This paper analyzes the factors that are easy to cause microbial pollution from six aspects: personnel, factory buildings and facilities, equipment, materials, technology and others.
1 personnel
People are the main source of pollution in the production of sterile drugs, and the possibility of pollution caused by personnel operation exceeds 70%. The clean room (area) should be limited to the production and operation personnel and approved personnel in the area, and the number of personnel should be strictly controlled to guide and supervise the temporary foreign personnel entering the clean room (area).
1. 1 Number of aseptic operators: According to the above analysis of personnel pollution, it is very important to determine the number of personnel to control aseptic production areas. In addition, the operating range of aseptic operators should be standardized to minimize exercise. The number of personnel can only be determined if it is verified that it has no influence on the relevant indicators of aseptic environment.
1.2 non-production personnel, such as visitors, equipment maintenance personnel, quality inspectors, etc. Without professional training in microbial knowledge, aseptic dressing requirements and aseptic operation requirements, the operation in dressing and aseptic production area is likely to bring microbial pollution to aseptic production area. Therefore, non-production personnel should be strictly controlled to enter the sterile production area. If you need to enter, you should be strictly trained and led by the personnel in the sterile production area, and guide and monitor them.
1.3 Personnel qualification: Operators in aseptic production areas are advised to choose production personnel with patience and technical secondary school education or above (aseptic production areas have strict control requirements, and operators need to adhere to S·O·P and related regulations for a long time).
1.4 personnel training: As sterile drugs, what personnel in sterile production areas need most is the training of microbiology knowledge, disinfection and sterilization knowledge, and the training of aseptic dressing and aseptic operation is also very important.
1.5 aseptic operator: the aseptic operation of personnel is very important, because direct or close contact with drugs may bring microbial pollution.
The possible risks of aseptic operators are as follows: ① Non-production personnel are not aware of aseptic operation, resulting in pollution of environment, equipment and drugs. ② The current aseptic protection device can't guarantee the pollution caused by personnel themselves. ③ Frequent contact with gloves by sterile operators may pollute hands. (4) aseptic operators do not disinfect in time or enter the 100-level operation area without disinfection; ⑤ Excessive movement or action of aseptic operators can easily lead to the increase of human excreta and microorganisms. ⑥ Sterilization operators may be contaminated through the purification dead corner of aseptic production area. ⑦ When filling, the aseptic operator may operate above the medicine whose bottle mouth is not sealed, which may cause the contaminated microorganisms on the human body or aseptic clothes to directly enter the liquid medicine in the bottle.
2 factories and facilities
Sterile environment is the basic guarantee for producing qualified sterile drugs. It is hard to imagine that a non-sterile production environment can continuously produce sterile products. Therefore, aseptic production environment is very important, which mainly involves design, layout, facilities, environmental disinfection, air flow and so on.