Exposure Risk Assessment Challanges

Exposure Risk Assessment Challenges:
Occupational Hygiene in the Pharmaceutical
and Chemical Industries
AIHA 2013
Asia Pacific OH Conference, Singapore
Maharshi Mehta, CSP, CIH
President
International Safety Systems, Inc.,
Washingtonville New York, USA
www.issehs.com
Samson Ponselvan
Head, Corporate EHS
Shasun Pharmaceuticals
Limited, Chennai, India

Agenda: Two Part Presentation
Part 1: Maharshi Mehta
 Growing need for sustainable Industrial hygiene
and process safety in Emerging Economies
 Introduction to potential health and process
safety risk
 Risk Assessment and Risk Controls
 Challenges Encountered
 Approaches adopted
 Lessons Learned
©International Safety Systems, Inc.
www.issehs.com

Part-2 : Samson - Agenda
1. Background /Introduction
A. Why is this important ?
B. HSE Trends in Asian countries
C. IH in Pharma and Chemical industries
2. Challenges in managing potential health
risks and solutions
3. Hierarchy of controls
- At Source / At Path / At Work
4. IH Management System Models
5. Integration of IH and handling of potent
APIs
6. Conclusion
Slide 3

Introduction
 Pharmaceutical manufacturing is growing 8% to
12% per year in emerging economies
 India is the world’s largest producer of bulk
drugs
 Supply chain, third party manufacturing are
increasing rapidly
 Outsourcing expected to exceed $53B
 More than 100 FDA-approved pharmaceutical
facilities are in India- the largest number in any
country outside the U.S
4

Infrastructure
 Over 450
colleges/departments offering
degree and other education
programs in pharmaceutical
science
 More than 50,000 students
graduates/year
 Manufacturing equipment,
containment technologies
 R&D centers , laboratories
 Two colleges offering
Master in Industrial
Hygiene Program
 150 Industrial Hygienists
for all companies in India
total
 5 CIHs
 Safety professionals or
occupational physicians
practicing IH
 No Accredited Lab for
API/Surrogate
5
Pharma Manufacturing EHS

Introduction-Pharmaceutical and
Chemical Industries
 Active Pharmaceutical Ingredient (API)
Manufacturing similar to typical chemical
industries
– Bulk drug is manufactured
– Potential process safety risk and chemical exposure
risk is high
– Large volume potential solid exposure risk is high
after solid liquid separation
 Formulation or Dosage Form
– Solids and liquid pharmaceuticals are made
– Potential solid API exposure risk is high
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API/Chemical Manufacturing –Process Safety
– The highest priority
 Low flash points solvent. Most commonly used:
– Toluene, Methanol, Dimethyl Formamide, Acetonitrile
 Unit operations
– Tanker unloading and tank farm, barrel transfer
– Reactor vessel charging and cleaning
– Solid liquid separation, distillation
 Most common Contributory factors
– Open handling of solvents
– Validation of inerting
– Non-conductive container handling
– Effectiveness of grounding and bonding
– “Explosion Proof” lighting©International Safety Systems, Inc.
www.issehs.com

Example of Process Safety Incident
A massive explosion and fire
gutted a pharmaceutical supply
plant, killing at least three people
and injuring more than two dozen
others -- about 12 of them
critically.
A volatile mix of air and
suspended dust caused the
explosion The explosion was so
powerful it blew doors open on
houses more than a mile away
and sent debris flying, with some
pieces landing more than two
miles away
Authorities
recommended
residents within a mile
radius around the plant
to evacuate

Process Safety - Most
common recommendations
 Process safety risk is manageable
 Awareness and Risk Assessment (HAZOP)
 Storage tank integrity, flame arrestor
breather valves, dyking
 Validation of inerting-flow rate, volume,
O2<4%. Inerting of not just process vessels
– Centrifuge
 Static electricity controls
– Painted surfaces
– Continuity, resistance and earthing
 Conductive containers
 Specifics on intrinsically safe lighting
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Industrial Hygiene
Hazard Anticipation - Hazards likely to be present?
Hazard Recognition - What are health hazards?
Risk Evaluation - Exposed to health hazard? How much?
Risk Control - How can exposure be reduced?
And potential for occupational illnesses, material loss are
reduced and the company liability minimized
So that…Health risk is minimized

Hazards – Exposures – Controls - and
Risk: example…Low Risk Compression
Activity
Health Hazard: API
Enclosed compression
machine
Potential for exposure
from fugitive
emission
Reduced risk due to effective
use of airline respirator

Industrial Hygiene - Methodology
(Compression)
 Health Hazard Identification
– Obtain hazard data for API from MSDS and label
 Exposure/Risk Assessment
– How frequently and how long compression
machine is running?
– How frequently compression machine is cleaned?
– Are exposure controls effective in reducing
exposure?
– Are recommended RPE/PPEs used?
– Is exposure monitoring conducted?
– Is the exposure below OEG?

