Cleaning Room Environment Validation and Process Water Testing - Cleaning Room Environment Validation and Process Water Testing - Medical Devices

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” -GB50591-2019；“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.

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”

-GB50591-2019；“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.

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