EU GMP Annex 1, the guideline for the manufacture of sterile medicinal products, was revised with significant changes that impact cleanroom design and operations. Key changes include:
Enhanced Contamination Control Strategy (CCS)
A holistic approach to contamination control covering all aspects of sterile manufacturing from facility design to personnel behavior.
Revised Cleanroom Classification
Updated particle limits, requirement for continuous monitoring in Grade A zones, and emphasis on rapid microbial testing methods. Stricter requirements for air visualization studies (smoke studies) and airflow pattern documentation.
Impact on Cleanroom Operations
These changes require cleanroom operators to enhance their environmental monitoring, improve gowning procedures, and implement more robust cleaning and disinfection programs. Sz Pharma helps clients navigate these regulatory changes with compliant cleanroom designs.