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Flexible Containment Concepts in Real Application

Flexible Containment Concepts in Real Application. Jon Gast Steven Meszaros PSG 2009. PSC Guideline Presentation Overview. RBEC History Motivation Scope Strategy Expectations Gap Analysis & RBEC Checklists Fixed Containment Flexible Containment Solutions. PSC Guideline History.

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Flexible Containment Concepts in Real Application

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  1. Flexible Containment Concepts in Real Application Jon Gast Steven Meszaros PSG 2009

  2. PSC Guideline Presentation Overview • RBEC History • Motivation • Scope • Strategy • Expectations • Gap Analysis & RBEC Checklists • Fixed Containment • Flexible Containment Solutions

  3. PSC Guideline History OC Technical Guidelines - 1994 RBEC Guideline -1998, revised 2001 RBEC Interpretation Guideline - 2002 PSC Task Force 2003 PSC Guideline – 2004 EHS Policy 404 IH Policy 401 Containment Technology Matrix (CTM) – 2009

  4. PSC Guideline: Motivation • Regulatory Requirements: • API Product Cross Contamination • Worker Health & Safety • Environmental – Air, Water & Waste - PNAEELs • Third Party Contractual Obligations & Liability • cGMP Harmonization - CS 14-8-4 • OHC, OEGs and RBEC levels • Aligned with R&D & TO&PS Decision Gates

  5. Historical PSC Risk Control Issues • Pre-RBEC Facility Designs & Equipment • Historical levels > 1,000 X OEG • Cross Contamination Potential • Pharmaceuticals In the Environment

  6. Real Risks

  7. PSC Guideline: Scope R&D API Manufacturing & Handling Pharmaceutical Manufacturing BioPharmaceutical Manufacturing New Products Facilities and Areas Renovated Facilities and Areas Third Party Manufacturing Requires project-specific RBEC Criteria interpretation - -The key is to design is to meet our OEG !

  8. Rollout Strategy Endorsement from TO&PS and R&D senior management Stakeholder meetings planned for: TO&PS, R&D–CPD/PDC GES, GSS, QA Major Solid Dosage Sites Key PSC manufacturing Sites

  9. PSC Guideline: New Expectations Responsibilities Defined Timelines for Conformance Specified cGMP Cross Contamination Harmonization of Engineering & EHS approaches GAP Analysis Short Term, Long Term Actions Conformance Action Plans & Site Master Plans

  10. RBEC: Risk Based Exposure Control 4-Tier Banding System Aligned to OEG Conforms to Pharmaceutical Industry Hierarchy of Controls Engineering Project Guidance RBEC Criteria Tables Containment Technology Matrix

  11. PSC RBEC Criteria Table & Gap Checklist Facility Design for Containment Room & Work Surfaces HVAC Systems Local Exhaust Ventilation Process Equipment Unit Operations: milling, blending, sieving, etc. Product Transfers Maintenance & Cleaning Medical Surveillance Work Methods & SOPs PPE & Respirators Waste Containment & Disposal cGMP & Regulatory conformance

  12. PSC GAP Assessment Facility Team: EHS, Engineering, management, and Quality Assurance. RBEC Gap Checklist - For each API by area, process or unit operations. Facility: Unit Operation / Area: Prepared By: Date: Parameter Criteria PSC Gap Actions Priority Yes No S-M-L Containment and Control of API Processing Area No special containment or control strategies are required for handling or processing API. cGMP requires that separate space be provided for the processing, manufacturing and laboratory testing. cGMP requires space not be shared with non-API processing or laboratory functions (e.g., offices or maintenance operations); (i.e., cGMP for nutritionals and nutriceuticals). RBEC 3 Gap Checklist

  13. API Dispensing: Containment

  14. New Technologies: Bin Blending

  15. Surrogate Testing Protocol Containment Technology Matrix • Real conditions • Assume sub-optimal technique • Worst case operator shift

