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Compiled by-Shamon Ahmad M.Pharma Q.A Chandigarh Group of Colleges Landra MohaliPunjab 28/12/2012 INDUSTRIAL HAZARDS INTRODUCTION Hazard is a term associated with a substance that is likelihood to cause an injury in a given environment or situation. “Industrial hazard may be defined as any condition/substance produced by industries that may cause injury or death to personnel or loss of product or property”. Safety in simple terms means freedom from the occurrence of risk or injury or loss. Industrial safety refers to the protection of workers from the danger of industrial accidents. Accidents: Human factor is the contributing cause of accidents in most situations.For people who are likely to have accidents the treatment is divided into three main categories Medical assistance- in 13 percent cases Personality readjustment- in 22 percent cases Operating defects- the remaining 65 percent cases Accident reduction: Accident proneness is acceptable to a certain extent it does not mean that nothing can be done to reduce the number of accidents Accidents can be reduced by two approaches Actuarial approach- It involves studying the statistics to determine accidents based on actual data . The factors related to the accident frequency should be identified. The violations of safety rules must be clearly identified. Safety educational campaign -Safety education must be conducted by management to the employee groups. Types of Industrial Hazards 1. Chemical hazards 2. Physical hazards 3. Biological hazards CHEMICAL HAZARD Chemical hazards are posed by toxic germicides e.g. formaldehyde and glutaraldehyde and sterilizing gases i.e. ethylene oxide. Reaction GasesCarbon mono oxideso2. Whenever possible less hazardous agents should be selected e.g. alcohols ammonium compounds. Sterilization of raw materials and equipment may be performed by high-pressure steam or toxic gases i.e. diluted

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ethylene oxide gas mixtures . Sterilization vessels can be located in separate areas with remote instrument and control systems. Workers should be trained on standard operating instructions safe work practices and appropriate emergency response. Gas sterilization chambers should be fully evacuatedkhalispace under vacuum and purged with air to minimize fugitive workplace emissions before sterilized goods are removed. Gas emissions from sterilization chambers can be vented to air control devices e.g. carbon adsorption or catalytic converters to reduce atmospheric emissions. Occupational hygiene monitoring measures worker exposures to chemical germicides and sterilizing gases helping to assess the adequacy of control measures. Safety hazards involve high-pressure steam and hot water moving machine parts in washing filling capping and packaging equipment high noise levels and repetitive manual tasks. CLEANING AND MAINTENANCE ACTIVITIES Non-routine tasks may occur when cleaning repairing and maintaining equipment utilities and workplaces. Although unique hazards may arise during non-routine tasks recurring health and safety concerns are encountered. Workplace and equipment surfaces may be contaminated by hazardous materials and drug substances requiring them to be cleaned before unprotected workers conduct servicing or maintenance work. Cleaning is performed by washing or wiping liquids and sweeping or vacuuming dusts. Dry sweeping and blowing solids with compressed air are not recommended since they create high worker exposures to airborne dusts. Wet mopping and vacuuming reduce worker exposures to dusts during cleaning activities. Vacuum cleaners with HEPA filters may be needed when cleaning hazardous substances and high-potency drugs. Explosion-proof equipment and conductive materials may be required in vacuum systems for explosive dusts. Eyewashes and safety showers and PPE reduce the effect of workers’ accidental contact with corrosive and irritating detergents and cleaning liquids. Hazardous mechanical electrical pneumatic or thermal energy may need to be released or controlled before equipment and utilities are serviced repaired or maintained. Contract workers may perform special production or engineering tasks in pharmaceutical plants without adequate training on safety precautions. Careful supervision of contract workers is important so they do not violate safety rules or perform work that creates a fire explosion or other serious health and safety hazards. Special contractor safety programmes are required when working with highly hazardous materials e.g. toxic reactive flammable or explosive and processes e.g. exothermic or high pressure in bulk pharmaceutical and dosage-form manufacturing facilities. GENERAL HEALTH AND SAFETY HAZARDS Ergonomics and material handling The materials shipped stored handled processed and packaged in the pharmaceutical industry range from large quantities of raw materials to small packages containing pharmaceutical products. Raw materials for bulk chemical production are shipped in bulk containers e.g. tank trucks rail cars metal and fibre drums reinforced paper and plastic bags. Pharmaceutical production uses smaller quantities of raw materials due to the reduced scale of the operations. Material-handling devices e.g.

