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Sterility test process isolator

A technology of isolator and process, applied in the direction of manufacturing tools, manipulators, chemistry, etc., to achieve the effect of reducing pollution, lowering the requirements of cleanliness level, and increasing controllability

Inactive Publication Date: 2015-02-18
上海东富龙爱瑞思科技有限公司 +1
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] The problem to be solved by the present invention is to provide a stable solution for the operation link of the quality sterility inspection of pharmaceutical companies, reduce the risk of sample contamination, reduce the environmental level of the sterility inspection room, and simplify the changing procedures of personnel.

Method used

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  • Sterility test process isolator
  • Sterility test process isolator
  • Sterility test process isolator

Examples

Experimental program
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Effect test

Embodiment

[0030] Such as figure 1 As shown, it is a schematic structural view of a sterile inspection process isolator provided by the present invention, including a frame assembly 5 at the bottom, a glove box assembly 4 arranged on the frame assembly 5, an air handling system 3 at the top, and an integrated Electrical system 2 of hydrogen peroxide vapor sterilization system 1.

[0031] Such as figure 2 As shown, the air treatment system 3 includes the air treatment system mounting bracket 6 and the lighting lamp 7, the flow equalizing film 8, the fresh air assembly 9, the fresh air valve assembly 10, the internal circulation catalytic decomposition unit 11, Circulation fan assembly 12, exhaust valve assembly 13, exhaust assembly 14, liquid tank sealing filter 15, lighting lamp 7 are fixed on the mounting bracket through the lighting lamp mounting seat installed on the air treatment system bracket 6, and the flow equalizing membrane 8 , the fresh air assembly 9, the fresh air valve a...

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Abstract

The invention discloses a sterility test process isolator which is characterized by comprising a frame component at the bottom, a glove operation box component arranged on the frame component, an air handling system at the top and an electric system, wherein a hydrogen peroxide steam sterilization system is integrated on one side of the electric system. The isolator completely isolates internal production environment from operators and external environment, reduces the risk of artificial pollution and meanwhile reduces pollution to the operators and the external environment; the isolator reduces a production cleaning area, greatly increases the controllability of a production area and further lowers the operating cost and the maintenance cost; besides, the integrated hydrogen peroxide steam sterilization system is arranged, so that the on-line SIP is realized and the sterility of operating environment is guaranteed.

Description

technical field [0001] The invention relates to an aseptic inspection process isolator, which provides a stable, low-pollution-risk, low-energy-consumption, and completely isolated grade-A aseptic area for the operation link of quality aseptic inspection in pharmaceutical enterprises. Background technique [0002] Sterile drugs have different production processes depending on the nature of the drug. From sterile freeze-dried preparations to sterile raw materials, from sterile infusions to sterile eye drops, they are all inseparable from sterility. In addition to the strict control of the production environment, production process, and operation, the requirement to ensure sterility is more critical to carry out sterility inspection on the finished product to prove that the final product meets the sterility requirements. [0003] The process of sterility inspection is to take samples according to a certain proportion of the production products, and extract the samples for samp...

Claims

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Application Information

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IPC IPC(8): A61L2/20B25J21/02A61L101/22
Inventor 郑效东
Owner 上海东富龙爱瑞思科技有限公司
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