Hazard Management in Pharma

Industries
Design & Operation for Safety Enhancement

PRESENTATION BY

P. ESHWAR REDDY, CEO

RAMKY PHARMA CITY (INDIA) LIMITED

27, March 2009

 HAZARD MANAGEMENT ISSUES

Unplanned growth of Pharma Clusters

No proper zoning
Insufficient land, buffer zone, infrastructure
Inadequate knowledge of processes and operations
Lack of safety awareness, risk analysis, emergency
prepardness
In adequate knowledge on run away reactions, safe
storage and handling of chemicals
Inadequate process details given to operations staff
Technology piracy
CONVENTIAL PROCESS

Raw Material Product

Process
Energy By-Product

Waste

Recover & Recycle Treatment &

Disposal
STEPS INVOLVED IN PROCESS SELECTION
1. Selection of solvents
2. Quality of raw materials
3. Equilibrium reactions, by-products
4. Sequential reactions, remove product as it forms
5. Mixing
6. Alternate process routes
7. Batch or continuous processing
8. Addition of reactants & addition sequence
9. Cooling & heating systems in reactors
10.Process controls (pH, Temperature, Pressure etc..)
 POINTS FOR DISCUSSION FOR SAFETY IN
OPERATIONS

1. LAYOUT
2. DESIGNS
3. ENGINEERING STANDARDS
4. OPERATING PROCEDURES
5. TRAINING
6. HOUSEKEEPING
LAYOUT
1. TANK FARMS
2. EQUIPMENT LAYOUT
3. DISTANCE BETWEEN UTILITIES & PROCESS PLANT

DESIGNS & STANDARDS

1. REACTIONS ABOVE FLASH POINT
2. STATIC ELECTRICITY
3. VACCUM SYSTEMS
4. PIPING & CROSS CONTAMINATION
5. UTILITIES COMPATIBILITY
6. BATCH DISTILLATIONS
WRONG OPERATION : ONE COMPONENT NOT ADDED

Componenet - B (Not added)

Chlorine

Component - A

(-) 25 deg C

Material rejection and Drumming

UREA GOT REACTED WITH CHLORINE AND BYPRODUCT

NITROGEN TRICHLORIDE FORMED (HIGHLY EXPLOSIVE)
BAD ENGINEERING AND WRONG OPERATION
TO VENT

TO VACUUM SYSTEM

REFLUX

HEXANE

(-) 25 deg C

BOTH VENTS CLOSED BY OPERATOR

BAD ENGINEERING : WRONG PIPING

ACIDIC MASS SULPHIDES Na2S + 2 HCl 2 NaCl + H2S

QUANTITY : 7 kg HCl
H2S GENERATED : 2.2 m3
EMPTY SPACE IN FILTER :100 Lt
PRESSURE DEVELOPED : 22 kg/cm2
Nitrogen

SULPHIDES

FILTER
UTILITIES COMPATABILITY : WRONG COOLING MEDIA

CT WATER OUT

CT WATER IN

Eg: REACTION WITH ACIDCHLORIDES WATER INGRESS AND

EXPLOSION
STANDARD OPERATING PROCEDURES

1. IDENTIFICATION OF MATERIALS
2. BATCH QUANTITIES
3. OPERATING PARAMETERS
4. SEQUENCE OF OPERATION
5. USAGE OF CATALYSTS
6. MSDS
 HAZARD ANALYSIS

This is applying quantitative methods to safety problems

Three stages of hazard analysis

1. Estimating how often a incident can occur

2. Estimating the consequences to employees, public,

plant and profits

3. Compare results of 1 &2 above with target or criterion ( Reduce

probability of occurance,minimise risk, ignore the risk)
 IN BRIEF THE STAGES ARE

1.HOW OFTEN ?
2.HOW BIG ?
3.SO WHAT ?
 Example of target Hazard Rate

CASE A: One person killed every year for 100 years

CASE B: 100 people killed once in 100 years

What should be priority: Prevention of Case A or Case B

Arguments in favor of prevention of Case A:

Case B will never happen if plant life is 10 years(odds are 10 to 1 against)
It is certain one person will be killed every year- so why not prevent

Arguments in favor of prevention of Case B:

Press, public and government make more fuss
Case B disrupts organisation and local community
May cause production to be halted for long time,perhaps for ever
Estimating how often an incident will occur

1.Hazard rate- eg.rate of pressure increase

2.Protective systems in place
3.Demand rate (no. of times protective
system to operate)
4.Failure rate of protective systems
5.Fractional dead time of protective system
Main sources of error in Hazard analysis

1. Failure to foresee all ways in which a Hazard can arise

2. Errors in the logic

3. Failure to see poor designs of protection systems

4. Design assumptions not followed

5. Wrong data
 Hazard Identifying and Assessing

Methods of identifying Hazards Methods of Assessing Hazards

Obvious Obvious

See what happens Experienced

HAZARDS
Check List Codes of Practice

Hazop Hazard Analysis

 HAZOP

This is a Hazard and Operability study to identify hazards

and problems which prevent efficient operation

GUIDE WORDS

None

More of

Less of

Part of

More than

Others
 HAZOP-Deviations Generated by each Guide
Word

GUIDE WORD DEVIATION

NONE No Flow, Reverse Flow

MORE OF Higher flow,Teperature, Pressure etc.

LESS OF Lower flow, Temperature, Pressure

etc.
PART OF Change in ratio of components,
component missing
MORE THAN More components than design, extra
phases,impurities, corrosion products .
OTHERS Start up, Shut Down, failure of utilities,
catalyst charge
 HAZOP TEAM
New Designs Existing Plant

Design Engineer Plant Manager

Process Engineer Process Operator

Commissioning Manager Plant Engineer

Instrumentation Engineer Instrumentation Manager

R&D Chemist Safety Manager

Process Consultant Independent Team Leader

Independent Team Leader

 HAZOP STUDY

Prerequisites
Detailed Process Description
P & I Updated Diagrams
MSDS
Standard Operating Procedures
Operator Log-Sheets

Points - of - Watch
Do not get carried away
Hardware and Software
Modifications without authorization
Over confidence- no need for Hazard identification
SOME MORE EXAMPLES OF ACTUAL

INCIDENTS
 RECOMMENDED ACTION PLAN

Establish guide lines for establishing the Pharma cluster

industries
Provide consultancy / training in designs, process
evaluation, project planning etc.
Establish core centre for providing services in Hazards
identification, evaluation and mitigation
Provide services , facilities and training in emergency
prepardness and emergency plans
Provide training in plant operations, documentation, bulk
chemicals storage and handling
Guide in conducting hazardous reactions such as
halogenation, hydrogenation, nitration, ethoxylations and
high pressure/temperature reactions
 AND NOW THE FINAL WORD

SAFETY LIES IN OUR MIND

Safe actions follow if we build belief in

Right Methods
Safe Practices
Safe Processes.
Thank You