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Research on the sterilization effect of sterile isolator

Release time:

10 Aug,2022

Aseptic inspection isolator, also known as laboratory isolator, is a kind of equipment that provides a sterile environment for aseptic inspection and testing. It can better prevent microorganisms from contaminating the samples to be tested, and can avoid contamination of test items and auxiliary equipment. The accuracy of the aseptic inspection test results has been improved, and it has been widely used in the global pharmaceutical industry.

At present, the sterilization of sterile inspection isolators is usually carried out using hydrogen peroxide steam sterilizer.A hydrogen peroxide generator is integrated inside the isolator, which can convert a high-concentration hydrogen peroxide solution into a gaseous state through the generator and distribute it evenly in the isolator cabin. Sterilization is carried out under certain concentration and time conditions, and after the sterilization is completed, the residual hydrogen peroxide vapor in the cabin is discharged and decomposed by a ventilation system with a high-efficiency filter to achieve the final sterilization effect.After the sterilization of the aseptic inspection isolator is completed, the microbial load of the internal environment of the cabin should meet the requirements of Class A cleanliness in GMP regulations, and the sterilization process will not affect the microorganisms in the article and the test sample.

The system verification of the sterile inspection isolator is a necessary condition to ensure the sterile environment required for the sterile inspection, and the sterilization effect verification of the sterile isolator is one of the most important verification items in the entire system verification.The evaluation of the sterilization effect of the sterile isolator includes not only the evaluation of the sterilization effect of sterilization on the surface of the article, but also the evaluation of the degree of influence of sterilization on the internal microorganisms of the article and the sample to be tested, and the evaluation of the degree of influence of sterilization residues on the article and the microorganisms of the sample to be tested.