Hierarchy of Controls
 Elimination – Avoid Compression?
 Substitution – Use of low potency
compound?
 Process Changes – Vacuum transfer blend in
compression hopper?
– Not feasible due to business constraints e.g., product
validation and registration process
 Engineering Controls – Complete enclosure of
compression machine and tablet container?
 Administrative Controls – Reducing or restricting
exposure duration?
 Personal Protective Equipment and Respiratory Protective
Equipment – Eye Protection, cleaning disinfecting
respirator, storing respirator in a zip lock plastic bag?

API Chemical Plants: Health
Hazards - Solvents
 Toluene and DMF
– Potential reproductive hazards
 Acetonitrile
– CN formation
 Tetrahydrofuran (also peroxide forming agent)
 Isopropanol
 Small Volume Highly Toxic compounds
– Aniline
– Iodine
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API/Chemical Plants: Solvent
Exposure Potential to Exceed
OEL
 Solid liquid separation – Centrifuge - Manual
digging
 Short term exposure – Tanker/barrel QC Sample
taking, tanker hose disconnecting, residual
tanker solvent collecting
 Reactor, vessel cleaning
 Distillation residue collection
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API/Chemical Plants: Solvent
Exposure Controls
 Agitated Nutche
Filter/Filter Dryer in place
of Centrifuge
 Tanker QC sample from
bottom nozzle and not by
opening dome
 Nitrogen for pushing
solvents before opening
hose after tanker unloading
 Local Exhaust Ventilation
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Acute Pharmacological Effects
Pharma compound Exposure Incident: An operator
working on the manufacture of a product containing
Barbiturates was admitted to hospital in
hypoglycaemic coma and the report of a study by the
Pharma company found that operators absorbed
through skin significant levels of Barbiturates.
Health effects described in this and subsequent slides
potentially could occur from overexposure when
effective exposure controls are not in place.
www.issehs.com

Hormones
Endocrine Gland Hormone Main function(s)
Pancreas Insulin Regulates blood sugar levels.
Thyroid
Triiodothyronine and
thyroxine
Development of the brain and reproductive tract, and
regulation of metabolism
Adrenal Cortisol Immune suppression and stress response
Ovary
Estrogens (estradiol,
estrone, estriol)
Growth promotion, maintain elasticity of connective
tissues, preserve bone mass and, vascular compliance,
Testosterone Precursor for oestrogen and acts on libido.
Testis Testosterone
Growth of male secondary sexual characteristics,
sperm production and libido
Dihydrotestosterone Some male secondary sexual characteristics.
Placenta Progesterone Maintenance of pregnancy
Overexposure to hormone during manufacturing, development and testing may
result in elevated levels of hormone in the body and affect the normal functions
of the related endocrine gland.
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Steroids – Health Effects
 Male Employees:
– Gynecomastia (excessive development of the mammary
glands), decreased libido, reduced testicular size,
increased pigmentation of the nipple area, nipple
sensitivity, dysspermia (the occurrence of pain during
ejaculation), weight loss, and headaches
 Female Employees:
– Menstrual disorders (such as increased flow or
intermenstrual spotting), nausea, headaches, breast pain,
leukorrhea (vaginal discharge), and swollen ankles
 Adverse effect on skin such as acne and erythema
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Antibiotics - Health Effects
 Allergic reactions:
– Itching and redness of eyes, runny nose, skin rashes,
asthma, anaphylaxis
 Vitamin deficiency:
– Workers with repeated exposure to antibiotics
experience change in number and type of bacteria
which are normally present in intestines which break
down and absorb vitamins in intestines
 Fungal infections:
– Daily exposure to antibiotic dust can lead to fungal
infections of the skin and nails.
– Women workers may develop vaginal yeast
infections following exposure to antibiotics
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 Acute effects: severe soft-tissue damage, fetotoxicity,
headaches, lightheadedness, dizziness, nausea and allergic
reactions
 Effect on growth and reproduction of the normal cells as
Cytotoxic drugs may not distinguish between normal and
cancerous cells
 Other secondary malignancies, such as bladder cancer and
lymphoma
 Chromosomal damage (e.g., Chlorambucil)
 Testicular and ovarian dysfunction, including sterility
 Biological effects (even at very low levels of absorption)
Antineoplastic - Health Effects
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OELs
 Occupational Exposure Limits (OELs)
 Airborne concentration limit of a substance to which it is believed that
a worker may be exposed, without adverse health effects, expressed as
an average concentration.
 The time weighted average concentration for 8 hr work-day, 40 hour
work-week , to which nearly all workers may be repeatedly exposed,
day after day, without adverse effect.
 An OEL is substance-specific and is a level at which workplace
exposure is expected to be without detectable pharmacological or
toxicological effect in occupational circumstances.
 Industrial Hygienists conduct personal exposure monitoring to assess
employees’ exposure relative to these levels.
Exposure limits are not
a fine line between safe and
dangerous concentrations

