Bacterial interception test device and test method

Abstract

The invention provides a bacterial interception test device. The bacterial interception test device comprises a stock solution tank body, a first peristaltic pump, a valve, a filtering passage and a circulating tank body, wherein the stock solution tank body, the first peristaltic pump, the filtering passage and the circulating tank body are sequentially connected through pipelines; the bottom of the circulating tank body is connected between the first peristaltic pump and the filtering passage through a pipeline to form a communicating loop; the valve is arranged on the pipeline. The bacterial interception test device can be used for evaluating and verifying the filtering and sterilizing efficiency under the production process condition, can realize independent verification of each passage without mutual interference, is more accurate in filtering volume, can realize circulating filtration, and overcomes the defects in the prior art.

Description

technical field [0001] The invention relates to the technical field of pharmacy, in particular to a bacterial retention test device and a test method. Background technique [0002] According to the content requirements of the "Good Manufacturing Practice for Drugs (Revised in 2010)", pharmaceutical manufacturers need to verify the performance of the filter itself and the filtration process of the sterile filtration system. The verification of the filter itself is mainly completed by the filter manufacturer, including integrity testing, biological safety testing, flow rate testing, etc. The filtration process verification is completed by the filter manufacturer or a third-party laboratory, and it is necessary to ensure that the verification content covers the operating parameters and allowable extreme values ​​​​in the actual production process. [0003] Bacterial retention test is part of the filtration process verification, the purpose is to simulate the worst conditions i...

AI Technical Summary

Problems solved by technology

The bacterial retention detection device used in this 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, etc.

[0005] 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 control of pressure difference and flow rate during filtration at the same time

The traditional bacterial retention test uses quadruple filters, of which three batches of filter membranes are tested in three sets, and the other is used for positive control filter membrane tests. It is difficult to ensure that the amount of liquid medicine dispensed by each set is consistent.

If the filtration resistance of one of the filter membranes becomes larger due to clogging of the filtrate, it will aggravate the uneven distribution of the liquid medicine and affect the verification results of the filtration process.

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