1

Welcome
Best Safety Practices
in
SUN Pharmaceutical Industries Ltd.
Plot : A-7 / 8 , MIDC Industrial Area ,
Ahmednagar
Date: 08.10.2015
B.F.Shirude VP Operation
Pramod Pisal - EHS Manager,
V.M.Dengle Tech . Asst . Production.

Best Safety Practices at

SUN Pharmaceutical Industries Limited,
Ahmednagar (MS)

Safety Management of Pharmaceutical Industry

October 08,2015
NSC MS & DISH, Mumbai

Total Manpower : Staff : 980 & Worker: 180 : Total:1160

EHS Policy & PLI Policy

FACILITIES
Best Safety Practices

Production , Engineering & quality Block

Best Safety Practices

Engineering

Quality Block

Production Plants

1. Process Safety Problem consequences Quantification in terms of human loss, property

damage , financial loss & Effect of business continuity.

Sr. No.

Process Safety Problem

Consequences

01

Reaction
Chemical handling , Pressurization & Exothermic.

Fire , Explosion, Gas leakage & injury

02

Operation of Centrifuge & dryer Chemical handling

Fire , Vibration , Static charge & Injury

03

Handling of Flammable chemicals like Methanol, Acetone , IPA

etc.

Fire , Explosion, Inhalation of solvents and

spillage

04

Handling of Corrosive chemicals like Sulphuric Acid, Caustic lye &

Hcl

Skin Burn & Spillage

05

Tanker unloading and loading of flammable and corrosive

chemicals.

Spillage , fire hazards.

SAFETY STATICS 2012- 2015

Year
2012
2013
2014
2015
Nos. of Incident
1
1
3
2
Man Day lost
340
16
42
7
Property damage in Rs.
5000
1200
5090
90000
Financial loss in Rs.
7640000
72000
69000
37000
Effect on Business continuity No Impact No Impact No Impact No Impact

2. Methodology of Hazard / Risk identification

Procedures: To establish implement and maintain procedures for the ongoing hazard identification, risk
assessment, and determination of necessary controls.
No

Activities
Services

01

Acetone
drum filling
From
Storage
tank
( Routine )

Cond
ition
N

Hazard

Handling
of Empty
& filled
MS drum

Harm

Hand
injury

Hazards
no.
HAZ/01/
H01

Legal
Yes /
No

1. Storage tank PESO License

required.
2. Safety Inspection of tank to
be carried out.
2. Competent person required.
3. MSDS required.
4. MS drum earthing and
continuity & dip pipe.
5. PPEs required.

L 01
AB
Due
to
(E01)

Fall of
Acetone
drum
leads
Spillage

Exposur
e of
Acetone
vapor
Health
hazard
and
Fire.

Existing

Controls

Yes

As per
The
Factori
es act
1948 &
MFR
1963 &
Petrole
um
Rule

( Routine )

Determined Controls

HAZ02/H
01

Abbreviations
N
Normal
AB
Abnormal it covers startup, shutdown, emergency
BR
Base risk

In Addition to above following

control are required.
1. Emergency rescue team.
2. As built safety system
required breathing air , SCBA
& Fire protection system.
3. On site Emergency plan
required.

RR
A
NA

1. SS 15 KL storage tank
PESO License valid up to
31.12.17 with safety
fitting like, breather valve
with flame arrester.
2. Safety Inspection as
per SOP carried out
3. Tech. person provided.
4. MSDS at woekplace.
5. MS drum having
earthing & continuity
checked.
6. PPEs provided like
a. Multigas mask
b. and gloves
c.. Safety goggle
In
to above
e.Addition
Safety helmet
following
f. Safetycontrol
shoes are
provided.
1. Emergency rescue
team at site.
2. As built safety
Breathing air, SCBA & Fire
protection system.
3. On site Emergency plan
available.

Residual risk
Acceptable
Non Acceptable

L
E
Se

Risk

Se

Risk
score

Risk
level

BR

15

03

RR

02

01

A/
NA

A 01

BR
RR

Legal
Emergency
Severity

4
1

2
2

08
02

02
01
A 02

Probability of hazard
occurrence

Additional
control
proposed
Bund and
dyke valve
provided as
per 110% of
largest tank
in storage
tank.

