ISPE DACH Critical Utilities Working Group
Recap Lounges 2025
What you always wanted to know about pharmaceutical water
Basic Session - what you always wanted to know about pharmaceutical water. ISPE has the answers. "Best Practices for Pharmaceutical Water Systems" - Information and exchange on best practices in the planning, operation and monitoring of pharmaceutical water systems Focus of the presentation: - ISPE Baseline Water and Steam System - ISPE Good Practice Guide Critical Utilities [...]
Become a member of the ISPE
Discuss with us; ask your questions and get testimonials from our team
Electronic Production Records
- Electronic production records - Relevant data - Data acquisition / data input - Data flow (process view) - Review by exception
Become a member of the ISPE
Discuss with us; ask your questions and get testimonials from our team
Become a member of the ISPE
Discuss with us; ask your questions and get testimonials from our team
WFI - Reference project: Sustainability - thought through to the end
The presentation will introduce a new MWFI system for a manufacturer of sterile primary packaging. The special features are: - Membrane-based WFI generator with full redundancy - Total water yield (WFI/feed water) > 85% - Direct supply of cold and hot consumers without a tank - Extensive reduction in steam requirement thanks to heat recovery - Improved water quality in terms of contamination potential, particle load, PFAS and non-condensable gases - Measurement [...]
Vulnerability Management & Patch Management
In IT environments, the general principle is to apply security patches at an early stage in order to minimize the potential for attacks on your own infrastructure and prevent risks and possible damage. This has proven to be an effective and important component of "cyber hygiene". Why this is not (always) the best approach in OT environments and how risk-based vulnerability management can be used instead as a pragmatic approach to [...]
(AI) enablement of existing GxP production processes
(AI) enablement of existing GxP production processes through low-code/no-code platforms
GAMP Community of Practice - Update
I. GAMP Community of Practice - Update II. Smart validation through clever integration of risk & knowledge management - How can QA be strategically aligned to manage knowledge and risks in a targeted manner, ensure compliance and guarantee quality? - How can the flood of documents be reduced in order to achieve efficient and lean validation without bureaucratic hurdles?