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Zhengzhou mingyi instrument equipment co.,ltd

HomeIndustry InformationMedical steam sterilizer autoclave application

Medical steam sterilizer autoclave application

A sterile item means that the item does not contain any living microorganisms. However, for any batch of products, sterility is neither guaranteed nor tested, as it is not possible to perform sterility testing on each small package. In fact, physical or chemical means have shown that the killing curve of microorganisms follows the logarithmic rule, therefore, the sterility criteria for batched items are generally defined in the probability sense as the pollution unit is as low as acceptable. Generally used for the probability of microbial survival after the item - the sterility assurance level SAL (SterilityAssuranceLevel). The sterility assurance value of the probability of microbial survival of the final product product is generally not lower than 10-6, that is, the probability of microbial survival is not more than one millionth. The sterility assurance value is closely related to the quantity and characteristics of microorganisms present in the product. Therefore, all effective means (including filtration and other measures) should be taken at all stages of product production to reduce the microbial contamination of the product and control it at the specified limit. Inside. The level of sterility assurance that has been achieved by the product can be determined by verification.

The sterility assurance of the product does not depend on the sterility test of the final product, but on the use of a qualified process, strict GMP management and a good overall quality assurance system in the production process. The formulation of the process determines the factors that should be considered in terms of the nature of the article, the effectiveness of the method, and the economics, as well as the integrity and stability of the product.

Verification of the program is an essential part of the sterility assurance. For products (including final containers and packaging), the method must be verified before it can be used for actual use. The verification content includes:

(1) Write a verification plan and develop evaluation criteria.

(2) Confirm that the equipment technical information is complete, installed correctly, and can be in normal operation (installation confirmation).

(3) Confirm that the key control equipment and instruments can operate normally within the specified parameters (operation confirmation).

(4) Repeat the test using the item or the simulated item, and provide the range of each parameter to confirm that the effect meets the requirements (performance confirmation).

(5) Summarize and improve various documents and records, and write a complete verification report.

In daily production, the operation of the process program should be monitored to confirm that all key parameters (such as temperature, pressure, time, humidity, gas concentration, and absorbed radiation absorbed dose) are within the scope of verification. The critical equipment and processes in the procedures that have been adopted should be re-verified on a regular basis. When the program changes greatly, (including changes in the loading method and quantity of the items in the cabinet), it should be re-verified.

The sterility assurance of the product in this probabilistic sense does not depend on the sterility test of the final product, but on the use of a qualified process, strict GMP management and a good overall quality assurance system in the production process. This means that the monitoring of the batch process will reflect the sterility assurance level of the product more than the batch sterility test results. The sterility assurance of the product is related to the degree of contamination of the previous product and the characteristics of the contaminating bacteria. Therefore, the level of microbial contamination and the tolerance of contaminated bacteria should be strictly monitored, and various measures should be taken at all stages of production to reduce pollution and ensure that microbial contamination is controlled within prescribed limits.

Otherwise, the necessary measures should be taken to reduce pollution and eliminate resistant strains, and even to re-verify the process. The items should be prevented from being contaminated again. In all cases, the container and its sealing system should be required to ensure that the product meets the sterility requirements during the life of the product.portable autoclave

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