What is the standard of GMP purification workshop?

GMP purification workshop is to eliminate potential biological activity, dust, pollution, and fundamentally eliminate the impact on the production of high-quality substances. Therefore, the GMP purification workshop must follow the relevant design requirements to ensure that the quality of the final product meets the regulatory requirements. Shanghai Lijing purification specializes in the design and construction of air purification and other projects. Today, we will take the GMP purification workshop of food factory as an example to analyze the design requirements of GMP purification workshop in detail.


I. Design of purification structure


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


2. In terms of layout, it is necessary to follow the order of the processing process of the product, so that the product processing transitions from the unclean link to the cleaning link, and does not allow cross and reverse flow in the processing process;


3. The workshop is equipped with a cleaning area, disinfection room, cleaning tank, disinfection tank and rinsing tank for cleaning and disinfecting public utensils. If necessary, it can also be used for hot and cold water, but the temperature of hot water can not be lower than 82℃;


4. The purification workshop should have good dust removal ventilation conditions and ensure that the direction of air flow should be 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 can not use the same entrance, and their own 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 the clean area directly reaches each production post, intermediate material or internal material storage room, which can effectively prevent 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 the layout of process operation equipment, if the parameters of the air conditioning system 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 different designs of different supply air and return air systems used in the purification workshop are decisive factors to determine the different cleanliness levels of the workshop.


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


2. Clean workshop ceiling installation FFU industrial air purifier directly to the clean room air supply + return air column return air system + ceiling type air conditioner refrigeration. This form is generally used for occasions where the environmental cleanliness requirements are not very high, and the cost is relatively low.


GMP purification is a complex comprehensive project, the production environment, process, production equipment, auxiliary equipment, testing 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 visit our official website "Shanghai Lijing" for consultation and understanding.


News recommendation

What is the standard of GMP purification workshop?

2024-11-06
Previous

没有了!

Next

没有了!