Cleanroom Analysis

A Clean Room is defined as a room in which the concentration of airborne particles is controlled to meet a specified airborne particulate cleanliness class. In addition, the concentration of microorganisms in the environment is monitored; each cleanliness class defined is also assigned a microbial level for air, surface, and personnel. These requirements apply to Pharmaceutical, Medical Device, Clinical Laboratories and Compounding Pharmacies.

A Clean Room should have, as a minimum design specification, the following:

 

A Clean Room or controlled environment will perform under dynamic conditions. Those attributes should be monitored and statistically evaluated to understand the efficacy and standardize your specific alert and action limits.

Dynatec can certify your clean room, conduct investigations, or develop monitoring programs. Call 915-849-1322(ext. 106) or email dynatec@sbcglobal.net.

 

References:

 

Key factors in controlling contamination:

 

Indirect Processes

 


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