CN202699659U - On-line sterilization device used for lyophilizer - Google Patents
On-line sterilization device used for lyophilizer Download PDFInfo
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- CN202699659U CN202699659U CN 201220174219 CN201220174219U CN202699659U CN 202699659 U CN202699659 U CN 202699659U CN 201220174219 CN201220174219 CN 201220174219 CN 201220174219 U CN201220174219 U CN 201220174219U CN 202699659 U CN202699659 U CN 202699659U
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- freeze dryer
- hydrogen peroxide
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- sterilizing
- sterilization
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Abstract
The utility model discloses an on-line sterilization device used for a lyophilizer. The on-line sterilization device used for the lyophilizer comprises a hydrogen peroxide liquid storage bottle, a compressed air inlet connecting port, a vaporizer used to mix hydrogen peroxide liquid and compressed air into hydrogen peroxide vapor, a programmable logic controller (PLC) electric appliance control system and a machine shell used to fix each component, wherein the compressed air becomes the hydrogen peroxide vapor by mixing with the hydrogen peroxide liquid in the vaporizer, the hydrogen peroxide vapor sterilizes the inner surfaces of a drying chamber, a vacuum condensing chamber and relevant pipelines of the lyophilizer, so that a sterile environment suitable for the production of medicines is created, and the risk that the medicines are polluted by microorganisms in the process of freezing and drying is avoided. The on-line sterilization device used for the lyophilizer has the advantages of being good in sterilization process repeatability, free from harm and pollution after sterilization, and the like.
Description
Technical field
This utility model relates to a kind of device for the online sterilization of freeze dryer, particularly a kind of device that is applicable to the vaporized hydrogen peroxide sterilization.
Background technology
Chinese Pharmacopoeia is as further improving, in 2010 editions appendix sterilizations clear and definite aseptic freeze-dried be one of sterile production technique the most widely, the device that is used for the online sterilization of freeze dryer is by the inner surface sterilization to the dry chamber of freeze dryer, vacuum condensation chamber, associated conduit, create a gnotobasis that is suitable for pharmaceutical production, avoid in the freezing dry process medicine being caused the risk of microbial contamination.At present the online sterilizing methods of freeze dryer mainly contains three kinds of steam sterilizations, ethylene oxide sterilizing, vaporized hydrogen peroxide sterilization, and its main equipment is freeze dryer.
In above-mentioned three kinds of methods, the online sterilizing methods of oxirane is because the high pressure that gas itself exists, the problem such as inflammable, explosive, poisonous, and the employing probability is less, substantially stops using at present; Steam sterilization is because easily so that produce larger pressure reduction variation in the sterilization chamber, equipment is needed certain requirement of withstand voltage, and damp and hot steam gas easily destroys the stainless passivating film of freeze dryer cavity inner surface, cause the problems such as shortened equipment life, the method be present freeze dryer the widest carry online sterilizing methods, but its energy consumption is high, needs complicated pressure vessel and tubing, needs before use in addition its cooling of wait consuming time; And the vaporized hydrogen peroxide sterilization technology, because sterilization process good reproducibility, the method that safe, sterilising cycle is short, the harmless advantage such as pollution-free becomes pharmacopoeia of each country, GMP, disinfecting technical specification recommends, range of application is also extensive.
Summary of the invention
The purpose of this utility model is to provide a kind of device for the online sterilization of freeze dryer, device by the online sterilization of this kind, inner surface to dry chamber, vacuum condensation chamber and the associated conduit of freeze dryer is sterilized, create a gnotobasis that is suitable for pharmaceutical production, avoid in the freezing dry process medicine being caused the risk of microbial contamination.
In order to achieve the above object, the technical solution of the utility model is: a kind of device for the online sterilization of freeze dryer is provided, comprise that hydrogen peroxide liquid containing bottle, compressed air intake interface, mixing hydrogen peroxide liquid and compressed air become carburator, the PLC electrical apparatus control system of hydrogen peroxide steam and the casing of fixing each parts, are connected with electrical ball valve, control valve A, high efficiency particulate air filter, trachea assembly, preheater in turn between described intake interface and the carburator; The set interface of giving vent to anger of described carburator is provided with the connection tube that connects freeze dryer; Described PLC electrical apparatus control system is provided with the communication interface that connects the control freeze dryer.
