Pharmaceutical industrial safety

PHARMACEUTICAL INDUSTRIAL SAFETY

Compiled and delivered by,

Mr. Namdeo G. ShindeM. Pharm.

Assistant professorSatara College of Pharmacy, Satara.

Shivaji University, Kolhapur.Maharashtra INDIA 415004.

25-Aug-15 1SATARA COLLEGE OF PHARMACY, SATARA.

CONTENTS

1.INTRODUCTION2.TYPES OF HAZARDS IN AN INDUSTRY3.SAFETY ASPECTS IN THE PHARMA INDUSTRY4.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. 25-Aug-15 16SATARA COLLEGE OF PHARMACY, SATARA.

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.INTRODUCTIONDEFENITION 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 borders25-Aug-15 26SATARA COLLEGE OF PHARMACY, SATARA.

Industrial HazardsAll 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

BodyThere 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. 25-Aug-15 29SATARA COLLEGE OF PHARMACY, SATARA.

2007Rank

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 HazardousSubstances 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, papersetc.,.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).


CausesSmoking in the factoryDefective heating equipment, electrical equipment & wiring.Explosive gas leakage.Inadequate protection of electric motorsSparking of electric wires & equipmentProtection & preventionTypes of fire


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


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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



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



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 extiguisherNon-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


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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 TOXICSIrritantsIpecac,podophyllumetc .,.AsphyxiantsCarbondioxide, monoxide, methane, ethane, hydrogen cyanide,hydrogen sulphide, helium,nitrogen etc.,.Narcotics/anaestheticsAcetone, ether, chloroform, methyl-ethyl ketone etc.,. CARCINOGENSCoaltar, 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.


http://upload.wikimedia.org/wikipedia/commons/f/fa/Benzo-a-pyrene.svg

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

Foulkes EC., Proc Soc Exp Biol Med. 223: 234-40, 2000.


Exposure to Heavy Metals

Breathing vapors

ATSDR (2005), www.atsdr.cdc.gov/cxcx3.htmlCEPA (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)

Interfering with essential metals ions (Zn, Ca, Na) on their channels


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, E25-Aug-15 56SATARA COLLEGE OF PHARMACY, SATARA.

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 acid


http://upload.wikimedia.org/wikipedia/commons/5/57/Formaldehyde-2D.svg

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 manifestationsacute exacerbation of eczema after injection of

hepatitis B vaccine containing formaldehyde Skin pruritus, burning, and redness Painful, enlarged, and haemorrhagic gingival

margins 25-Aug-15 59SATARA COLLEGE OF PHARMACY, SATARA.


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.


MethanolMethyl 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. 25-Aug-15 64SATARA COLLEGE OF PHARMACY, SATARA.


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 25-Aug-15 65SATARA COLLEGE OF PHARMACY, SATARA.


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.25-Aug-15 68SATARA COLLEGE OF PHARMACY, SATARA.


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 antibodiesleukopenia.



Benzene ToxicitiesChronic

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.25-Aug-15 71SATARA COLLEGE OF PHARMACY, SATARA.


NitrobenzeneNitrobenzene 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 ToxicitiesAcute / 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 ToxicitiesAcute / 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 TetrachlorideCarbon 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

Acuteliver and kidneys damages. CNS depression: headache, weakness,

lethargy, nausea, and vomiting.Pulmonary edema.

ChronicChronic 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.25-Aug-15 78SATARA COLLEGE OF PHARMACY, SATARA.

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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.25-Aug-15 79SATARA COLLEGE OF PHARMACY, SATARA.


Asbestos Toxicities Occupational studies have reported that

exposure to asbestos via inhalation can cause lung cancer and MesotheliomaMesothelioma 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 1000ppmacetone 1000ppmMethyline 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. 25-Aug-15 85SATARA COLLEGE OF PHARMACY, SATARA.

Biological hazards Disease due to biological hazards Brucellosis (dairy industry) Byssinosis (textile industry) Bagassosis (sugar-cane) Loco motor disorder Preventive measures

Periodic health check upPersonal protectionThe manufacturer should also provide

First aid facilitiesInitial examinationFacility for vaccinationRoutine sanitation programme



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



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.



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



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



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 systemsTagout 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 withthe 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 upPersonal protectionThe manufacturer should also provide

First aid facilitiesInitial examinationFacility for vaccinationRoutine sanitation programme



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



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.



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



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



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.25-Aug-15 100SATARA COLLEGE OF PHARMACY, 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).25-Aug-15 101SATARA COLLEGE OF PHARMACY, SATARA.

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 Typesa. Air pollutionb. Water pollutionc. Thermal pollutiond. Sound pollution

Air pollution Sources Automobiles Industries Domestic



i. Those suitable for removing particulate matter a. Ventilation

Exhaust ventilation Plenum ventilation

b. Air purifying equipmentii. Those associated with removing gaseous pollutants Water pollution1. Types of water pollutants Physical Chemical Physiological Biological


Preventive measures


2. Problems of water pollution3. Preventive measure a. Control of water pollutioni. Physical treatment Storage Filtrationii. Chemical treatmentiii. Biological treatment b. Treatment of industrial waste

Primary treatmentSecondary treatmentTertiary treatment25-Aug-15 109SATARA COLLEGE OF PHARMACY, SATARA.

Preventive measures


c. Thermal pollution Effects Damage to aquatic environment Reduction in assimilative capacity of organic waste

Various off stream cooling systemsi. Wet cooling towersii. Dry cooling towersiii. Cooling pondsiv. Spray ponds


Preventive measures


Recommendations & suggestions

Proper treatment & disposal methods for effluents should be adopted

An awareness program

Measures for increase efficiency of the water use



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.


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.


(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.


(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


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Pharmaceutical industrial safety

Health & Medicine

Transcript of Pharmaceutical industrial safety