Proposed Amendments to Chapter 15, Article X: Wetland Conservation Areas
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Industrial Hygiene and PSM in Pharma industries Hangzhou, China 2013
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Applied Industrial Hygiene and Process
Safety In Pharmaceutical Industries
Maharshi Mehta, CIH, CSP
International Safety Systems, Inc.
Maharshi.mehta@issehs.com
+1 203 331 6464
www.issehs.com
The 9th RDPAC EHS Association
Conference, Hangzhou October 31, 2008
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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
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The Need
โข Prevent occupational illness by reducing/eliminating
health risk
โข Corporate Requirements
โข Significant cost savings by reducing/recovering
particulate/vapor emissions
โข Regulatory requirements
โข Productivity increase
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Introduction
โข Qualitative Exposure Assessment
โ Determines exposure potential
โ Based on process observations, health hazards, and interview
โ Prerequisite for quantitative exposure assessment
โ All processes, tasks, operations that use or create chemicals must
undergo this stage
โข Quantitative Exposure Assessment
โ Conducted by competent industrial hygiene professional
โ Quantify magnitude of exposure
โ Based on exposure monitoring methods
โ Often used as primary means of determining exposures without
qualitative exposure assessment
Skip exposure assessment and place
exposure controls first when exposure is
obvious
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Exposure Assessment Model Developed for
Pharmaceutical Industry
โข Health Hazard Ranking based on OEL for APIs
โข Frequency/Duration Ranking
โข Control Ranking
โข Overall Risk Ranking
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Direct Reading Instruments
โข Spot measurements
โข Provide a quick indication of contaminant levels
โข Not suitable for exposure determination
โข Useful in identifying:
โ Oxygen deficient atmospheres,
โ Toxic levels of airborne contaminants,
โ Flammable atmospheres,
โ Radioactive hazards, and
โ Leaks
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Direct Reading Instruments
โข Portable gas chromatographs
โ Measures organics more specifically and accurately
โข Substance specific analyzers:
โ Mercury vapor analyzer-gold film analyzer
โ Ozone meter
โ Oxygen meters
โข Particulate monitors
โข Combustible gas analyzers
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Calibration of Direct Reading Instruments
โข Follow instrumentโs instruction manual for calibration method and frequency
โข The calibration substance should represent the substance for which the
instrument is designed to be used
โข The calibration substance concentration should be close to the concentration of
concern (if you are interested in determining CO concentration around 30 ppm, the calibration gas
concentration should be around 30 ppm)
โข Preferred Frequency of Calibration from Manufacturers:
โ Once every six months to annually from the manufacturers
โ Daily field calibration
โข Confidence:
โ In addition to calibration certificate, obtain data on the calibration
concentration, + and โ error identified during calibration
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Colorimetric Detector Tubes-
Principle and Use
โข Principle:
โ Known volume of air is drawn through a detector tube
โ Change in tube color is proportional to concentration and air volume
drawn
โข Use:
โ For quick indication of contaminant concentration
โ For leak detection
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Detector Tubes- Strengths and
Limitations
โข Strengths:
โ Quick indication of concentration
โ Does not require a laboratory to analyze the sample
โ Readily available
โข Limitations:
โ Limited availability for organic and inorganic vapors/gaseous
compounds and some aerosols
โ Can not be used for particulate contaminants
โ Not suitable to determine exposure accurately (Accuracy is + / -
25%)
โ Lack of specificity (many indicators are not highly selective and
can cross-react with other compounds)
โ One brand of the tube can not be used with another brand of the
pump
โ Shelf life at 25 ยฐC of one to two years
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Passive/Diffusion Devices-
Sampling Method
โข Select a passive sampler for a substance of concern
โข Remove the sampler from the sealed pouch
(Keep all parts for future use)
โข Record the start time on the sampler label
โข Attach the sampler to the person with potential for exposure near the breathing
zone; the small holes should be facing out
โข At the end of the sampling period, remove the sampler from the person, and
immediately seal it with cap and O-ring provided with the sampler. Record the
stop time.
