Cleanroom Validation & Microbiological Risk Assessment: A GMP-Compliant Strategy How to Validate Cleanrooms and Perform Microbiological Risk Assessment in Pharma Introduction Cleanroom validation and microbiological risk assessment are essential components of any GMP-compliant pharmaceutical facility. Cleanrooms support critical manufacturing environments such as aseptic filling, sterile filtration, and compounding. Regulatory guidelines including EU GMP Annex 1, ISO 14644-1/2, and FDA’s Guidance on Aseptic Processing define clear expectations for cleanroom classification, validation, and microbiological monitoring. Cleanroom Grades and Classification Cleanrooms are classified based on their airborne particulate levels, especially in aseptic manufacturing. The grades are as follows: Grade Use Particulate Limits (≥0.5…