes of the unwary population. Many who panicked
and ran out also got crushed in stampedes.
 Around 500,000 were estimated to be exposed to the
gas & around 20,000 have died as a result. Over
120,000 continue to suffer from the from the effects of
the disaster.

 Doctors and Hospitals were unaware of the nature of
the Gas, nor were they informed of the proper
treatment of the inhalation of MIC gas, being merely
asked to give cough medicine & eye drops.
 If they were informed about the same, proper
treatment could have been instituted & a lot of lives
could have been saved.

Post Bhopal Gas Disaster
 Factories Act was amended to assign
responsibility for workplace safety to the
Occupier.
 Environment Protection Act was introduced in
1986.
 The Manufacture, Storage & Import of
Hazardous Chemicals Rules,1989.
 The Chemical Accidents, Emergency Planning,
Preparedness and Response,1996 introduced.

 India at present is achieving new milestones, major
economic breakthroughs and moving ahead towards
the vision of a developed nation. A sustained
industrial growth including progress of the chemical
sector is crucial to attaining this goal.
 The growth of the chemical sector has led to increase
in the manufacture, storage and use of Hazardous
chemicals (Hazchem) resulting in enhanced threats of
accidents. Occurrence of accidents remains a cause
of concern.

 The Indian Chemical Industry contributes to 6.7% of the
GDP.
 Indian Fertilizer Industry is the fourth largest in the
world.
 Largest manufacturer of Pesticides in Asia second only to
Japan.
 Indian Pharmaceutical industry is the largest in the
developing world

1.INTRODUCTION
DEFENITION OF INDUSTRIAL SAFETY
Industrial safety refers to reduce the risk of injury or
loss and danger to persons, property from the industrial
hazards. (Shah Prakashan,2007).
WHAT DOES A INDUSTRIAL HAZARD MEANT?
Hazard is a term associated with a substance,
That is likely to cause injury to a personnel,
(or)
One which may lead to loss of property, products etc;
(or)
A substance that might prove fatal to the personnel.

 Toxic corrosive chemicals, fire explosions and personnel
falling into accident are major health and safety hazards
encountered in the operations of chemical and pharmaceutical
industries.
 Identification of hazards and employing protective measures to
control the hazards are important to protect the people from
their consequences.

OBJECTIVES OF INDUSTRIAL SAFETY
 Understand the harmful effects of industrial hazards
 Define the relationship between hazard and risk
 Explore the routes of exposure to industrial hazards
 Shed lights on type of toxicity by industrial hazards
 Know the most toxic environmental hazardous substances.

INDUSTRIAL HAZARD V/S RISK
 Hazard is the potential of a substance to cause damage.
 Toxicity is the hazard of a substance which can cause
poisoning.
 Risk is a measure of the probability that harm will occur under
defined conditions of exposure to a chemical. (Patrick et al.,
1986).

R = f (H x E) = f (H x D x t)
Where R=Risk, f=function, H=Hazard, E= Exposure ,D=Dose,
t=time.
 Thus, chemicals which pose only a small hazard but to which
there is frequent or excessive exposure may pose as much risk
as chemicals which have a high degree of hazard but to which
only limited exposure occurs
 Reducing risk is based on reducing exposure

WHAT IS AN ACCIDENT ???
“An accident is an
unplanned &
uncontrolled event
which causes or is likely
to cause an injury”.
 It is some thing which un-expected ,
un-predictable or intended or not
desired.
 An accidents may cause a result of some
unsafe activity, act, working condition
etc ,…..

 Hazards may arise when impure or contaminated chemicals
are used.
 By products may accumulate relatively high concentrations in
parts of the plant and cause un expected effects.
 In pharmaceutical industry most of the dermatitis can be
attributed to synthetic drugs, especially acridines and
phenothiazines.

Industrial Hazards
 Large exposures to chemicals can affect human
health directly or indirectly.
 disrupting ecological systems that exist in rivers,
lakes, oceans, streams, and wetlands
 The release of chemicals into the environment
can have global impacts
 Chemicals can be transported throughout the
atmosphere and are not bound by borders

Industrial Hazards
 All the changes that occur in the
environment affect people.
 Ultimately people can be exposed to any
substance that enters the environment

Routes of Industrial hazards
Entry into the Body
There are three main routes by which hazardous
chemicals enter the body:
 absorption through the respiratory tract
through inhalation.
 absorption or injection through the skin or
eyes.
 absorption through the digestive tract. This
can occur through eating or smoking with
contaminated hands or in contaminated work
areas.

