2/11/2014
Process Hazards in Bulk Drug Industry
and identified solutions
Dr.Kameswar Rao AV, General Manager-EHS, Biocon Limited, Bangalore
Content
• Types of Process hazards in Bulk Drug industry
• Types of emergencies in bulk drug industry
• Root Cause for emergency
• Control &Preventive Measures
• Emergency preparedness and Response
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Hazards in bulk drug industry
Fire and Explosion Toxic Release
Chemical Spill Lighting protection Dust Explosion
Types of Hazards in bulk drug industry
• Fire and Explosion
• Toxic Gas release
• Static electricity
• Runaway Reaction
• Dust explosion Hazard
• Storage and Handling of non compatible materials
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Sources of Hazards in Pharma
• Handling and storage of huge quantity hazardous chemicals .
• Transferring, loading and unloading of solvents and chemicals to reaction vessels.
• Human errors while handling hazardous chemicals.
• Emission of Hazardous Air pollutants from reaction vessels due to over loading or under designed
reaction vessels.
• volatile organic compounds releases from un contained ( or not connected to scrubbers )
reaction vessels and most common VOCs include methanol, dichloromethane, toluene, ethylene
glycol, N,Ndimethylformamide ,and acetonitrile.
• Leaks of effluents from wastewater treatment plants or from effluent collection sumps from
process area.
Some Environment Hazards by Pharma Firm
• The hazards from the pharmaceuticals could be categorized as:
• Ecotoxic - damage is caused to the environment.
• Carcinogenic - contribute to the causation of cancer.
• Persistent - remain dangerous for a long time.
• Bio-accumulative – accumulates as it makes its way up the food chain.
• Disastrous due to a catastrophe, mishap, calamity or grave occurrence in
any area.
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Fire and Explosion
Source
Vapor cloud Explosion
Electrical spark
Static Electricity
Hot Work- welding Cutting, grinding, etc
Improper addition. ( Human Error)
Control Measures .
Closed Operation and Inerting the
reactors/Vessels
Adequate Ventilation system to avoid
formation of vapour cloud
Flameproof Electrical Fittings
Earthing and Bonding.
Adherence of Work Permit system
Safe Operating Procedures for Handling
Chemicals
Conducting mock drills to get prepare for
mitigating emergencies.
Toxic Chemical Spill and Gas release
Causes & Consequence
Improper storage and Handling .
Pipeline Rupture .
Leakage from storage tank and containers.
Inadequate scrubbing systems
Loss of human Life
Control Measures
Adequate storing facility with defined inventory Norms.
Storing hazardous chemicals in suitable compatable
mode.
Adequate Scrubbing system with suitable scrubbing
solution
Periodic inspection of Pipelines ( pressure and corrosion
Test)
Secondary Containment facility for chemical storage
Tanks
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Static electricity
Source of Static charge
liquid flows through a pipe or hose, or though
an opening in a pipe or hose.
Spraying or coating.
Blending or mixing.
Filling tanks, drums, cans or pails.
Dry powdered material passes through
chutes or pneumatic conveyors.
non-conductive conveyor belts or drive belts
and moving appliances are plugged into
electrical outlets.
.
Static electricity
Controlling of static electricity
Proper Earthing & Bonding
Humidification
Static collectors
Additives
Controlling static electricity on
people
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Dust Explosion
Source of Dust generation
Drying
Blending
Milling
Sieving
Packing
Control Measures
Closed Loop Operation
Intertization of the equipment with Nitrogen
Adequate Exhaust Ventilation
Equipment used for milling operation must have
rigid “Earthing and Bonding”
Usage of Antistatic bag while packing the material
Processes Hazards : Over pressurization of reactor
Source
Closure of condenser vent
Excessive heating
Incorrect material addition
Water addition from separator
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Processes Hazards : Solvent addition
Control measures :
Fire inside the reactor :
Static electricity Copper jumpers
High oxygen content Dip pipes
Improper method of addition Nitrogen purging
Splashing of solvents
Double Earthing of reactors and sample tubes
No splashing of solvents for cleaning
Use of flame proof Electrical Equipment's
Runaway Reaction
Causes
improper addition of the Raw material
Vigours Agitation
Failure of cooling systems
Contamination
Control Measures
Control addition of raw materials by procedural control
Adopting Best Engineering practices
Keep ready for Suitable inhibitor
Preventive Measure
Complete process safety study should be done before starting commercial
process.
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Preventive Safety Measures
Process Risk Assessment – HAZOP, FTA etc New process, and major
changes
Hazards area classification- Electrical appliance as per Zone classification
Environment Impact- EIA aspect for new process, design
Chemical Risk Assessment- Assessment for compatibility , storage , toxicity
etc
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EMERGENCY RESPONSE VEHICLE
• Emergency response vehicle is made available in plant premises
round the clock.
5th June, 2011
• Dedicated communication facility is made available to avoid the
WORLD ENVIRONMENT DAY
miscommunication.
