A3P - Single Use System
X ray / Integrity testing / Contamination management (PFAS) / Standardization / Single Use sensor involvement
Introduction
Pharmaceutical regulatory standards and industry best practices are constantly evolving as the demand for sterile drug production capacity grows. Appendix 1 is the international reference text for the latest sterile drug manufacturing standards. It encourages the use of innovative technologies, including barrier technologies, which are becoming essential. Annex 1 also sets out in greater detail the requirements for Lyophilization and opens the door to new strategies.
While Appendix 1 makes numerous references to “Barrier Technologies”, with the main aim of reducing direct interactions between sources of contamination and aseptic processes, the requirements for interfaces with Lyophilizers remain an area of little detail, but one which is a real issue and challenge at industrial level. This is why the “Barrier Technologies” and “Lyophilization” GICs have decided to join forces for this event.
Over the course of these A3P Barrier Technologies and Lyophilization 2025 days, we will address the future challenges facing our industry through technical and regulatory issues, and provide answers through practical applications:
- Regulatory updates
- Dealing with weak points: ergonomics, transfers, glove integrity/management
- Set-up challenges for indirect product contact surfaces (parts in contact with stoppers)
- RABS specificities
- Use of new technologies in design phases (augmented/virtual reality, etc.)
- Campaign mode on a Lyophilizer with automatic loading under barrier technology
- Challenges at the interface between isolator and freeze-dryer
- Biological indicator issues and prospects for enzymatic indicators
And many other subjects covered by 2 GIC enthusiasts !
Official conference language: French
Simultaneous translation: English
