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.
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:
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Verification of cleanroom and HVAC system installation;
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HVAC qualification;
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НЕРА filter testing;
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Adjustment and balancing of ventilation systems;
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Monitoring of cleanrooms;
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Qualification of laminar-flow cabinets;
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Qualification of laminar-flow boxes;
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Qualification of biological safety cabinets;
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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.
We conduct all qualification stages for cleanrooms, laminar-flow cabinets, biological safety cabinets, sampling areas, etc.:
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DQ (Design qualification);
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IQ (Installation qualification);
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OQ (Operation qualification);
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PQ (Performance qualification).
Our company performed cleanroom qualification of:
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Sterile and non-sterile product manufacturing facilities;
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Immunobiological product and vaccine manufacturing facilities;
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Microbiology laboratories;
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Maternity units;
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Microelectronics manufacturing;
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Biosafety level 3 laboratories;
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Hematology oncology centers.
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.
Why perform?
According to GMP regulations, the manufacturing of medicinal products should be carried out in clean areas equipped with appropriate Heating, Ventilation and Air Conditioning Systems (HVAC). The point is to create a clean manufacturing environment, protect critical processes and avoid risks associated with product quality. The air quality inside cleanrooms directly affects the quality of products, and as HVAC systems and all cleanrooms belong to critical systems, they, accordingly, should be qualified.
Moreover, HVAC systems and cleanrooms belong to systems operating in continuous mode, which requires regular monitoring of critical functions and parameters and periodic re-qualification.