What is the standard of GMP cleanroom?

Published on.

2022-08-24 14:28

GMP cleanrooms are designed to eliminate potential bioactivity, dust, and contaminants, and to fundamentally eliminate substances that affect the production of high quality. Therefore, GMP cleanroom should follow the relevant design requirements to ensure the quality of the final product meets the regulatory requirements. Today, we will take the GMP cleanroom of food factory as an example and analyze the design requirements of GMP cleanroom in detail.

I. Design of purification structure

1. the production links should be connected to each other, but also to facilitate sanitary control during processing to avoid cross-contamination.

2. in the layout, to follow the order of the processing process of the product, so that the product processing from the unclean link transition to the clean link, do not allow cross and backflow in the processing process.

3. The workshop is set up in the apparatus cleaning area, disinfection room, configuration of public apparatus cleaning, disinfection with the cleaning tank, disinfection tank and rinsing tank. If necessary, hot and cold water is also available, but the temperature of hot water should not be lower than 82℃.

4. cleanroom should have good dust removal ventilation and ensure that the direction of airflow should flow from clean to non-clean areas.

5. Workshop lamps should be equipped with protective cover.

II. Design of human flow and logistics

1. To avoid cross-contamination, operators and materials entering the clean area should not use the same entrance, and should set up their own purification rooms or take corresponding purification measures.

2. only production-related equipment should be set up in the clean production area to avoid contamination of food.

3. ensure that the passage of the clean area directly reaches each production post, intermediate or inner package material storage room, which can effectively prevent cross-contamination of different varieties of food caused by material transportation and operator flow.

4. Without affecting the process flow and process operation equipment arrangement, if the air conditioning system parameters are the same, the adjacent clean operation room can open the door on the partition wall, open the transfer window or set up a conveyor belt used to transfer materials.

III. Installation and design of air conditioning system

The different design of air supply and return air system is the decisive factor to decide the different cleanliness level of the cleanroom.

1. Standard combined air conditioning cabinet + air filtration system + clean room ventilation insulation duct + HEPA high efficiency air supply outlet + clean room return air duct system. This form can continuously circulate and supplement the new air into the clean room workshop to achieve the cleanliness required by the production environment.

2. Cleanroom ceiling installation FFU industrial air purifier directly to the clean room air supply + return column return air system + ceiling-mounted air conditioning unit cooling. This form is generally used in the environment cleanliness requirements are not very high occasions, and the cost is relatively low.

GMP purification is a complex and comprehensive project, the production environment, process, production equipment, auxiliary equipment, testing means and personnel quality and other professional knowledge are involved. In future articles, Shanghai Lizhen will introduce other aspects of cleanroom in detail, if you have more questions or needs, you can visit our official website "Shanghai Tobetter" for consultation and understanding.