Microbial limit filtration used in pharmaceutical field

The microbial limit test device uses a high-performance diaphragm pump to drain directly, without the need for a filter bottle, and can form a complete membrane filtration device through different pump heads with special filter cups or limit incubators.

Application of microbial limit test system in pharmaceutical industry:

1. To determine whether the medicine is contaminated or the contamination degree, and control the quality. Microorganisms widely exist in nature, and medicines are easily contaminated by them during production, transportation and storage. Under suitable conditions, polluted microorganisms can grow and reproduce, leading to deterioration of medicines and affecting their quality. Through microbial limit testing, we can know whether the medicine is contaminated and the contamination degree, find out the source of the pollution, and take appropriate methods to control it to ensure the medicine quality.

2. To ensure the effectiveness and safety of medication. As a special commodity, medicines should not only ensure the effectiveness of their treatment, but also ensure the safety. On the one hand, its safety refers to whether its chemical composition and content are safe, and on the other hand, it refers to whether the medicine is contaminated by microorganisms. Microbial contamination of medicines may decompose the active ingredients, resulting in reduced or lost efficacy. Microbial limit filtration of non-regulated sterilized preparations is one of the important measures to ensure their quality, safety and effectiveness.

3. It can be used as one of the bases to measure the hygiene level of the whole process of medicine production. All aspects of pharmaceutical production, such as raw materials, water, air, workshop equipment, packaging materials, operators, etc., may bring microbial contamination. The test results of microorganism limit test system can reflect the hygiene management level of the production enterprise.