Reference for clean room management regulations of health care products clean room

1. Use of clean room:

1.1 Production personnel entering the clean room

1.1.1 All staff entering the clean room shall first be trained in the basic knowledge of clean technology, so that they understand the relationship between clean technology and preparation production, attach importance to it, and consciously abide by the rules and regulations of clean room management.

1.1.2 Personnel entering the clean room must maintain personal hygiene, and shall not wear makeup, watches or accessories; they shall wear clean work clothes that have been cleaned and disinfected in this area, and enter in accordance with the "Standard Procedures for Personnel Entering and Exiting clean areas".

1.1.3 The material of clean clothes should be selected with small dust collection, not easy to cause fiber peeling, no static electricity, no wrinkles, and regular cleaning and disinfection. Clean once for each production, and keep records.

1.1.4 The number of operators entering the clean room must be controlled within the specified number of people, and the fixed-point and fixed-post operation system for each process shall be implemented.

1.1.5 When working in the clean room, the movements should be light, and talking and unnecessary movements should be minimized. The operation must be carried out according to the operating procedures, and non-production activities are strictly prohibited. Cleanroom operators should not make dust-generating and large movements (such as scratching their heads, walking fast, and running)

1.2 Materials used in cleanrooms

1.2.1 All materials and utensils used in the production process of cleanrooms shall comply with the "Standard Operating Procedures for Materials Entering and Leaving Clean Areas".

1.2.2 Objects that are not related to production and are prone to dust, such as pencils, erasers, pens, etc., cannot be brought into the cleanroom. Records should be made with ballpoint pens or signature pens.

1.2.3 Containers for raw and auxiliary materials should be easy to clean or disposable, and sealed with a cover. Materials should be protected from contamination during transportation.

1.2.4 Raw and auxiliary materials, packaging containers and packaging materials used in the workshop shall be collected according to production instructions. The remaining bulk raw and auxiliary materials in production shall be sealed in time, and the batcher shall indicate the unsealing date on the container. When unsealed and used again, the records shall be checked, and a post material balance card shall be established to record the collection, consumption and balance ledger.

1.2.5 Before the production of each variety or batch number begins, in order to prevent material contamination, the equipment, instruments, containers, etc. should be carefully checked for cleanliness, and there should be no retained materials from the previous production, otherwise new production operations cannot be carried out, etc.). Reduce the range of motion during operation and try to avoid unnecessary walking. To maintain the purification level of the clean room.

1.2.6 Operators in different clean level operation areas shall not walk around at will. When necessary, they must follow the purification and changing procedures for entering the operation area and change the clean clothes that should be worn in the corresponding area before entering.

2. Hygiene maintenance in the clean room:

2.1 Wipe doors, windows, walls, indoor appliances and outer walls of equipment with drinking water; scrub the floor, waste storage container, floor drain, drainage, etc. The waste generated by production should be cleared out of the clean room in time.

2.2 Fully wipe the workplace, walls, ceilings, lighting, exhaust and its ancillary devices; disinfect the room or determine the disinfection cycle based on the indoor bacterial inspection situation.

2.3 The disinfectant should be replaced every half month, and 0.02% new chlorhexidine and 75% ethanol should be used alternately.

3. Cleanroom cleanliness management

3.1 Before production, the integrity of the factory and equipment should be ensured to maintain their good cleanliness;

3.2 During production, the Air conditioning system is running to ensure the temperature and humidity in the clean room, so that the pressure difference between the high clean room and the low clean room meets the specified requirements.

3.3 In order to ensure the purification environment and cleanliness of the clean room, the clean room must be monitored regularly according to regulations. The monitoring content and standard requirements of the 100,000-level clean room are as follows:

3.4 Establish a comprehensive safety system for the clean room and set up fire protection, emergency, lighting and other facilities.

3.5 In addition to relying on the daily management of the user, the air purification system shall be maintained in accordance with the corresponding provisions of the "Air Conditioning Purification System Operation and Maintenance Regulations".

4. Management of non-clean room staff entering the clean area

4.1 Maintenance personnel need to enter the clean room, notify the person in charge of the workshop, and wear special clean clothes for maintenance personnel before entering.

4.2 Outsiders need to Enter the clean room, and they can enter only after approval by the supervisor and wearing clean clothes.