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
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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 PROTOCOLS
Determining 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
PROBLEMS with Study Design
& Data Interpretation
Exercises
&
Equipment
Data
Evaluation
Interpretation
EXAMPLES of INCONSISTENCIES
Time
Sensitivity
Type & # of exercises
Test subjects
Exercises &
Equipment
Average PF
Individual PFs
Safety Factors
Data
Evaluation
Interpretations
Application of Results
Non-detects
SWPF
WPF
Determining the “Real” APF
CASE STUDIES - SUMMARY
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
Respirator Type
*APF of 1000 only where scientifically valid study
Same respirator, different protection? Who is to decipher & decide?
EMPLOYERS are left trying to define proper protection
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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, must
reflect actual differences in protection and not differences
in study protocols or geographical region.
Let’s start the dialogue and begin to harmonize!
Q&A
ACKNOWLEDGMENTS
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Erik Kateman – Oss, NE
Chris Cooper – Cramlington, UK
Merck’s Independent Testing Lab
Respirator manufacturers
Merck’s Independent Consultant
BACKUP SLIDES
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References
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HSG53 Respiratory protective equipement at work, HSE, 2005.
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Selectie en gebruik van adembeschermingsmiddelen, NVvA, 2001.
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NEN-EN 529:2005 Respiratory protective devices –recommandations for
selection, use, care and maintanance
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NEN-EN 14594
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Assigned Protection Factors for the Revised Respiratory Protection
standard, OSHA 3352-02 2009.
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NIOSH Respirator Selection Logic, N.Bollinger, DHHS Publication No. 2005100
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AIHAJ 62:595–604 (2001)
Simulated Workplace Protection Factor Study of Powered Air-Purifing and
Supplied Air Respirators, AIHAH (62) 2001.
Respiratory Protective Equipement, R.M. Howie, OEM 2005 (62) 423-428
Workplace Protection Factors – Supplied Air Hoods, T.J. Nelsen, AIHAJ (62)
2001
Merck-sponsored SWPF studies & consultant reviews
Respirator manufacturers’ sponsored SWPF studies