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Disinfectant filtering-sterilizing and cleaning system capable of performing CIP/SIP on line

A sterilization system and disinfectant technology, applied in filtration, disinfection, chemical/physical processes, etc., can solve problems such as affecting efficiency, contamination, complicated operation, etc., to speed up filtration, avoid easy leakage, and reduce losses.

Inactive Publication Date: 2019-02-22
LI MIN PHARM FAB OF LIVZON PHARM GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

On the one hand, the operation is complicated, which affects the efficiency. On the other hand, there is a risk of bacterial contamination in the process of offline sterilization and reinstallation, and the filter pipeline must pass through B-level and C-level areas, which has certain risks

Method used

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  • Disinfectant filtering-sterilizing and cleaning system capable of performing CIP/SIP on line

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] As shown in the figure, connect the components of the system, including: (1) pure steam, (2) compressed air, (3) water for injection, (4) heat exchanger, (5) respirator, (6) preparation tank , (7) Sterilization filter for injection water, (8) Sterilization filter for disinfectant, (9) receiving barrel, (10) receiving barrel, (11) CIP / SIP connecting pipe, (12) compressed air pressure reducing valve A, (13) valve B, (14) valve C, (15) valve D, (16) valve E, (17) valve F, (18) valve G, (19) trap H, (20) valve I , (21) valve J, (22) valve K, (23) valve L, (24) valve M, (25) valve N, (26) valve O, (27) trap P, (28) sampling port Q .

Embodiment 2

[0025] Example 2 Filtration of water for injection:

[0026] Turn on the heat exchanger (4), reduce the temperature of the water for injection to the required temperature, open the valve (D), valve (F), and valve (I). After the water for injection passes through the water for injection sterilization filter (7), it is filtered to Water for injection receiving barrel (9).

Embodiment 3

[0027] Example 3 Filtration of disinfectant solution:

[0028] The disinfectant is prepared and put into the preparation tank, or after the disinfectant is added to the preparation tank, a certain amount of water for injection is added in proportion to prepare. After preparing the disinfectant, open the compressed air pressure reducing valve (A), valve (C), and valve (L). The disinfectant is driven by the compressed air through the disinfectant sterilization filter (8) and then filtered to the disinfectant. Receive bucket (10).

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Abstract

The invention provides a disinfectant filtering and online cleaning sterilization system comprising a heat exchanger (4), a respirator (5), a preparation tank (6), an injection water sterilization filter (7), a disinfectant sterilization filter (8) and a CIP / SIP connecting pipe (11). According to the system, 1) due to the adoption of medium-assisted delivery, the disinfectant filtering speed can be increased, the disinfectant filtering dosage is higher, and the system is suitable for a workshop with relatively large sterile area; 2) due to the adoption of the medium-assisted delivery, a disinfectant can be more completely filtered, and the loss is lower; 3) CIP / SIP can be performed on line, so that the workload of offline sterilization realized by dismounting the system by operating staffis reduced, and the phenomenon of leakage easily caused by frequently dismounting the system can also be avoided; and 4) the system can be used for the workshop with high filtration requirement duringdisinfectant preparation and high disinfectant dosage.

Description

Technical field [0001] The invention relates to an industrial system, in particular to a disinfectant preparation and filtration system. Background technique [0002] In the pharmaceutical industry, disinfectant is often used to disinfect equipment, floors, and personnel in clean areas, so the amount of microorganisms in the disinfectant itself should be strictly controlled. In order to avoid the contamination of the clean area by the disinfectant itself, according to Chapter 9 of the 2010 GMP Annex Sterile Drugs, the A / B level clean area should use sterile or sterile disinfectants and detergents. Disinfectant preparation and filtration systems have no clear regulations in regulations, so the requirements of the disinfectant preparation and filtration systems are inconsistent. Disinfectant preparation and filtration systems on the market are relatively rare, and most of them are designed and used by the manufacturers themselves. Most of the disinfectant preparation filtration sy...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L2/18A61L2/02A61L2/26B01F3/20B08B9/093B01F23/70
CPCA61L2/022A61L2/18A61L2/26B08B9/093A61L2202/17B01F23/708
Inventor 李建彬雷婷江晓漫
Owner LI MIN PHARM FAB OF LIVZON PHARM GRP
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