Exposure Risk Assessment Challenges : Occupational Hygiene in the Pharmaceutical and Chemical Industries, AIHA 2013, Asia Pacific OH Conference, Singapore
The 3rd Intl. Workshop on NL-based Software Engineering
Exposure Risk Assessment Challanges
1. 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
3. 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
4. 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
5. 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
8. 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
10. 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
11. 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
12. 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?
13. 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?
22. 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
27. 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
28. 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
31. 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)
35. 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
37. 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
38. API/Chemical Plants: Exposure Controls: Tanker
Unloading
Nitrogen – pushing
residual chemical
Secured connections with
arrangement to rinse piping
before disconnecting
39. 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
40. 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
44. 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
45. 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
46. 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
47. 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
48. 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
49. 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
50. 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
51. 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
52. 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+
54. 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
59. 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
60. 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
61. 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
62. 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
63. 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