Methodology of Hazard / Risk identification

H: Risk based control plan.

RISK

ACCEPTABLE

NON

ACCEPTABLE RISK

Risk
Level
No.

Risk
score

Risk level

Action

1-5

Trivial

No action is required and no documentary record needs to

be kept.

6 - 10

Tolerable

No additional controls are required. Consideration may be

given to a more cost effective solution or improvement that
imposes no additional cost burden. Monitoring is required
to ensure that the controls are maintained.

11-15

Moderate

Efforts should be made to reduce the risk but the cost of

prevention should be carefully measured and limited. Risk
reduction measures should be implemented.

16-20

Substantial

21-25

Intolerance

Work should not be started untill the risk has been

controlled / reduced. Considerable resources may have to
be allocated to reduce the risk where the risk involves
work in progress urgent action should be taken.
Work should not be started or continued until the risk has
been reduced. It is not possible to reduce risk even with
unlimited resources, work has to remain prohibited.

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Methodology of Hazard / Risk identification

Compentency Matrix : Production
Name of Employee : Mr. K.D.Indulkar
Name of
Operation

IMS Awareness

Expectation

90

90

Rating

90

90

Legal
Requirements

Handling of
Chemicals &
MSDS

On-site
Emergency Plan

Work Permit
System

Unit Operation

First Aid

90

90

90

90

90

90

80

85

75

80

80

80

90

70

EHS & Quality Departmental

Policy
Aspects /HIRA

3. EXISTING CONTROL MEASURES

Process Safety Information :
# Material Safety Datasheet ( MSDS ) through Chemwatch paid software and hard copy available at workplace.
# Basic design and Engineering of equipment by installation, operational & performance qualification.( IQ,OQ & PQ)
# Process flow Diagram & Critical Operating Parameters mentioned in Batch Manufacturing record.
# Electrical Flameproof equipment as per Area Classification.
Reactor & Storage Tank Safety measure taken:
Safety relief value and Rupture disc to pressure vessel with Six monthly & yearly testing frequency.
Provision of knock out vessel to pressure vessel .
Temperature & Pressure indicators are provided.
Flame arrester is provided to flammable chemical storage tanks .
All reaction vessel , centrifuge , dryers are undergone preventative maintenance schedule for better operation
and avoid the brake down and ensure the 100% compliance.

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4. Approach / Methodology to resolve the problem

Involvement of all the level of employees.
Demonstration of Safety is a line Management responsibility.
Methodology to resolve the problem: The site is having daily meeting at shop floor and discuss with all level with
best solution and award in Great Place to work by appreciation and gifts etc.
Employee Participation: Celebration of National Safety week, Fire service week, World Environment Day & Road
Safety week at site .
Safety is a line Management responsibility:
Process Hazard Analysis: Every product technology transfer reviewed by HAZOP , Risk Assessment by HIRA &
ASPECT Identification. ( SOP & Formats )
Work Permit System: Job Safety analysis through ; Five types of permit are maintained by line management . All
permit records are duly maintained as per the standards. (Types of permit: General, Hot, Vessel Entry, Electrical &
Working at height / Excavation work etc.) . Technical & EHS Training imparted by line management .

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4. Involvement of all the level of employees.

Demonstration of Safety is a line Management responsibility.

Six monthly internal audit through checklist.

Biometric access , Restriction of Mobil , No Smoking policy, No drugs & No alcohol & frisking with checking
through Alcohol meter if any symptoms observed .
PPEs Matrix as per unit operation activity.
Uniform at workplace .
AMC for Safety & Fire equipment's.
Self contained breathing apparatus. (09 set and two spare cylinder )
Near miss , incident reporting and Investigation with root cause analysis.
Legal monitoring on monthly basis.
Emergency management system Mock drill on Monthly basis to Plant level & six monthly for all site.
Site Safety Inspection on six monthly basis.
Site Safety meeting on quarterly basis.
Safety Champion team of 81 member working all shift and resolves the shop floor problem.
Sheel Technology membership for monthly new letter and legal update for all site.

