Isolator biological purification development verification method and system

Abstract

The invention discloses an isolator biological purification development verification method and system, and the method comprises the steps: 1), carrying out the performance confirmation of an isolator, and enabling the isolator to meet the development requirements of a biological purification program; 2) in a biological purification program development process, determining a relatively poor biological purification effect point position in the isolator through different test items, and evaluating to obtain a final difference point position; 3) pre-verification: after setting a set of hydrogen peroxide sterilization parameters, starting hydrogen peroxide sterilization, arranging a biological indicator at each final difference point, pre-verifying the established hydrogen peroxide sterilization parameters, and judging whether the fatality rate of the biological indicator reaches a set threshold value or not after the sterilization is finished; if so, finishing sterilization pre-verification of the set of hydrogen peroxide sterilization parameters; and 4) verification: verifying the hydrogen peroxide sterilization parameters passing the sterilization pre-verification for multiple timesuntil the hydrogen peroxide sterilization parameters are confirmed to meet the killing requirements of all point locations. The method has the advantages of low cost and the like.

Description

technical field [0001] The invention mainly relates to the technical fields of medicine and food packaging, in particular to a development and verification method and system for isolator biological purification. Background technique [0002] The method of hydrogen peroxide steam sterilization has been applied to the sterilization of various spaces, and the isolator is one of them. The 2015 edition of the "Chinese Pharmacopoeia" in the third part of the sterilization method mentions the gas hydrogen peroxide sterilization method, but there is no literature or information on the development of the sterilization process or the sterilization blind spot test. Details. [0003] In the sterilization industry, "unexpected positive growth" has always caused a lot of confusion for people. Hydrogen peroxide sterilization Due to the limited penetration ability, the state of the spores on the carrier surface after sterilization is critical. Whereas the presence of any debris within th...

AI Technical Summary

Problems solved by technology

The 2015 edition of the "Chinese Pharmacopoeia" in the third part of the sterilization method mentions the gas hydrogen peroxide sterilization method, but there is no literature or information on the development of the sterilization process or the sterilization blind spot test. detailed introduction

[0006] (1) There is no SAT confirmation, which makes it difficult to complete the cycle development quickly, resulting in waste of BI, which makes the cost of the verification scheme high; among them, BI (biological indicator) is expensive

[0007] (2) The air flow pattern test, temperature uniformity test, CI discoloration uniformity confirmation test, BI discoloration uniformity confirmation test, etc. are all routine tests, and there is no targeted design for the isolator to meet the technical requirements of biological purification program development requirements , making it difficult to quickly find cycle development parameters, leading to waste of BI, making the verification scheme costly

[0008] (3) There is no risk assessment, which makes it difficult to quickly find the cycle development site, resulting in waste of BI, which makes the cost of the verification scheme high

[0009] (4) There is no pre-verification confirmation test, which may cause errors in the confirmation of cycle development parameters, resulting in waste of BI, making the cost of the verification solution high

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