CN202184966U - Challenge device for chemical gas sterilization - Google Patents
Challenge device for chemical gas sterilization Download PDFInfo
- Publication number
- CN202184966U CN202184966U CN2011202575645U CN201120257564U CN202184966U CN 202184966 U CN202184966 U CN 202184966U CN 2011202575645 U CN2011202575645 U CN 2011202575645U CN 201120257564 U CN201120257564 U CN 201120257564U CN 202184966 U CN202184966 U CN 202184966U
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- sterilization
- chemical gas
- chemical
- indicator
- annular seal
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Abstract
The utility model relates to a challenge device for chemical gas sterilization, which aims to solve the problem in the prior art that during the process that the chemical gas is adopted for sterilization to achieve the sterile effect, the sterilization effect is difficult to judge as per the passive results of indicator reagent. The challenge device for chemical gas sterilization comprises a tube cavity, an indicator reagent sealing cavity, a sterilizing-grade gas filter and a cavity cover, and compared the device with the method that biological indicator reagent and chemical indicator are placed in the product packing, the penetration efficacy of chemical sterilization gas can be confirmed visually, and the reliability of chemical gas sterilization process can be evaluated accurately.
Description
Technical field
This utility model relates generally to a kind of sterilization challenge device, especially a kind of challenge device that is applicable to the chemical gas sterilization.
Background technology
The method that adopts chemical gas to sterilize is widely used already, for example adopts oxirane, formaldehyde gas to handle all kinds of medical products to reach aseptic requirement.The technology of new development in recent years is with the representative as the novel sterilizing medium of hydrogen peroxide plasma, ozone and hydrogen peroxide vapor, fields such as the also more production that is applied to all kinds of medical and health-care products, clinical treatment.
Yet the present chemical gas sterilizing methods that adopts all is based on this mechanism: the chemical gas sterile medium is contacted with the microorganism that is applied, the biochemical action through complicacy so that the microbial cell of classifications such as antibacterial and fungus lose activity.Just being based on this mechanism, is the prerequisite that guarantees that sterilization is successful with effective contact of chemosterilization gas and microorganism.
In order to confirm whether sterilization process gets a desired effect; Multiple sterilization monitoring device is developed and applies in the sterilization process monitoring; For example will contain sterilization chemical gas is had a specific drag the sporeformer sheet as the biological indicator and put into by the sterilizing article packing material; After together the process sterilization cycle is handled with product; Take out the biological indicator and be inoculated in the corresponding culture medium, under certain conditions (temperature, time), cultivate, confirm according to the variations such as turbidity of culture medium whether sterilization is qualified then.Same class methods will contain and contact chemical reaction (being generally variable color) takes place in the back indicator with sterilizing gas and be positioned over and carry out the sterilization process monitoring in the product package material, judge according to physicochemical characteristicses such as change color whether sterilization reaches requirement.There is a common problem in these existing class methods: can't confirm that biological indicator and chemical indicator are positioned over the representativeness in the product package material, are difficult to the crucial effects such as penetration capacity that the result judges chemical gas that are applied according to indicator.In addition; Because complicated various by sterilizing article; Although select at material, will consider during structural design and the product sterilization process between the compatibility; But when sterilizing monitoring, the position (position that sterilizing gas is difficult to arrive) of difficult sterilization is difficult to confirm, needs a kind of challenge device of sterilizing of design to confirm the effectiveness of sterilization process.
Summary of the invention
This utility model is difficult to be applied the problem that the result judges the sterilization process effectiveness according to indicator when the available technology adopting chemical gas is sterilized for solving; A kind of device that can challenge the chemical gas sterilization process is provided, to be used for monitoring to sterilization process.
The technical scheme that this utility model solves existing issue is: design a kind of chemical gas sterilization challenge device; Comprise tube chamber 1, indicator annular seal space 2, degerming level pneumatic filter 3; It is characterized in that described indicator annular seal space 2 is connected with tube chamber 1 one ends, described degerming level pneumatic filter 3 is connected in the opening of tube chamber.Indicator annular seal space 2 other ends are provided with opening 4, and described opening 4 matches with Pit cover 5 and seals.
Improvement as this utility model; The tube chamber of described challenge device be internal diameter between 1.0～3.0mm, length is the round tube of 300～2000mm; Formula is coiled arrangement architecture in the shape of a spiral, and the internal diameter of indicator annular seal space is 5～15mm circular configuration, or the inner chamber width is 5～20mm; The inner chamber height is 1～20mm, and the degree of depth is the rectangular configuration of 5～30mm.
As the further improvement of this utility model, be connected through modes such as screw thread, anchor ears between the opening of described indicator annular seal space and the Pit cover.
As the further improvement of this utility model, the degerming level pneumatic filter 3 that described tube chamber opening connects is not more than the air filter of 0.45 μ m for the aperture.
