Event Type: | Date: | Location: Virtual Workshop
17th/18th & 24th/25th March 2021, 10:00 - 12:30 each day
Aseptic processing is increasingly due to development of biologically based products including advanced medicinal therapeutic products (ATMPs) that would otherwise be impacted by terminal sterilisation. Although the revision of Annex 1; manufacture of sterile medicinal products covers both aseptically processed products and terminally sterilized products many aspects of Annex 1 cover aseptic processing and align with the guidance to industry from the USA FDA on aseptic processing. Annex 1 also relates to bioburden control for ingredients/ substances that form part of sterile products so the scope is extensive.
The upcoming PHSS Aseptic processing workshop covers training on key elements of aseptic processing for Annex 1 compliance. To manage the workshop as a virtual engagement key topics have been split into two sessions on consecutive weeks.
Aseptic processing workshops with be delivered by SMEs and specialists with experience in aseptic processing and GMP compliance. There will be a use of case studies to assist connection of training guidance with actual application.
Following each session (non-commercial) technical and practical demonstrations are to be completed by technical specialists from vendor companies that provide supporting technologies. Such knowledge is key to selection and appropriate application of technologies for GMP compliance.
Key topics include:
Session No Topic Description
1 Environmental Classification and Qualification for Annex 1 compliance.
2 Risk assessments in Contamination control and environmental monitoring.
3 Cleanroom and barrier technology gowning together with Cleanroom behaviour and key aspects of good aseptic technique.
4 Manual cleaning and disinfection of GMP controlled areas and RABS barrier systems.
5 Contamination Control strategy (CCS) for Annex 1 compliance and considerations in Cross contamination control strategy with an Aseptic Processing Containment strategy (ACS).
6 Moist heat sterilization. Autoclave qualification and cycle development for aseptic processing load sterilization.
7 Single Use Systems used in Aseptic processing; Including Product Bags/ tubing & aseptic connectors/ PUPSIT configurations.
8 Recombinant technology – considerations and processes