Assigned Protection Factors (APFs)
A Need for Harmonization -----
Merck’s Experience
International Society for Respiratory Protection (ISRP)
York, UK - April 11, 2013
Prepared By: Theresa Lane, CIH, CSP, Global Director of IH
Erik Kateman, Site IH Oss, NL
Presented By: Chris Cooper, Site IH Cramlington, UK
1
AGENDA
• Background
• Problem Statement
• Case Studies Summary
• Conclusions
• Recommendations
• Q & As
BACKGROUND – ABOUT MERCK
• Merck (MSD) is a global healthcare leader that discovers, manufactures, and supplies innovative human health and animal health medicines, including vaccines
• Merck operates in more than 140 countries
• Workers must be protected by the hierarchy of IH controls during our development and manufacturing processes
BACKGROUND – ABOUT PROTECTION FACTORS
• Assigned Protection Factor (APF) - the level of protection that a respirator/class of respirators is expected to provide where an effective respiratory protection program is in place – Established by regulation, consensus groups, and / or suppliers
• Nominal Protection Factor (NPF) – minimum level of protection needed to gain “approval” for respirators
PROBLEM STATEMENT
• NPFs are indicative of laboratory performance; actual performance expected to be less
• APFs for same respirator / respirator class are not consistent
• Respiratory protection study methods are not consistent, easy to conduct, or transparent– Simulated Workplace Protection Factor Studies (SWPF)
– Workplace Protection Factor (WPF) Studies
Results in confusion and wasted resources
PROBLEMS With CURRENT STUDY PROTOCOLSDetermining the “Real” APF
• Merck confirms:
– Site has implemented an effective Respiratory Protection Program
– Respirator’s established APF is founded on scientifically valid and defensible studies
• Evaluate SWPF studies against “ORC-like” study protocol sponsored by the pharmaceutical industry
• Inconsistencies with study protocols & interpretations
• WPF studies extremely difficult to perform within pharmaceutical industry
Test subjects
Type & # of exercises
Individual PFs
Average PF
Non-detectsApplication of Results
Safety Factors
SWPF WPF
EXAMPLES of INCONSISTENCIES
SensitivityTime
*APF of 1000 only where scientifically valid study
Respirator Type US-OSHA*
APF
UK-HSE
APF
Germany
APF`
Finland
APF
Manufacturer’s
(APF / NPF)
Independent
(ORC-like - APF)
A - PAPR 25/1000* 40 100 200 1000 (APF) 825
B - PAPR 25/1000* 40 100 200 1000 (APF) 715
C - PAPR 25/1000* 40 100 200 1000 (APF) 670
D - SAR 25/1000* - 100 - 1000 (APF) 1000
E - SAR 25/1000* - 100 - 1000 (APF) 1000
F - SAR NA - 100 - 200 (NPF) 1000
G – SAR with blouse NA - 100 - 200 (NPF) 170
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Determining the “Real” APFCASE STUDIES - SUMMARY
Same respirator, different protection? Who is to decipher & decide?
EMPLOYERS are left trying to define proper protection
Establishing APF Values: CONCLUSIONS
• Employers must ensure effective RPE program
• Regulators & Manufacturers need to identify consistent criteria:– Study type & design
• Robust, representative, and transferrable SWPF studies
– Data handling & interpretations
– Pre-approval / endorsement by regulatory bodies
– Management of Change
• Users need simplicity and transparency
Currently, Employers need to understand how APFs are established to ensure adequate protection
Establishing an APF Value: RECOMMENDATIONS
• Need consistent, robust and representative criteria – Study design, execution, data evaluation and interpretation
– Harmonization
– Involvement & approval from regulatory bodies
• Need improved transparancy from suppliers
• Need easy-to-understand & interpret APFs
• Need to identify the “real” APFs
Differences in APFs for a given respirator / class, mustreflect actual differences in protection and not differences in study protocols or geographical region.
Let’s start the dialogue and begin to harmonize!
ACKNOWLEDGMENTS
• Erik Kateman – Oss, NE
• Chris Cooper – Cramlington, UK
• Merck’s Independent Testing Lab
• Respirator manufacturers
• Merck’s Independent Consultant
References
• HSG53 Respiratory protective equipement at work, HSE, 2005.
• Selectie en gebruik van adembeschermingsmiddelen, NVvA, 2001.
• Simulated Workplace Protection Factor Study of Powered Air-Purifing and Supplied Air Respirators, AIHAH (62) 2001.
• NEN-EN 529:2005 Respiratory protective devices –recommandations for selection, use, care and maintanance
• NEN-EN 14594
• Respiratory Protective Equipement, R.M. Howie, OEM 2005 (62) 423-428
• Workplace Protection Factors – Supplied Air Hoods, T.J. Nelsen, AIHAJ (62) 2001
• Assigned Protection Factors for the Revised Respiratory Protection standard, OSHA 3352-02 2009.
• NIOSH Respirator Selection Logic, N.Bollinger, DHHS Publication No. 2005- 100
• AIHAJ 62:595–604 (2001)
• Merck-sponsored SWPF studies & consultant reviews
• Respirator manufacturers’ sponsored SWPF studies