Cleanroom Classification for Microbial Contamination

The level of microbial contamination should be determined as part of cleanroom qualification.

The number of sampling locations should be based on:

• a documented risk assessment,
• the results of cleanroom classification,
• airflow visualization studies
• and knowledge of the processes and/or operations to be carried out in the area

All of these should be taken into account when setting this number.

• Table 2 gives the microbial contamination limits for each class during qualification.
• Qualification should cover both the "at rest" and "in operation" states.