Class II Medical Devices Cleanroom in Anhui, China

Class II Medical Device Cleanroom

Project Location: Anhui, China

Project Name: Class II Medical Device Workshop

Cleanliness Class: Class 10,000 laboratory; Class 100,000 cleanroom

Wall Structure: Magnesium oxide (MGO) color steel panels

Cleanroom Equipment & HVAC: Central cleanroom HVAC system, purified water system, pass-through boxes

Piping: Stainless steel purified water system, drainage system, air duct system

Instrumentation: Airflow control valves, differential pressure gauges

Electrical: Power distribution cabinets, cleanroom lighting fixtures, switches and sockets, UV lamps, ozone system

Flooring: Epoxy self-leveling flooring, PVC flooring

Testing: Passed inspection by the National Medical Products Administration (NMPA)

This Class II medical device GMP cleanroom features cleanliness levels of Class 300,000 or Class 100,000, tailored to specific product requirements. It strictly adheres to medical device GMP standards, ensuring the separation of personnel and material flows while maintaining precise control over particulates, microorganisms, pressure differentials, temperature, and humidity. Utilizing a modular, prefabricated design—with factory-made wall panels and purification units assembled rapidly on-site—the facility offers a short construction period, minimal pollution, and a flexible layout that allows for disassembly and expansion. Equipped with AHU purification systems, air showers, pass-through boxes, and environmental monitoring systems, the facility undergoes IQ/OQ/PQ validation to meet the inspection requirements for production licenses covering Class II medical devices, such as sterile dressings and disposable consumables.