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Method for inspecting cleanliness of asepsis room

An inspection method and sterile room technology, applied in the field of medicine, can solve the problems of unable to obtain qualified products, unable to effectively control the quality of medicines, loss of manufacturers, etc.

Inactive Publication Date: 2015-03-11
SICHUAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] In medicine, pharmacy needs to be carried out in an environment with high cleanliness requirements. Otherwise, the produced medicine will be polluted in various ways, and the quality of the medicine cannot be effectively controlled, so that qualified products cannot be obtained. Make manufacturers suffer huge losses

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015] The cleanliness inspection method of the sterile room is to detect the number of colonies in the air after the sterile room is disinfected, and before the aseptic test and during the operation. The specific detection method is: put the sampler and the petri dish into the sterile room In the room to be tested, the culture medium is cultivated, and then sampling is done at regular intervals.

[0016] The sampler is a sampler with an impact mechanism.

[0017] The sampler is a slit or centrifugal sampler.

[0018] The sampler is also equipped with a flow meter and a timer.

[0019] During the actual inspection, the sampler using the impact mechanism generally adopts a slit or centrifugal sampler, and is equipped with a flow meter and a timer. It is operated strictly according to the requirements of the instrument manual and checked regularly. The sampler and the petri dish enter The room to be tested should be sterilized with the disinfectant of the room before being tes...

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PUM

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Abstract

The invention discloses a method for inspecting cleanliness of asepsis rooms. According to the method, after disinfection of the asepsis room and before and during the sterile experiment, the colony number in air is inspected. The inspecting method is as follows: placing a sampler and a culture dish into the asepsis room to be inspected, culturing the culture medium, and sampling at set time. The invention can effectively check the aseptic environment for medicament production in a simple and effective way, provides the basis for production of high quality medicaments by pharmaceutical enterprises, and can find pollutants in the asepsis room simply, effectively and timely.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a method for checking the cleanliness of a sterile room. Background technique [0002] The sterile room is generally an independent small room (isolated from the outside) with a height of 4-5 square meters and 2.5 meters. It is specially designed for microbiology laboratories and can be built with plates and glass. A buffer room should be set up outside the sterile room, and the doors should be staggered to prevent airflow from bringing in bacteria. Both the sterile room and the buffer room must be airtight, and the ventilation equipment equipped in the room must have an air filter. [0003] In medicine, pharmacy needs to be carried out in an environment with high cleanliness requirements. Otherwise, the produced medicine will be polluted in various ways, and the quality of the medicine cannot be effectively controlled, so that qualified products cannot be obtained. Manufacturers suffer...

Claims

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Application Information

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IPC IPC(8): C12Q1/22C12Q1/06
Inventor 沈千万周璇刘萍
Owner SICHUAN PHARMA
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