Types of Hazards Toxicity
 Acute poisoning is characterized by rapid absorption of
the substance and the exposure is sudden &
severe. Normally, a single large exposure is
involved. Examples: carbon monoxide or cyanide
poisoning.
 Chronic poisoning is characterized by prolonged or
repeated exposures of a duration measured in days,
months or years. Symptoms may not be immediately
apparent, but tend to build up in the body as a result of
chronic exposure. The effects are not seen until a critical
body burden is reached. Examples: lead or mercury
poisoning or pesticide exposure.

2007
Ran
k
SUBSTANCE NAME
2005
RANK
1 ARSENIC 1
2 LEAD 2
3 MERCURY 3
4 VINYL CHLORIDE 4
5 POLYCHLORINATED BIPHENYLS 5
6 BENZENE 6
7 CADMIUM 8
8
POLYCYCLIC AROMATIC
HYDROCARBONS
7
9 BENZO(A)PYRENE 9
10 BENZO(B)FLUORANTHENE 10
2007 Most Toxic Hazardous
Substances List (ATSDR)

2.TYPES OF HAZARDS
• Fire hazards
• Chemical hazards
• Electrical hazards
• Mechanical hazards and
• pharmaceutical hazards.

FIRE HAZARDS
Fire:
The self-sustaining process of rapid oxidation of a fuel which
produces heat and light.
Fire is an exothermic chemical reaction between oxygen
and fuel at certain temperature.
Three things essential for the combustion of fire are
 Fuel (any combustible material)
 Oxygen (At concentrations above 23 %
in air, the situation becomes
dangerous due to the
increased fire hazard)
 Temperature.

SOURCES OF FIRE HAZARDS
Fuels include solids, liquids, vapours and gases.
solid fuels
wood, fabrics, synthetic materials, packing materials, papers
etc.,.
Liquid fuels
flammable liquids (e.g., nitrophenol, ammonium nitrate and
pottassium chlorate, paint and oil soaked rags, cotton or
cellulose soaked with sulphuric acid etc.,.).
Other sources include flame, sparks, spontaneous ignition
and self combustible chemicals. (Khanna,1992).

Causes
Smoking in the factory
Defective heating equipment, electrical equipment &
wiring.
Explosive gas leakage.
Inadequate protection of electric motors
Sparking of electric wires & equipment
Protection & prevention
Types of fire
25-Aug-1534 SATARA COLLEGE OF PHARMACY,
SATARA.
Fire & explosion hazards

CLASSIFCATION OF FIRES
Most fires that occur will fall into
one or more of the following
categories
Class A
Fires involving ordinary
combustible materials, such as Paper,
wood, and textile fibers, where a
cooling, blanketing, or wetting
extinguishing agent is needed.

Class B:
Fires involving flammable
liquids such as gasoline, thinners,
oil-based paints and greases.
Extinguishers for this type of fire
include carbon dioxide, dry
chemical* and halogenated agent
types.

Class C
Fires involving energized
electrical equipment, where a non
conducting gaseous clean agent or
smothering agent is needed. The
most common type of extinguisher
for this class is a carbon dioxide
exinguisher.

Class D
Fires involving
combustible metals such as
magnesium, sodium, potassium,
titanium, and aluminum. Special
dry powder extinguishing
agents are required for this class
of fire, and must be tailored to
the specific hazardous metal.

Class K
Fires involving commercial
cooking appliances with vegetable
oils, animal oils or fats at high
temperatures. A wet potassium
acetate, low pH-based agent is
used for this class of fire.

DETECTION OF FIRE HAZARDS
Many automatic fire detection systems are used today in industry.
Some include
• Thermal expansion detectors,
• Heat sensitive insulation,
• Photoelectric fires,
• Ionization or radiation sensors and
• Ultraviolet or I .R detectors.
These sound an alarm through which fire flames are detected.

FIRE ALARMS
FIRE SENSORS

PREVENTION OF FIRE HAZARDS
 Well planned design and layout
 Proper ventilated systems
 Chemical data sheets
 Proper training of personnel
 Proper maintenance of
surroundings
 use of fire extinguishers,
alarms ,sensors, detectors
 Fire fighting equipment
 Sprinkler systems

Preventive measures
 Prohibition of smoking in manufacturing areas.
 Oxygen present in the inflammable atmosphere may
be ↓by dilution with gases such as nitrogen, co2,steam
or combination of these.
 Hazardous operation should be isolated
 Eliminating the ignition sources
 Using fire resistant material in construction
 Suitable emergency exits
 Adequate venting
SATARA.

