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Reducing Particulate Exposure in
Pharmaceutical Industries
Maharshi Mehta, CSP, CIH
International Safety Sy...
Agenda
 Introduction
 Unique Challenges in Reducing Particulate
Exposures
 Occupational Exposure Bands
 Determining Ne...
Pharmaceutical Compounds
 Active Pharmaceutical Ingredients
 Excipients
 Low Occupational Exposure Limits
 OELs are no...
Occupational Exposure Bands-Example
OELs
(µg/m3)
OEB
> 1000 1
1000 - 101 2
100 -1 3
< 1 4
OEBs example
Determining Needs for Exposure
Controls
 Qualitative Exposure Assessment
 API Exposure Monitoring
 Surrogate Exposure M...
API Exposure
Monitoring
 Determining method
 Parameters such as flow rates and sample volume
 Task based and Time Weigh...
Surrogate Monitoring
 International Society for Pharmaceutical Engineering (ISPE)
 Standardized Measurement of Equipment...
OEB 1 Design Criteria
Parameters Criteria
Room Design GMP
Process Equip. GMP
Product Transfer GMP
Local Exhaust GMP
Genera...
OEB 2 Design Criteria
Parameters Criteria
Room Design Semi enclosed
Process Equip. Semi enclosed
Product Transfer GMP
Loca...
OEB 3 Design Criteria
Parameters Criteria
Room Design Air lock entry
Process Equip. Enclosed
Product Transfer Enclosed
Loc...
OEB 4 Design Criteria
Parameters Criteria
Room Design Air lock entry
Process Equip. Isolation Technology
Product Transfer ...
Dispensing and Weighing of Solids - Small
Volume
Not Effective: Potential for exposure during
manual dispensing and handli...
Reactor Charging
 Not Effective: Potential for exposure during:
– Manual charging of solids
– Handling of empty bags/supe...
Blending
Double cone blender
Vacuum transfer V Blender-IBC Docking In
Glove Box
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Milling
Very Effective: In-Line
Cone Mill
Very Effective: Contained
Milling Station
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Compression
Not Effective
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Example of Personal exposure during
Laboratory Scale weighing in VBSE
(API)
 Sample size: 9
 Range of results: < 0.04 – ...
Respiratory Protection -Powered Air Purifying
Respirators (PAPRs)
Strengths:
• Light-weight
• Mobility of operator (not re...
Gowning-Degowning Practices
and PPE
 Reusable Vs. Disposable
 Shoe cover
 Carry over of contaminants
 Gowning De-gowni...
Thank you!
Questions?
www.issehs.com
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Particulate exposure controls in pharma industries- Guangzhou China 2016

Particulate exposure controls in pharma industries- Guangzhou China 2016

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Particulate exposure controls in pharma industries- Guangzhou China 2016

  1. 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. 2. Agenda  Introduction  Unique Challenges in Reducing Particulate Exposures  Occupational Exposure Bands  Determining Need for Exposure Controls  Exposure Controls in Unit operations www.issehs.com
  3. 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) www.issehs.com
  4. 4. Occupational Exposure Bands-Example OELs (µg/m3) OEB > 1000 1 1000 - 101 2 100 -1 3 < 1 4
  5. 5. OEBs example
  6. 6. Determining Needs for Exposure Controls  Qualitative Exposure Assessment  API Exposure Monitoring  Surrogate Exposure Monitoring  Controls based on OEBs www.issehs.com
  7. 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 www.issehs.com
  8. 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 www.issehs.com
  9. 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 www.issehs.com
  10. 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 www.issehs.com
  11. 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 www.issehs.com
  12. 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 www.issehs.com
  13. 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 www.issehs.com
  14. 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 www.issehs.com
  15. 15. Blending Double cone blender Vacuum transfer V Blender-IBC Docking In Glove Box www.issehs.com
  16. 16. Milling Very Effective: In-Line Cone Mill Very Effective: Contained Milling Station www.issehs.com
  17. 17. Compression Not Effective www.issehs.com
  18. 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 www.issehs.com
  19. 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) www.issehs.com
  20. 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 www.issehs.com
  21. 21. Thank you! Questions? www.issehs.com

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