De-Risking Aseptic Cleanroom Design: The New Mandate Post-EU GMP Annex 1 (2022)
The transition to the revised EU GMP Annex 1 (2022) demands a shift from simply building a clean space to engineering a comprehensive Contamination Control Strategy (CCS). Validation issues are often rooted in the design phase, where planning assumptions misalign with operational reality.
If your facility design does not thoroughly address risks associated with operator interventions or material and equipment transfer to sterile areas, you are potentially compromising your sterility assurance.