3/20/2014. Potency. When are Occ Hazard Categories and Occ Exposure Limits Assigned? How are OHC s and OEL s Calculated?

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1 The challenge of preventing exposures to highly potent chemicals To dilute a pinch of salt to 200 nanograms/m3 (OHC 5) Unique Chemical Challenges & Solutions in the Pharma and Consumer Healthcare Industry You need 1,250,000 m3 of air 5.24 GSK Houses 500 Olympic Sized Swimming Pools Ron Joines, MD MPH AOHC il, 2014 Ron is employed by and is a shareholder in GlaxoSmithKline. He has no other conflicts of interest Today s journey Areas of focus Materials Scale & Complexity The challenge is growing each year More than double the number Substances Substances 1. Potency of the Pharma and Consumer Healthcare Pipeline 2. Unique Health Challenges in Controlling Workplace Exposures 1. Safe exposure limits 2. Risk assessment and hygiene monitoring 3. Containment/control t/ t 4. Risk based health surveillance 3. Impacts 4. The future: new manufacturing and containment technologies 5000 OHC Least hazardous Lowest (263) (258) e.g.., paracetamol 1000 Potency OHC (269) (277) 100 OHC (1674*) (1920*) 10 OHC (153) (189) Special considerations apply in planning, Most Highest hazardous Potency design, review and implementation OHC-5 e.g.., hycamtin -seek specialist assistance (26) ure Limit per cubic metre) Exposu (micrograms p * Includes 495 provisional OHC When are Occ Hazard Categories and Occ Exposure Limits Assigned? How are OHC s and OEL s Calculated? Disease selection Target family selection Discovery and Pre-Clinical Phase 1 Full Clinical Development (Phase 2/3) ket Surveillance OHC Determination = Structure Activity Relationship Database, Related Compounds, Pre-Clinical Data, Benchmarking Commit to product type Lead (CEDD entry) Initiate hazard profile and assign default OHC Candidate Approval for selection FTIM Assign initial datadriven OHC - APIs Proof of concept Commit to & Commit to Phase III Phase IIB Assign initial OEL - APIs Commit to file and launch Review OEL (amend as needed) - APIs GSK OEL = Key Points NOAEL (mg/day) / safety factors 1. NOAEL= Observed Adverse Effect Level Assign initial OHC for isolated intermediates & novel reagents (entry into chemical pilot plant) 2. Safety factors = Animal or Human Data, Intraspecies Variability or Sensitivity, Adequacy of Information, Severity of Effect (1-10,000) 3. Safety factor can change with additional information 4. Also consider bioavailability, kinetics, and pharmacologic activity Physicians may need info outside SDS--- call the Rx/Cx manufacturer 1

2 A Process for Managing Chemical Risks (1) General risk assessment Review a potentially significant chemical action required Unique Challenges & Solutions in Controlling Workplace Exposures Maintain Inspect Test - use controls - procedures - training - surveillance Chemical Risk Assessment, Exposure Monitoring a significant Select controls A Process for Managing Chemical Risks (2) Common Exposure Hot Spots: Secondary Manufacturing = health involvement General risk assessment Review a potentially significant chemical action required Maintain Inspect Test - use controls - hazard and risk communication - training - surveillance Chemical Risk Assessment, Exposure Monitoring a significant Select controls Controlling exposures requires... Good. Communications and Teamwork Key Points: Assessment of Chemical Risks Process & Task Understanding. Materials Safety Data & Physical Properties Chemical Risk Assessment (CRA) Reference Proven Engineering Controls. Validated & Quality Compliant Preferred Supplier Strategy Leveraged Standard Way of Working (SWoW) Training and Supervision Essential. Standard Maintenance Life Plans Meeting Business Requirements Essential Operations team Engineering Project & Maintenance Occupational Health & Hygiene Successful Control Requires Teamwork Procurement Quality EHS Ergonomics Zero Access Process Safety If you see dust or liquid in a pharmaceutical or consumer healthcare manufacturing walkthrough, it is a problem. Question why it is there. Next steps: Understand process and high risk tasks (% active, amounts, energy in) Understand most important routes of exposure Ask for additional toxicology information beyond MSDS Ask to see (or participate in) the workplace chem risk assessment Review hygiene monitoring results (validated chemical sampling & analytic methods, breathing zone results, 6 or more samples or Bayesian statistics and STEL/8H TWA) Ask about other locations experiences 2

