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Method for inspecting heat resistance of microorganisms in liquid medicine before medicine sterilization

An inspection method and heat resistance technology, applied in biochemical equipment and methods, microbial determination/inspection, etc., can solve the problem that the folding method and placement direction of the filter membrane are not clearly defined, the filter membrane is stuck in the upper layer of the heat-resistant test tube, and it cannot be Complete immersion and other problems to achieve the effect of reducing the risk of contamination, reducing the risk of personnel operation, and ensuring reliability

Pending Publication Date: 2021-08-10
费森尤斯卡比华瑞制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] In the prior art, there are no detailed requirements for the heat resistance test operation before sterilization in the operation method of the heat resistance test of the liquid medicine before the medicine is sterilized, and it is only indicated that after the liquid medicine is filtered, the filter is filtered with sterile tweezers. The membrane is transferred to the corresponding heat-resistant test tube, and the folding method and placement direction of the filter membrane are not specified, so it is easy to cause the filter membrane to be stuck in the upper layer of the heat-resistant test tube and cannot be completely immersed in the solution at the bottom of the heat-resistant test tube; the heat-resistant test tube After the FTM medium is poured, the filter membrane in the heat-resistant test tube still floats on the upper layer of the heat-resistant test tube and is not completely submerged in the medium, which is prone to the risk of bacterial contamination

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] A method for checking the microbial heat resistance of a drug solution before sterilization of a drug. The drug solution to be checked is 50% glucose injection. The specific checking method includes the following steps:

[0034] Step a. In a sterile environment, connect the membrane filter to the latex tube with the injection needle and fix it on the peristaltic pump, open the membrane filter, and place the opened membrane filter cover on the peristaltic pump with the opening facing up. On the special filter bracket next to the pump, use sterile tweezers to take out the gasket in the filter membrane filter, place it in the filter cover on the bracket, then clamp the filter membrane from the membrane remover, and place the filter membrane grid on the In the membrane filter, put the gasket in the membrane filter cover into the filter, cover the membrane filter cover, and tighten the membrane filter;

[0035] Step b. Insert the sampling needle into the eluent bottle contai...

Embodiment 2

[0049] A method for checking the microbial heat resistance of a drug solution before sterilization of a drug. The drug solution to be checked is 20% alanyl glutamine injection. The specific checking method includes the following steps:

[0050] Step a. In a sterile environment, connect the membrane filter to the latex tube with the injection needle and fix it on the peristaltic pump, open the membrane filter, and place the opened membrane filter cover on the peristaltic pump with the opening facing up. On the special filter bracket next to the pump, use sterile tweezers to take out the gasket in the filter membrane filter, place it in the filter cover on the bracket, then clamp the filter membrane from the membrane remover, and place the filter membrane grid on the In the membrane filter, put the gasket in the membrane filter cover into the filter, cover the membrane filter cover, and tighten the membrane filter;

[0051] Step b. Insert the sampling needle into the eluent bott...

Embodiment 3

[0065] A method for checking the microbial heat resistance of a drug solution before sterilization of a drug. The drug solution to be checked is a 5% compound amino acid injection. The specific inspection method includes the following steps:

[0066] Step a. In a sterile environment, connect the membrane filter to the latex tube with the injection needle and fix it on the peristaltic pump, open the membrane filter, and place the opened membrane filter cover on the peristaltic pump with the opening facing up. On the special filter bracket next to the pump, use sterile tweezers to take out the gasket in the filter membrane filter, place it in the filter cover on the bracket, then clamp the filter membrane from the membrane remover, and place the filter membrane grid on the In the membrane filter, put the gasket in the membrane filter cover into the filter, cover the membrane filter cover, and tighten the membrane filter;

[0067] Step b. Insert the sampling needle into the eluen...

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Abstract

The invention relates to a method for inspecting the heat resistance of microorganisms in liquid medicine before medicine sterilization. The method comprises the following steps: assembly of a filter system and a filter membrane, filter membrane wetting, sample filtering, leaching, disinfecting and transferring of a heat-resistant test tube, transferring of the filter membrane into the heat-resistant test tube, heat treatment of the heat-resistant test tube, disinfecting and transferring of the heat-resistant test tube after the heat treatment, disinfecting and transferring of an FTM culture medium, pouring of the FTM culture medium, requirement of the filter membrane in the heat-resistant test tube after pouring, heat-resistant test tube wrapping with a sealing film, and culturing. After the method disclosed by the invention is implemented, the microbiological contamination rate in the microbiological heat resistance inspection of all products is 0, so that the improved method greatly reduces the operation risk of personnel in the daily inspection operation, and improves the accuracy and reliability of the microbiological heat resistance inspection result of the liquid medicine before the medicine sterilization.

Description

technical field [0001] The invention relates to an inspection method in the pharmaceutical industry, in particular to an inspection method for the heat resistance of microorganisms in liquid medicines before medicines are sterilized. Background technique [0002] In the prior art, there are no detailed requirements for the heat resistance test operation before sterilization in the operation method of the heat resistance test of the liquid medicine before the medicine is sterilized, and it is only indicated that after the liquid medicine is filtered, the filter is filtered with sterile tweezers. The membrane is transferred to the corresponding heat-resistant test tube, and the folding method and placement direction of the filter membrane are not specified, so it is easy to cause the filter membrane to be stuck in the upper layer of the heat-resistant test tube and cannot be completely immersed in the solution at the bottom of the heat-resistant test tube; the heat-resistant te...

Claims

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Application Information

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IPC IPC(8): C12Q1/02
CPCC12Q1/02
Inventor 王华丁晨蕙
Owner 费森尤斯卡比华瑞制药有限公司
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