 Automatic sprinklers
 Equipment should design to meet the specifications &
code of recognized authorities, such as ISA, API
&ASME
 The design & construction of pressure vessels &
storage tanks should follow API & ASME codes.
 Inspection
SATARA.

FIRE SUPRESSION
It is done by using hydrant systems/water sprinkler systems
and fire extinguishers.
 Hydrant systems include
 Water sprinklers
 Semi automatic hydrant system
 Automatic sprinkler and
 Manually hydrant system.

 Fire extinguishers include
 Water and water based extinguishers
• portable extinguishers
• soda acid extinguishers
• antifreeze extinguishers.
 Foam extinguishers.
 Dry chemical extinguishers.
 Carbon dioxide extinguishers.
 Halon extinguishers
• Halon1301( bromo tri fluoromethane)
• Vaporizing liquid.

Halotron 1 Fire extiguisher
Non-Magnetic stored pressure
deionized water mist fire
extinguisher
ABC Dry chemical fire
extinguisher
Carbon dioxide (CO2)
Portable fire
extinguisher
K Class Wet chemical
extinguisher.
Spinkler systems

CHEMICAL HAZARDS
 Many chemicals can cause severe burns, if these coming to
contact with living tissue or other routes like inhalation.
 Living tissue may be destroyed by chemical reactions such as
dehydration, digestion, oxidation etc.
 Eye and mucus membrane of the throat are particularly
susceptible to the effect of corrosive dust, mist and gases.
 Chloroform, benzene, chlorinated hydro carbons, low boiling
fractions of petroleum are some of the common organic
solvents used in pharmaceutical industry.(Muir,2002).

SOURCES OF CHEMICAL HAZARDS
 AIR BORN TOXICS
Irritants
Ipecac,podophyllumetc .,.
Asphyxiants
Carbondioxide, monoxide, methane, ethane, hydrogen cyanide,
hydrogen sulphide, helium,nitrogen etc.,.
Narcotics/anaesthetics
Acetone, ether, chloroform, methyl-ethyl ketone etc.,.
 CARCINOGENS
Coaltar, cresote oil, anthracene oil, parafin oils, chromium,
nickel, cobalt etc.,.

Benzo[a]pyrene (BaP)
 One of the best-studied examples of PAHs is
benzo[a]pyrene (BaP).
 It does not attack DNA itself, but reactive
intermediates are formed within cells, with a
reactive epoxide ring.
 This modified molecule is perfectly designed to
be a mutagen.
 The flat, planar ring looks just like a DNA base,
so the molecule slips into the stack of bases
comfortably. Then, the reactive epoxide attacks
a neighboring adenine or guanine nucleotide,
forming a covalent bond.25-Aug-15 50SATARA COLLEGE OF PHARMACY, SATARA.

Benzo[a]pyrene
 Upon oxidation, PAHs
produce highly reactive
diol epoxide enantiomers.
 Upon binding chemically
to DNA, it gives rise to
DNA adducts with very
different structures and
biological activities.
 The DNA adducts is a
bulky aromatic ring
attached to the base of
DNA, block replication
and transcription.
Benzo[a]pyrene

Heavy Metals
 Metals comprise three-fourths of the elements in the
periodic table.
 A few of the metals are essential for life. Most of the
known metals are quite toxic to living organisms when
present in excess.

Metals Classification
Class B
(Sr)
Class C
(Zn, Cu)
Class D
(Hg, Pb)
Class A
(Fe)
Toxicity
BiologicalFunction
Foulkes EC., Proc Soc Exp Biol Med. 223: 234-40, 2000.

Exposure to Heavy Metals
Breathing vapors
ATSDR (2005), www.atsdr.cdc.gov/cxcx3.html
CEPA (2006), www.ec.gc.ca/CEPARegistry/subs_list/Toxicupdate.cfm
Industrial Activities & Waste
Dental Amalgam Contaminated Solis

Mechanisms of Heavy
Metals Toxicities
 Inhibition of heme biosynthesis, heme is
the essential structural component of
hemoglobin, myoglobin and cytochromes
(Pb)
 Binds to sulfhydryl groups (-SH groups) of
proteins and enzymes.
 Inhalation: lung - local irritation and
inhibition of alpha1-antitrypsin associated
with emphysema (Cd)