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fork-lift trucks pallet lifts vacuum hoists and drum jacks assist material handling during warehousing and production operations. Heavy manual work may create ergonomic risks when moving materials and equipment if mechanical devices are not available. Good industrial engineering and facility management practices reduce injuries from material handling by improving the design and features of equipment and the workplace and decreasing the size and weight of containers Cole 1990. Engineering control measures e.g. ergonomic design of tools materials and equipment and administrative practices e.g. rotating workers providing worker training reduce the risks of cumulative trauma injuries during highly repetitive production and packaging operations. Machine guarding and control of hazardous energy Unguarded moving machine parts in pharmaceutical manufacturing and packaging equipment create mechanical hazards. Exposed “crush and nip points” in open equipment may seriously injure workers. Mechanical hazards are exacerbated by the large numbers and different designs of equipment crowded workplace conditions and frequent interactions between workers and equipment. Interlocked guards control switches emergency stop devices and operator training are important means of reducing mechanical hazards. Loose hair long-sleeved clothing jewellery or other objects may become trapped in equipment. Routine inspection and repair activities identify and control mechanical hazards during production and packaging operations. Hazardous electrical pneumatic and thermal energy must be released or controlled before working on active equipment and utilities. Workers are protected from sources of hazardous energy by implementing lockout/tagout procedures. Noise exposures High sound levels may be generated by manufacturing equipment and utilities e.g. compressed air vacuum sources and ventilation systems. Due to the enclosed design of pharmaceutical workplace modules workers are often located close to machines during manufacturing and packaging operations. Workers observe and interact with production and packaging equipment thereby increasing their exposure to noise. Engineering methods reduce sound levels by modifying enclosing and dampening noise sources. Employee rotation and use of hearing-protective devices e.g. ear muffs and plugs reduce workers’ exposure to high noise levels. Comprehensive hearing conservation programmes identify noise sources reduce workplace sound levels and train workers on the hazards of noise exposure and proper use of hearing-protective devices. Noise monitoring and medical surveillance i.e. audiometry assess worker exposures to noise and their resulting loss of hearing. This helps to identify noise problems and evaluate the adequacy of corrective measures. Solvent vapour and potent compound exposures Special concerns may arise when workers are exposed to toxic solvent vapours and potent drugs as airborne dusts. Worker exposures to solvent vapours and potent compounds may occur during various manufacturing operations which need to be identified evaluated and controlled to ensure that workers are protected. Engineering controls are the preferred means of controlling these exposures due to their inherent effectiveness and reliability Cole 1990 Naumann et al. 1996. Enclosed process equipment and material handling systems prevent worker exposures while LEV and PPE supplement these measures. Increased facility and process containment is needed for controlling highly toxic solvents e.g. benzene chlorinated hydrocarbons ketones and potent

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compounds. Positive-pressure respirators e.g. powered-air purifying and supplied-air and PPE are needed when highly toxic solvents and potent compounds are handled and processed. Special concerns are posed by operations where high levels of solvent vapours e.g. compounding granulating and tablet coating and dusts e.g. drying milling and blending are generated. Locker and shower rooms decontamination practices and good sanitary practices e.g. washing and showering are necessary to prevent or minimize the effects of worker exposures inside and outside the workplace. Process safety management Process safety programmes are implemented in the pharmaceutical industry due to the complex chemistry hazardous materials and operations in bulk chemical manufacturing Crowl and Louvar 1990. Highly hazardous materials and processes may be employed in multi-step organic synthesis reactions to produce the desired drug substance. The thermodynamics and kinetics of these chemical reactions must be evaluated since they may involve highly toxic and reactive materials lachrymators and flammable or explosive compounds. Process safety management involves conducting physical hazard testing of materials and reactions performing hazard analysis studies to review the process chemistry and engineering practices examining preventive maintenance and mechanical integrity of the process equipment and utilities implementing worker training and developing operating instructions and emergency response procedures. Special engineering features for process safety include selecting proper pressure-rated vessels installing isolation and suppression systems and providing pressure relief venting with catch tanks. Process safety management practices are similar in the pharmaceutical and chemical industries when manufacturing bulk pharmaceuticals as speciality organic chemicals Crowl and Louvar 1990 Kroschwitz 1992. Environmental Issues The different pharmaceutical manufacturing processes each have their own environmental issues as discussed below. INDUSTRIAL HAZARDS : HAZARD It means anything with potential for producing an accident. It is a term associated with a substance that is likelihood to cause an injury in a given environment or situation. Industrial hazard may be defined as any condition produced by industries that may cause injury or death to personnel or loss of product or property. Industrial hazards are threats to people and life-support systems that arise from the mass production of goods and services. Toxic and corrosive chemicals fire explosions and personnel falling into accidents are the major health and safety hazards encountered in the operations of chemical and pharmaceutical related industries.

