Design points of freeze-dried powder injection workshop

2021-02-08

The production process of freeze-dried powder injection includes bottle washing and drying and sterilization, rubber stopper treatment and sterilization, aluminum cap washing and sterilization, sub-packaging and half-stopping, freeze-drying, capping, packaging, etc. As shown below.

The general key points and technical requirements of freeze-dried powder injection workshop design are as follows:

1：According to GMP regulations, the air cleanliness level of its production area is divided into A, B, C and D under the background of B level. Among them, the filling and half stoppering, lyophilization, capping, and clean bottle stopper storage are classified as Class A under a Class B environment, preparation and filtration are Class C, and the bottle stopper is cleaned and dried and sterilized as Class D.

2：The workshop design strives to have a reasonable layout, follow the principle of separation of people and logistics, and do not cross backflow. Personnel entering the workshop must go through different levels of purification procedures to enter the Class D, Class C and Class B clean areas respectively. Those entering the Class A area under the background of Class B must wear sterile work clothes. The air pressure in the aseptic work area is higher than other areas, and the aseptic work area should be arranged in the center of the workshop as much as possible, so that the air pressure will flow from the higher room to the lower room.

3：The purification air-conditioning and comfort air-conditioning system in the workshop can effectively control the temperature and humidity; and can ensure the temperature and humidity requirements of the cultivation room; the temperature of the control zone is 18~26℃, and the relative humidity is 45%~65%. UV lamps must be installed in each process.

4：The layout of auxiliary rooms should be reasonable. The cleaning tool room and the container cleaning room should be located outside the aseptic operation area, and the non-sterile process operations cannot be arranged in the aseptic operation area. When materials or other items enter the aseptic work area, sterilization rooms or sterilization equipment should be set up for the disinfection or sterilization of materials and items. The containers and utensils after washing should be disinfected or sterilized before entering the aseptic work area.

5：Arrange the pipelines of pure water and water for injection in accordance with GMP regulations.

6：If there is a live bacteria culture such as a freeze-drying workshop for biological vaccine products, it is required to strictly divide the clean area into a live bacteria area and a dead bacteria area, and control and treat the air discharge in the live bacteria area and sewage with live bacteria.

Clean room system control

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