This utility model compared with prior art; Its beneficial effect is: adopt this challenge device; With respect to the method that directly biological indicator and chemical indicator is put in product package material; Can confirm the effectiveness that penetrates of chemosterilization gas more intuitively, thus the reliability of evaluating chemical gaseous sterilization technology more accurately.
Description of drawings
Fig. 1 is the structural representation of this utility model
The specific embodiment
It is 1500mm that challenge device tube chamber adopts length; Wall thickness is 1mm, and internal diameter is the stainless steel tube of 2mm, should manage according to the about 100～150mm of diameter and carry out helical arrangement; It is the air filter of 0.22 μ m that opening connects the aperture; The other end and indicator annular seal space adopt welding procedure to be tightly connected, and biological indicator's carrier is put into from indicator annular seal space opening, seal with Pit cover.To challenge device and pack in the product package material, put into ethylene oxide sterilizer and carry out sterilization treatment, sterilizing parameter: temperature is 50 ℃, and relative humidity is 35%～70%, and the ethylene oxide gas bulk concentration is 600mg/L, and be 2 hours action time.After the sterilization biological indicator is taken out, be inoculated in the broth bouillon and cultivate, confirm according to cultivation results whether the ethylene oxide sterilizing effect reaches requirement.
Claims (4)
1. device is challenged in a chemical gas sterilization; Comprise tube chamber (1), indicator annular seal space (2), degerming level pneumatic filter (3); It is characterized in that described indicator annular seal space (2) is connected with tube chamber (1) one end; Described degerming level pneumatic filter (3) is connected in the opening of tube chamber, and indicator annular seal space (2) other end is provided with opening (4), and described opening (4) matches with Pit cover (5) and seals.
2. chemical gas according to claim 1 sterilization challenge device is characterized in that: described tube chamber be internal diameter between 1.0～3.0mm, length is the round tube of 300～2000mm, formula coiling arrangement architecture in the shape of a spiral; The internal diameter of indicator annular seal space is 5～15mm circular configuration, or the inner chamber width is 5～20mm, and the inner chamber height is 1～20mm, and the degree of depth is the rectangular configuration of 5～30mm.
3. chemical gas according to claim 1 sterilization challenge device is characterized in that: be connected through modes such as screw thread, anchor ears between described indicator annular seal space opening and the Pit cover.
4. chemical gas sterilization challenge device according to claim 1, it is characterized in that: the degerming level pneumatic filter 3 that described tube chamber opening connects is not more than the air filter of 0.45 μ m for the aperture.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2011202575645U CN202184966U (en) | 2011-07-20 | 2011-07-20 | Challenge device for chemical gas sterilization |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2011202575645U CN202184966U (en) | 2011-07-20 | 2011-07-20 | Challenge device for chemical gas sterilization |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN202184966U true CN202184966U (en) | 2012-04-11 |
Family
ID=45916446
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2011202575645U Expired - Fee Related CN202184966U (en) | 2011-07-20 | 2011-07-20 | Challenge device for chemical gas sterilization |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN202184966U (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106267277A (en) * | 2016-09-28 | 2017-01-04 | 中国科学院苏州生物医学工程技术研究所 | Biological indicator for monitoring lumen class apparatus sterilizing effect detects device |
| CN112469448A (en) * | 2018-08-21 | 2021-03-09 | Gke德国有限责任公司 | Multi-stage process challenge device, indicator system and process challenge device system |
-
2011
- 2011-07-20 CN CN2011202575645U patent/CN202184966U/en not_active Expired - Fee Related
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106267277A (en) * | 2016-09-28 | 2017-01-04 | 中国科学院苏州生物医学工程技术研究所 | Biological indicator for monitoring lumen class apparatus sterilizing effect detects device |
| CN112469448A (en) * | 2018-08-21 | 2021-03-09 | Gke德国有限责任公司 | Multi-stage process challenge device, indicator system and process challenge device system |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| C56 | Change in the name or address of the patentee |
Owner name: ZHEJIANG TAILIN BIOTECHNOLOGY CO., LTD. Free format text: FORMER NAME: HANGZHOU TAILIN BIOTECHNOLOGY EQUIPMENT CO., LTD. |
|
| CP03 | Change of name, title or address |
Address after: 310052 Binjiang District, Zhejiang, South Ring Road, No. 2930, No. Patentee after: ZHEJIANG TAILIN BIOENGINEERING CO., LTD. Address before: The South Ring Road of Binjiang District Hangzhou city Zhejiang province 310052 No. 2930 Hangzhou Tailin Bioengineering Equipment Co. Ltd. Patentee before: Hangzhou Tailin Biotechnology Equipment Co., Ltd. |
|
| CF01 | Termination of patent right due to non-payment of annual fee | ||
| CF01 | Termination of patent right due to non-payment of annual fee |
Granted publication date: 20120411 Termination date: 20180720 |