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Germ entrapping detection apparatus and method by virtue of filter

A detection device and detection method technology, applied in chemical instruments and methods, semi-permeable membrane separation, membrane technology, etc. Conditions for sterilization and filtration, etc.

Inactive Publication Date: 2014-01-29
上海中立德检测技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The bacterial retention detection device used in the ASTM F-838 standard cannot meet the conditions of sterile filtration in the pharmaceutical production process when testing the bacterial retention capacity of the membrane filter. These conditions include filtration time, process pressure difference, process flow rate, process temperature, etc. content
In the prior art, the device and method for detecting the bacterial retention characteristics of the sterilizing filter, such as the device used in ASTM F-838, are not suitable for the long situation of the medicinal liquid filtration time in the industrial production process; Can not meet the pressure difference and flow control during filtration at the same time

Method used

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  • Germ entrapping detection apparatus and method by virtue of filter
  • Germ entrapping detection apparatus and method by virtue of filter
  • Germ entrapping detection apparatus and method by virtue of filter

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] Example 1 Negative Control Assay

[0048] Negative control test needs to be carried out before carrying out filter bacterial interception test, to test the sterility state of the device of the present invention after sterilization. Such as image 3 As shown, the filter bacterial retention detection device of the present invention further includes components for negative control experiments, including: a negative control membrane filter 3b and a valve 10d arranged after the filter 2 .

[0049] The entire filter bacterial retention detection device was subjected to high-pressure steam sterilization, and then sterile saline was placed in the pressure tank 1 as a negative control. A sterile buffer solution can also be placed in the pressure tank 1 as a negative control. Close valve 10a, valve 10b, and valve 10d, and set a certain pressure (for example, pressurize to 30 psi, or about 207 KPa). Then open the valve 10a, and pour liquid into the filter 2. Open the exhaust...

Embodiment 2

[0051] Example 2 Filter pre-wetting operation

[0052] Put a sufficient amount of sterile wetting agent in the pressure tank 1, preferably a water-soluble wetting agent with good compatibility with the filter membrane and low surface tension, such as ethanol, isopropanol, and surfactants of water etc. Membrane wetting agents, preferably, have a maximum surface tension of 26 dynes / cm2. The specific amount of sterile wetting agent is determined by the size and type of membrane filter used in the test and the wetting requirements of the filter membrane. In this embodiment, the aseptic wetting agent is isopropanol, and its addition amount is 20% (volume ratio). Close valve 10a, valve 10b, and valve 10d, open the exhaust valve, and pressurize to 5 psi (34.5 kPa), generally not exceeding the bubble point pressure of the wetting agent on the filter membrane. Then, open the valve 10a, pour the wetting agent into the filter 2, and close the exhaust valve after filling. Filter al...

Embodiment 3

[0053] Example 3 Filter Bacterial Retention Test Method

[0054] Carry out autoclave steam sterilization to filter bacterial interception detection device of the present invention, as in-situ steam sterilization, before detection, filter 2 and the downstream pipeline that are arranged after are sterilized, for example, the outlet of filter 2 and the inlet The connectors are wrapped in sterile paper; sterilization is performed with each valve open. Autoclave sterilization is carried out at 15psi (about 103 kPa) pressure and 121°C for about 30-45 minutes.

[0055] After the filter bacterial interception detection device of the present invention is sterilized, it is adjusted to a maximum working pressure difference of 30Psig (about 204KPa), 0.5~1.0 GPM / ft 2 Effective filter area (approximately 2~4×10 -3 LPM / cm 2 ), the concentration of Pseudomonas diminuta (ATCC 19146) bacterial solution is not less than 10 7 CFU / cm 2 Effective filter area.

[0056] Start detection, put...

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Abstract

The invention discloses a germ entrapping detection apparatus by virtue of a filter. The apparatus comprises a pressure withstanding tank used for storing medicine liquid, a filter used for entrapping germs in the medicine liquid, a filter membrane device used for adsorbing germs which are not entrapping by the filter, a liquid storage tank used for storing the medicine liquid after being filtered by the filter membrane device, and a germ liquid tank used for storing germ liquid and communicated with the liquid storage tank through a pipeline, wherein the germ liquid tank is used for conveying the germ liquid to the liquid storage tank; the pressure withstanding tank, the filter, the filter membrane device and the liquid storage tank are communicated with one another through pipelines; the liquid storage tank is communicated with the pressure withstanding tank through a pipeline to form a communicating loop. The invention further discloses a germ entrapping detection method by virtue of the filter. According to the invention, degerming and filtering conditions in a medicine production process, including filtering time, process pressure difference, process velocity and process temperature, are completely simulated and reach and exceed process indexes. The germ entrapping detection apparatus and method can be used for evaluating and verifying the filtering and degerming efficiency under the condition of the production process.

Description

technical field [0001] The invention relates to the technical field of pharmacy, in particular to a circulating filter bacteria retention detection device and detection method. Background technique [0002] Sterilization-grade liquid filter refers to the effective filtration area per square centimeter that can intercept 10 7 CFU of Pseudomonas diminuta (B. diminuta ) ATCC ?19146 TM ) filter. The filter supplier has verified the microbial retention capacity of the filter using standard methods. However, merely demonstrating retention of P. diminuta in a standard solution, but not in a specific product, is not sufficient to validate a sterile filtration process for the manufacture of that product. [0003] To determine the correct bacterial retention test method, P. diminuta should be inoculated directly into the carrier fluid (product or surrogate) to demonstrate viability. P. diminuta was cultured in the same manner as used in the bacterial retention assay to preserve i...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): B01D65/10
Inventor 戎隆富朱小红宋丽丽马素丽
Owner 上海中立德检测技术有限公司