3 Key Points: Occupational Hygiene Tools and Methods Containment Solutions: Downflow Booth 5D Screen IOM Particulate Sampling Train- Measures Breathing Zone, Inhalable Fraction Filter cassette: holds collection media Sample collection device: GSK standard is Inst of Occ Med (IOM) head Estimates inhalable fraction others devices may be stipulated by hygiene sampling method Pump: need to be intrinsically safe capable of drawing air at constant flow rate for entire sampling period EHM Occ Hygiene Session 5: uary 2005 Static (Area) Sampling Use: To provide background measurements Advantages: Fixed sampling location Can estimate visitor exposures/extent of migration Depending on location can: identify sources of emissions measure effectiveness of engineering controls Disadvantage Can not estimate breathing zone exposures Park 5D screen to one side when not in use Containment Solutions: Loading IBC s SoloFLEX - Stainless Frame Flexible Isolators Useful for quick fixes or short infrequent campaigns Keg Inverter in Downflow Booth 15 Containment Solutions: High Containment Tablet Press High Containment valves for transfers Inflatable gaskets Automatic wash in place Fully contained deduster d and metal check (CIP) Continuous liner for waste tablets and for tablet set up : tablet direct discharge into IBC Double BI/BO HEPA filter on air Key Points: Risk Based Health Surveillance (1) When? Without overexposure there is no risk Triggers Qualitative: Medium to High dermal or inhalation exposure risk Quantitative: Bayesian 95% CI, > 50% of OEL or STEL or surface contamination Performed at C max Who? At risk staff both normal and non routine operations Need admin processes to identify new, existing and transferred workers Compliance approaches Why? To confirm control strategy, hygiene monitoring results, OEL, etc are effective Temporarily: in absence of hygiene method/monitoring to confirm control Regulatory or corporate compliance

4 Key Points: Risk Based Health Surveillance (2) Does controlling exposures make a difference? What? Does a company guideline exist? Confer with company toxicologists to understand lead health effects and pharmacokinetics a questionnaire and/or tests that are sufficiently sensitive and specific? Minimally invasive? Pre-placement baseline? Proper timing and frequency of periodic surveillance to maximize yield and detect lead effects challenges of batch manufacturing Interpretation and follow up Number of dermal / respiratory ill-health cases in GMS Number of tasks >40x OEL Unique aspects of Dermal and Respiratory Sensitisers protective OEL once sensitised Risk highest during first 2 years of exposure History of atopy Variable With Variable N RR 95% confidence level P-val. tasks > 40x OEL Ill-health cases (adjusted) 19 The Future: Ever Safer Manufacturing Processes The Future More potent and targeted therapies el technologies telescoping processes to reduce number of steps continuous processing liquid dosing of tablets Working with suppliers materials in pre-weighed packs to avoid dispensing standardising packaging and keg designs leverage equipment Vendor expertise 00 Presentation Month 0000 title in footer 21 Manufacturing Process and Task Complexity Some more complex than others! New: Liquid Dispensing Technology Primary Manufacturing Suitable for OHC 4 and 5 Containment using Split Butterfly valves and Isolators Respirator Free by Design Tablets are manufactured by dispensing a microlitre quantity of a liquid formulation, containing the drug, onto the surface of an inert carrier tablet API & POLYMER LAYER OVERCOAT APPLIED BY PAD TAMPING PROCESS CARRIER TABLET FILM COAT BICONCAVE CARRIER TABLET CORE 23 4

5 Thank you Contact: 5

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