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5.Modified Process
6. Method of implementation, measuring & monitoring
for sustaining of the process

Standard Operating
Procedures

EHS Best Practices

Fire Protection
system

Internal Audit &

Inspection by checklist

EHS Training

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5. Production details
Best Safety Practices

We have manufacturing 95 products of different category.

Analgesic, antiinflammatory

Antidepressant

Antineoplastic

Anticonvulsant

Antidiabetic

Antiallergic

Raw Material

Reaction &
Crystallization
Centrifugation

Drying

Milling

Packing

Finished Product

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Content of Standard Operating Procedures ( SOP ) :

Safe Operating Procedures

1. Purpose:

2. Scope:

3. References &
Attachments:

4. Responsibilities:

5.Distribution:

6. Definition &
Abbreviation

7. Procedures:

8. History:

--

1) Standard Operating Procedures :

Implementation of standard operating

Procedures for activity with regular
training to employees and displayed at
workplace for availability.
Total SOP at Site: 947

Best Safety Practices:01

Installation of Knock out pots to all pressure vessel, this shall leads to
following. Benefit: a. Avoiding personal injury b. Avoiding Environmental pollution and spillage
Best Safety Practices

c. Saving costly products d. Avoiding facility damage. e. Legal compliance.

0.25KL Hydrogenation vessel to 0.3 KL knock out pot.

1.5 KL Hydrogenation vessel to 2.0 KL knock out pot.

2.0 KL Hydrogenation vessel to 3.0 KL knock out pot.

5.0 KL Hydrogenation vessel to 5.0 KL knock out pot.

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Best Safety Practices :02 & 03

Best Safety Practices

2. Installation of chemical Pipelines with respect to

the nature of material ( Safety at design ) .
Benefit:
a. For Sulphuric Acid & HCL : MSPTFE
b. For Solvent : SS 316 with jumper
c. SS eye wash shower in workplace.

3. Chemical storage tank equipped with Safety

fitting.
a. Tank Capacity b. Name of Chemical inside storage
c. MOC of Tank d. UN class label or NFPA diamond
e. Name plate on every valve
f. Level indicator & dip pipe
g. Flame arrester
h. Bund and Dyke valve

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20

Best Safety Practices :04

Best Safety Practices

4. Installation of two Briquette (biomass) Fired

Boiler:
12 TPH & 15 TPH (standby) boiler for steam generation
instead of Furnace Oil based.
Benefit: SO2 & SPM emission is reduced.

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Best Safety Practices :05

Best Safety Practices

5. Installation of Powder transfer system ( PTS ):

PTS installed for closed charging of solid state raw /
intermediate to reaction vessel results into
Benefits:
a. No chemicals exposure to employees.
b. No manhole opening while batch charging.
c. Enhanced employee , Product & Process Safety.
d. Safe work place.
e. Elimination of Static charge.

Total PTS in the Factory: 11 Nos.

Powder
Transfer
System
PTS to
V- 904

Suction
Pipe of
PTS to
V- 904

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Best Safety Practices :06

Best Safety Practices

6. Installation of SS charging Port & Nitrogen

blanketing for closed charging of solid state raw /
intermediate material to reaction vessel .

Benefits:
a. No chemical exposure to employees.
b. No manhole open while batch charging.
c. Enhanced employee , Product & Process Safety.
d. Safe work place.
e. Provision of inert atmosphere due to N2 blanketing.
f. Elimination of Static charge.

Total SS Charging Port in the Factory: 47 Nos.

Nitrogen
Blanketing

SS
Charging
Port

Best Safety Practices :07

Best Safety Practices

7. EHS awareness boards at site for visual Safety , Health

and Environment Management system
Ex: The Big Difference for Safety shoe importance , Staircase
railing safety , Machine guard, Risk assessment , Hand
protection , Gas cylinder Safety , Chemical classification by UN
class boards, Emergency instruction & Confined space entry.
( All board in Marathi Language to understand all employees )

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Best Safety Practices :8 & 9

Best Safety Practices

8. Fire detection and declaration system : Smoke + Heat

detection (65Deg.C ) & Public address system installed.
Make: Shrack.
Benefits:
a. Detection & communication of Fire hazard.
b. Enhance the Plant Safety.
c. Compliance of Fire protection.
Fire Detection Panel

