The process layout of the pharmaceutical industry clean workshop should meet the following basic requirements:

1. It should meet the requirements of drug production process;

2. It should meet the requirements of air cleanliness level.

Process layout should prevent cross-contamination between human flow and material flow, and meet the following basic requirements:

1. The entrances and exits for personnel and materials entering and exiting the production area shall be respectively set. Special entrances and exits should be set up for materials that are likely to cause pollution during the production process.

2. The purification rooms and facilities before personnel and materials enter the medical clean room should be respectively set up.

3. The setting of process equipment and facilities in the pharmaceutical clean room should meet the production process and air cleanliness level requirements. Production and storage areas shall not be used as passages for non-local workers.

4. Elevators for transporting personnel and materials should be set up separately. Elevators should not be installed in medical clean rooms. When the process requires that a device for vertical conveying of materials must be installed in the medical clean room, measures should be taken to ensure that the air cleanliness level of the medical clean room is not affected and cross contamination is avoided.

5. The material transfer route in the clean workshop of the pharmaceutical industry should meet the needs of the process and production process, and be short and smooth.

Suzhou Pharma Machinery Co.,Ltd.

2023/05/23

Birkey