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ROUTES OF INDUSTRIAL HAZARDS ENTRY INTO THE BODY There are three main routes by which hazardous chemicals entered the body: Absorption through the respiratory tract through inhalation. Absorption or injection through the skin or eyes. Absorption through the digestive tract. HAZARD CATEGORIES Chemical Hazards Gas Hazards Dust Explosion Fire and Explosion Hazards Biological Hazards CHEMICAL HAZARDS Some chemicals have the potential to cause fires and explosions and other serious accidents. Chemical exposure may cause or contribute to many serious health effects such as heart diseases central nervous system damage kidney and lung damage sterility cancer burns and rashes. Chemicals may be found in solid liquid aerosol or gas and vapor form. The degree of danger varies according to the form of the chemical and the factors like Its physical propertiesphAcidflammable Its toxicitypoision The way it is usedeyerespiratory The environment in which it is encounteredSO2.CH4 Routes of entry - Inhalation Ingestion skin absorption. Chemical agents can be classified into- 1 Metals - Lead TEL As Hg Cd Ni Co 2 Aromatic Hydrocarbons - Benzene Toluene phenol 3 Aliphatic Hydrocarbons - Methyl alcohol 4 Gases - Simple asphyxiants : N 2 CH 4 CO 2 Chemical asphyxiants : CO H 2 S HCN Irritant gases: Ammonia SO 2 Cl 2 Systemic poison: CS 2 Not all forms of a chemical pose a health hazard. For example a lead pipe is not a significant health hazard. However the lead can become a human health hazard if the pipe is welded producing a lead dust or fumes. The dust or fumes can become inhaled or it can leach into water and be ingested. A chemical may be hazardous even in solid form. For example individuals who are sensitized to nickel may develop dermatitis from skin contact with the metal. Some solids are not a hazard alone but become hazardous when they come into contact with other chemicals.

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MANAGEMENT OF OVER-EXPOSURE TO CHEMICALS 1. Removal from Exposure: Prompt removal of the person from the exposure site is the first step. Air respirators and lifelines are first aid. 2. Resuscitation: Resuscitation means restoration of life of one who is apparently dead collapsed or shocked. Further supportive care should be provided as with any other medical emergency. 3. Decontamination: A victim whose skin or clothing has been contaminated requires immediate removal of garments and shoes. Then body showering with soap and water including attention to the fingernails and scalphead sir is advised. 4. Symptomatic Treatment: Acute over-exposure may result in a variety of signs and symptoms that require general supportive medical management regardless of the specific agent. Examples include the control of convulsive seizures treatment of bronchospasm etc. TLV CONCEPT Threshold Limit Value-Time Weighted Average TLV-TWA: Time-weighted average concentration for a normal 8-hour working day and a 40-hour working week to which nearly all workers may be repeatedly exposed day after day without adverse effect. Threshold Limit Value-Short Term Exposure Limit TLV-STEL: It is defined as a 15-minute time-weighted average which should not be exceeded at any time during a working day even if the 8-hour time-weighted average is within the TLV. The workers should not be exposed to the substances more than these limits. TLVs are only guidelines and are not intended as absolute boundaries between safe and dangerous concentrations. Every occupational health professional should have a copy of the current TLVs. HAZARDOUS GASES: Several volatile and flammable liquids are employed in chemical industries. These liquids get vaporized when exposed to at or above room temperature causing air pollution. The vapour gets ignited causing fire accidents and explosions. Further they tend to spread rapidly into the surrounding area. Result in loss of life and property. Hence storage and handling of these hazardous gases need special attention to avoid hazards. Combustible Gases Explosion hazard. Must maintain below lower explosive limit.

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Toxic Gases Hazardous to human health. Employee exposure must be limited. Oxygen Displacing Gases Indirect human health hazard. Deficiency of breathing oxygen. HYDROGEN SULFIDE H 2 S in Air Toxic Symptoms 1 ppm Odor detected irritation of respiratory tract 10 ppm Allowable for 8 hours exposure 20 ppm Protective equipment is necessary 100 ppm Smell killed in 5 to 15 minutes. May burn eyes and throat coughing 500 ppm Respiratory disturbances in 2 to 15 minutes. Coughing collapse unconsciousness 1000 ppm immediate unconsciousness Brain damage may result unless rescued promptly. Death in 3 to 5minutes. OXYGEN DEFICIENCY: Oxygen Symptoms Developed 20.9 Normal oxygen concentration in air 15 - 19 Decreased ability to work strenuously 12 - 14 Respiration increases in exertion pulse up impaired coordination perception judgment 8 - 10 Mental failure fainting unconsciousness blueness of lips nausea vomiting 6 - 8 8 min 100 fatal 6min 50 fatal 4 - 5min recovery with treatment 4 - 6 Coma in 40 seconds convulsions respiration ceases death. HAZARDOUS GASES MANAGEMENT: Compressed gases are filled in cylinders and transported to the place of use. The important precautions to be followed are given below: 1. Cylinders should not be permitted to strikemarnahit against each other.