Adjusted Occupational Exposure Limits (AOEL)*
Activity Duration Activity Multiplier (AM)
Up to 10 min 5
> 10 to 30 min 3
From > 30 min up to 1
hour
2.5
From > 1 hour up to 2
hours
2
From > 2 hours up to 4
hours
1.5
From > 4 hours up to 8
hours
1
*AOEL = AM X OEL-TWA (basis ACGIH Excursion Limits)©International Safety Systems, Inc.
www.issehs.com

Occupational Exposure Bands (OEBs) – Categorization
OEB 2
1000 - 100 ug/m3
OEB 3
100 - 10 ug/m3
OEB 1
5000- 1000 ug/m3
OEB 4
10 - 1 ug/m3
1000
10
100
≤1
OEB 5
≤1 ug/m3
Not harmful, not irritating, low pharmacological activity e.g.
predicted therapeutic dose >100mg/day, Examples – many
excipients
Harmful, may be irritant, Moderate pharmacological
activity, predicted therapeutic dose >10 - 100mg/day,
Examples – Loratadine
5000
Moderate toxic and /or high pharmacological activity, predicted
therapeutic dose >1–10mg/day, Respiratory sensitizers and potent
dermal sensitizers, Severe irritants and corrosives, also default
category, Examples – many penicillin & cephalosporin antibiotics
Toxic Serious irreversible effects, Carcinogens, Mutagens,
Reproductive and Developmental Toxins,
Potent respiratory sensitisers, predicted therapeutic dose 1mg/day,
Examples –Corticosteroids, some oncology drugs
Extremely toxic and or extremely high pharmacological activity
predicted therapeutic dose 1mg/day, Serious irreversible
effects, Potent Carcinogens, Mutagens, Reproductive and
Developmental Toxins, Examples - potent hormones or
hormone effectors, select anti-cancer drugs
IncreasingToxicityand/orPotency
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Risk Assessment Model
 Most model considers
– Potency
– Frequency duration of exposure
– Air-borne Potential
– Exposure Controls
 Formulation
– Small volume, less frequency/duration high potent
compounds considerations
 Potential skin and ingestion risks are also critical
www.issehs.com
Risk Ranking Criteria are summarized in next 3
slides