“'Forests: Nature at Your Service'”
Items Items
Advanced Firefighting Technology Respirator
Fire Extinguisher (CO2-22.5 KG) Water gel blanket
Fire Extinguishers (MF) Spill Control Kit
Fire Extinguisher (DCP-50 KG) Electrical gloves
Rope Chemical suit
SCBA set Fire Axe
SCBA spare cylinder Gum Boot
Caution Tape PVC Gloves
Fire Proximity suit Chemical Sorbent Boom
a. Nomex Suit Aluminum Ladder
b. Gum boot Helmet (red color)
c. Gloves Helmet (Green color)
d. Helmet Public Address System
EMERGENCY SAFETY CUPBOARDS
• Emergency safety cupboards are equipped with various
emergency equipments to use in case of emergency.
• Cup boards are place5th June, 2011 strategic locations and includes:
at various
Self contained breathing apparatus DAY
WORLD ENVIRONMENT
Resuscitator“'Forests: Nature at Your Service'”
Air purifying respirator
Portable oxy pack
Fire axe
First aid burn dressing
Water gel blanket
Helmet with face shield
Spill control pads
Aluminum ladder
Fire suit
Manila rope
Canvas stretcher
Gloves
Gum boots
Helmet
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EMERGENCY PREPAREDNESS AND RESPONSE DRILL
First aid service Shut down Procedure
Head Count compilation Observation briefing session
Corporate EHS presentation, Biocon
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Limited
EHS TRAINING
• EHS developed modular based training programmes for
effectiveness. Various modules are:
S. No Module number Description
1 Module – I Chemical safety
2 Module – II Laboratory safety
3 Module – III Safety in process operations
4 Module – IV Operation of emergency safety equipment
5 Module – V EHS systems
6 Module – VI EHS legislations
7 Module – VII Emergency response procedure
8 Module – VIII Safety in maintenance activities
9 Module – IX Process safety management
10 Module – X Contractor safety
11 -- Specialized trainings
Corporate EHS presentation, Biocon
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Limited
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UNIQUE PRACTICES IN THE PROCESS
SAFETY MANAGEMENT
Implemented integrated Process Safety Management
From design to finished goods stage.
Process Hazard Analysis
HAZOP
FMEA
Fire Index
What if Analysis
Job Safety Analysis
Failure Tree Analysis.
Risk Assessment
Pre Start-up, Safety Review
Powder Testing to know M I E
Practices of Industrial Hygiene
Work Place Monitoring includes Implemented
Volatile Organic Compounds integrated
Carbon monoxide Industrial
Light sensitivity Hygiene
Noise levels Management
Temperature From design to
Humidity finished goods
Carbon Dioxide stage.
Particulate matter
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INDUSTRIAL HYGIENE FOR POTENT DRUGS
• Strategy for addressing potent drugs health and safety
issues is as follows:
Understanding routes of exposure
Establishment Occupational Exposure Limits (OEL)
Assigning Occupational Exposure Bands (OEB)
Exposure assessment
Risk characterization
Control and containment approach
INDUSTRIAL HYGIENE FOR POTENT DRUGS
• Occupational Exposure Bands are assigned by considering
various health hazards.
• Criteria for assigning OEBs is as follows:
Hazard UOM OEB 1 OEB 2 OEB 3 OEB 4 OEB 5
OEL, dust µg/m3 1000-5000 100-1000 10-100 10-1 <1
OEL, vapour ppm >1000 100-1000 10-<100 1-<10 <1
Therapeutic daily
mg/day 100<TDD 10<TDD<100 1<TDD<10 0.1<TDD<1 TDD<0.1
dose
Oral toxicity, LD 50 mg/kg >2000 300-2000 50-300 5-50 <5
Dermal toxicity, LD 50 mg/kg >2000 400-2000 50-400 1-50 <1
Chronic health effect Half life Minutes Hours Days Weeks Years
Corrosivity pH 6-9 5-6 or 9-10 3-5 or 10-12 1-3 or 12-14 <1 or >14
R-Phrases - Nil Class 1 Class 2 Class 3 Class 4
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Importance of H & S “Education”/ “Training”
CHEMICAL SAFETY
EHS LEGISLATIONS
LABORATORY SAFETY
EMERGENCY
RESPONSE
PROCEDURE
SAFETY IN PROCESS
OPERATIONS
Modular Based Safety SAFETY IN
Training for all MAINTENANCE
workforce. Designed ACTIVITIES
OPERATION OF based on the employees
EMERGENCY activity/ operation CONTRACTOR
SAFETY EQUIPTS
requirement SAFETY
SPECIALISED
EHS SYSTEMS
TRAININGS
HEALTH & SAFETY PRACTICES
Emergency Number: 2000 Complete Safety inbuilt
Ambulance Contact: 1008 infrastructure ( FAS, Detectors and
CCTV etc.)
Emergency Rescue Vehicle Equipped Hydro Carbon concentration detectors
with 42 variety of Emergency at all solvent storage yard
Equipment, PPE and Emergency
Items.
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