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Dave Eherts-Control Banding Control Banding from the Pharma Perspective Staying Ahead of the Regulations David Eherts, PhD, CIH Purdue Pharma LP SCHC 2004 International Program on Chemical Safety Are you a partner or a stakeholder? Partners Partners in this international effort include: IPCS (International Labour Organization and World Health Organization); International Occupational Hygiene Association (IOHA); The Health and Safety Executive (HSE) in Great Britain; US National Institute for Occupational Safety and Health (NIOSH); and the German Gesellschaft für Technische Zusammenarbeit (GTZ). Stakeholders Stakeholders include implementers (including employers), researchers and workers/users of chemicals. Bodies that may be involved in the implementation of this Strategy include: intergovernmental and international non-governmental organizations (such as IOHA); government agencies; industry, including associations of chemical producers and suppliers; employer and employee associations; industrial hygienists;labourunions;labourinspectors; researchers; and training professionals. Overview •Control Banding –What it is –Why the pharmaceutical industry is so far ahead –The difference between Hazard and Risk –What OELs and OEBs are •How we apply OEBs to determine appropriate equipment and control technologies »Understand how OELs and OEBs are calculated »Understand exposures related to typical process steps »Understand how to determine acceptable control »Understand concept of 8-hr TWA »Understand protection factors for various respiratory protection equipment (RPE) Definition: • Effective and efficient hazard communication is an important component in assuring employees’health and safety. • Use of Occupational Exposure Bands (OEB 1 –5) provide common and understandable ”language”to accomplish this communication. A band describes a distinct range of OELs, grouped so that a single recommendation for exposure control technology can adequately protect employees engaged in similar tasks or process. • The 1-5 categorizations serve as the keystone for “Safe Handling Guidelines”that communicate typical safe handling methods and degree of containment that should be achieved when handling or processing pharmaceutical actives. Purdue’s Bands: OEB Range of OEL Description (mcg/m3) 1 > 1000 Not harmful, not irritating and/or low pharmacological activity 2 100-1000 Harmful, may be irritant and/or moderate pharmacological activity 3 10-100 Moderate toxic and/or high pharmacological activity 4 1-10 Toxic, may be corrosive, sensitizing or genotoxic and/or very high pharmacological activity 5 < 1 Extremely toxic, may be corrosive, sensitizing or genotoxic and/or extremely high pharmacological activity ABPI Bands: OEB Range of OEL Description (mcg/m3) A > 1000 Not harmful, not irritating and/or low pharmacological activity B 100-1000 Harmful, may be irritant and/or moderate pharmacological activity C 10-100 Moderate toxic and/or high pharmacological activity D 1-10 Toxic, may be corrosive, sensitizing or genotoxic and/or very high pharmacological activity < 1 Extremely toxic, may be corrosive, sensitizing or genotoxic and/or extremely high pharmacological activity Pharma Industry Bands: Company 1 Company 2 Company 3 Company 4 Company 5 Company 6 Company 7 Company 8 Company 9 Company 10 Company 11 Company 12 Company 13 Company 14 Company 15 Company 16 Company 17 Company 18 Company 19 Distribution of Pharma OELs: 1998 1999 600 2000 2001 500 2002 400 300 200 100 0 1mg 10mcg 0.1mcg <10ng OEL (LOWER LIMIT) Distribution of Regulatory PELs 350 2004 300 250 200 150 100 50 0 1000 10 OEL (LOWER LIMIT) Internal OELs and OEBs • Occupational Exposure Limits (OELs) –the airborne limit concentrations of compounds that are believed to safeguard the health of employees –the concentration for an 8-hour workday, 40-hour work week, to which nearly all workers maybe repeatedly exposed, day after day, without adverse effect –Industrial hygienists conduct monitoring to assess employees’ exposures relative to these levels • Occupational Exposure Bands (OEBs) –1 through 5 based upon range of OEL •But may be qualitatively driven also •Communicate the recommendation for appropriate ECM –Provide everyone with a common and understandable language to accomplish effective hazard communication Setting a Pharmaceutical OEL NOEL mg x 50 kg x 1 dy x 1 x a = OEL mg kg-dy employee 10 m3 UF b m3 e.g.: if you have a NOEL of 10 mg/kg-dy in a chronic rat study, to establish the OEL: 10 mg/kg-dy x 50kg/10m3 x 1/100 = 0.5 mg/m3 or 500 mcg/m3 a = bioavailability in test species b = bioavailability in exposed workers Uncertainty Factors: 10X Interspecies Variation, 10X Intraspecies Variation 10X Sub-Chronic to Chronic, 10X LOEL to NOEL Setting Bands with R Phrases Relative Toxicity or Pharmacologic