High Potent Compound in
Chemical Industries
 Beryllium - OEL 2 ug/m3
 Hex chrome – OEL 5 ug/m3
 Ni Carbonyl – OEL 50 ppb
 Chloromethyl isothiazolone – Kethon – very low
OEL used as biocide
 Bis chloromethyl ether OEL 1 ppb
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Rank Frequency Duration Health Hazard
Daily Weekly monthly Yearly Chemicals API
1
Minimal
(under 30
minutes)
Any / Minimal
(under 5 hours)
Any / Minimal
(under 20
hours)
Any / Minimal
(under 250
hours)
OEL in range
3.1 to 10
mg/m3
or >
1000 ppm
OEB1, OEL >1000
µg/m3
2
About 30 min
to < 2 hour
5 to 15 hours
per week
20 to 60 hours
per month
250 to 500
hours per year
OEL in range
0.51 to 3
mg/m3
or 101
to 1000 ppm
OEB 2, OEL 100
µg/m3
- 1000
µg/m3
3
About ½ Shift
(2 to 4 hours)
15 to 25 hours
per week
60 to 80 hours
per month
Use More
Frequent
Basis
OEL in range
0.01 to 0.5
mg/m3
or 10 to
100 ppm
OEB 3, OEL 100
µg/m3
- 1000
µg/m3
4 About ¾ Shift
(4 to 7 hours)
25 to 30 hours
per week
Use More
Frequent Basis
Use More
Frequent
Basis
OEL < 0.01
mg/m3
or < 10
ppm
OEB 3, OEL 10
µg/m3
- 100 µg/m3
5
(over 7 hours)
Use More
Frequent Basis
Use More
Frequent Basis
Use More
Frequent
Basis
OEB 4, OEL 1
µg/m3
- 10 µg/m3
6
OEB 4, OEL 0.01
µg/m3
- 1 µg/m3
7
OEB 5, OEL <
0.01 µg/m3

Rank
Airborne Potential
Engineering
Control
Skin Exposure
Skin Hazard
Exposure
Potential
1 Low
Total enclosure
validated by IH
monitoring
No skin hazard,
temporary effects
2 Medium
Total enclosure
NOT validated
3 High
4
Moderate (LEV)
validated
Probable skin irritants,
materials may cause
dermatitis.
Short term
skin exposure
5
6
Moderate not
Validated
7
Will cause skin irritation,
sensitizers, corrosives
(acids, caustics, nickel).
Repeated-long
Skin exposure
8
Non-fixed controls
movable LEV
9
10 No controls
Materials toxic to skin
(ACGIH) Skin
Skin exposure
certain

Final Risk Ranking Criteria
www.issehs.com
Description
Final Risk
Ranking
1-100
Low Risk – process is well controlled and personal exposures are
obviously unlikely to become significant – no further action
required other than periodic review
1
100-
200
Medium Risk - Further evaluation required by monitoring. 2
200-
300
Potenial High risk - implement exposure controls, conduct
exposure monitoring, control employee exposure using
respiratory protection until engineering controls are
implemented
3
> 300 Very High Risk -Implement exposure controls immediately 4

Quantitative Exposure
Monitoring
Sampling pump
Sampling media
Sampling media
Calibrator

Important Considerations
 What to sample?
– Contaminants with higher degree of toxicity with potential
for exposure identified during qualitative exposure
assessment
 Whom to sample?
– Personnel potentially exposed to identified contaminants
 Are all personnel required to be sampled?
– No, sample few from those having similar exposures
known as Similar Exposure Group (SEG) (e.g., charging
personnel, Dispensing personnel)

Important Considerations
 How many samples to be collected?
– 6 (minimum) for each contaminant in SEG
– Additional samples need to be collected for high potent
compounds or when variability in exposure results is
significant
 Where to sample?
– Areas/activities/operations with potential for exposures
defined during Industrial Hygiene Risk Assessment
 When should the sampling be done?
– Representative sampling in all shifts
– Different operators, different shifts
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Challenges in API Exposure
Monitoring
 OELs are not available for large number of APIs and
intermediates
 Validated methods are not available for large number of API
analysis
 Potent compounds require meticulous handling of samples to
avoid cross contamination
 Limited accredited laboratories are available in USA for APIs
– Each API employee and swab sampling method validation
include sensitivity (LOQ lower than high API), desorption
efficiency, number of spike samples and other critical
parameters
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Addressing Challenges API
Exposure Monitoring
 Use validated methods and accredited lab with API
analysis experience especially for highly potent
APIs as employee health depends on the results
 Follow rigorous validated sampling methods to
avoid sample contamination (disposal powder free
gloves, plastic Ziplock bag for every sample)
 Use surrogate monitoring if API validated methods
are not available
www.issehs.com
Implement Established Exposure Controls
following Control Banding Approach

Surrogate Monitoring
Good Practices Guidelines - ISPE
 International Society for Pharmaceutical Engineering (ISPE)
 Standardized Measurement of Equipment Particulate Airborne
Concentration (SMEPAC) Committee
 ISPE Good Practice Guide: Assessing the Particulate
Containment Performance of Pharmaceutical Equipment
 Standardized method of measuring
– Performance of containment systems against specific
challenge
– Establish an agreed and valid method that can be used to
meet the requirements of practitioners and supplier
organizations

