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On-line integrity test method of filter

A test method and integrity detection technology, applied in chemical instruments and methods, filtration separation, separation methods, etc., can solve problems such as low pressure, and achieve the effect of improving production efficiency, ensuring real-time monitoring, and ensuring accuracy

Active Publication Date: 2012-05-02
SHANGHAI TOFFLON SCI & TECH CO LTD
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  • Abstract
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Problems solved by technology

Then, at a high temperature of 121°C, the pressure it can withstand will be lower

Method used

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  • On-line integrity test method of filter
  • On-line integrity test method of filter

Examples

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Embodiment Construction

[0024] In order to make the present invention more obvious and understandable, a preferred embodiment is hereby described in detail as follows in conjunction with the accompanying drawings for the post-SIP integrity detection of the sterilizing filter.

[0025] A filter online integrity testing method provided in this embodiment relies on such as figure 1 The sterilizing filtration system shown, the system includes two cascaded sterilizing filters 1, a heat exchanger 2, an air filter 3 and an integrity testing machine, the liquid medicine is connected through the liquid medicine feeding pipeline All levels of sterilizing filters, the entire integrity detection circuit is connected by WFI pipeline and compressed air pipeline.

[0026] combine figure 1 , an online integrity testing method after a filter SIP in the present embodiment, the steps are:

[0027] Step 1. Connect the bypass of the integrity testing machine in series on the compressed air pipeline of the sterilizing f...

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Abstract

The invention provides an on-line integrity test method of a filter. The method is characterized by: making an integrity test machine bypass form series connection with a compressed air pipe line of a sterilization filtration system comprising at least one sterilization filter so as to form a closed detection gas path; setting a liquid level induction meter on the top of the each sterilization filter so as to meter a water yield of the sterilization filter; after sterilization in place (SIP) is performed to the sterilization filtration system or the sterilization filtration system is used, injecting sterile compressed air so as to cool a filter core of the sterilization filter; then feeding water for injection at the temperature of 20-25 DEG C so as to carry out wetting; and then performing a routine bubbling point test, a diffusion flow test or a pressure maintenance test so as to perform the integrity detection of the filter core. Accuracy of the filter integrity test can be ensured. Aseptic production and real-time monitoring of medicine can be guaranteed and a production efficiency can be increased.

Description

technical field [0001] The invention relates to an online integrity testing method for filters used in aseptic filtration processes in the pharmaceutical industry. Background technique [0002] In the pharmaceutical industry, sterile drugs can be divided into two categories according to the production process: the first category is the terminal sterilization type using the terminal sterilization process, and the second category is the non-terminal sterilization type using the aseptic production process in part or all of the process. type. Sterilization of sterile preparations is the key to the production process of the entire product. For drugs with high heat sensitivity, most of them use sterile filtration to filter out microorganisms because they cannot be sterilized by heat. In the process of sterile filtration, the filter is one of the most critical components in the process. It is as important as the autoclave in the terminal sterilization process, providing sterility ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01D21/00B01D35/143
Inventor 郑效东
Owner SHANGHAI TOFFLON SCI & TECH CO LTD
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