Activity: OEB Range of OEL Description (mcg/m3) 1 > 1000 Not harmful, not irritating and/or low pharmacological activity 2 100-1000 Harmful, may be irritant and/or moderate pharmacological activity 3 10-100 Moderate toxic and/or high pharmacological activity 4 1-10 Toxic, may be corrosive, sensitizing or genotoxic and/or very high pharmacological activity 5 < 1 Extremely toxic, may be corrosive, sensitizing or genotoxic and/or extremely high pharmacological activity Examples of Qualitative Defaults Effect OEB 1 OEB 2 OEB 3 OEB 4 OEB 5 Sensitization Negative Slight cutaneous Moderate / strong Prevalent allergic reactions cutaneous allergic moderate to reactions strong respiratory allergic reactions Mutagenicity Negative Negative Positive in some in Mutagenic in most vitro assays, not relevant in vivo and confirmed in vivo in vitro assays Carcinogenicity Negative Negative Some evidence in Confirmed in OEB5 may be animals animals and assigned based on humans relatively high potency DaRT Negative Inadequate Evidence of Evidence of strong evidence in animals moderate reprotoxic defects reprotoxic defects in animals and/or in animals (OEB 3 suspected or may be assigned proved in humans for human teratogens with relatively low potency) Not a Bright Line! •Occupational Exposure Guidelines (OEGs) are guidelines to be used by board certified industrial hygienists in assessing whether pharmaceutical dust is controlled satisfactorily to safeguard the health of employees. •Industrial hygienists conduct monitoring to assess employees’exposures relative to these guidelines but the OEG is NOT a bright line between a safe and unsafe environment. •There are significant safety factors built into the calculation of the OEG (see the OEG Best Practice Document for further detail). Risk •Risk = f (Hazard, Exposure) –Hazard is inherent in the molecule •Defined by an OEL or an OEB –Exposure is controllable Extent of Exposure •Particle size •Wetness Naso-pharyngeal •Vapor Pressure Region (> 10 um) •Batch size •Type of vessel Tracheal-bronchial Region (3 -10 um) •Amount of imparted energy… Pulmonary •Engineering Control Region (0.5 -3 um) •PPE To Control Risk: •Bands simply communicate the hazard inherent in the molecule •To control risk therefore, increasing hazard levels require increasing levels of exposure control: R (1) = Hazard (103) x Exposure (10-3) OEBs for Chemicals Pharma has done the same: Pharma Industry Collaboration: Communication Occupational Toxicology Occupational Health Industrial Hygiene and Engineering The following slides are my opinion only i.e., best estimate of the exposure based upon specified control technology. Personal attention to detail, experience and motivation will vary significantly! Industry Experience -Sampling Engineering Control Measure OEB Exposure (mcg/m3) No ECM 3 10-100 LEV with well-designed hood 4 1-10 Downdraft laminar flow booth 4 1-10 Isolator 5 < 1 Industry Experience -Weighing Engineering Control Measure OEB Exposure (mcg/m3) No ECM 1 1000-10,000 Downdraft laminar flow booth 2 100-1000 Downdraft laminar flow booth with 4 1-10 special workstation Isolator 5 < 1 Industry Experience -Reactor Charging By scooping into the manway Engineering Control Measure OEB Exposure (mcg/m3) No ECM > 10,000 LEV 1 1000-10,000 LEV with ventilated charge hopper 2 100-1000 Horizontal laminar flow booth 2 100-1000 Downdraft laminar flow booth 3 10-100 Industry Experience -Reactor Charging By direct tipping within containment Engineering Control Measure OEB Exposure (mcg/m3) No ECM > 10,000 Horizontal laminar flow booth 2 100-1000 Glove bags 3 10-100 Downdraft laminar flow booth 3 10-100 Ventilated hopper with drum cone 2 10-100 Industry Experience -Reactor Charging Automated drum tipping system Engineering Control Measure OEB Exposure (mcg/m3) No ECM > 10,000 Horizontal laminar flow booth 3 10-100 Downdraft laminar flow booth 4 1-10 Glove box isolator 5 < 1 Industry Experience -Reactor Charging Vacuum Transfer Engineering Control Measure OEB Exposure (mcg/m3) No ECM 1 1000-10,000 Downdraft laminar flow booth 3 10-100 Industry Experience -Product Isolation Discharging a filter or centrifuge Activity ECM OEB Exposure (mcg/m3) Scooping No ECM or LEV only 1 1000-10,000 Into an attached sack No ECM or LEV only 1 1000-10,000 Glove bag No additional 3 10-100 Via an inflatable packing-off Laminar flow booth 3 10-100 head Via an inflatable packing-off Laminar flow booth 4 1-10 head with continuous liner Industry Experience -Drying Charging a tray dryer with damp powder Activity ECM OEB Exposure (mcg/m3) Charging trays by scooping No ECM 3 10-100 LEV 4 1-10 Laminar downflow 4 1-10 booth Industry Experience -Drying Discharging a tray dryer Activity ECM OEB Exposure (mcg/m3) Scooping from trays or No ECM > 10,000 trays tipped directly
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