CN204319339U - Sterility test technique isolator - Google Patents
Sterility test technique isolator Download PDFInfo
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- CN204319339U CN204319339U CN201420650075.XU CN201420650075U CN204319339U CN 204319339 U CN204319339 U CN 204319339U CN 201420650075 U CN201420650075 U CN 201420650075U CN 204319339 U CN204319339 U CN 204319339U
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Abstract
The utility model discloses a kind of sterility test technique isolator, it is characterized in that, the electrical system of the integrated hydrogen peroxide vapor sterilization system of air treatment system and side at the frame assembly bottom comprising, the glove box assembly be located on frame assembly, top.This utility model makes that internal pair production environment and operator and external environment condition are completely isolated to be opened, and decreases the risk of artificial contamination, decreases the pollution of product to operator and external environment condition simultaneously; And the controllability making production clean area reduce, make Production Regional increases greatly, and then reduce operating cost and maintenance cost, simultaneously with integrated form hydrogen peroxide sterilization system, online SIP can be realized, ensure that the aseptic of operating environment.
Description
Technical field
This utility model relates to a kind of sterility test technique isolator, the operation link that this device is pharmacy corporation quality sterility test provides stable, low stain risk, low power consuming, completely isolated A level aseptic area.
Background technology
Aseptic medicine is according to the difference of the character of medicine, and processing technology is also not quite similar, and from sterile freeze-drying preparation to sterile bulk drug, from aseptic infusion solutions to aseptic eye drop, all be unable to do without aseptic.So ensure that the requirement of aseptic is except needs will strictly control its production environment, production process, operation etc., so more crucial carries out aseptic inspection to finished product exactly, proves that its final products meet aseptic requirement.
Sterility test process is sampled according to the certain proportion producing product, and the sample of extraction sampling observation is through dilution, by germ collector, liquid pumping is passed through bacteria gathering device filter membrane, then inject culture medium and carry out bacterium colony cultivation, and judge the whether microbiological contamination of sampling observation sample, judge the quality of producing medicine by the gross by test result.
At present, in aseptic medicine is produced, there is lower column defects in sterility test operating procedure:
1, the Sterility testing operation of conventional aseptic medicine, also rest on simple hundred grades of laminar flow hood, hundred grades of hold court from behind a screen structure or hundred-grade super-clean platforms at present, but cannot accomplish that real and extraneous environment and operator keep apart, internal pair production ambient parameter cannot be made completely controlled, more can not ensure the sterile transfer without material and operation tool, the verity how reducing false-positive occurrence probability and negative control result in Sterility testing process becomes the difficult problem needing to solve;
In the Sterility testing operating process of 2, aseptic medicine, laminar flow hood or super-clean bench is adopted to carry out non-enclosed isolation drawback a lot.First, the requirement of " potent medicine must be avoided contacting with operator as far as possible " can not be met; Secondly, require strict for Production Regional ambient parameter, parameter cannot be reached completely controlled, and the requirement that can verify cannot be reached; Finally, CIP(Clean in place on-line cleaning cannot be accomplished in Production Regional inside) and the online sterilizing of SIP(Sterilize in Place) be easy to cross-contamination effects testing result occurs;
3, traditional Sterility testing area requirement background operation environmental rating is higher, and cause involving great expense of aseptic working area, the operator wearing aseptic working clothing not only reduce production efficiency, and needs to increase the pollution cost processing operator and bring.
Although 4 present Ye You producer isolators do sterility test, the most material of isolator be the soft wall of PVC, inner pressure reduction cannot be ensured, easily damaged, large to the corrosivity of the material of isolator own during sterilizing, the effect of laminar flow cannot be reached.
Summary of the invention
Problem to be solved in the utility model is the program of changing one's clothes for the operation link of pharmacy corporation quality sterility test provides stable, reduces the contaminated risk of sample, reduces the environmental grade in sterility test room, simplifies personnel.
In order to solve the problem, the technical solution of the utility model there is provided a kind of isolator for sterility detection process, it is characterized in that, the electrical system of the integrated hydrogen peroxide vapor sterilization system of air treatment system and side at the frame assembly bottom comprising, the glove box assembly be located on frame assembly, top.
Preferably, the illuminating lamp that described air treatment system comprises air treatment system mounting bracket and is located on air treatment system mounting bracket, current-sharing film, new wind assembly, new air-valve assembly, inner loop catalytic decomposition unit, circulating fan assembly, exhaust valve assembly, air draft assembly, flume seal filter, illuminating lamp is fixed on mounting bracket by the illuminating lamp mount pad be arranged on air treatment system support, current-sharing film, new wind assembly, new air-valve assembly, inner loop catalytic decomposition unit, circulating fan assembly, exhaust valve assembly, air draft assembly, flume seal filter is fixed on air treatment system mounting bracket.