  16. PDC CONTAINMENT PROJECT AN OVERVIEW

  17. Facility: Airlocks Added

  18. Facility: Expansion of Process Areas

  19. Flexible Containment Systems Summary

  20. Flexible Containment Concept Designs SMI Press O-Hara Coater Korsch XL100 & De-duster LB Bohle Cone Mill Nica S450 Strea 1 Pro Glatt GPGC2 Nica E140 In-Process Isolator Gerteis Mini-Pactor 10L/25L Collette Note: Glove-ports in not shown in all concept sketches. Blender and Mi-Pro & SMI system not shown

  21. Transfer Systems • All the isolator systems provided with a Bag in/out canister to allow contained transfer in and out of materials. The canister is 11.73” internal diameter. • This canister also serves a duel purpose of allowing connection of the In-Process Isolator to them. Canisters are mounted at standard height to allow easy connection. • The only isolators that the In-Process isolator can not connect to directly are the Extruder and Spheronizer systems (due to height issues.). A connection can be made using a length continuous liner if it is required.

  22. In-Process Isolator The In-Process Isolator is a general purpose piece of equipment designed to allow any number of tasks to be carried out. It can be used independently or connected to other flexible isolator systems as shown.

  23. Typical Process Flow Subdivision/Weighing: In-process isolator can be directly connected to Granulator or Blender or used independently. Place materials & tools required into In-process isolator using pass in ports and carry out subdivision & weighing process. After process is complete pass materials directly to granulator or blender (if connected) or out via bag out port. Granulation Pass weighed materials/tools required into granulator isolator using pass in ports and process. After process is complete pass materials out via bag out port. Blender Pass weighed materials/tools required into blender isolator using pass in ports and process. After process is complete pass materials out via bag out port. Mill Pass weighed materials/tools required into Mill isolator using pass in ports and process. After process is complete pass materials out via bag out port. A

  24. Typical Process Flow Extruder/Spheronizer Pass materials/tools required into Extruder or Spheronizer isolator using pass in ports and process. After process is complete pass materials out via bag out port. FBD Pass materials/tools required into FBD isolator using pass in ports and process. After process is complete pass materials out via bag out port. A B Mill Pass materials/tools required into Mill isolator using pass in ports and process. After process is complete pass materials out via bag out port. Roller Compaction Pass materials/tools required into Roller Compactor isolator using pass in ports and process. After process is complete pass materials out via bag out port.

  25. Typical Process Flow Compression Pass materials/tools required into Compression isolator using pass in ports and process. After process is complete pass materials out via bag out port. The In-process Isolator can be connected for testing of tablets and for use as a staging area for tools, etc. O-Hara Coater B Coating Pass tablets/tools required into Coating isolator using pass in ports and process. After process is complete pass materials out via bag out port. The In-process Isolator can be connected for testing of tablets and for use as a staging area for tools, etc. END

  26. Extruder & Spheronizer Design Progress Flange Mock Up Flanges Installed Finalized 3D Design Drawing Enclosure Installed December2008

  27. Glatt GPCG1 Design Progress Finalized 3D Design Drawing Ergonomic & Flange Mock Up Enclosure Installed December 2008

  28. Korsch Design Progress Finalized 3D Design Drawing Enclosure Installed December 2008

  29. Procept & SMI Press SMI Press Flange Installed Enclosure Installed December 2008 Procept Final Design

  30. Strea Design Progress Finalized 3D Design Drawing for Flange Enclosure Installed December 2008

  31. Roller Compactor Design Progress Finalized Design Concept Final Assembly Shipped to Newbridge December 2008 Gerteis Mini-Pactor

  32. Bohle BTS-100 Cone Mill Finalized 3D Design Drawing Enclosure Installed December 2008

  33. Collette UltimaGral 10 – 25 Liter Finalized 3D Design Drawing Enclosure Installed December 2008

  34. Installation Training Training Carried Out January 2009

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