Gmp Clean Room

GMP, full name (GOOD MANUFACTURING PRACTICES). GMP clean room not only means that the overall environment of its production plant and auxiliary function room has reached the required level of air cleanliness (number of dust particles per unit), it also has an important function to control life particles (for example: single-celled algae, fungi, native Animals, bacteria, viruses, etc.) to achieve a sterile and clean environment.

GMP divides the cleanliness of the GMP clean room into four levels: A, B, C, and D. A and B grades should have independent air-conditioning systems, and C and D grades should preferably be separately equipped with air-conditioning systems, when the area is very small, a set of air-conditioning systems can be used together.

Class A: high-risk operation area, unidirectional flow, dynamic and static grade 100, uniform air supply, wind speed of 0.36-0.54m/s (guidance value).

Class B: the background area of the high-risk operation class A area, mixed flow, static class 100 and dynamic class 100.

Class C and D: Clean operation area of lower importance.

Class C: Mixed flow, static 10,000-level dynamic 100,000-level.

Class D: Mixed flow, static 100000 and dynamic level is not specified.

General GMP production plant area is divided into production area, administrative area, living area.

Production area includes purification production workshop, warehouse, general engineering.

GMP workshop should consider the nature of the workshop and the requirements of cleanliness level.

With the development of medicine and food industry, new clean room continue to be built, and the original production plant must also be transformed to meet the requirements of modern purification production.

http://www.lhcleanroom.com/