Treatment strategies
 Removal of the subject from the source(s) of
exposure.
 Treatment with chelating agents, such as EDTA,
Succimer, and Cysteine and N-Acetyl Cysteine
(NAC)
 Hemodialysis and/or chelating agent
 Administration of some antioxidants, Vitamin C, E

Formaldehyde
 Formaldehyde is also known as methanal, is a
gas with a strong pungent smell.
 Formaldehyde readily results from the
incomplete combustion of carbon-containing
materials.
 Formaldehyde is produced industrially by the
catalytic oxidation of methanol. It may be found
in the smoke from forest fires, in automobile
exhaust, and in tobacco smoke.
 Formaldehyde is readily oxidized by atmospheric
oxygen to form formic acid25-Aug-15 57SATARA COLLEGE OF PHARMACY, SATARA.

Formaldehyde
 Most formaldehyde is used in the production of
polymers and other chemicals, in many
construction materials, including carpet, and
spray-on insulating foams.
 formaldehyde is one of the more common indoor
air pollutants.
 Formaldehyde is classified as a probable human
carcinogen by the U.S. Environmental Protection
Agency. The International Agency for Research
on Cancer

Formaldehyde Toxicities
 Carcinogenicity: although the risk is small or non-
existent, the possibility that formaldehyde is a human
carcinogen cannot be excluded.
 Urinary Tract Disease: dysuria, suprapubic pain,
ureteric and bladder fibrosis, hydronephrosis,
vesicoureteral reflux
 Hypersensitivity : Hypersensitivity to
formaldehyde has had several manifestations
 acute exacerbation of eczema after injection of
hepatitis B vaccine containing formaldehyde
 Skin pruritus, burning, and redness
 Painful, enlarged, and haemorrhagic gingival margins

Treatment of Formaldehyde
Toxicities
 Treat signs and symptoms; no known antidote
 Contaminated skin should be washed with soap
and water
 After ingestion water, milk, and/or charcoal,
should be given
 Acidosis, resulting from metabolism of
formaldehyde to formic acid, may require IV
NaHCO3 or Na lactate.
 Haemodialysis could be beneficial
 If seizure occurred, IV benzodiazepines or
barbiturates could be given.25-Aug-15 60SATARA COLLEGE OF PHARMACY, SATARA.

Methanol
 Methyl alcohol is used as a pharmaceutical
and industrial solvent.
 It is also used as `wood naphtha' to
denature ethanol in the preparation of
industrial methylated spirits.
 Methyl alcohol is also used as an
extraction solvent in food processing.
 Methyl alcohol is readily absorbed from
the gastrointestinal tract and distributed
throughout the body fluids.

Methanol Toxicity
 Characteristic symptoms of methyl alcohol
poisoning are caused by toxic metabolites and
develop after a latent period of about 12 to 24
hours, or longer
 metabolic acidosis with rapid, shallow
breathing
 visual disturbances which often proceed to
irreversible blindness,
 severe abdominal pain, gastrointestinal
disturbances, pain in the back and extremities
 coma which in severe cases may terminate in
death due to respiratory failure or, rarely, to
circulatory collapse

Treatment of Methanol
Toxicities
 Gastric lavage may be considered if the patient
presents within 1 hour of ingesting methyl alcohol
 Activated charcoal is probably of little use as it does
not absorb significant amounts of methyl alcohol
 Metabolic acidosis should be corrected immediately with
intravenous sodium bicarbonate.
 Haemodialysis may be indicated to increase the
removal of methyl alcohol and its toxic metabolites

Treatment of Methanol
Toxicities
 Fomepizole, an inhibitor of alcohol
dehydrogenase, is also used; it inhibits the
metabolism of methyl alcohol to its toxic
metabolites.
 Folinic acid and folic acid have been
given in the treatment of methyl alcohol
toxicity because they may enhance the
metabolism of formic acid.

