What is the standard of GMP purification workshop

Industrial modular Clean Room time:2022/09/16 08:37:04 click:21

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

What is the standard of 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 processing process to avoid cross-contamination;

2. In the layout, it is necessary to follow the sequence of the product processing process, so that the product processing from the unclean link to the clean link, and the crossing and backflow in the processing process are not allowed;

3. The workshop shall be equipped with a cleaning area and a disinfection room for tools, and a cleaning tank, a disinfection tank and a rinsing tank for the cleaning and disinfection of public tools. When necessary, it can also be cold and hot 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 airflow direction should flow from the clean area to the non-clean area;

5. The workshop lamps shall be equipped with protective covers.

. Design of flow of people and logistics

1. In order to avoid cross contamination, operators and materials entering the clean area should not use the same entrance, and should set up their own purification room or take corresponding purification measures;

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 or inner material storage room, which can effectively prevent the cross contamination of different kinds 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 design of different air supply and return air systems in the purification workshop is the decisive factor to determine the different cleanliness levels of the workshop.

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

2. The ceiling of clean workshop is installed with FFU industrial air purifier directly to the clean room + return air column return air system + top-suction type air conditioner refrigeration. This form is generally used for environmental cleanliness requirements are not very high occasions, and the cost is relatively low.

GMP purification is a complex comprehensive project, production environment, technological 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 for you. If you have more questions or needs, you can log on our official website "Shanghai Lijing" for consultation.