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2. Special and standard tools should be used on valves. Normally these are provided by manufacturers. 4. Cylinders should be protected against extrem of weather particularly against excessive rise in the temperaturethan cylinder fat jyega. 5. Cylinders received should bear a conspicuous standard label indicating the kind of gas. The colour of the label shows whether gas is inflammable corrosive or inert. 6. Full cylinders should be separated from empty cylinders. GAS SENSOR PLACEMENT Place sensors close to possible gas source. Place sensors in areas where gas might accumulate. Place toxic gas and oxygen deficiency sensors in the “breathing zone”. Consider accessibility and maintenance issues. GAS WEIGHT IN RELATION TO AIR Carbon Monoxide Slightly Lighter Ethylene Slightly Lighter Ammonia Lightermeans its effect upper side/near flore Methane Lighter Hydrogen Lighter Butane Heavier Chlorine Heavierit nt simply out to room Heptane Heavier Ethane Slightly Heavier DUSTS EXPLOSION Dust means if the maximum particle size of the solids in the mixture is 500 mm. Dust explosion is a rapid combustion of a dust cloud. During the process heat and reaction products are evolved. The required oxygen for combustion is mostly supplied by air. If iron or stone pieces get into the disintegrator or grinding mill sparks are emitted which may bring about explosion with some easily combustible materials. It has been found that in pharmaceutical industry dust of starch and dextrin besides organic substances are extremely hazardous. FACTORS IMPACTING A DUST EXPLOSIONdhmakavisfot 1. Particle size 2. Chemical properties of a dust 3. Moisture content 4. Cloud dispersion COMBUSTION PRINCIPLES Fire is a rapid oxidation process with the evolution of light and heat in varying intensities. 2C + O 2 2CO SO2+2H2O H 2 SO 4

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DUSTS MANAGEMENT: 1. Avoiding the development of explosive mixtures: Dust should not be accumulated at a place. Removed from the site as soon as it forms. 2. Replacing the atmospheric oxygen by inert gas or using inert dust: This process is also known as inerting. Explosion dusts can be changed into mixture by the addition of inert dust such as rock salt and sodium sulphate so that dust is diluted to a level less than its lower limit of explosive range. 3. Preventing the occurrence of effective ignition source: Some of the ignition sources are welding smoking cutting and mechanically generated sparks and the resulting hot sources. The premises must be kept very clean eliminating all sources of ignition. CONTROL OF DUST EXPLOSION In pharmaceutical industry dust is controlled by three methods. Filtration Inertial separation Electrostatic precipitation FIRE AND EXPLOSION HAZARDS Spontaneous combustion and non-explosion proof electrical equipment is the potential ignition source. The severity of the burns depends on the intensity of the fire and the explosion time. Fire occurs in the industry more frequently than explosions and toxic release although the consequences in terms of loss of life are generally less. So fire might be less hazardous. CONTROL OF FIRE AND EXPLOSION 1. Careful plant layout and judiciousspecific choice of constructional materials can reduce fire and explosion hazards. 2. Fire resistancerokne wale brick-walls can limit the effects of an explosion. 3. The roof is designed to lift easily under an explosive force. 4. Possible sources of fire are reduced by eliminating the unnecessary ignitionjalne wale sources such as flames spark smoking welding etc. 5. The installation of sufficient fire alarms temperature alarms fire-fighting equipment and sprinkler systems must be specified. Building Construction: Building should be constructed such that fire can’t be separated from one building to another. When combustible construction is necessry firewall cutoffs should be provided.

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Exit Points: The exit points of adequate capacity should be provided so as to enable the employees to reach a place of safety outside the building in case of fire. Fire Alarm Equipment: Fire alarm systems are placed in conspicuous locations in all parts of the plant for promptly notifying the fire brigade and for exit of employees. Sprinkler Systems: Automatic sprinkler is a device for discharging water automatically on a fire. Safety and Fire Protection Organization: A central committee composed of the plant manager as permanent chairman and safety and fire protection supervisor as permanent secretary. Fire Extinguishers: Fire extinguishers are installed inside hose. These are designed for extinguishing the incipient fires. The incipient fires are divided into three categories Class A fires: These fires are originated from ordinary combustiblejalne wale materials. These fires are controlled using water which produces quenching and cooling effects. Class B fires: These fires are originated from oil’s greases flammable liquids etc. The extinguishing agent should produce a blanketing or smoothening effect. Class C fires: These fires are originated in electrical equipment. The extinguishing agent produces a non-conducting property. BIOLOGICAL HAZARD This can include medical waste or samples of a microorganism virus or toxin that can impact human health.It can also include substances harmful to animals. Biological hazards cause a lot number of diseases like Brucellosis: it usually occurs in dairy farm workers. Symptoms - fever arthritis and enlarged spleen etc. Byssinosis: It usually found in textile industries workers due to inhalation of the cotton fibre dust over long period of time. Symptoms - Cough breathlessness slight fever and bronchitis. Others are baggosis and locomotor disorder.

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