1. Materials entering and exiting the clean area must be strictly separated from the human flow passage, and enter and exit through the special passage for materials in the production workshop.

2. When the materials enter, the raw and auxiliary materials are removed from the package by the person in charge of the preparation team or the surface is cleaned, and then sent to the raw and auxiliary material temporary storage room of the workshop through the pass box; after the inner packaging materials are removed from the outer temporary storage room, It is sent to the inner private room through the pass box. The workshop integrator handles the handover of materials with the person in charge of the preparation and inner packaging process.

3. When passing through the pass box, the regulations of "one opening and one closing" of the inner and outer doors of the pass box must be strictly followed, and the two doors cannot be opened at the same time. After opening the outer door to put the materials in, close the door first, then open the inner door to take out the materials, close the door, and so on.

4. When the materials in the clean area are sent out, the materials should be transported to the relevant material intermediate station first, and moved out of the clean area according to the reverse procedure when the materials enter.

5. All semi-finished products shipped out of the clean area must be sent from the pass box to the outer temporary storage room, and then transferred to the outer packaging room through the logistics channel.

6. After the materials come in and out, clean up the clean-up rooms or intermediate stations and the delivery windows in time, close the inner and outer access doors of the delivery windows, and do a good job of cleaning and disinfection.

Suzhou Pharma Machinery Co.,Ltd.

2023/04/19

Birkey