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Filtration sterilization device and process for sterile medicines

A technology for filtration, sterilization, and medicine, applied in filtration, filtration separation, water supply devices, etc., can solve the problems of loss, increased production cost, easy to block filter elements, etc., to improve the level of sterility assurance, reduce losses, and reduce risks.

Pending Publication Date: 2019-04-02
SHANDONG TAIBANG BIOLOGICAL PROD CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] However, in the prior art, there are the following technical problems when the medicine is sterilized by filtration: when the medicine liquid is sterilized by the filter sterilization filter, part of the medicine liquid is easy to block the filter element during the sterilization process, causing the production line to break down, thereby Leading to shutdown and maintenance, resulting in a certain loss; the sterilized product has a certain loss in the transfer pipeline, resulting in an increase in production costs

Method used

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  • Filtration sterilization device and process for sterile medicines
  • Filtration sterilization device and process for sterile medicines

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Such as figure 1 As shown, a sterile drug filtration and sterilization device includes a drug solution preparation tank 1. The discharge port of the drug solution preparation tank 1 is connected to a first-level sterilization filter 3 and a main filter through a sterilization transfer pipe 2 in turn 4 is connected, the discharge port of the main filter 4 is connected to the sub-packing buffer tank 5 and the filling machine 6 in turn through a pipeline, the first-stage sterilization filter is arranged in parallel, and the first-stage sterilization filter A compressed air inlet 7 is provided on the sterilization transfer pipeline behind the device, and the compressed air inlet is connected to a compressed air source 8 through the pipeline.

[0036] The upper end of the medicinal solution preparation tank 1 is provided with a compressed air inlet 7, which is connected to a compressed air source 8 through a pipe.

[0037] An air filter 9 is arranged on the pipeline between the c...

Embodiment 2

[0044] A sterile drug filtration and sterilization process is performed by using the device described in Example 1, and specifically includes the following steps:

[0045] (1) Preparation process for sterilization

[0046] 1) First, clean the device with water for injection;

[0047] 2) Check the membrane integrity of the primary filter, main filter and air filter before use;

[0048] 3) Carry out pure steam online sterilization on the air filter and the sterilization transfer pipeline after the primary sterilization filter. At this time, the sterilization transfer pipeline is connected to the main filter for the tooling generation connection;

[0049] 4) Clean the main filter, the sub-packing buffer tank, the filling machine and the connecting pipeline between the three. After cleaning, wrap the opening with a breathing bag and place it in a pulsating vacuum sterilization cabinet for humid and hot steam sterilization ;

[0050] 5) Disassemble the tooling where the sterilization transfe...

Embodiment 3

[0059] A sterile drug filtration and sterilization process is performed by using the device described in Example 1, and specifically includes the following steps:

[0060] 1. Prepare the two-stage sterilization filter, liquid medicine transfer pipeline, buffer tank and filling equipment before use.

[0061] 1.1 First, clean the filter housing, pipes and other appliances of the sterilization filter with water for injection, which should meet the cleaning requirements before use.

[0062] 1.2 Check the membrane integrity of the sterile filter element before use.

[0063] 1.3 Perform pure steam online sterilization on the compressed air sterilization filter and the pipeline after the primary sterilization filter. At this time, the end of the liquid medicine transfer pipeline is connected to the main filter for tooling connection.

[0064] 1.4 Clean the main filter, buffer tank, filling needle, and pipeline before use. After they are connected, wrap the opening with a breathing bag and pla...

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Abstract

The invention relates to the technical field of sterile medicine production, and particularly relates to a filtration sterilization device and process for sterile medicines. The filtration sterilization device comprises a liquid medicine preparation tank, wherein a discharge port of the liquid medicine preparation tank is sequentially connected with first-stage sterilization filters and a main filter through pipelines; a discharge port of the main filter is sequentially connected with a sub-packaging buffer tank and a filling machine; a plurality of the first-stage sterilization filters are connected in parallel; a sterilizing and transferring pipeline behind the first-stage sterilization filters is provided with a compressed air inlet; and the compressed air inlet is connected with a compressed air source through a pipeline. According to the invention, the yield of product sterilization can be well improved, the liquid medicine transferring pipelines and the filters can be sterilizedwithout dead corners, risks in filtration and sterilization of medicines are reduced to the maximum extent, and the sterility assurance level of the medicines is greatly improved.

Description

Technical field [0001] The invention relates to the technical field of sterile medicine production, in particular to a sterile medicine filtration and sterilization device and process. Background technique [0002] In the production process of sterile drugs, national regulations require that non-terminally sterilized drugs should be produced with a 0.22μm sterilization filter to filter the drug solution into a pre-sterilized container for sterilization. In order to meet the requirements of national regulations, companies need to filter and sterilize drugs in the production of sterile drugs. [0003] However, in the prior art, the following technical problems exist when filtering and sterilizing medicines: when using a filtering and sterilizing filter to sterilize the liquid medicine, part of the liquid medicine is likely to block the filter element during the sterilization process, causing the production line to malfunction, and thus It leads to the suspension of production and ma...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): B01D29/56B01D61/00B01D46/00B08B9/093A61L2/10A61L2/07A61L2/02
CPCA61L2/022A61L2/07A61L2/10B01D29/56B01D46/00B01D61/00B08B9/093A61L2202/21
Inventor 赵国李斌孙丰斌王鑫磊
Owner SHANDONG TAIBANG BIOLOGICAL PROD CO LTD
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