Example of Laminar
Flow
Booth Surrogate
Monitoring at LFB

API/Chemical Plants: Exposure Controls:
Reactor Charging
 Potential for exposure during:
– Manual charging of solids
– Handling of empty bags/super-sacks –
(major source of exposure)
Very effective:
Charging booth
Effective: Reactor
Charging with LEV
Empty
bags
collected
in plastic
bag from
inside of
glove box

API/Chemical Plants: Exposure Controls: Tanker
Unloading
Nitrogen – pushing
residual chemical
Secured connections with
arrangement to rinse piping
before disconnecting

API/Chemical Plants: Exposure Controls: Tanker
Unloading Barrel Transfer of Chemicals
Potential for exposure during transfer
with left in hose
A barrel decanting unit
reduces leaks, spills and
exposures
Never to use air pressure

Dispensing and Weighing of Solids - Small
Volume
Not Effective: LFB are nt effective in
reducing exposure below about 50 ug/m3
Dispense cell, isolator for high
potent compounds

Solid
Discharging
Fully Contained Discharge Through Weigh Isolator

Ventilated Balance Safety Enclosure
(VBSE)® – For High Potent
Compounds in laboratory
 Face velocity
– Not too high
– Not too low
– 50 fpm to 70 fpm
 HEPA filtration
 Ducted
 Size of opening for weighing -
adjustable
 Air flow monitor and alarm
 Can be customized
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Principles of General Ventilation System
 Maintain always negative air pressure in the
contamination generating room with respect to rest
of the building
 Replace exhaust air by make-up air
 Do not install an exhaust fan near an intake opening
or window (e.g., contaminated air will be pulled back
into building rather than exhausted)
 Ensure contaminated air does not pass through
breathing zone

Efficient Local Exhaust Ventilation (LEV)
 Inefficient ventilation system design is one of the most
common walkthrough findings
 The designing contractors are often not knowledgeable of
design principles
 Adequate capture efficiency has not been accomplished
despite money spent in energy consumption
 Knowing basic principles of ventilation system helps in (a)
modifying existing ventilation systems and (b) in guiding
designing contractors towards efficient ventilation system
design
In an efficient LEV, energy consumption is minimum and
contaminant removal from operator’s breathing zone is maximum

Hood
Provide a flange or hood at the air inlet. 25% more energy is required to
capture contaminates from the front, when a flange or hood is not provided
Locate hood closed to contaminant generation
Air is drawn from
back side also
Air drawn from
front only
PreferredReduce distance if feasible

Hood
Tapered hood are more efficient than right angle hoods
Locate hood so that contaminants do not pass through the
breathing zone of an operator
Enclose sides as
much as feasible

Duct
Straight duct is more efficient than a duct with many
bends and elbows. Smaller duct length and smoother duct
surface improves efficiency
Abrupt change in duct diameter and branch entry reduce the efficiency
For most of LEVs, round duct is
preferred over rectangular duct
–Prevents accumulation of
solids
–Makes less noise
–Durable
Examples of inefficient ducts

Application of LEV
Solid charging
Empty bags are placed in this large bag
Solid filling in drums
Barrel decanting
Glove box for highly
toxic compounds Portable extractor

Ventilation measurements
 Velocity measurement on
the face of the hood is best
indicator of efficiency
 Depending on the face
area, measure air velocity
at several points on the
face and determine
average face velocity
 The face velocity to
capture most of the
contaminants is 100 f/min
(0.5 m/sec)
Instruments used to
measure face and duct
velocities

Range of Capture Velocities
Condition
of
Dispersion
Examples Capture Velocity
(f/min)
Capture
Velocity
(m/sec)
Released with
practically no
velocity into
quiet air
Evaporation from tanks;
degreasing, etc.
100 0.5
Released at
low velocity
into
moderately
still air
Spray booths; intermittent container
filling; low speed conveyer transfers;
welding; plating; pickling
100-200 0.5-1
Active
generation
into zone of
rapid air
motion
Spray painting in shallow booths; barrel
filling; conveyer loading; crushers
200-500 1-2.5

