Sterile cabin fully automatic drug sterility inspection and enrichment system and its operation method

Abstract

The invention discloses a full-automatic drug sterility inspection enrichment system of a sterile bin and an operation method of the system. The enrichment system comprises a sterile operation car, an automatic operation manipulator and an operation table; the sterile operation car comprises a car base, a wastewater box, a filter containing box and a garbage box are arranged on the car base, filter hole sites are arranged over a water inlet of the wastewater box, a container frame is installed on a support frame arranged on one side of the car base and provided with container containing hole sites used for containing containers of at least one type and at least one operation hole site used for containing a container to be operated, and needle clamping devices are arranged at the corresponding operation hole sites; a clamping mechanism, a peristaltic pump, a pressure detection mechanism and a sealed cutting mechanism are installed on the operation table. Accordingly, the high-efficiency full-automatic drug sterility inspection enrichment process can be achieved in a sterile environment of the sterile bin, artificial participation is not needed, the hidden danger that the sterile environment is manually destroyed does not exist, and the system can be suitable for conducting enrichment operation on bacterium inspection of various kinds of drugs packaged in various kinds of drug bottles or bags.

Description

Technical field [0001] The invention relates to a sterile cabin full-automatic drug sterility inspection enrichment system and an operation method thereof, and belongs to the technical field of drug sterility inspection. Background technique [0002] Drug sterility testing is an important part of ensuring drug safety. Current regulations require that "sterile testing should be carried out by personnel trained in strict aseptic operations, in a local Class A unidirectional air area or in an isolated system under the background of cleanliness Class B." [0003] At present, drug sterility testing is usually carried out with an isolator that can be repeatedly sterilized inside. The isolator is mainly maintained in an ideal aseptic environment through a high-efficiency air filter. Most of the isolators used for drug sterility testing include a sterilization chamber and an operating chamber. In the isolator, medical testing personnel wear gloves and use manual methods to complete the en...

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Problems solved by technology

[0004] From actual implementation, it can be found that the above-mentioned isolator has the following defects: first, the gloves made of natural rubber will accelerate aging and cracking after being subjected to multiple VHP gas effects, so holes that can pass microorganisms are very likely to exist on the gloves. Therefore, There are many safety hazards in the use of gloves, which are potentially destructive to the sterile environment; second, the sensitivity of wearing gloves is low, and large movements will reduce the life of the gloves, and there are disadvantages of low work efficiency; Third, the manual method has disadvantages such as high operation error rate, high labor cost, and low work efficiency.

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