What links do materials need to go through in and out of the GMP clean workshop?

The following is the process of materials entering the GMP clean workshop formulated by a user unit. This process has a certain reference value, but it may need to be appropriately adjusted and improved according to the actual situation.

1. Necessary preparations need to be made before the materials enter the workshop. This includes determining the type and quantity of materials, checking the integrity and quality of the materials, and in the external unpacking room, the outer packaging of the materials needs to be removed, and the name and quantity of the inner packaging need to be checked to ensure that it meets the production process requirements;

2. To avoid cross-infection, all materials must be entered and exited through a dedicated channel, and cannot be mixed with the personnel channel. This can effectively limit the flow path of the materials, and ensure that personnel and materials can be completely separated from each other during the entry and exit process, thereby minimizing the possibility of cross-infection;

3. Strict cleaning and disinfection are required before the materials enter the workshop. Before the materials are placed in the transfer window, the outer surface must be cleaned and disinfected. After the materials are placed in the transfer window, the ultraviolet lamp is activated for sterilization. The estimated time is 10 minutes before entering the clean room;

4. When passing through the transfer window, it is necessary to note that the two doors cannot be opened at the same time to avoid bringing in bacteria. The correct operation sequence is to open the outer door first to put the materials into the transfer window, then close the outer door, and finally open the inner door to take out the materials;

5. After the materials enter the workshop, they need to be received and inspected by special personnel. These personnel need to have relevant knowledge and experience to carefully check the identification, packaging, and quantity of the materials to ensure the accuracy and compliance of the materials. The finished products produced in the clean area also need to be transported through the inner and outer doors of the transfer window when they are transported out.

6. Next, the materials need to be properly stored and managed. For those materials and wastes that are prone to contamination, they need to be sealed and stored in a clean area and transported out of the transfer window in time. At the same time, it is necessary to pay attention to the separate transportation of pollutants and other items, which needs to meet the requirements of GMP standards to prevent cross-contamination;

7. The outbound process of materials also needs to meet relevant requirements. After the material delivery is completed, be sure to remember to close the door of the transfer window in time, record the outbound information of the relevant materials, and properly mark and package the outbound materials.

The above is an introduction to the process of materials entering and leaving the GMP clean room. During the operation, the staff must strictly follow these steps. For purification equipment such as transfer windows used to transfer materials, Zhongjing Purification has an independently developed purification equipment production factory with professional production technology and rich production experience. The improved design of the transfer window has been optimized in terms of the sealing details, material quality, and functional performance of the equipment, and is more suitable for the material transfer needs of pharmaceutical factories, hospital operating rooms, biological laboratories, and other places.