As further improvement, be provided with the adjust blood pressure filtration system between described control valve A and the high efficiency particulate air filter, the compressed air of described adjust blood pressure filtration system adjust blood pressure filter pressure＜0.6Mpa, and being provided with flow monitoring system between adjust blood pressure filtration system and the high efficiency particulate air filter, monitoring is also controlled the amount that enters the gas in the freeze dryer.
As further improvement, described electrical ball valve is the sanitation-grade electrical ball valve; Above-mentioned preheater adopts the duct type heating arrangement, and the gas that guarantees to enter freeze dryer can be by homogeneous heating, and can not produce the hydrogen peroxide condensation in pipeline; Above-mentioned connection tube is flexible pipe; Above-mentioned intake interface, the interface of giving vent to anger all adopt the sanitation-grade quick coupling device.
As further improvement, described high efficiency particulate air filter is provided with the filter pressure monitoring device by the monitoring of two ends pressure reduction, high efficiency particulate air filter guarantees to enter and is aseptic gas after the interior hydrogen peroxide gas of freeze dryer is processed through high efficiency particulate air filter, and the effective monitoring of filter pressure monitoring device also guarantees the high efficiency particulate air filter integrity.
As further improvement, also comprise the control module of flow control assembly, temperature, humidity, pressure display module.
As further improvement, also comprise the quantitative remedy-adding system that is arranged in the casing, described quantitative remedy-adding system is connected by control valve B with the hydrogen peroxide liquid containing bottle, in order to control in real time the hydrogen peroxide chemical feeding quantity, guarantees the effect of sterilization.
As further improvement, the mini-printer of the every sterilizing parameter record of printout is installed on the described casing; Export in real time to guarantee the sterilizing parameter data; The color touch screen is installed, to make things convenient for the parameter setting and to strengthen operability on the above-mentioned casing; Above-mentioned casing below is equipped with Moving caster, with the movement of convenient online bactericidal unit, and can realize the requirement that an online bactericidal unit is sterilized to many freeze dryer equipment.
Compared with prior art, compressed air passes through intake interface, the sanitation-grade electrical ball valve, control valve A, the adjust blood pressure filtration system, flow monitoring system, high efficiency particulate air filter, the trachea assembly, behind the preheater, after mixing, carburator becomes hydrogen peroxide steam with hydrogen peroxide liquid, through the interface of giving vent to anger, connecting hose is sent the hydrogen peroxide sterilizing gas into freeze dryer, dry chamber to freeze dryer, the inner surface of vacuum condensation chamber and associated conduit is sterilized, create a gnotobasis that is suitable for pharmaceutical production, avoid in the freezing dry process medicine being caused the risk of microbial contamination.Device for the online sterilization of freeze dryer described in the utility model has the sterilization process good reproducibility, and safe, energy consumption is low, and operating cost is low, and sterilising cycle is short, the harmless pollution-free beneficial effect that waits after the sterilization.
Description of drawings
Below in conjunction with drawings and Examples this utility model is further specified.
Fig. 1 is the online company's of sterilization machine schematic diagram of this utility model and freeze dryer;
Fig. 2 is front view of the present utility model;
Fig. 3 is top view of the present utility model;
Fig. 4 is rearview of the present utility model;
Fig. 5 is the A-A view of Fig. 2;
Fig. 6 is the B-B view of Fig. 2.
The specific embodiment
Referring to Fig. 1-6, the implementation case comprises hydrogen peroxide liquid containing bottle 2, compressed air intake interface 6, mix carburator 14, PLC electrical apparatus control system 20 that hydrogen peroxide liquid and compressed air become hydrogen peroxide steam, be arranged at the quantitative remedy-adding system 11 in the casing 1 and the casing 1 of fixing each parts, is connected with electrical ball valve 17, control valve A 8, high efficiency particulate air filter 9, trachea assembly 13, preheater 10 between intake interface 6 and the carburator 14 in turn; The carburator 14 set interfaces 7 of giving vent to anger are provided with the connection tube 19 that connects freeze dryer; PLC electrical apparatus control system 20 is provided with the communication interface that connects the control freeze dryer.Quantitative remedy-adding system 11 is connected by control valve B12 with hydrogen peroxide liquid containing bottle 2.
