NJ AIHA PDC 12309

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NJ AIHA PDC 12/3/09

• Practical Solutions for Handling and Containing
  Potent Compounds and Other Dust Generating
  Operations

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Todays 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

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Todays 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

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About Hydro

• Full-Service Environmental Consulting
  Engineering Firm
• Founded in 1986
• Comprehensive Range of Services
• Highly-Qualified Professional Staff
• National Presence and Reputation

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About Hydro

• Four Divisions
• Environmental Services
• Environmental Health Safety
• Risk Management Consulting
• Industrial Services

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Services

• Environmental Site Assessments Audits
• Risk Characterization
• Site Remediation Design Implementation
• Industrial Hygiene/Occupational Health Safety
• Environmental Permitting
• Claim Support
• Litigation/Expert Witness

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Office Network

• Home Office
• Acton, Massachusetts
• Regional/Branch Offices
• California
• Connecticut
• Florida
• Georgia
• Massachusetts
• Missouri
• New Jersey
• New York
• Texas

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Potent Compounds Summary

• Potent Compounds
• Regulations/Standards/Guidelines
• Performance-Based Approach
• Work Practices/Housekeeping
• Sampling/Analytical Issues
• Medical Surveillance
• Practical Dust Control Concepts

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Disclaimer.

• Any similarity to actual persons, (or
  corporations), living or dead (or
  acquired/downsized), is purely coincidental.

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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
• 1980s - Pharma companies recognized special
  hazards associated with some of their products
  (especially hormones)
• Products with genotoxic, carcinogenic, other
  repro issues and or highly toxic

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Potent Compounds Overview

• Regulatory History/Evolution
• PELS/TLVs/RELS
• 1910.1000 Air Contaminants
• 1910.134 Respiratory Protection
• Protection Factors/MUCs

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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

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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

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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

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Potent Compounds Perspective

• With few PEL/TLV/RELs available internal
  standards needed to be developed
• Exposure Control Limit (ECLs)
• Occupational Exposure Limits (OELs)
• Potent Compound OELS were low
• Moved from measuring total dust gravimetrically
  to active ingredients
• Performance-Based Exposure Control Limits
• Naumann et al
• Banding concepts

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AIHA Journal,1996 (Naumann et al)
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Performance-Based Exposure Control Limits
(Naumann et. al)
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Performance-Based Exposure Control Limits
(Naumann et. al)
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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?

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Helpful Resources

• ACGIH Excursion limits
• 3 x 5 rule
• Excursions in worker exposure levels may exceed 3
  times the TLVTWA for no more than a total of 30
  minutes during a workday, and under no
  circumstances should they exceed 5 times the
  TLVTWA, provided that the TLVTWA is not
  exceeded

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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 STELS

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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 for the 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.

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Medical Surveillance

• Medical Surveillance
• Product by product requirements
• Testing where appropriate
• Medical History Questionnaires
• Baseline/Periodic
• Follow-up

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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