Annex 1 of the EU Guide to Good Manufacturing Practice (GMP) is considered the most important European regulatory standard for the manufacture of sterile pharmaceutical products.
Due to the revised version of GMP Annex 1 (2022), stricter requirements now apply to cleanroom garment systems as part of the contamination control strategy (CCS). The implementation of a contamination control strategy brings advantages and new requirements for the cleanroom industry.
A sterile eye cover is mandatory since 25.08.2023 in order to form a complete barrier together with sterile garments to minimise particles in critical environments. In addition, the maximum life cycles of cleanroom garment systems should be defined - how can you be sure about the amount of cycles your equipment in use already has?
This presentation will show how RFID technology is used to ensure that all products which have reached their defined life cycle are reliably sorted out and replaced. You will be given an overview of the processes that sterile cleanroom goggles go through to ensure a validated and reproducible result, cycle after cycle. Find out about requirements and qualification of sterile barriers and how we can support you in selecting the best barriers for your process.