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The construction, acceptance and operation of the clean production workshop of medical devices shall comply with the requirements of The Quality Management Specification for 澳门英皇宫殿国际官方网 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 E nvironmental T esting S ervices :

Test items

Object

澳门英皇宫殿国际官方网 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 ”

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

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Test items

Object

澳门英皇宫殿国际官方网 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 （GMT+8 8:30~17:00）
[email protected]