~Suzhou Pharma Small Class~

1. Hands are the medium of cross contamination. Operators should wash their hands when entering the clean room. Do not touch high-purity products and high-purity packaging materials with hands; Disinfection is also required for drug production and operation personnel.

2. The following personnel are not allowed to enter the clean room: patients with cold, cough, eczema and other diseases; Those who do not wash off cosmetics, nail polish and wear clean work clothes as required; Operators should wash their hair, change their clothes and cut their nails frequently.

3. When working in the clean room, the operators should act lightly, strictly follow the operating procedures, do not make large movements that are prone to dust, do not drag feet, and do not do unnecessary actions; It is not allowed to wear clean work clothes to the toilet.

4. In the clean room, gloves should be worn according to the requirements, and the wrist should not be exposed. The gloves should be replaced frequently.

5. Relevant training and education shall be carried out for the personnel entering the clean room: master the characteristics, structure, general knowledge of clean technology of the clean room, personnel purification procedures and material purification route requirements, the use and cleaning requirements of clean work clothes, the cleaning, cleaning and disinfection of the clean room, the safety facilities and safety management regulations of the clean room.

6. Clean work clothes should be made of materials with low dust production and anti-static property. Generally, the sub-packaging type is used in the clean room of grade 10000 to 100000, and the connecting type is used in the clean room of grade 100 to 1000. Clean shoe covers should be disposable. Clean shoes should be washable. Generally, the number of particles emitted by people wearing clean clothes when walking is 40-60 times less than that of people wearing ordinary clothes, so this is very important for the maintenance and management of high cleanliness plants.

7. Clean work clothes shall be managed by special personnel, inspected and cleaned regularly. Generally, it should be cleaned once a week. Generally, it should be checked to determine whether it is scrapped after 50-100 times of cleaning.

8. The "5S" operation in the clean room needs to ensure timeliness and continuity, and the site management personnel should carry out regional positioning management.

9. As the production place of pharmaceutical enterprises, the clean room has strict regulations and requirements for the environment and personnel. The environment in the clean area can be strictly managed and controlled through the online environmental monitoring system (EMS), and the personnel can be controlled and managed through the management system and specifications. However, the operation behavior of the personnel in the clean area, the operation status of the equipment, and the production and operation process have formed a management gap to a certain extent. Because the clean area, as a management area with high requirements for environment and human flow, is fundamentally different from other management areas of pharmaceutical enterprises, it is impossible to control the above three types of processes on site, and the management mode of remote off-site supervision of the clean area has become an inevitable choice. The remote off-site supervision of the clean area can be realized through the multi-point and fixed-point arrangement of the embedded dedicated camera in the clean area. The embedded special camera in the clean area is a special camera for real-time monitoring of important equipment/key posts in the clean area and clean room. This camera flat panel design style adopts the installation method of embedded color steel plate. After installation, the camera panel is flush with the color steel plate wall, realizing the zero sanitary dead angle of the camera in the clean area, which is convenient for cleaning, and realizing the cleaning of the camera while cleaning the wall. The camera adopts standard POE power supply mode, which can quickly deploy control at multiple points and is compatible with mainstream video systems. Because of the incomparable advantages of the embedded camera in the clean area, it has been widely used in pharmaceutical enterprises.

                 

                 

                 

Suzhou Pharma Machinery Co.,Ltd.

2023/02/14

Alice