GMP ISO Clean Rooms For Medical Devices

GMP Medical Instrument Cleanroom

International Medical Instrument Cleanroom Standards

International Standard: ISO/DIS 14644

Chinese Standards: GB50073, GB50591, GB 50243

American Standards: GMP-97, GMP-98, FS209E

It is required to build clean rooms that meet relevant standards for sterile medical device production workshops, pharmaceutical production workshops, medical biology laboratories, and operating rooms.

The following issues need to be considered in this projects:

1. Purification materials required for clean room engineering;

2. Comprehensive services such as design, installation, commissioning and maintenance of clean room of medical equipment and packaging workshop factory;

3. Medical equipment packaging workshop clean room engineering air conditioning purification section

The design, construction, monitoring and management of clean rooms are equally important. The clean room construction of sterile medical devices must start from the design, and the clean room monitoring involves the company's own management procedures and personnel's operation training. The clean room should be verified before the operation, and the design, engineering preparation, construction cycle monitoring, static monitoring after completion, and dynamic monitoring of the actual production process should be carried out. Enterprises should develop a scientific and effective clean room management system and procedures to manage problems in a timely manner and analyze them.

The Code for the Design of Cleanrooms for the Pharmaceutical Industry (GB50457-2008) was released in November 2008 and will be implemented on June 1, 2009. This is another part of the Code for Design of Clean Plants (GB 50073-2001). National standards will provide guidelines for the design of pharmaceutical cleanrooms. With the introduction of operability standards, monitoring the clean room will be an important guarantee for a clean production environment.The Code for the Design of Cleanrooms for the Pharmaceutical Industry (GB50457-2008) was released in November 2008 and will be implemented on June 1, 2009. This is another part of the Code for Design of Clean Plants (GB 50073-2001). National standards will provide guidelines for the design of pharmaceutical cleanrooms. With the introduction of operability standards, monitoring the clean room will be an important guarantee for a clean production environment.