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

PROBLEMS with Study Design & Data Interpretation

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!

Q & A

ACKNOWLEDGMENTS

• Erik Kateman – Oss, NE

• Chris Cooper – Cramlington, UK

• Merck’s Independent Testing Lab

• Respirator manufacturers

• Merck’s Independent Consultant

BACKUP SLIDES

14

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