It is known that GMP workshops are specially designed for food, pharmaceuticals, and other products, featuring an environment that is nearly dust-free and sterile to ensure the quality of products. Not only must the design and decoration prevent contamination, but strict requirements also apply to the entry and exit of personnel and materials. Having previously discussed personnel, today we will talk about the process for materials entering a GMP clean workshop.
The following process for materials entering a GMP clean workshop, as established by a certain company, holds significant reference value:
- The entry and exit of all materials must go through dedicated passages, not to be mixed with personnel passages, to avoid cross-contamination.
- In the external unpacking area, remove the outer packaging of materials and check whether the inner product name and quantity match the material requisition list.
- Before placing materials into the transfer window, it is essential to clean and disinfect their outer surface. After placing them in the transfer window, turn on the ultraviolet light for sterilization treatment for about 10 minutes before they can enter the clean room.
- When using the transfer window, be mindful that both doors should not be open simultaneously to prevent bacterial ingress. The correct procedure is to first open the outer door to place the materials inside the transfer window, then close the door, and finally open the inner door to retrieve the materials.
- Finished products produced in the clean area are also transported out through the inner and outer doors of the transfer window.
- For materials and waste that are particularly prone to causing contamination, they should be sealed and stored within the clean area and promptly transported out through the transfer window. It is important to separate the transport of contaminants from other materials.
- After transporting materials, remember to promptly close the doors of the transfer window.
