What is the standard of GMP purification workshop?

GMP purification workshop is to eliminate potential bioactivity, dust and pollutants, and fundamentally eliminate substances that affect the production of high-quality products. Therefore, the GMP purification workshop should follow the relevant design requirements to ensure that the quality of the final product meets the regulatory requirements.

I Design of purification structure

1. All production links should be connected with each other, and it is also convenient for health control in the processing process to avoid cross pollution;

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

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

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

5. Workshop lamps must be equipped with protective covers.

II Design of people flow and logistics

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

2. Only production related equipment shall be set in the clean production area to avoid food contamination;

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 kinds 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 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.

III Installation and design of air conditioning system

The different design of air supply and return systems used 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 + ventilation and insulation pipe of clean room + HEPA high-efficiency air supply outlet + return air pipe system of clean room. This form can continuously circulate and supplement fresh air into the clean room workshop, so as to achieve the cleanliness required by the production environment.

2. FFU industrial air purifier shall be installed on the ceiling of the clean workshop to directly supply air to the clean room + return air column return air system + ceiling air conditioner. This form is generally used in occasions where environmental cleanliness requirements are not very high, and the cost is relatively low.