Range of Duct Velocities
Material Example Duct Velocity
(f/min)
Duct velocity
(m/sec)
Vapors, gases All vapors and gases 1000-1500 5-7.5
Spray painting Paint aerosols 1000-3000 5-15
Fumes Lead, welding 1500-2000 7.5-10
Dry dusts Fine rubber dust 2500-3500 12.5-17.5
General
industrial dust
Clay dust, silica flour 3500-4000 17.5-20
Heavy dusts Sand blast dust 4000-4500 20-22.5
Heavy or moist
dust
Moist cement dusts 4500 + 22.5+

Measuring Ventilation System
Performance
Manometer/Magneh
elic gauge that
continuously
measures pressure
drop across filter.
Assists in
determining when to
change filter

HVAC System and Dust
Collectors
 Directional flow in Room: Clean air flows top-down and
contaminated air flows bottom-side, away from operator
breathing zone
 Recirculation through HEPA filter is permitted for OEB1-2
 Recirculated air from OEB 3 and 4 API Rooms through dual
HEPA
 OEB 4 compounds, “Sink” airlock to provide negative
pressure gradients from both process area and common
corridor
 Bag-In/Bag-Out safe change system at exhaust grills to
minimize duct contamination

Zoning for High Potent
Compound Handling
 Red
– Potentially contaminated area
– Not used for gowning
 Yellow
– Less or no contamination
– De-gowning area
 Green Zoning
– Clean non-contaminated area
– Paper work is done
– Gowning is done
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Importance of Swab Sampling
to determine degree of surface
contamination
 Determines degree of surface
contamination
 Useful in determining if Green
Zone is contaminated or not
 Contact Surfaces (door handles)
 Acceptable Surface Limits
 Lessons learned
– Do no assume ethanol is good
decontaminating agents for all
APIs
– Do not assume cleaning method
has decontaminated areas©International Safety Systems, Inc.
www.issehs.com

Gowning –Degowning for High
Potent Compounds
 Two pairs of disposable
– Gloves
– Gowns
– Shoe Cover
 Disposal of outer pair after work is done in Red
Zone just before entering Yellow Zone
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Challenges in Respiratory
Protection
 Variable Assigned Protection Factor for
Powered Air Purifying Respirators
– 50 to 1000
 Disposable Vs. Reusable hood
– Disposable preferred – cost is high
– Reusable – API contamination of PAPR hood
identified
 Cleaning validation
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Challenges
 Limited Resources – IH professionals
 QA in exposure assessment data
 Financial constrains
– Price Controls
– Competition
 Manufacturing and outsourcing is increasing rapidly and
corporate EHS and other resources are decreasing
 Trained corporate EHS professionals are unable to cop-up
with demand for assistance
 Distance, time difference
 Limited sensitivity of site professionals to potent
compounds 59

Approaches: Corporate and
Regional EHS
 Commendable efforts
 Audits
 Regional training programs and meetings
 Strong contract manufacturing programs
 Emphasis on selection of credible, competent
and cost-effective EHS service providers
 Providing limited financial support
60

Approaches
 Education Programs in Industrial Hygiene
– University Level
– Pharma specific training modules
 Managing cost effectively
– Cost effective consulting
– Exposure assessment strategy – three samples
/HEG/API , never 1 sample
– Analytical cost discounts
– Return on investment (e.g., savings from loss of API)
– Not loosing focus on QA 61

Approaches
 Empowering region and manufacturing sites in
EHS
 Training
– At the foundation of sustainable EHS program
– Site specific, anecdotal , workshop at the site
– One corporation spends closed to $1B in all training
 Qualitative Risk assessment and Control Banding
– If exposure is obvious, why do monitoring?
– Exposure control and then monitoring
 Sanofi approach of Industrial Hygiene Education
Academy 62

Approaches – Supply Chain
 Corporate requirement for supplier to demonstrate
exposure is below OEL through surrogate monitoring
 Corporate and third party due diligence audits
 Local services provider to do hand-holding for some
time
– On site training on process safety and IH
– Limited exposure assessment
– Periodic supervision
– 7/24 support
 Limit number of suppliers based on EHS performance
 Shutting down operation when risk is imminent- provide
limited assistance in reducing risk 63

Conclusions
 Potential process safety and chemical exposure risks are
high in pharmaceutical and chemical industries. The
risks are manageable
– Understanding and communicating
– Empowering line managers
– Capitalizing on available resources
– Implementing feasible risk control measures
 Potential risk is even higher at supply manufacturing
sites. The risk is manageable
– Effective auditing
– Limited hand-holding
www.issehs.com

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