Requirements for bacteriometer to perform sterility test

Bacteria are everywhere. In order to protect patients from harmful bacteria and other pathogens, pharmaceutical companies use bacteriometer sterility tests, which touch on strict rules to minimize the risk of infection. Pharmaceutical companies use bacteriometer sterility tests in the production of sterile drugs. Keeping the environment as clean as possible is of proper importance to the sterility test, where the policy is to eliminate bacteria, and the policy of cleanliness is to reduce the number of bacteria as much as possible. Next, we also want to talk to you about the conditions required for sterility test of bacteria collection instrument.

(I) Environmental monitoring
The air should be evaluated in a clean room environment with scientific and reasonable sampling, testing, data analysis and other methods, which should be independently supervised by the quality assurance section. Sampling orientation and adequate sampling are key components of the bacteriometer asepsis test. It should be stipulated in the standard operating procedure that air and surface samples should be collected in the local area where there is high activity or the product is exposed.
(ii) Air monitoring
The air monitoring of total particles is carried out for particles between 0.5 and 5 and larger than 5 microns. The clean room is classified according to these counts. The on-line air monitoring system with remote probes can continuously count particles at static and during operation. Active particles can be monitored either by an air sampler or by a settling plate.
(iii) Personnel supervision
Personnel is a major risk factor in the asepsis test process of the bacteriometer. At each stage, gloves and robes are regularly sampled and monitored for aerobic bacteria, yeast and fungi, and anaerobic bacteria, especially propionibacterium acnes, a kind of plenative anaerobic bacteria, which is part of the normal skin flora, are required to be monitored for personnel health monitoring and physical examination. The normal flora from these people, particularly from fingernails, hands, hair, etc., to find the source of contamination.
(iv) Personnel training

All operators should be trained and certified on various procedures, including their knowledge of the procedures, their importance in aseptic manufacturing operations, and the effects or risks of not following these procedures on drug quality. Training in clean room operations should focus on minimizing particle production and air flow damage. Examples of personnel training include bacterial-collection instrument asepsis testing, clean room behavior, Microbiology, hygiene, patient safety hazards caused by non-sterile drugs, and specific procedures for preparation operations. Regarding general skills and operations in the clean room, emphasis should be placed on only using sterile instruments to touch sterile materials, not directly touching sterile products, containers, and closings.