Ethylene Glycol
 Ethylene glycol is commonly encountered
in antifreeze solutions and has been used
illicitly to sweeten some wines
 Ethylene glycol is absorbed from the
gastrointestinal tract and is metabolised,
chiefly in the liver, by alcohol
dehydrogenase

Ethylene Glycol Toxicities
 Toxic effects arising from ingestion of ethylene
glycol result from its major metabolites:
aldehydes, glycolate, lactate, and oxalate
 Clinical features may be divided into three
stages depending on the time elapsed since
ingestion:
 0 -12 hours: the patient may show signs of
drunkenness, nausea, vomiting, convulsions and
neurological defects.
 12 - 24 hours: tachycardia, mild hypertension,
pulmonary oedema, and heart failure.
 24 - 72 hours: flank pain, proteinuria, oxaluria,
haematuria, renal failure, respiratory failure,
cardiovascular collapse, and sometimes coma and
death

Treatment of Ethylene
Glycol Toxicities
 The stomach should be emptied by lavage
if ingestion of ethylene glycol was within
the preceding hour.
 metabolic acidosis should be corrected
with sodium bicarbonate intravenously
and hypocalcaemia corrected with calcium
gluconate
 Haemodialysis or peritoneal dialysis may
be of value

BENZENE
 Benzene occurs as a volatile, colorless, highly
flammable liquid that dissolves easily in water.
 Benzene is used as a constituent in motor fuels;
as a solvent for fats, waxes, resins, oils, inks,
paints, plastics, and rubber; in the extraction of
oils from seeds.
 It is also used as a chemical intermediate, in the
manufacture of detergents, explosives,
pharmaceuticals, and dyestuffs.

Benzene Toxicities
 Acute
 Coexposure to benzene with ethanol increase benzene
toxicity.
 Inhalation of benzene causes drowsiness, dizziness,
headaches, and unconsciousness in humans.
 Ingestion of large amounts of benzene may result in
vomiting, dizziness, convulsions, and death in humans.
 Exposure to liquid and vapor may irritate the skin (red
skin), eyes, and upper respiratory tract.
 Death may result from exposure to very high levels of
benzene.

Benzene Toxicities
 Chronic
 Long-term inhalation of benzene causes disorders in
the blood in humans. specifically affects bone
marrow causing aplastic anemia.
 Excessive bleeding.
 Damage to the immune system.
changes in blood levels of antibodies
leukopenia.

Benzene Toxicities
 Chronic
 Structural and numerical chromosomal
aberrations in humans.
 Menstrual disorders and a decreased size of
ovaries.
 Teratogenecity such as low birth weight, delayed
bone formation, and bone marrow damage.
 Leukemia has been observed in humans
occupationally exposed to benzene.

Nitrobenzene
 Nitrobenzene is an oily yellow liquid with
an almond-like or shoe-polish smell.
 The majority of nitrobenzene is used to
manufacture aniline, which is a chemical
used in the manufacture of polyurethane.
 Nitrobenzene is also used to produce
lubricating oils and in the manufacture of
dyes, drugs, pesticides, and synthetic
rubber.

Nitrobenzene Toxicities
 Acute / Chronic
 Methemoglobinemia:
conversion of hemoglobin to methemoglobin in
the blood, which lowers the oxygen released to
the tissues of the body.
it is associated with fatigue, weakness, dyspnea,
headache, dizziness, bluish color skin, and you
may have nausea, vomiting.
Detected by measuring methemoglobin level.
 Respiratory failure, bluish-gray skin, disturbed
vision, coma, and ultimately death may occur.

Nitrobenzene Toxicities
 Acute / Chronic
 Reproductive toxicities such as a decrease in
fertility, reduced testicular weights, and
decreased sperm production have been noted in
inhalation and oral animal studies.
 Animal studies indicate that inhalation exposure
to nitrobenzene does not result in
developmental effects, such as birth defects or
embryotoxic effects.

Treatment of Nitrobenzene
Toxicities
 Immediate removal from the exposure and
transport to medical facilities.
 Oxygen should be administered with assisted
ventilation of necessary.
 Methylene blue given IV at 1-2 mg/kg as 1%
solution to reduce the methemoglobin half-life.
 Contaminated clothing should be removed and
the patient washed to remove skin
contaminations.25-Aug-15 75SATARA COLLEGE OF PHARMACY, SATARA.

Carbon Tetrachloride
 Carbon tetrachloride is a clear, nonflammable
liquid which is almost insoluble in water.
 Carbon tetrachloride is used as a solvent for
oils, fats, rubber waxes, and resins and as a
starting material in the manufacture of
organic compounds.
 Carbon tetrachloride was formerly used as a
dry cleaning agent, and pesticide.

Carbon Tetrachloride
Toxicities Acute
 liver and kidneys damages.
 CNS depression: headache, weakness, lethargy,
nausea, and vomiting.
 Pulmonary edema.
 Chronic
 Chronic inhalation or oral exposure to carbon
tetrachloride produces liver and kidney damage in
humans and animals.
 Birth defects have not been observed in animals
exposed to carbon tetrachloride by inhalation or
ingestion.

