Container Testing: A Contract Laboratory's Perspective on Industry Confusion
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The document discusses the confusion in the industry regarding container testing standards, particularly highlighting the challenges presented by USP <661> and USP <671>. It emphasizes the lack of explicit guidance on issues such as buffering capacity and spectral transmission, leading to misunderstandings among clients about testing requirements. The conclusion stresses the need for clearer directives to avoid ongoing confusion in packaging standards.
Container Testing: A Contract Laboratory's Perspective on Industry Confusion
- 1. Container Testing: A Contract Laboratory’s Perspective on Industry Confusion Brandon Zurawlow Container Department Manager & Project Manager, CCIT Whitehouse Laboratories Whitehouse, NJ 08888, USA www.whitehouselabs.com Pharmapack North America, NYC, 9 June, 2015
- 2. AGENDA Introduction USP <661> “The Closure Dilemma” Client Example: Buffering Capacity USP <671> Permeations Client Example: Spectral (Light) Transmission Conclusion Pharmapack North America, NYC, 9 June, 2015
- 3. INTRODUCTION Whitehouse Laboratories Founded in 2002 Origins in Container Testing Pharmaceuticals, animal health, component manufacturers, pharmacies, etc. The trend? Confusion Goal: Not to bash, but to highlight issues we face through client interaction Pharmapack North America, NYC, 9 June, 2015
- 4. USP <661> - “The Closure Dilemma” Introduction to USP <661> States: “It is the purpose of this chapter to provide standards for plastic materials and components used to package medical articles.” Theoretically includes closure systems Lack of guidance on closures – chapter is tailored to containers Raises the questions: Should we test? How do we test? Pharmapack North America, NYC, 9 June, 2015
- 5. USP <661> - “The Closure Dilemma” The Anatomy of a Closure Outer Cap - PP Inner Cap - HDPE Liner - Layered How To Test Not at all Composite Sample Equal parts, physicochemical Individual Sub-Components Applicable tests per sub-component Pharmapack North America, NYC, 9 June, 2015 Closure Sub-components
- 6. USP <661> - Buffering Capacity The Request: Buffering Capacity per USP <661> Pharmapack North America, NYC, 9 June, 2015 The Confusion: Their bottle was PET Buffering capacity is not required. Or is it?
- 7. USP <661> - Buffering Capacity Introduction to USP <661> States: Pharmapack North America, NYC, 9 June, 2015 From where did the confusion originate? The sections for HDPE and LDPE State: The section for PP States: The section for PET and PETG State: Nothing about buffering capacity It is assumed that PET / PETG will be holding a liquid product
- 8. USP <661> - Other Complications Pharmapack North America, NYC, 9 June, 2015 Coated Paperstock Seen in suture packaging, closure liners, films, etc. Often yield high nonvolatile residue results, even after filtering LDPE Bags Used for bulk storage, secondary packaging, etc. Often assumed pure LDPE by the client but yield OOS results Investigation reveals that the sample is a blend of LLPDE and LDPE, etc. Is <661> really intended to evaluate these components? Under-testing components and polymers with the least history Packaging advances outpace guidance -> confusion
- 9. USP <671> - Permeation Testing Introduction to USP <671>: Pharmapack North America, NYC, 9 June, 2015 Barrier Protection added to USP <671> effective Dec. 1, 2014 Confusion regarding its implementation – “Do I have to do this?” Confusion regarding the specs – none listed in <671>
- 10. USP <671> - Permeation Testing Upon contacting USP: Pharmapack North America, NYC, 9 June, 2015 Choice of method up to the client Barrier protection requires specs TBD by the client Should be prepared to justify use of the methods – FDA inspector may ask why certain tests were not performed
- 11. USP <671> - Spectral Transmission The Request: The “revision” was their light transmission spec The Confusion: Their HDPE bottle was natural (clear) Pharmapack North America, NYC, 9 June, 2015 Natural Bottle in Front of Light Source
- 12. USP <671> - Spectral Transmission From where did the confusion originate? Pharmapack North America, NYC, 9 June, 2015 Introduction to <671> in USP37
- 13. USP <671> - Spectral Transmission From where did the confusion originate? Pharmapack North America, NYC, 9 June, 2015 USP38-NF33 : <671> Containers – Performance Testing Suggestion to the client: Seek clarification in <659> Packaging and Storage Requirements
- 14. USP <671> - Spectral Transmission From where did the confusion originate? Pharmapack North America, NYC, 9 June, 2015 USP38-NF33 : <659> Packaging and Storage Requirements Effective until April 30th, 2016 Conclusion: • Not explicitly stated that such a bottle is exempt from spectral transmission requirements. • Current chapters leave room for (mis)interpretation
- 15. CONCLUSIONS Pharmapack North America, NYC, 9 June, 2015 Lack of explicit direction in USP <661> and <671> Results in industry confusion “Target audience” is composed of scientists, etc. Can still have easy language If you have ________, perform _________. i.e. proposed revision to guidance chapter <1207> Confusion is likely to continue or worsen with revisions to <661> Test materials of composition or complete packaging system? Detailed expectations are helpful (USP FAQ, for example).