In the implementation case, also comprise the control module of flow control assembly, temperature, humidity, pressure display module.Be provided with adjust blood pressure filtration system 15 between control valve A 8 and the high efficiency particulate air filter 9, the compressed air of adjust blood pressure filtration system 15 adjust blood pressure filter pressure＜0.6Mpa.And be provided with flow monitoring system 16 between adjust blood pressure filtration system 15 and the high efficiency particulate air filter 9.
Wherein electrical ball valve 17 is the sanitation-grade electrical ball valve, and preheater 10 adopts the duct type heating arrangement, and intake interface 6, the interface 7 of giving vent to anger all adopt the sanitation-grade quick coupling device, and high efficiency particulate air filter 9 is provided with the filter pressure monitoring device 3 by the monitoring of two ends pressure reduction; Connection tube 19 is flexible pipe.
Mini-printer 5 and the color touch screen 4 of the every sterilizing parameter record of printout are installed on the casing 1.Casing 1 below is equipped with Moving caster 18.
Device front for the online sterilization of freeze dryer described in the utility model is provided with human-machine operation color touch screen 4, emergency stop switch, fault alarm, status indicator lamp, filter pressure monitoring device 3, mini-printer 5, on and off switch.
In Fig. 1 and Fig. 6, the device that is used for the online sterilization of freeze dryer with the freeze dryer communication connection after, enter freeze dryer disinfecting action interface, sanitation-grade electrical ball valve 17, control valve A 8 autoshutdowns, then open freeze dryer, the lyophilizing chamber of freeze dryer is improved as further, cup and condensation chamber are as further improving, rear chamber is by heating, evacuation carries out drying, and hydrogen peroxide gas produces condensation when preventing from sterilizing, and affects sterilization effect, utilize the vacuum pumping technology of freeze dryer, as further improving, cup and condensation chamber are as further improving with freeze dryer lyophilizing chamber, and rear chamber is evacuated to≤20Pa.
In Fig. 5 and Fig. 6, when the freeze dryer vacuum pressure reaches setup parameter, after the pressure switch of freeze dryer provides feedback signal, online bactericidal unit is started working: at first external gas source control valve A 8 opens, gas is through adjust blood pressure filtration system 15, flow monitoring system 16, preheater 10, high efficiency particulate air filter 9, trachea assembly 13 enters carburator 14, after the temperature in the temperature control system monitoring carburator reaches setup parameter, control valve B 12 opens, quantitative remedy-adding system 11 dosing of starting working, the hydrogen peroxide steam of high concentration enters in the freeze dryer ventilation shaft by connecting hose 19, behind the freeze dryer ventilation filter, enter the dry chamber of freeze dryer and vacuum condensation chamber, associated conduit is carried out surface sterilizing and is processed.By the indoor pressure of freeze dryer chamber and vacuum condensation and the addition of humidity detection control hydrogen peroxide; When the pressure that reaches setting or humidity value, stop to inject hydrogen peroxide gas, quantitative remedy-adding system 11, control valve A 8, control valve B 12, preheater 10 quits work; Hydrogen peroxide gas is at the inner certain hour that keeps of freeze dryer, until sterilization is finished.
Sterilization phase can according to the volume size of freeze dryer, repeatedly carry out evacuation and inject hydrogen peroxide gas.
By repeatedly evacuation and emptying, the residual hydrogen dioxide that the dry chamber of freeze dryer and vacuum condensation is indoor and catabolite steam thereof and oxygen were discharged after sterilization finished, and were lower than 1ppm until residual hydrogen dioxide is dense.
Claims (13)
1. one kind is used for the online device of sterilizing of freeze dryer, it is characterized in that: comprise hydrogen peroxide liquid containing bottle (2), compressed air intake interface (6), mix the carburator (14) that hydrogen peroxide liquid and compressed air become hydrogen peroxide steam, PLC electrical apparatus control system (20) and the casing (1) of fixing each parts are connected with electrical ball valve (17) in turn between described intake interface (6) and the carburator (14), control valve A (8), high efficiency particulate air filter (9), trachea assembly (13), preheater (10); The set interface of giving vent to anger of described carburator (14) (7) is provided with the connection tube (19) that connects freeze dryer; Described PLC electrical apparatus control system (20) is provided with the communication interface that connects the control freeze dryer.
