What are the standards for GMP purification workshop

Industrial modular Clean Room time:2021/12/20 08:41:06 click:45

GMP purification workshop is to eliminate potential biological activity, dust, pollution, fundamentally eliminate the impact of the production of high-quality substances. Therefore, GMP purification workshops must follow the relevant design requirements to ensure that the quality of the final product meets the regulatory requirements. Shanghai Lijing purification specializing in air purification and other engineering design and construction, today to food factory GMP purification workshop as an example, with you a detailed analysis of the GMP purification workshop in the design requirements.

 What are the standards for GMP purification workshop

I. Design of purification structure

1. Each production link should be connected with each other, and it should be convenient for health control in the process of processing to avoid cross-contamination;

2. In the layout, to follow the processing process of the product order, so that the product processing from the unclean link to the clean link, not allowed to cross and reverse flow in the processing process;

3. The workshop shall be equipped with a utensil cleaning area, disinfection room, cleaning tank, disinfection tank and rinsing tank for common utensil cleaning. When necessary, it can also be used for cold and hot water, but the temperature of hot water can not be lower than 82℃;

4. Purification workshop should have good dust removal ventilation conditions and ensure that the direction of air flow should flow from the clean area to the non-clean area;

5. Workshop lamps shall be equipped with protective cover.

2. Design of people flow and logistics

1. In order to avoid cross-contamination, operators and materials entering the clean area should not use the same entrance. Separate purification rooms should be set up or corresponding purification measures should be taken;

2. Only production-related equipment is set up in the clean production area to avoid food contamination;

3. Ensure that the channel of clean area directly reaches each production post, intermediate or inner material storage room, so as to effectively prevent the cross contamination of different varieties of food caused by material transportation and operator flow;

4. On the premise of not affecting the process flow and process operation equipment layout, 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 to transfer materials.

Installation and design of air conditioning system

The selection of different air supply and return system design in the purification workshop is the decisive factor to determine the different cleanliness levels of the workshop.

1. Standard combined air conditioner air cabinet + air filtration system + clean room ventilation and insulation pipe +HEPA efficient air supply port + clean room return air pipe system. This form can continuously circulate and replenish fresh air into the clean room workshop to achieve the cleanliness required by the production environment.

2. Install FFU industrial air purifier on the ceiling of clean workshop to supply air directly to clean room + return air column return air system + ceiling air conditioner for refrigeration. This form is generally used in the environment cleanliness requirements are not very high, and the cost is relatively low.

GMP purification is a complex comprehensive engineering, production environment, process, production equipment, auxiliary equipment, detection means and personnel quality and other professional knowledge are involved. In the future article, Shanghai Lijing will introduce other aspects of the purification workshop in detail. If you have more questions or needs, you can log in our official website "Shanghai Lijing" for consultation and understanding.