Sterility test process isolator for double-sided laminar flow operation

Abstract

The invention discloses a double-sided sterility test process isolator. The isolator is characterized by comprising a glove bin system and an electrical cabinet system, wherein an air treatment system is arranged at the top of the glove bin system; the glove bin system comprises a bin body; a glove operation component is arranged on the bin body, and comprises operation window sealing glass; and gloves are connected with the operation window sealing glass by virtue of a glove connection component. The sterility test process of sterile medicines can be carried out under a controlled environment all the time by virtue of the sterility test isolator, so that toxic substances inside the sterile medicines cannot hurt operators, pollutants in the external environment are prevented from entering the operation space and polluting to-be-tested products, and the requirement of a production region for the cleanness of a background environment can be reduced. Changes of an arbitrary environment parameter inside the sterility test process isolator can be correspondingly regulated and controlled, so that isolation of the sterility test step after production of sterility medicines can be realized.

Description

Technical field [0001] The invention relates to a double-sided laminar flow operation sterile inspection process isolator, which provides stable, low pollution risk, low energy consumption, and completely isolated Class A sterility for the operation link of the quality sterility inspection of pharmaceutical enterprises. area. Background technique [0002] Sterile medicines have different manufacturing processes depending on the nature of the medicines. From sterile freeze-dried preparations to sterile bulk drugs, from sterile large infusions to sterile eye drops, sterility is inseparable. In addition to the strict control of the production environment, production process, operation, etc., the requirements for ensuring sterility are to conduct sterility inspections on the finished products to prove that the final products meet the sterility requirements. [0003] The process of sterility inspection is to take samples according to a certain proportion of the products produced, and e...

AI Technical Summary

Problems solved by technology

[0011] The problem to be solved by the present invention is to provide a stable, low-level aseptic inspection environment for the operation link of the quality sterility inspection of pharmaceutical companies, which reduces the risk of sample contamination.

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