โข Document activity performed by the person
โข Ship the sampler to an accredited laboratory (discussed later) for analysis
โข Document temperature and humidity
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Industrial Hygiene
โข Industrial Hygiene Field Sampling
(Quantitative Exposure Assessment)
โ Conducted by competent Industrial Hygienist
โ Quantify magnitude of exposure
โ Based on exposure monitoring methods
โข APIs, Chemical and Surrogate exposure
monitoring
โ Active monitoring with sampling pumps
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Active Air Monitoring-
Survey Protocol Development
โข What to sample? Contaminants with higher degree of
toxicity with potential for exposure identified during
qualitative exposure assessment
โข Whom to sample? Personnel potentially exposed to the
contaminants identified
โข Are all personnel required to be sampled? No, sample few
from those having similar exposures also known as
homogeneous exposure group (e.g., charging personnel)
โข Where to sample? Areas/activities/operations with potential
for exposures defined during qualitative exposure
assessment
โข How many samples to be collected? Six (minimum) for
each contaminant in a homogeneous exposure group
โข When should the sampling be done? Representative
sampling in all shifts
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Air Monitoring
โข Process:
โ Air drawn with battery operated sampling pump
though sampling media in breathing zone
โ Sampling media analyzed to determine weight of
contaminant
โ Weight divided by volume of air drawn through
media to determine contaminant concentration
โข Determines exposure during actual work duration. Not
instantaneous concentration determination as in direct
reading instrument
โข Substance-specific accurate identification of exposure
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Personal Sampling and Area Sampling
Area Sampling:
โข Collected at fixed location in workplace
โข Collected to identify contaminant
concentration in general workplace and
potential exposure to people working in area
โข Collected to evaluate efficiency and
sufficiency of control measures
โข To identify source of contaminant
Personal Sampling:
โข Collected in breathing zone of employee
โข Preferred method to identify personal
exposure to employee
โข Only method considered valid for accurate
determination of employee exposure
Area Sampling
Personal Sampling
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Pre-Sampling Procedure
โข Calibrate air sampling pump
โข Label sampling media
โข Ensure proper connections in
sampling train
โข Explain employee about need of
monitoring, function of
instrument and to perform work
as normal workday
โข Write down,
โ information about employee
and activity to be sampled
โ start time
โ Start air sampling
instrument
Pre Calibration
Air Sampling Train
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Placing Air Sampling
Pump
โข Attach sampling media (e.g., filter cassette, charcoal
tube) in breathing zone a hemisphere in front of
shoulders with radius of 6 to 9 inches or (15 to 22.5 cm)
โข Position sampling media outside respirator/hood and
protective clothing
โข Ensure inlet is in downward vertical position
โข Position sampling equipment and excess tubing to avoid
interference with work performance
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During Monitoringโฆ
โข Check pump every one hour to ensure it is
running
โข Observe work practices to identify sources of
exposures
โข Take digital pictures and make notes on
โ Visible airborne contaminants
โ Work practices
โ Use of Personal Protective Equipment (PPE)
โ Potential interferences
โ Effectiveness of engineering and process
controls
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Post-Sampling Procedures
โข At end of sampling duration,
remove sampling pump, cap media
and place it in refrigerator (for
solvents)
โข Write down activities on that day,
deviation from normal work
practices and abnormalities, if any
(e.g., spill, leak)
โข Post calibrate flow rate
immediately after removing
sampling pump
โข Record all data in Chain-of-
Custody form
Post Calibration
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Sample Analysis
โข Samples are shipped with chain of custody form to
American Industrial Hygiene Association accredited lab in
USA
โข Laboratory reported results are interpreted
โข The degree of exposure determined and compared with
occupational exposure limit
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Surrogate Monitoring
โข Companies requires API supplier to conduct surrogate
monitoring
โข Lactose with USP defined particle size and moisture
content is used
โข Three personal samples collected with each operator
โข Three area samples collected in each of the unit operations
โข Background samples collected before lactose monitoring
began
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Contributory Factors: Work Practices
โข Material leaking from flange joints on Sieve and RMG
โข Over filling of scoop while manual charging of
compression
โข Shaking while emptying of Lactose with plastic bags
โข Compressed air used for cleaning
โข Dry sweeping in place of using a vacuum equipped with a
HEPA filter.
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Recommendations
โข Containment and Local
Exhaust Ventilation
โข Vacuum transfer
โข IBC use and gravity feed
โข Enclosure of compression
and de-dusting area
โข HEPA equipped vacuum
cleaning
โข PAPR
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Challenges
โข High risk operations
โข Trained professionals not available
โข Quality Control
โข Cost concerns
โข Availability of resources
โข Corporate EHS
โ Not able to cop-up at manufacturing locations and
contract manufacturers (CM)
โ Liability and public images continues to be a concern
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Our Experience with a Pharma Company โ
Pant level - IH
โข No IH process safety program in place
โข Exposure monitoring data available
โ All bellow exposure limits (??)
โข Dust mask used
โข Dry sweeping
โข Containment not used or not validated
โข Coporate Audit identified some of the concerns
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Our Experience with a Pharma Company โ
Pant level โ Process and general Safety
โข Process Safety
โ Open plastic bucket used for solvent transfer
โ Reactor Inertting done
โ Cylinders not labeled
โ No Rota Meter to determine flow of ineting
โ Inerting not validated with O2 Measurements
โ Plastic hose used in Centrifuge
โข General Safety
โ Tanker unloading
โ Nitrogen pressure used to transfer chemical
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Approaches adopted
โข Walkthrough
โข Exposure Assessment
โข Process Safety Reviews
โข Recommend Exposure Control Measures
โข Developed SOPs
โข Developed plant specific training manual with digital
images
โข Conducted IH, PSM and Safety Workshop of 4 days at
plant site
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Outcome
โข Reduced Process safety and IH risk
โข Trained line managers and supervisors
โข Self-sufficient program
โข Limited involvement of consultant
โข Limited involvement of Corporate IH Process Safety
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Our Experience with Contract Manufacturers
โข Conducted IH and PSM review at 15 CMs
โข Gross unsafe working conditions and unsafe work
practices
โ Tanks with no vent
โ Reactor with no ineting
โ No reactor โ open handling
โข To keep us satisfied brand new gloves and respirator used
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Approached adopted
โข Conducted baseline exposure assessment
โข Recommended cost effective exposure control measures
โข Develop easy to understand SOPs
โข Few of the non-cooperative CMs removed from companyโs list
โข One unit was shutdown and allowed to start only after PSM
improvements are made
โข Containment validation for new APIs
โข Conducted a 3 day training program for all CMs
โ 2 persons from each CM came
โข Outcome
โ Improved working conditions and work practices
โ Reduced company liability
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Corporate Support
โข Developed Industry Specific Training Manual
โ Based on APIs manufactured
โ Raw Materials used
โ Operations and Activities conducted
โ Reviewed by Corporate and Plant His
โข Conducted one training program in each region
โ Asia-Pacific, EU, US, LAM
โ Program conducted at companyโs manufacturing site
โข Outcome
โ 600 line managers trained in IH 101 in 22 training
programs conducted