2. as claimed in claim 1 for the online device of sterilizing of freeze dryer, it is characterized in that: be provided with adjust blood pressure filtration system (15) between described control valve A (8) and the high efficiency particulate air filter (9), the compressed air of described adjust blood pressure filtration system (15) adjust blood pressure filter pressure＜0.6Mpa.
3. the device for the online sterilization of freeze dryer as claimed in claim 2 is characterized in that: be provided with flow monitoring system (16) between described adjust blood pressure filtration system (15) and the high efficiency particulate air filter (9).
4. as claimed in claim 1 for the online device of sterilizing of freeze dryer, it is characterized in that: described electrical ball valve (17) is the sanitation-grade electrical ball valve.
5. the device for the online sterilization of freeze dryer as claimed in claim 1 is characterized in that: described preheater (10) employing duct type heating arrangement.
6. as claimed in claim 1 for the online device of sterilizing of freeze dryer, it is characterized in that: described intake interface (6), the interface of giving vent to anger (7) all adopt the sanitation-grade quick coupling device.
7. as claimed in claim 1 for the online device of sterilizing of freeze dryer, it is characterized in that: described high efficiency particulate air filter (9) is provided with the filter pressure monitoring device (3) by the monitoring of two ends pressure reduction.
8. the device for the online sterilization of freeze dryer as claimed in claim 1 is characterized in that: also comprise the control module of flow control assembly, temperature, humidity, pressure display module.
9. as claimed in claim 1 for the online device of sterilizing of freeze dryer, it is characterized in that: also comprise the quantitative remedy-adding system (11) that is arranged in the casing (1), described quantitative remedy-adding system (11) is connected by control valve B (12) with hydrogen peroxide liquid containing bottle (2).
10. as claimed in claim 1 for the online device of sterilizing of freeze dryer, it is characterized in that: described connection tube (19) is flexible pipe.
11. the device for the online sterilization of freeze dryer as claimed in claim 1 is characterized in that: the mini-printer (5) that the every sterilizing parameter record of printout is installed on the described casing (1).
12. the device for the online sterilization of freeze dryer as claimed in claim 1 is characterized in that: color touch screen (4) is installed on the described casing (1).
13. the device for the online sterilization of freeze dryer as claimed in claim 1 is characterized in that: described casing (1) below is equipped with Moving caster (18).
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 201220174219 CN202699659U (en) | 2012-04-16 | 2012-04-16 | On-line sterilization device used for lyophilizer |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 201220174219 CN202699659U (en) | 2012-04-16 | 2012-04-16 | On-line sterilization device used for lyophilizer |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN202699659U true CN202699659U (en) | 2013-01-30 |
Family
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 201220174219 Withdrawn - After Issue CN202699659U (en) | 2012-04-16 | 2012-04-16 | On-line sterilization device used for lyophilizer |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN202699659U (en) |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102631692A (en) * | 2012-04-16 | 2012-08-15 | 杭州泰林生物技术设备有限公司 | On-line sterilization method used for freeze dryers and device thereof |
| CN108698723A (en) * | 2016-02-12 | 2018-10-23 | 伊马股份公司 | Component for carrying out sterilizing and depyrogenation to container |
| CN110755660A (en) * | 2019-10-09 | 2020-02-07 | 江苏新美星包装机械股份有限公司 | Vaporization device |
-
2012
- 2012-04-16 CN CN 201220174219 patent/CN202699659U/en not_active Withdrawn - After Issue
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102631692A (en) * | 2012-04-16 | 2012-08-15 | 杭州泰林生物技术设备有限公司 | On-line sterilization method used for freeze dryers and device thereof |
| CN102631692B (en) * | 2012-04-16 | 2014-12-10 | 杭州泰林生物技术设备有限公司 | On-line sterilization method used for freeze dryers and device thereof |
| CN108698723A (en) * | 2016-02-12 | 2018-10-23 | 伊马股份公司 | Component for carrying out sterilizing and depyrogenation to container |
| CN110755660A (en) * | 2019-10-09 | 2020-02-07 | 江苏新美星包装机械股份有限公司 | Vaporization device |
| CN110755660B (en) * | 2019-10-09 | 2023-08-29 | 江苏新美星包装机械股份有限公司 | Vaporization device |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| AV01 | Patent right actively abandoned |
Granted publication date: 20130130 Effective date of abandoning: 20141210 |
|
| RGAV | Abandon patent right to avoid regrant |