Particulate exposure controls in pharma industries- Guangzhou China 2016

1. www.issehs.com
Reducing Particulate Exposure in
Pharmaceutical Industries
Maharshi Mehta, CSP, CIH
International Safety Systems, Inc.
PO Box 475 Washingtonville,
New York, USA 10926
Maharshi.mehta@issehs.com
Ms. Lili Deng
Project Manager, China North East Asia
International Safety Systems, Inc.
Shanghai, China
Lili.deng@issehs.com +86- 135 2406 1672

2. Agenda
 Introduction
 Unique Challenges in Reducing Particulate
Exposures
 Occupational Exposure Bands
 Determining Need for Exposure Controls
 Exposure Controls in Unit operations
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3. Pharmaceutical Compounds
 Active Pharmaceutical Ingredients
 Excipients
 Low Occupational Exposure Limits
 OELs are not available for many compounds.
OELs are not available for intermediated
 Sampling and analytical methods are also not
available
 Exposure Controls Based on Occupational
Exposure Band (OEB)
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4. Occupational Exposure Bands-Example
OELs
(µg/m3)
OEB
> 1000 1
1000 - 101 2
100 -1 3
< 1 4

5. OEBs example

6. Determining Needs for Exposure
Controls
 Qualitative Exposure Assessment
 API Exposure Monitoring
 Surrogate Exposure Monitoring
 Controls based on OEBs
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7. API Exposure
Monitoring
 Determining method
 Parameters such as flow rates and sample volume
 Task based and Time Weighted Average (TWA)
monitoring
 Analytical Laboratories
 Sample result interpretations
Sampling Media
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8. Surrogate Monitoring
 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
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9. OEB 1 Design Criteria
Parameters Criteria
Room Design GMP
Process Equip. GMP
Product Transfer GMP
Local Exhaust GMP
General Ventilation GMP
Recirculation Yes, if HEPA
Air Changes > 15 per hour
Pressure Diff. Not Applicable
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10. OEB 2 Design Criteria
Parameters Criteria
Room Design Semi enclosed
Process Equip. Semi enclosed
Product Transfer GMP
Local Exhaust Directional
General Ventilation HEPA filtered
Recirculation Yes, if HEPA
Air Changes > 15 per hour
Pressure Diff. 0.03 in H2O
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11. OEB 3 Design Criteria
Parameters Criteria
Room Design Air lock entry
Process Equip. Enclosed
Product Transfer Enclosed
Local Exhaust HEPA out
General Ventilation HEPA filtered in/out
Recirculation Not Allowed
Air Changes > 15 per hour
Pressure Diff. 0.05 in H2O
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12. OEB 4 Design Criteria
Parameters Criteria
Room Design Air lock entry
Process Equip. Isolation Technology
Product Transfer Isolation Technology
Local Exhaust GMP HEPA out
General Ventilation HEPA filtered in/out
Recirculation Not Allowed
Air Changes > 10 per hour
Pressure Diff. 0.05 in H2O
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13. Dispensing and Weighing of Solids - Small
Volume
Not Effective: Potential for exposure during
manual dispensing and handling of empty bags
Effective: Laminar Flow Booth Very effective: Dispensing Cell
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14. Reactor Charging
 Not Effective: 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
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15. Blending
Double cone blender
Vacuum transfer V Blender-IBC Docking In
Glove Box
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16. Milling
Very Effective: In-Line
Cone Mill
Very Effective: Contained
Milling Station
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17. Compression
Not Effective
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18. Example of Personal exposure during
Laboratory Scale weighing in VBSE
(API)
 Sample size: 9
 Range of results: < 0.04 – 0.41 μg/m3
 Sample Duration: 27 - 34 Minutes
 Sample Weight: < 1 gram
 Eight out of nine samples < detection
limit (< 0.04 - < 0.93 μg/m3 )
18
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19. Respiratory Protection -Powered Air Purifying
Respirators (PAPRs)
Strengths:
• Light-weight
• Mobility of operator (not restricted as with
airline respirators)
• Less breathing resistance due to powered
filtering
• Can be used for longer work duration
Limitations:
• Variability in Assigned Protection factor
• Does not provide protection if not used
properly (inner flap tucked inside gown)
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20. Gowning-Degowning Practices
and PPE
 Reusable Vs. Disposable
 Shoe cover
 Carry over of contaminants
 Gowning De-gowning Practices
 Air lock – operator entry exist
 Mist Shower
 Two pair of gloves
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21. Thank you!
Questions?
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