Asbestos
 Asbestos are composed of minerals which are made up of
long, thin fibers that are somewhat similar to fiberglass.
 Asbestos is neither volatile nor soluble; however, small
fibers may occur in suspension in both air and water.
 The main uses of asbestos are in building materials, paper
products, asbestoscement products, textiles, packings and
asbestosreinforced plastics.
 Asbestos use is currently decreasing.

Asbestos Toxicities
 Chronic inhalation exposure to asbestos in humans can
lead to:
 Asbestosis: is a diffuse fibrous scarring of
the lungs.
 Symptoms of asbestosis include shortness of
breath, difficulty in breathing, and coughing.
 Asbestosis is a progressive disease, i.e., the
severity of symptoms tends to increase with time,
even after the exposure has stopped.
 In severe cases, this disease can lead to death,
due to impairment of respiratory function.
 Pulmonary hypertension
 Immunological diseases.

Asbestos Toxicities
 Occupational studies have reported that
exposure to asbestos via inhalation can cause
lung cancer and Mesothelioma
 Mesothelioma is a asbestos-induced cancer
develop in the mesothelium, a protective
lining that covers most of the body's internal
organs.
 No studies were located on the developmental
or reproductive effects of asbestos in animals or
humans via inhalation.
 Birth defects were not noted in the offspring of
animals exposed to asbestos in the diet during
pregnancy.25-Aug-15 80SATARA COLLEGE OF PHARMACY, SATARA.

SAFETY ASPECTS IN CHEMICAL HAZARDS
 Application of barrier creams before commencing the work
has been found useful in protecting individuals from hazardous
chemicals.
 While using the high vapor pressure solvents and grinding of
vegetable drugs (e.g., capsicum and podophyllum) safety
goggles are to be worn. Because these will effects the eyes.

 We must know the exposure limits and toxicity of different
chemicals.
chemicals Exposure limit
(ppm)
Ethyl alcohol 1000ppm
acetone 1000ppm
Methyline
chloride
125ppm
Isopropyl alcohol 400ppm

 Tolerance levels for toxic chemicals should be followed as set
by Federal regulations.
 Occupational safety and health administration also include to
Check
• Compiling of process safety information
• Maintaining safe operating procedures
• Training and educating employees
• Conducting incident investigations
• Developing safety compliance audits
• Conducting emergency response plans. (Niosh,2005).

MECHANCAL HAZARDS
• These are associated with powers-driven machine, whether
automated or manually operated by steam, hydraulic and/or
electric power introduced new hazards into work place.
• Mechanical hazards are exacerbated by the large number and
different designs of equipment, crowded work place conditions
and different interaction between workers and equipment.
• Hazardous electrical and pneumatic thermal energy must be
released or controlled before working on active equipment.
• High sound levels may be generated by manufacturing
equipment (e.g., ball mill) there by increasing their exposure to
noise.
• Injuries like cutting, tearing, shearing, puncturing and crushing
may occur with moving machinery. (Barbara et al.,2005).25-Aug-15 84SATARA COLLEGE OF PHARMACY, SATARA.

PREVENTON OF MECHANICAL HAZARDS
Mechanical hazards can be reduced by the application of
appropriate safeguards.
REQUIREMENTS OF SAFEGUARDS
• Prevent contact
• Securable and durable
• Protect against falling objects
• Do not create new hazard
• Do not create interference
• Allow safe mantainance.
TYPES OF SAFEGUARDS
Point of operation guards-Fixed guards, interlocked guards and
adjustable guards.

Biological hazards
 Disease due to biological hazards
 Brucellosis (dairy industry)
 Byssinosis (textile industry)
 Bagassosis (sugar-cane)
 Loco motor disorder
 Preventive measures
Periodic health check up
Personal protection
The manufacturer should also provide
First aid facilities
Initial examination
Facility for vaccination
Routine sanitation programme
SATARA.

Mechanical hazards
 Accidents usually take place by the combination of unsafe
condition & carelessness.
 Most of industrial accidents are due to
 Faulty inspection
 Inability of employee
 Poor discipline
 Lack of concentration
 Unsafe practice
 Mental & physical unfitness for job
 Faulty equipment or improper working condition
 Improper training regarding the safety aspects
SATARA.

Building planning
 Floors must be of unskid/non-slippery type.
 Enough space for employees to work.
 Passages between working places.
 Proper arrangements of temperature control; like fans,
A.C., heaters.
SATARA.