Environment for use due to sterility test technique isolator is minimum can be D level, headspace processing system is to ensure inner A level environment, isolator is entered after all new wind entering isolator inside has to pass through the process of new wind assembly, the function of air draft assembly is for processing the gas getting rid of isolator on the one hand, ensure the safety of Exhaust Gas, prevent on the other hand when shutting down suddenly, the dirty air of outside enters isolator inside and pollutes, due to isolator internal request system layer stream, air is passed through flume seal filter and current-sharing film by all circulating fan assemblies that passes through, form the air-flow protection of vertical laminar flow, inner loop catalytic decomposition unit is in order to the ventilating stage in hydrogen peroxide vapor sterilization can reduce concentration faster, accelerate the sterilising cycle time, in functional module hydrogen peroxide steam being had to catalyticing decomposition action that isolator inside is arranged, illuminating lamp can provide the requirement of whole isolator inside cavity illumination, ensure the comfort level of human users, new air-valve assembly and exhaust valve assembly can ensure the seal of whole cavity in leakage test and sterilization process.
Preferably, described glove box assembly comprises rustless steel casing, and rustless steel casing is provided with operation window, and operation window is provided with at least one group of operation glove mechanism.
Further, the left and right sides of described operation window is connected with rustless steel casing by nitrogen spring, and upside is connected by hinge with rustless steel casing, is provided with door latch assembly between downside and rustless steel casing.
Further, described door latch assembly is provided with alarm device.
Further, when described operation window is closed, itself and rustless steel casing contact position are provided with door sealing system.
Further, described door sealing system comprises I shape hermetic seal mounting groove, the side of hermetic seal mounting groove is connected with operation window, be provided with air inflation sealing device between operation window and hermetic seal mounting groove, the inflation end of air inflation sealing device is connected with hermetic seal gas charging system after the opposite side of hermetic seal mounting groove exposes.
Further, vacuum protection system is provided with between described air inflation sealing device and operation window.
The fence structure of rustless steel casing and operation window construction system, internal system production environment and external environment condition and the completely isolated device of operator are opened, operator only allows logical operator grip assembly to carry out the technological operation of completion system inside, the sealing of operation window is ensured by door sealing system, the door latch assembly that the on off state of operation window can be reported to the police by band is monitored, supported by nitrogen spring when operation window is opened, ensure the convenience of operator's switching manipulation window, operation window is connected with rustless steel casing by hinge.
Preferably, described hydrogen peroxide vapor sterilization system comprises on-line weighting system, on-line weighting system is provided with hydrogen peroxide container, hydrogen peroxide is pumped on hydrogen peroxide steam flash distillation dish by pumping system by hydrogen peroxide container, produces the hydrogen peroxide steam be used for the isolator cavity sterilizing that air treatment system and glove box assemblies interior surface are formed.
This utility model can realize being in all the time in the sterility test process of aseptic medicine a controlled environment by sterility test isolator to carry out, inner noxious substance is made to jeopardize operator, also the pollutant in external environment condition are prevented to enter working place internal contamination product to be tested, make test result have more credibility and cogency, also reduce the requirement of Production Regional to the lustration class of background environment simultaneously.The change of the inner any ambient parameter of aseptic test technology isolator, all can obtain corresponding regulation and control, thus the production achieving aseptic medicine complete after the isolation of sterility test link.
The utility model has the advantages that and make that internal pair production environment and operator and external environment condition are completely isolated to be opened, decrease the risk of artificial contamination, decrease the pollution of product to operator and external environment condition simultaneously; And the controllability making production clean area reduce, make Production Regional increases greatly, and then reduce operating cost and maintenance cost, simultaneously with integrated form hydrogen peroxide sterilization system, online SIP can be realized, ensure that the aseptic of operating environment.
Accompanying drawing explanation
The structural representation of a kind of sterility test technique isolator that Fig. 1 provides for this utility model;
Fig. 2 is the structural representation of air treatment system;
Fig. 3 is the structural representation of glove box assembly;
Fig. 4 is the structural representation of door sealing system;
Fig. 5 is the structural representation of hydrogen peroxide vapor sterilization system.
Detailed description of the invention
For making this utility model become apparent, hereby with preferred embodiment, and accompanying drawing is coordinated to be described in detail below.
Embodiment
As shown in Figure 1, for the structural representation of a kind of sterility test technique isolator that this utility model provides, the electrical system 2 of the integrated hydrogen peroxide vapor sterilization system 1 of air treatment system 3 and side at the frame assembly 5 bottom comprising, the glove box assembly 4 be located on frame assembly 5, top.
