Clean Room Setup
Medical research cleanrooms are used in the pursuit of medical understanding, research and experimentation, and the development of treatments. Medical research cleanrooms are often required to be biosafe, and have extra safeguards in place to protect employees and their important work from potential biosecurity risks.
Types of Airflow Method in Cleanroom
Laminar Flow Reinraum
Turbulenter Flow Reinraum
The design basis for a GMP (Good Manufacturing Practice) cleanroom in the field of biopharmaceuticals
1) “Guidelines for Good Manufacturing Practices for Pharmaceutical Products” (Revised in 1992) by the Ministry of Health.
2) “Design Specifications for Cleanrooms in the Pharmaceutical Industry” (1997).
3) “Implementation Guidelines for Pharmaceutical Production Management Standards” (1992).
4) “Design Specifications for Cleanrooms” (1984).
5) “Design Specifications for Ventilation and Air Conditioning” (GBJ19-87).
6) “Management Standards for Non-woven Medical Device Production” (YV/T-0033-90).
7) Technical documentation provided by owners, including process layout drawings, and other related materials.
Food Enclosure Structure Solution
In the “Good Manufacturing Practice for Beverage Enterprises” (GB12695-2003), it is required that the filling area is partially Class 100 (Level 5), the clean area is Class 10000 (Level 7), and the quasi-clean area is Class 100000 (Level 8).
Other design codes include:
Technical Codes for Building Cleanrooms in the Food Industry GB50687-2011, Heating Ventilation and Air Conditioning Design Code GBJ50019-2003, Cleanroom Plant Design Code GB50073-2001, Cleanroom Construction and Acceptance Codes JGJ71-90, Codes for Construction of Acceptance Quality of Ventilation and Air-conditioning Projects GB50243-2002, Specifications for Construction and Acceptance of Refrigeration Equipment Installation Projects GB50210-2001, Specifications for Indoor Environmental Pollution Control in Civil Construction Projects GB50325-2001