 Careless handling of heavy materials and components
should be avoided.
 Full use of mechanical material handling equipment.
 All material handling equipments should be repaired
and maintained properly.
 Containers employed to transport liquids should not
be defective or leaking.
Safe material handling
SATARA.

 Protection of head by using hard hats/helmets.
 Protection of ears by using earmufffs and plugs.
 Protection of face by using face marks, face
shields.
Personal protective devices
SATARA.

Point of operation devices-photoelectric devices, radiofrequency
devices, pull back devices, restraint devices and safety trip
devices.
Feeding and ejection systems-automatic feed system, semi
automatic, automatic and semiautomatic ejection systems.
Robot safeguards.
LOCKOUT/TAGOUT SYSTEMS
Padlock systems
Tagout systems.
(Shah Prakashan,2007).

SAFETY ASPECTS IN MECHANICAL HAZARDS
 All the operators should be trained in safe operation,
maintainance and emergency procedures to take care when
accidents occur.
 Inspection ,adjustment repair and calibration of safe guards
should be carried out regularly.
 Ear protection devices must be used to prevent the excessive
noise.
 Effort should be made to reduce the noise to a safe level.

ELECTRICAL HAZARDS
Electrical hazards occurs when a person come in contact with
the conductor carrying current and simultaneously contacts
with the ground, usually known to be work place hazard.
SOURCES OF ELECTRCAL HAZARDS
 Short circuts
 Electrostatic hazards
 Arcs and spark hazards
 Combustible and explosive materials
 Improper wiring
 Insulation failure

Biological hazards
 Disease due to biological hazards
 Brucellosis (dairy industry)
 Byssinosis (textile industry)
 Bagassosis (sugar-cane)
 Loco motor disorder
 Preventive measures
Periodic health check up
Personal protection
The manufacturer should also provide
First aid facilities
Initial examination
Facility for vaccination
Routine sanitation programme
SATARA.

Mechanical hazards
 Accidents usually take place by the combination of unsafe
condition & carelessness.
 Most of industrial accidents are due to
 Faulty inspection
 Inability of employee
 Poor discipline
 Lack of concentration
 Unsafe practice
 Mental & physical unfitness for job
 Faulty equipment or improper working condition
 Improper training regarding the safety aspects
SATARA.

Building planning
 Floors must be of unskid/non-slippery type.
 Enough space for employees to work.
 Passages between working places.
 Proper arrangements of temperature control; like fans,
A.C., heaters.
SATARA.

 Careless handling of heavy materials and components
should be avoided.
 Full use of mechanical material handling equipment.
 All material handling equipments should be repaired
and maintained properly.
 Containers employed to transport liquids should not
be defective or leaking.
Safe material handling
SATARA.

 Protection of head by using hard hats/helmets.
 Protection of ears by using earmufffs and plugs.
 Protection of face by using face marks, face
shields.
Personal protective devices
SATARA.

DETECTION OF ELECTRICAL HAZARDS
 Circuit tester
 Receptance wiring tester.
PREVENTION OF ELECTRCAL HAZARDS
 Grounding of electrical equipments
 Prevention of static electricity
 Bending and grounding
 Humidification
 Antistatic materials
 Ionizers and electrostatic neutralizers
 Radioactive neutralizers and
 Magnetic circuit breaker.

Electrical hazards
 Shocks
 Sparking
 Fire
 Wiring faults
Preventive measures
 Proper maintenance of wiring & equipment
 High voltage equipment should be properly enclosed
 Good house keeping
 Water should not be used for dousing electric fire
 Worker should avoid working in electric circuits or
equipment in wet clothing or shoes.
SATARA.

SAFETY ASPECTS IN ELECTRICAL HAZARDS
 Ensure that power has been disconnected from the system
working with it.
 Do not wear conductive material like such as metal jewellary.
 Perodically inspect insullation.
 Verify circuit voltages.
 Use only explosion proof devices and non sparkling switches
in flammable liquid storage areas.
 All electrical parts should confirm ISI specifications.
 Ensure all flexible wires and power cables are properly
insulated.
 Installation of earth trip devices for all electrical equipments.
 Safe guarding is essential for all electrical equipments.
(Niosh,1986).

PHARMACEUTICAL HAZARDS
 Hazardous drugs that pose a potential health risk to health care
workers who may be exposed during drug manufacturing,
packing and storage.
CRITERIA FOR DEFINING HAZARDOUS DRUGS
Drugs that meet one or more of the following criteria should be
hazardous.
 Carcinogenicity.
 Teratogenicity.
 Reproductive toxicity.
 Organ toxicity at lower doses.

