Challenges in Extractables and Leachables Studies of Plastic Process Materials | CPhI North America

 

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Challenges in Extractables and Leachables Studies of Plastic Process Materials

Dujuan Lu, Ph.D. (Ph.D., Manager/Global Leader-E&L, SGS Life Sciences)

Location: E353c

Date: Tuesday, April 30

Time: 3:00pm - 3:45pm

Track: Drug Manufacturing

Vault Recording: TBD

Extractables and leachables (E&L) from pharmaceutical packaging, medical devices, and process equipment can potentially pose risks to the safety, efficacy, and stability of pharmaceutical or medical products. Extractables and leachables investigations have received significantly increased emphasis from regulatory agencies in recent years.


This presentation will overview the key elements when it comes to the Extractables and Leachables Studies of plastic process materials during pharmaceutical manufacturing. Risk assessment and standard extraction protocol recommended by USP and BPOG guideline will be discussed. Several case studies on extractable and leachable studies of plastic process materials will be presented.