Cleanroom qualification

Cleanroom certification provides evidence that controlled environments are suitable for the activities performed and are maintained under defined environmental and operational conditions.

SteriLandBio supports companies in designing, planning, reviewing and documenting cleanroom certification and requalification activities, including the definition of applicable tests, classification strategy, monitoring approach and documentation requirements.

Our support may include cleanroom classification support, review of qualification protocols and reports, assessment of environmental and physical parameters, deviation or out-of-limit evaluation, cleanroom layout and process flow considerations, and alignment with environmental monitoring programs.

We help companies ensure that cleanroom certification activities are technically consistent, properly documented and integrated with the broader contamination control and quality management strategy.