Sterilization refers to a method of killing or removing a living microorganism in an article by appropriate physical or chemical means, thereby reducing the probability that the residue will remain at the desired level of sterility. This method applies to the preparation, raw materials, accessories and medical equipment and other items sterilization.
Sterile item means that the substance does not contain any live microorganisms. For any batch of sterile items, the absolute sterility can not be guaranteed, can not be used to confirm the test. The aseptic properties of a batch of items can only be expressed relatively simply by the probability of living microorganisms in an item to an acceptable level, ie Sterility assurance level (SAL). In the actual production process, sterilization refers to the probability of contamination of microorganisms in the article to the expected level of sterility assurance. The final sterilization of the microbial survival probability of the item, that is, the level of sterility should not be higher than 10-6. The sterile assurance level of the sterilized item can be determined by validation.
Sterile assurance of sterile articles can not rely on the sterility test of the final product, but depends on the use of qualified sterilization processes in the production process, strict GMP management and a good sterility assurance system. The determination of the sterilization process should take into account the nature of the product being sterilized, the effectiveness and economy of the sterilization method, the integrity and stability of the articles after sterilization.
Verification of the sterilization procedure is a necessary condition for aseptic assurance. After the sterilization procedure has been verified, it can be used for official use. Verification includes:
(1) write verification program and develop evaluation criteria.
(2) confirm the sterilization equipment technical information is complete, the installation is correct, and can be in normal operation (installation confirmation).
(3) Verify that the sterilization equipment, critical control and recording system can operate normally within the specified range of parameters (operation confirmation).
(4) Repeated tests shall be carried out using sterilized articles or simulated articles according to the intended sterilization procedure to confirm that the key processes and parameters meet the predetermined standards and that the sterile assurance level of the sterilized articles is in accordance with the regulations (performance confirmation).
(5) to summarize and improve the various documents and records, write verification report.
In the daily production, the operation of the sterilization procedure should be monitored to confirm that the key parameters (such as temperature, pressure, time, humidity, sterilization gas concentration and absorbed dose, etc.) are within the scope of validation. The sterilization procedure should be re-verified on a regular basis. When the sterilization equipment or program changes (including sterilization items loading and the number of changes), should be re-verified.
The sterility of the article is related to the sterilization process, the degree of contamination of the article before sterilization, and the characteristics of the contaminating bacteria. Therefore, according to the characteristics of the sterilization process to develop sterilization products before sterilization level and the tolerance of contaminated bacteria and monitoring, and in all aspects of production to take various measures to reduce pollution, to ensure that microbial contamination control in the provisions of Within the limits.
Sterilization of the cooling stage. Measures should be taken to prevent contaminated articles from being contaminated again. In any case, the container and its sealing system shall be required to ensure that the article meets the sterile requirements during the period of validity.