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NJ AIHA PDC 12/3/09

NJ AIHA PDC 12/3/09. Practical Solutions for Handling and Containing Potent Compounds and Other Dust Generating Operations. Today’s Presenters. Mark Ostapczuk, CIH, CSP Manager - Life Sciences Practices Hydro-Environmental Technologies, Inc. Steven I. Meszaros

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NJ AIHA PDC 12/3/09

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  1. NJ AIHA PDC 12/3/09 Practical Solutions for Handling and Containing Potent Compounds and Other Dust Generating Operations

  2. Today’s Presenters • Mark Ostapczuk, CIH, CSP • Manager - Life Sciences Practices • Hydro-Environmental Technologies, Inc. • Steven I. Meszaros • Director of EHS and Corporate Risk Management - Pfizer • Flexible Containment Concepts in Real Application NJ AIHA PDC 12/3/09

  3. Today’s Presenters • Robert Mc Cafferty, CIH • Corporate Manager, Industrial Hygiene • TEVA North America • Solving the Challenges of Containing an Existing Compression Process using Hard-wall and Flexible Containment • Hari Floura • President , Floura LLC. • The Role Of Flexible Technologies In Containment NJ AIHA PDC 12/3/09

  4. About Hydro • Full-Service Environmental Consulting & Engineering Firm • Founded in 1986 • Comprehensive Range of Services • Highly-Qualified Professional Staff • National Presence and Reputation NJ AIHA PDC 12/3/09

  5. About Hydro • Four Divisions • Environmental Services • Environmental Health & Safety • Risk Management Consulting • Industrial Services NJ AIHA PDC 12/3/09

  6. Services • Environmental Site Assessments & Audits • Risk Characterization • Site Remediation Design & Implementation • Industrial Hygiene/Occupational Health & Safety • Environmental Permitting • Claim Support • Litigation/Expert Witness NJ AIHA PDC 12/3/09

  7. Office Network • Home Office • Acton, Massachusetts • Regional/Branch Offices • California • Connecticut • Florida • Georgia • Massachusetts • Missouri • New Jersey • New York • Texas NJ AIHA PDC 12/3/09

  8. Potent Compounds Summary • Potent Compounds • Regulations/Standards/Guidelines • Performance-Based Approach • Work Practices/Housekeeping • Sampling/Analytical Issues • Medical Surveillance • Practical Dust Control Concepts NJ AIHA PDC 12/3/09

  9. Disclaimer…. • Any similarity to actual persons, (or corporations), living or dead (or acquired/downsized), is purely coincidental……. NJ AIHA PDC 12/3/09

  10. Potent Compounds Overview • “Potent Compounds” – • Generally refers to those compounds in the Pharma industry that are more selective receptor specific i.e. more potent at lower doses • Some select history • 1980’s - Pharma companies recognized special hazards associated with some of their products (especially hormones) • Products with genotoxic, carcinogenic, other repro issues and or highly toxic NJ AIHA PDC 12/3/09

  11. Potent Compounds Overview • Regulatory History/Evolution • PELS/TLV’s/RELS’ • 1910.1000 Air Contaminants • 1910.134 Respiratory Protection • Protection Factors/MUC’s NJ AIHA PDC 12/3/09

  12. Potent Compounds Overview • OSHA Technical Manual Section VI Chapter 2 • Controlling Occupational Exposure to Hazardous Drugs • Focus on handling of finished product in hospitals/pharmacies for Health Care Workers NJ AIHA PDC 12/3/09

  13. Potent Compounds Overview • OSHA Categorization drug as hazardous based on: • Genotoxcity • Carcinogenicity • Teratogenicity or fertility impairment • Serious organ or other toxic manifestations at low doses in experimental animals or treated patients • Some other designated as antineoplastic • Manufacturers suggested use of specials techniques in its handling, admin or disposal NJ AIHA PDC 12/3/09

  14. Potent Compounds Overview • NIOSH Alerts/Guidelines • Preventing Occupational Exposure to Antineoplastic and other Hazardous Drugs in Health Care Settings • Medical Surveillance for Health Care Workers Exposed to Hazardous Drugs • Personal Protective Equipment for Health Care Workers Who Work with Hazardous Drugs • Alternative Duty: Temporary Re-assignment for Health Care workers who work with Hazardous drugs NJ AIHA PDC 12/3/09

  15. Potent Compounds Perspective • With few PEL/TLV/REL’s available internal standards needed to be developed • Exposure Control Limit (ECL’s) • Occupational Exposure Limits (OEL’s) • Potent Compound OELS’ were low • Moved from measuring total dust gravimetrically to active ingredients • Performance-Based Exposure Control Limits • Naumann et al • Banding concepts NJ AIHA PDC 12/3/09

  16. AIHA Journal,1996 (Naumann et al) NJ AIHA PDC 12/3/09

  17. Performance-Based Exposure Control Limits (Naumann et. al) NJ AIHA PDC 12/3/09

  18. Performance-Based Exposure Control Limits (Naumann et. al) NJ AIHA PDC 12/3/09

  19. “Some Other Issues” • “Business Decisions” • Batch Operations vs. Dedicated Facilities • Time to Market • Work Practices • Housekeeping • Sampling Issues • Product Characteristics • Operator variability • Left or right shoulder? NJ AIHA PDC 12/3/09

  20. Helpful Resources • ACGIH Excursion limits • “3 x 5 rule” • Excursions in worker exposure levels may exceed 3 times the TLV–TWA for no more than a total of 30 minutes during a workday, and under no circumstances should they exceed 5 times the TLV–TWA, provided that the TLV–TWA is not exceeded NJ AIHA PDC 12/3/09

  21. Helpful Resources • 2006 OSHA amended Respiratory Protection Standard 1910.134 • Assigned protection factors • Maximum Use Concentration (MUC) • Represents limit at which class of respirator expected to provide protection • Protection Factor X OEL • Lead to calculating STEL’S NJ AIHA PDC 12/3/09

  22. MUC • Maximum Use Concentration (MUC) means the maximum atmospheric concentration of a hazardous substance from which an employee can be expected to be protected when wearing a respirator, and is determined by the assigned protection factor of the respirator or class of respirators and the exposure limit of the hazardous substance. The MUC usually can be determined mathematically by multiplying the assigned protection factor specified for a respirator by the permissible exposure limit (PEL), short term exposure limit, ceiling limit, peak limit, or any other exposure limit used forthe hazardous substance. • The MUC for respirators is calculated by multiplying the APF for the respirator by the PEL. The MUC is the upper limit at which the class of respirator is expected to provide protection. Whenever the exposures approach the MUC, then the employer should select the next higher class of respirators for the employees. NJ AIHA PDC 12/3/09

  23. Medical Surveillance • Medical Surveillance • Product by product requirements • Testing where appropriate • Medical History Questionnaires • Baseline/Periodic • Follow-up NJ AIHA PDC 12/3/09

  24. Medical Surveillance • NIOSH Publication 2007-117 • Medical Surveillance for Health Care Workers Exposed to Hazardous Drugs • Repro and General Health Questionnaires • Lab work (CBC, liver function, etc) • Physical Exam • Follow-up after exposure NJ AIHA PDC 12/3/09

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