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      Quality assurance of sterility test for medicinal glass bottles Release time: 2020-08-23 Visited: 335 Times

      The most important quality assurance of medical glass bottle depends on sterility test. In this regard, a good aseptic testing packaging is indispensable.


      The risk of sterility test of medical glass bottles generally comes from the following contents:


      1、 The following are the credibility of sterilization process; 2. The environmental pollution level of microbial strains of raw materials; 3. Whether a sound aseptic testing assurance system management has been formulated; 4. Whether a sound aseptic testing assurance system management has been formulated; 4;


      Then, to ensure the sterility test of medical glass bottles, we must start from the following contents:


      1. Effective sterilization methods should be selected, which can exceed the actual effect of complete sterilization. Generally speaking, ethylene oxide sterilization or cobalt 60 sterilization method should be used for sterilization. 2. To test the environmental pollution level of raw materials, generally speaking, the spread of microbial strains in solid raw materials will not be symmetrical, resulting in the test results may not necessarily mean the overall situation of the whole batch of raw materials. Relevant purchase specifications of raw and auxiliary materials should be formulated, and the relative microbial strain level should be required. 3. Select excellent processing technology to carry out manufacturing to ensure the excellent sealing performance of the bottle body, and select the matching cap with good sealing performance, so as to reasonably ensure the sealing. 4. Formulate and improve the aseptic testing system management to ensure that the environment of the production workshop and the relevant specifications of the purification workshop exceed the provisions of GMP and the company's own specifications.


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