ROUTES OF EXPOSURE TO HAZARDOUS DRUGS
 Inhalation of an aerosolized drug.
 Dermal absorption.
 Ingestion.
 Injection.
TYPES OF HAZARDS TOXICITY
 Acute poisoning.
 Chronic poisoning.(Akunuru,1997).

SAFETY ASPECTS IN PHARMACEUTICAL HAZARDS
Personal protective equipment for hazardous drug handling
 Disposable gowns made of fabric that has low permeability
to the agents in use, with closed fonts and cuffs,intended for
single use.
 Powder free gloves, labeled and tested for drugs used with
chemotherapy , made of latex, nitrile or neoprene.
 Face and eye protection when splashing is possible.
 Approved respirator when there is a risk of inhaling drug
aerosols. The labelling of solvents to indicate their properties
and health and fire hazards, is an extremely important method
for controlling the hazards.
 Substitution of more harmful material by one which is less
danger to health.

 To prevent or reduce dangerous expose to toxic materials.
i. Gas releases should be vented outside buildings and away
work areas and other populated areas.
ii. Exhausts and ventilations should be provided to remove
emissions.
 Every bulk drug and pharmaceutical unit must prepare its
disaster management plan.

3.SAFETY ASPECTS IN PHARMA INDUSTRY
 Standard operating procedures
 Handling of hazardous materials
 Water supply and drainage
 Floors and floor coverings
 Emergency exits
 Back up plan if anything goes wrong
 Specially trained personnel
 Health polices and insurance
 Written procedures
 Safety audits
 Risk analysis
 Appropriate training and education to employee
 Regular monitoring of workplace
 Written documentation of policies
 Create awareness of the environment.25-Aug-15 106SATARA COLLEGE OF PHARMACY, SATARA.

Pollution hazards
 Types
a. Air pollution
b. Water pollution
c. Thermal pollution
d. Sound pollution
Air pollution
 Sources
 Automobiles
 Industries
 Domestic
SATARA.

i. Those suitable for removing particulate matter
a. Ventilation
 Exhaust ventilation
 Plenum ventilation
b. Air purifying equipment
ii. Those associated with removing gaseous pollutants
Water pollution
1. Types of water pollutants
 Physical
 Chemical
 Physiological
 Biological 25-Aug-15108 SATARA COLLEGE OF PHARMACY,
SATARA.
Preventive measures

2. Problems of water pollution
3. Preventive measure
a. Control of water pollution
i. Physical treatment
 Storage
 Filtration
ii. Chemical treatment
iii. Biological treatment
b. Treatment of industrial waste
Primary treatment
Secondary treatment
Tertiary treatment
SATARA.
Preventive measures

c. Thermal pollution
 Effects
 Damage to aquatic environment
 Reduction in assimilative capacity of organic waste
 Various off stream cooling systems
i. Wet cooling towers
ii. Dry cooling towers
iii. Cooling ponds
iv. Spray ponds 25-Aug-15110 SATARA COLLEGE OF PHARMACY,
SATARA.
Preventive measures

Recommendations & suggestions
Proper treatment & disposal methods for effluents
should be adopted
An awareness program
Measures for increase efficiency of the water use
SATARA.

Classification of signs according to use –
(1) Danger signs.
The DANGER header is used when there is a hazardous
situation which has a high probability of death or severe
injury. It should not be considered for property damage
unless personal injury risk is present.
SATARA.

2) Caution signs. (i)
The CAUTION header is used to indicate a hazardous
situation which may result in minor or moderate
injury. However, Caution should not be used when
there is a possibility of death or serious injury.
SATARA.

(3) Safety instruction signs
General Safety Signs (SAFETY FIRST, BE
CAREFUL, THINK) should indicate general
instructions relative to safe work practices,
reminders of proper safety procedures, and the
location of safety equipment.
SATARA.

(4) Biological hazard signs.
The biological hazard warning shall be used to
signify the actual or potential presence of a
biohazard and to identify equipment, containers,
rooms, materials, experimental animals, or
combinations thereof, which contain, or are
contaminated with, viable hazardous agents.
11525-Aug-15 SATARA COLLEGE OF PHARMACY, SATARA.

Pictograph
Pictograph means a pictorial representation used to
identify a hazardous condition or to convey a safety
instruction
SATARA.

THANK
YOU...

Pharmaceutical industrial safety

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