PA System

9. Installation of Heat detection cable on Electrical cable

tray at high risk area.
Benefits:
a. Detection & communication of Fire hazard.
b. Enhance the Plant Safety.
c. Compliance of Fire protection.
Listec Cable and Panel

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Best Safety Practices :10 & 11

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Best Safety Practices

10. Electrostatic discharge ( ESD ) awareness training by

subject matter expert to 504 employees with practical
demo on ESD aspect and prevention equipment's by
External agency 4S Techno.
Benefit:
a. Employees awareness on Static charge concept is
increased.
b. Antistatic gown are provided in powder processing
area.
c. Static dissipation pads installed at workplace.

11. Provision of Lock Out & Tag Out ( LOTO ) : All

necessary LOTO devices are provided to Electrical team &
system is implement with SOP , Format , LOTO items and
linked with work permit system.

Training on ESD

Antistatic gown Digital touch pad

Best Safety Practices :12 & 13

Best Safety Practices

12. Installation of Personal Protective Equipment Rack.

Benefit:
a. Easy availability of PPEs.
b. Segregation of PPEs.
c. PPEs maintain in Good and hygienic condition.
d. Used PPEs are maintained in separate compartment
of rack and then discarded.
13 . Gas cylinder Safety
Site has maintain the Gas cylinder leak control kit with
training to concern employees.

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Best Safety Practices :14 to 17

Best Safety Practices

14. On line safety signage's displayed when actual

process is going on
Ex. Steam sanitation

16. Solvent tanker unloading by earth relay system, It

work on earthing continuity to Tanker and earth pit.

15. Spill control Kit : 15 Nos.

a. Pillow , Pad & boom to contain the spill.
b. Soda ash & Sodium Bicarbonate.
c. Dry sea sand.

17. Emergency evacuation & Safety System Plan at Plant

entry.

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Best Safety Practices :18

Best Safety Practices

18. Reactor Safety

Following controls are provided

a.
b.
c.
d.

Safety valve with yearly testing schedule.

Primary and secondary condenser.
Pressure gauges and vacuum gauges installed.
Scrubber system is provided to each plant, which
takes care of air emission and safety of process .
e. Predefined preventative maintenance schedule and
its effective implementation.
f. Machine guards.
g. Utility provision like cooling , chilling and Brine to
handle the process.

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Best Safety Practices :19 & 20

Best Safety Practices

19. Centrifuge Safety

Following Safety controls are provided
a. All pipeline having SS 316 with jumper provision.
b. Interlock : Lid , Vibration, Nitrogen & Zero RPM.
c. Ventilation by min. 20 air changes per hrs.
d. Illumination & Noise study on quarterly basis.
e. SS 316 Breathing air pipeline having color code white with red
band with instant male & female coupling
f. Provision of Nitrogen cooling to rotating parts.
20. Dryer Safety
Following Safety controls are provided
a. All pipeline having SS 316 with jumper provision.
b. Nitrogen blanketing with powder transfer system for charging.
c. Spent solvent collected in pot and recycle for same product.
d. Color code of pipeline Ex. Red color indicate the Hot water &
Nitrogen line green with yellow band. E. Fixed Machine guard .

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Best Safety Practices :21

Best Safety Practices

21. Bromine handling

Transfer & Handling of Bromine by with provision ;
a. Checklist to be filled by concern officer with safety
precaution like qty. to be transfer, First aid kit etc.
b. Barricaded palate
c. Spill control kit
d. Separate dedicate Bromine storage facility for filled and
empty bottles.
f. Bromine scrubber system to storage facility.
Trifluroacetic Acid (TFA)
Handling of corrosive chemicals with full body protective
equipment's at site with Fuming Hood which is connected
to scrubber system.

