Transcription of Compendial Effort to Revise Packaging Material …
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Compendial Effort to Revise Packaging Material …
2017 USP 1 Compendial Effort to Revise Packaging Material Standards: Glass, Plastic, Elastomer, and Other Desmond Hunt, PNP Stakeholder Forum October 19, 2017 Plastic Plastic Materials of Construction - < > Plastic Packaging System for pharmaceutical Use - < > Plastic Component and Systems Used in the Manufacturing of a Drug Product - <665> Elastomeric components used for pharmaceutical use Injectable Drug Products - <381> Functionality Testing - <382> Glass Containers Used for pharmaceutical Use - <660> Metal Containers Used for pharmaceutical Use - <662> Biocompatibility Testing of Plastic and Elastomeric Material Biological Reactivity, In Vitro - <87> Biological Reactivity, In Vivo - <88> Biocompatibility of Materials - <1031> 2 USP current efforts in revision of Packaging standards Building safety into a system by using well-characterized and safe materials of construction (Quality by Design).
• Plastic • Plastic Materials of Construction - <661.1> • Plastic Packaging System for Pharmaceutical Use - <661.2> • Plastic Component and Systems Used in the Manufacturing of a Drug Product - <665>
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