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Assigned Protection Factors (APFs) A Need for Harmonization ----- Merck’s Experience

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

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Assigned Protection Factors (APFs) A Need for Harmonization ----- Merck’s Experience

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  1. 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

  2. AGENDA • Background • Problem Statement • Case Studies Summary • Conclusions • Recommendations • Q & As

  3. 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

  4. 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

  5. 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

  6. 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

  7. PROBLEMS with Study Design & Data Interpretation

  8. EXAMPLES of INCONSISTENCIES Time Sensitivity Type & # of exercises Test subjects Average PF Safety Factors Individual PFs Application of Results Non-detects WPF SWPF

  9. Determining the “Real” APFCASE STUDIES - SUMMARY *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

  10. 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

  11. 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!

  12. Q & A

  13. Acknowledgments • Erik Kateman – Oss, NE • Chris Cooper – Cramlington, UK • Merck’s Independent Testing Lab • Respirator manufacturers • Merck’s Independent Consultant

  14. BACKUP SLIDES

  15. 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

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