4 CLEANING LEVEL IN GMP FACTORY
CLEANING ROOM STANDARD LEVEL A B C
Table of contents
1. What is the level of cleanliness?
2. 4 GMP . factory cleanliness
3. Levels of cleanliness in sterile drug production
1. What is the level of cleanliness?
Clean level is a level to evaluate the cleanliness of clean rooms, areas are controlled in terms of factors: limit of particles in the air, limit of bacterial contamination, temperature, humidity, light, difference. Pressure difference between rooms helps to ensure the production of quality products and safe for users…
The cleanliness level requirements of each production field will be different, for example, the cleanliness level of a pharmaceutical or functional food manufacturing facility will be different from the cleanliness level of a factory that manufactures components, equipment. electronic device. On the other hand, the cleanliness level of pharmaceutical and functional food manufacturing facilities is regulated and established in accordance with each different production stage (mixing, packaging, labeling, …) and for each form. different drugs (tablets, capsules, solution for infusion, eye drops, etc.)
2. 4 GMP factory cleanliness
The classification of 4 levels of cleanliness in GMP factories according to WHO regulations is based on 2 criteria: The first is the maximum amount of particles allowed in the air, the second is the limit of microbiological pollution. object.
In order to achieve clean air level A, B, C, D, GMP standard cleanliness level, the number of air exchanges needs to be appropriate to the room size, equipment and number of employees present. Typically, the number of air exchanges is at:
D level: 20 times
Level C: 30 times
Level B: 40 times
Level A: 60 times
HEPA filters must be leak tested according to ISO 146444-3, with a recommended frequency of every 6-12 months to ensure that the filter media, frame and internal joints are not exposed. Leakage.
4 levels of cleanliness in a GMP factory (A, B, C, D) according to the maximum amount of particles allowed in the air