Regulations on the Prevention of Pollution in Clean Areas of Pharmaceutical Factories

Purpose

Establish a management system to prevent pollution in the clean area of the pharmaceutical factory, and ensure that the hygiene of the clean area meets the 300,000-level cleanliness level standard.

Scope of application

300,000-level cleanliness level production area (mixing, washing room, changing room, Weighing Room, preparation room, 300,000-level sampling vehicle).

Responsibility

Clean area staff and management personnel are responsible for the implementation of this regulation, and the quality control department is responsible for supervising the implementation of this regulation.

(Figure 1: Pharmaceutical factory)

Content

1. Strictly abide by the "Factory Environmental Sanitation and Greening Management Regulations".

2. Strictly abide by the "Management System to Prevent Insects and Other Animals from Entering the Factory (Including Warehouse)".

3. Strictly abide by the "General Production Area and Clean Area Hygiene Management System".

4. Cleaners in the clean area can only use sponge mops, sponge blocks, hard nylon brushes, and plastic buckets; the tables and chairs should be made of materials that are free of shedding, easy to clean, and rust-free.

5. Personnel and materials entering the clean area shall follow the "Purification Procedure for Personnel Entering the Clean Area" and "Purification Procedure for Materials Entering the Clean Area". Only production operators in the clean area and personnel approved by the workshop director are allowed to enter: Temporary outsiders must be guided and supervised.

6. Doors, windows, various pipes, lamps, vents, and the junction between the wall and the ground should be kept clean and free of floating dust.

7. The floor drain should be clean, disinfected regularly, kept in a liquid-sealed state, and the upper cover should be tightly covered.

8. The inside and outside of the wash basin and tool washing basin should be kept clean and free of floating dust.

9. The two doors of the transfer chamber and buffer room cannot be opened at the same time. When not working, pay attention to closing.

(Figure 2: Clean room pollution prevention and control)

10. When operating in the clean area, the movements should be steady, light, and few; do not make movements unrelated to the operation and unnecessary conversations.

11. All materials in the clean area are placed according to the requirements.

12. Waste from the production process should be put into plastic bags in time. The plastic bags should be sealed in time and thrown away with the garbage after one-time use. Discard all.

13. Cleanrooms shall not be arranged for three-shift production, and sufficient time should be reserved for cleaning and disinfection every day. 

14. Clean primary and medium-efficiency Air Filters regularly and replace high-efficiency air filters. primary filters should be cleaned once a month, and medium-efficiency air filters should be cleaned once a quarter. For high-efficiency air filters, they must be replaced when the Air volume drops to 70% of the original air volume or there is an irreparable leakage. Generally, they should be replaced every two years.

(Figure 3: Clean room cleaning and disinfection)

15. Regularly monitor the environment of the cleanroom, find problems, and take corresponding measures in time until they meet the 300,000-level cleanliness requirements.

16. After each sampling, the sampling vehicle should thoroughly clean the inner wall of the sampling room.

17. The work clothes and dress of cleanroom personnel should be implemented in accordance with the "Management Regulations for the Selection and Dressing of Work Clothes" and "Regulations for the Cleaning and Replacement of Work Clothes and Shoes".

18. The locker room is cleaned by a dedicated person in accordance with the "Locker Room Hygiene Management Regulations".