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Cleanroom Qualification

  • 2024-01-05
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A cleanroom is an engineering solution for a certain room that allows to keep the concentration of contaminants within specified limits according to the applicable standards set for the manufacturing of different products. The qualification of cleanrooms is conducted to verify that the cleanroom is operating according to relevant standards and requirements.  How Can Certify Your Cleanroom Classifications

Cleanroom Qualification

Cleanroom qualification is documented evidence that a specific cleanroom (clean zone) complies with a given level of cleanliness. 

The following activities can be performed during cleanroom qualification: 

Verification of cleanroom and HVAC system installation; 

HVAC qualification; 

НЕРА filter testing; 

Adjustment and balancing of ventilation systems; 

Monitoring of cleanrooms

Qualification of laminar-flow cabinets;  

Qualification of laminar-flow boxes; 

Qualification of biological safety cabinets; 

Final certification of cleanrooms. 

Balancing (adjustment) of the ventilation system and training of employees on safe filter replacement (for biological laboratories) can be performed as agreed upon with the customer. Definition And Origin Of Cleanroom Technology

We conduct all qualification stages for cleanrooms, laminar-flow cabinets, biological safety cabinets, sampling areas, etc.: 

DQ (Design qualification); 

IQ (Installation qualification); 

OQ (Operation qualification); 

PQ (Performance qualification). 

Our company performed cleanroom qualification of: 

Sterile and non-sterile product manufacturing facilities; 

Immunobiological product and vaccine manufacturing facilities; 

Microbiology laboratories; 

Maternity units; 

Microelectronics manufacturing; 

Biosafety level 3 laboratories; 

Hematology oncology centers. 

Constructing and qualifying a new cleanroom is a huge investment of a company’s money, time, and resources. Given the purpose of the cleanroom and its role in product quality, there are extensive regulatory requirements surrounding cleanroom design and validation. With recent revisions to some of these requirements in ISO 14644 and proposed changes to Annex 1, will your qualification meet the new standard?How to Choose a Suitable Cleanroom

Our experience in performing cleanroom qualification enables us to conduct all the tests as quickly as possible to minimize the duration of the manufacturing process shutdown. 

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