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Clean Room ISO 8 & ISO 7

Medical devices injection is traditional area of expertise for Plax group. More than 50% of the company's products are in the field of medical care. Wanox’s philosophy is to introduce advanced technology and build China's localised medical customer.

Wanox has a 1090 m2 clean room workshop, which includes a 300 m2 clean room class 100.000 injection molding production workshop. This is equipped with 4 full electric injection molding machines ranging from 900kN to 3600kN. There is also a 130 m2 clean room class 10.000 for assembly and packaging.

Wanox design and establish Clean Room Grade C (ISO 7) and Grade 8 (ISO 8) based on GMP and URS.

Wanox has completed all the facility and utility validation processes for Clean Room Grade C (ISO 7) and Grade 8 (ISO 8), including HVAC system Installation, Operation and Performance Qualification. These processes are inspected and monitored by a qualified testing External Institution to ensure Wanox Clean Room meet Grade C (ISO 7) and Grade 8 (ISO 8) standards.

All production equipment, molding and auxiliary machinery located in the clean room has completed Installation and Operation Qualification, for production of plastic parts for medical devices.

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