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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

Dust Explosion

Toxic ReleaseFire and Explosion

Chemical Spill Lighting protection

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

� Fire inside the reactor :

� Static electricity

� High oxygen content

� Improper method of addition

� Splashing of solvents

Control measures :

� Copper jumpers

� Dip pipes

� Nitrogen purging

� 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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5th June, 2011

WORLD ENVIRONMENT DAY“'Forests: Nature at Your Service'”

EMERGENCY RESPONSE VEHICLE

• Emergency response vehicle is made available in plant premises

round the clock.

• Dedicated communication facility is made available to avoid the

miscommunication.

Items Items

Advanced Firefighting Technology

Fire Extinguisher (CO2-22.5 KG)

Fire Extinguishers (MF)

Fire Extinguisher (DCP-50 KG)

Rope

SCBA set

SCBA spare cylinder

Caution Tape

Fire Proximity suit

a. Nomex Suit

b. Gum boot

c. Gloves

d. Helmet

Respirator

Water gel blanket

Spill Control Kit

Electrical gloves

Chemical suit

Fire Axe

Gum Boot

PVC Gloves

Chemical Sorbent Boom

Aluminum Ladder

Helmet (red color)

Helmet (Green color)

Public Address System

5th June, 2011

WORLD ENVIRONMENT DAY“'Forests: Nature at Your Service'”

EMERGENCY SAFETY CUPBOARDS

• Emergency safety cupboards are equipped with various

emergency equipments to use in case of emergency.

• Cup boards are place at various strategic locations and includes:� Self contained breathing apparatus

� Resuscitator

� 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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2/11/2014Corporate EHS presentation, Biocon

Limited19

EMERGENCY PREPAREDNESS AND RESPONSE DRILL

First aid service Shut down Procedure

Head Count compilation Observation briefing session

2/11/2014Corporate EHS presentation, Biocon

Limited20

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

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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

Implemented

integrated

Industrial

Hygiene

Management

From design to

finished goods

stage.

Work Place Monitoring includes

� Volatile Organic Compounds

� Carbon monoxide

� Light sensitivity

� Noise levels

� Temperature

� Humidity

� Carbon Dioxide

� 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

dosemg/day 100<TDD 10<TDD<100 1<TDD<10 0.1<TDD<1 TDD<0.1

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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Modular Based Safety

Training for all

workforce. Designed

based on the employees

activity/ operation

requirement

Importance of H & S “Education”/ “Training”

CHEMICAL SAFETY

LABORATORY SAFETY

SAFETY IN PROCESS

OPERATIONS

OPERATION OF

EMERGENCY

SAFETY EQUIPTS

EHS SYSTEMS

EHS LEGISLATIONS

EMERGENCY

RESPONSE

PROCEDURE

SAFETY IN

MAINTENANCE

ACTIVITIES

CONTRACTOR

SAFETY

SPECIALISED

TRAININGS

HEALTH & SAFETY PRACTICES

� Complete Safety inbuilt

infrastructure ( FAS, Detectors and

CCTV etc.)

�Emergency Number: 2000

�Ambulance Contact: 1008

�Emergency Rescue Vehicle Equipped

with 42 variety of Emergency

Equipment, PPE and Emergency

Items.

�Hydro Carbon concentration detectors

at all solvent storage yard

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