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Isolator for sterility detection process

An isolator and process technology, applied in clean rooms and other directions, can solve problems such as artificial pollution, and achieve the effects of reducing pollution, increasing controllability, reducing operating costs and maintenance costs

Inactive Publication Date: 2012-06-20
SHANGHAI TOFFLON SCI & TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] The purpose of the present invention is to provide a stable, low-pollution risk, and completely isolated A-level aseptic area for the operation link of quality aseptic testing in pharmaceutical companies, fundamentally solve the problems caused by artificial pollution, and make the results of aseptic testing more convincing

Method used

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  • Isolator for sterility detection process
  • Isolator for sterility detection process
  • Isolator for sterility detection process

Examples

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Embodiment Construction

[0022] In order to make the present invention more comprehensible, a preferred embodiment is described in detail below with accompanying drawings.

[0023] Such as figure 1 As shown, a kind of aseptic detection process isolator provided by the present invention comprises a top air treatment system 1, a glove box assembly 2, and an aseptic transfer bin 3 is installed on the isolation wall of the glove box assembly 2 to realize material-free Bacteria transfer, the bottom frame assembly 4 is used to fix and support the glove box assembly 2 and realize the overall movement of the isolator in the aseptic room, the bag out device assembly 5 is installed at the bottom of the glove box assembly 2 to collect For the generated waste, the electrical cabinet assembly 6 installs the electric control part of the entire isolator in the electrical cabinet.

[0024] Such as figure 2 As shown, the air treatment system 1 includes a plenum housing 7, a circulating fan filter unit 8, an H14 fre...

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Abstract

The invention relates to an isolator for a sterility detection process, which is characterized by comprising an air processing system positioned at a top part, wherein a glove operating box assembly is positioned under the air processing system, a sterility deliver bin is arranged on an isolation wall of the glove operating box assembly so as to realize sterile material transfer, the glove operating box assembly can be fixed and supported by a movable bottom frame assembly, and a bag output device which is used for collecting waste gas produced during the sterility detection process is arranged at the bottom of the glove operating box assembly. The invention has the advantages that the inside growth environment is completely isolated from the outside environment, so that risk of artificial pollution is reduced, and simultaneously, the pollution of a product to operators and the outside environment is reduced; and the production clean area is reduced, the operability of the production area is greatly increased, and further, the running cost and the maintenance cost are reduced.

Description

technical field [0001] The invention relates to an aseptic detection process isolator, which provides a stable, low-pollution-risk, and completely isolated Class A aseptic area for the operation link of quality aseptic detection 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 testing on the finished product to prove that the final product meets the sterility requirements. [0003] The process of sterility testing is to sample a certain proportion of the products produced, and extract the samples to be diluted and injected into the culture medium for colony...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): B01L1/04
Inventor 郑效东
Owner SHANGHAI TOFFLON SCI & TECH CO LTD
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