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Cleaning Room Environment Validation and Process Water Testing

The construction, acceptance and operation of the clean production workshop of medical devices shall comply with the requirements of The Quality Management Specification for Medical Device Production and relevant clean room construction acceptance standards. At the same time, the testing of process water in the production process  of medical devices such as purified water and injection water, shall comply with the specify requirements of Chinese Pharmacopoeia.

Clean-room Environmental Testing Services:

Test items

Object

Testing standard

Wind speed/air volume/air change/pressure differential

temperature /humidity

suspended solids

Noise

Illuminance

Settling microbe/planktonic microbe/surface microorganisms

Wind speed/air volume/air change/pressure differential

temperature /humidity

suspended solids

Noise

Illuminance

Settling microbe/planktonic microbe/surface microorganisms

Code for construction and acceptance of cleanroom

-GB50591-2019Test method for airborne particles in clean room(zone)of the pharmaceutical industry-GB/T 16292-2010; Test method for airborne microbe in clean room(zone) of the pharmaceutical-GB/T 16293-2010Test method for settling microbe in clean room(zone) of the pharmaceutical industry-GB/T 16294-2010,Medical device production quality specifications.

Process Water Testing Services:

Test items

Object

Testing standard

pH, nitrite, ammonia, conductivity (25), total organic carbon, easily oxidized substances, NVOCs, heavy metals, bacterial endotoxin, microbial limit

Process water such as purified water and water for injection

Chinese Pharmacopoeia 2020 Edition

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+86 571 8720 6559 (EN)
Contact Us
+86 571 8720 6559 (EN)