AFI Digital Workshop – Package Integrity 16th May 2024
Live Workshop: ‘Package Integrity Industry Standards and Measurement Principles’
Ahead of the Simposio AFI, takin place in June this year, we are participating in the AFI Digital Workshop. Join Philip Cooper, Eibhlin Owen and the team at Emme 3 on 16th May 2024 for a live presentation on Industry Standards, Measurement Principles, Quality and Compliance.
The presentation explores the complex world of pharmaceutical manufacturing standards and regulations, with a specific focus on the integrity testing of containers for sterile medicinal products. It discusses the evolution of Annex 1 guidelines, highlighting the importance of container closure integrity testing, especially for containers closed through fusion methods. The emphasis is on the shift to more stringent testing requirements, stressing the need to assess, manage, and monitor parameters that impact seal integrity during operations.
Additionally, the presentation will highlight the intricacies of primary barrier packaging standards established by ASTM, underscoring the role of package design and development in guaranteeing the integrity of pharmaceutical products. It touches on various testing methods used, from vacuum decay to vacuum deflection, each essential in upholding the quality and safety of parenteral bags, vials, ampoules, and blister packs.
Essentially, the presentation acts as a detailed guide to the precise procedures involved in container closure integrity testing, merging aspects of GMP regulations, ASTM standards, USP1207, and Annex 1 guidelines to maintain the highest standards of quality and safety in the production of sterile medicinal products.
Agenda
Moderator   Marco Adam – AFI
14:30 – 14:45   EMME 3 – Introduction
Stefano Menghini (Sales Manager, Emme 3)
14:45 – 15:00   SEPHA – Introduction
Eibhlin Owen (Area Sales Manager, Sepha)
15:00 – 15:30   CCIT – Navigating Evolving Industry standards & Measurement Principles
Philip Cooper (Chairperson of the ASTM F2.40 Package Integrity Sub-Committee)
15:30 – 16:00   Blister Package Integrity – Ensuring Quality & Compliance
Philip Cooper (Head of Technology & New Product Development, Sepha)
16:00 – 16:30   Q&A
Interesting links