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Best Safety Practices :22

Best Safety Practices

22. Fire Load survey at site and evaluation of Fire protection system .
Plant / Department
Fire Extinguishers Hose post No. of jet Sprinklers Foam/Water monitor Hose reel Sand bucket MCP Smoke detector
Nozzle
CO2 DCP Foam
Quantity

139

134

54

84

Plants
Fire load - Kcal /Kg
Plant 1A
139110
Plant 1B
56004
Plant 1C
1617
Plant 1D
4161
Pilot
58535
Plant 3
831
Plant 2
77937
Plant 2E
43903
Plant 4
14002
Plant 5
45700
Plant 6
207473
Plant 7
34500
Plant 8
105749
Plant 9
134505
Total Fire Load in Kcal/Kg
924027

84

100

% Wise contributions
15.1
6.1
0.2
0.5
6.3
0.1
8.4
4.8
1.5
4.9
22.5
3.7
11.4
14.6
100.0

10

120

56

89

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Best Safety Practices :23

Best Safety Practices

23. EHS Training by External & Internal expert

MIDC Fire Dept. visited in Fire service week to site.

Drager Mission van visited to Site.

Fire demo for jet nozzle

Wet hose drill

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Best Safety Practices :23

Best Safety Practices

23. EHS Training by External & Internal expert

First aid by Red cross

Mist and Fire extinguisher demo by ASKA.

Snap of Safety Belt donning training at site.

Working
At height demo

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Best Safety Practices :24 & 25

Best Safety Practices

26. Road Safety : Installation of Convex mirror at every

corner at site.

27. Warehouse & Fork lift Safety:

a. Reverse horn with visual and audio.
b. Authorized Trained driver.
c. Safe working load displayed on rack system.
d. Preventative maint. by Godrej suppler only.
e. Yearly checking of Lifting tackles by competent
person.

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26. EHS Training by External & Internal expert

EHS
Training

EHS Topic covers;

1. HAZOP Study
2. HIRA & Aspect
3. Fire Fighting on Fire Extinguishers
operation & Fire hydrant dry and wet
hose drill & Donning of SCBA.
4. Material Safety data sheet
5. Chemical Safety
6. Electrostatic discharge
7. First aid
8. Work permit system
9. Fork lift safety
10. Safety System at site
11. SOP
12. Personal Protective Equipment's.

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7. Safety Organization Chart

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Best Safety Practices

8. Achievement , Awards to the organisation

Change in Safety culture in organisation..

We have several regulatory approval and achievements

Achievements

National Safety Council MS for lowest frequency rate

Safety Audit by MCCIA on the occasion of Safety Week

Quality Excellence Gold & Sliver award by IDMA

Regulatory Approval
USFDA
AIFA ITALY
MHRA
Netherland
WHO GMP
Europe GMP Audit by Berlin Authority

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Achievement , Awards to the organisation

Change in Safety culture in organisation..
CSR

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Achievement , Awards to the organisation

Change in Safety culture in organisation..
Best Safety Practices

Mr. Pramod Mane MPCB SRO awarded to SUN

Pharma for best Environmental Practices received
Memento by Mr. B.F. Shirude V.P. Operation
Cotton bag distributed to all employees , an
initiative taken to reduce use of polythene bags on
the occasion of World Environment Day 2015.

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Achievement , Awards to the organisation

Change in Safety culture in organisation..
CSR

Health, education, civic utilities and disaster relief are areas where we have focused our attention.

Primary health care project : Mobil medical unit , near about 10 villages under vigilance. Expenses: 1 Core.
Sanitation Project : 120 construction on Pilot basis in Vilad village. Expenses : 10 Lac.
Drinking water Project: In 12 School purified drinking water facility provision. Expenses: 6.5 Lac.
Rs. 75000/- Fund provided to Forest development corporation of Maharashtra Ltd to archive the 100 cores trees
plantation.
Drinking Water storage tanks provided to villages for collection of water in summer session.
Held Tree Planation Programs at School near about 350 new sampling on the occasion of World Environment Day
2015.

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Achievement , Awards to the organisation Change in

Safety culture in organisation..
By TUV Nord certification of management System
o Quality Management System ISO 9001:2008
o Environment Management System ISO 14001:2004
o Occupational Health Safety Assessment series OHSAS 18001:2007

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10. New concept for change in Safety

Week at School since last four year
EHS
Participati
on

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Thank You
DISH , NSC MS & Participation
Best Safety Practices award competition

2015

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