As shown in Figure 2, air treatment system 3 comprises air treatment system mounting bracket 6 and is located at the illuminating lamp 7 on air treatment system mounting bracket 6, current-sharing film 8, new wind assembly 9, new air-valve assembly 10, inner loop catalytic decomposition unit 11, circulating fan assembly 12, exhaust valve assembly 13, air draft assembly 14, flume seal filter 15, illuminating lamp 7 is fixed on mounting bracket by the illuminating lamp mount pad be arranged on air treatment system support 6, current-sharing film 8, new wind assembly 9, new air-valve assembly 10, inner loop catalytic decomposition unit 11, circulating fan assembly 12, exhaust valve assembly 13, air draft assembly 14 is bolted to be fixed on air treatment system mounting bracket 6, flume seal filter 15 adopts the mode of bolt presses to be fixed on mounting bracket 6 by compact heap.
Environment for use due to sterility test technique isolator is minimum can be D level, air treatment system 3 is to ensure inner A level environment, all new wind entering isolator inside enters isolator after having to pass through the process of new wind assembly 9, the function of air draft assembly 14 is for processing the gas getting rid of isolator on the one hand, ensure the safety of Exhaust Gas, prevent on the other hand when shutting down suddenly, the dirty air of outside enters isolator inside and pollutes, due to isolator internal request system layer stream, air is passed through flume seal filter 15 and current-sharing film 8 by all circulating fan assemblies 12 that passes through, form the air-flow protection of vertical laminar flow, inner loop catalytic decomposition unit 11 is in order to the ventilating stage in hydrogen peroxide vapor sterilization can reduce concentration faster, accelerate the sterilising cycle time, in functional module hydrogen peroxide steam being had to catalyticing decomposition action that isolator inside is arranged, illuminating lamp 7 can provide the requirement of whole isolator inside cavity illumination, ensure the comfort level of human users, new air-valve assembly 10 and exhaust valve assembly 13 can ensure the seal of whole cavity in leakage test and sterilization process.
As shown in Figure 3, glove box assembly 4 comprises rustless steel casing 16, and rustless steel casing 16 is provided with operation window 18, and operation window 18 is provided with four groups of transversely arranged operation glove mechanisms 17.The left and right sides of operation window 18 is connected with rustless steel casing 16 by nitrogen spring 22, and upside is connected by two hinges 20 with rustless steel casing 16, two groups of door latch assemblies 19 with alarm device between downside and rustless steel casing 16.When operation window 18 is closed, itself and rustless steel casing 16 contact position, namely the edge of operation window 18 is provided with door sealing system 21.
As shown in Figure 4, door sealing system 21 comprises I shape hermetic seal mounting groove 24, the side of hermetic seal mounting groove 24 is connected with operation window 18, be provided with air inflation sealing device 25 between operation window 18 and hermetic seal mounting groove 24, the inflation end of air inflation sealing device 25 is connected with hermetic seal gas charging system 23 after the opposite side of hermetic seal mounting groove 24 exposes.Be provided with vacuum protection system 26 between air inflation sealing device 25 and operation window 18, reach better sealing effectiveness.
The fence structure of rustless steel casing 16 and operation window 18 construction system, internal system production environment and external environment condition and the completely isolated device of operator are opened, operator only allows logical operation glove mechanism 17 to carry out the technological operation of completion system inside, the sealing of operation window 18 is ensured by door sealing system 21, the door latch assembly 19 that the on off state of operation window 18 can be reported to the police by band is monitored, supported by nitrogen spring 22 when operation window 18 is opened, ensure the convenience of operator's switching manipulation window 18, operation window 18 is connected with rustless steel casing 16 by hinge 20.
As shown in Figure 5, hydrogen peroxide vapor sterilization system 1 comprises on-line weighting system 28, on-line weighting system 28 is provided with hydrogen peroxide container 29, hydrogen peroxide is pumped on hydrogen peroxide steam flash distillation dish 31 by pumping system 30 by hydrogen peroxide container 29, produces the hydrogen peroxide steam be used for the isolator cavity sterilizing that air treatment system 3 and glove box assemblies 4 interior surface are formed.
Keep apart with operator and background environment completely during isolator for sterility detection process work, the endless form of inner total enclosing self-loopa enables isolator internal medium parameter be monitored in real time, that accuracy and the credibility of testing result after the production of aseptic medicine improves greatly, integrated form hydrogen peroxide sterilization system can make the inner online sterilizing of isolator, also reduce poisonous high sensitization medicine to the harm of operator simultaneously.
Claims (9)
1. a sterility test technique isolator, it is characterized in that, the electrical system (2) of the integrated hydrogen peroxide vapor sterilization system (1) of air treatment system (3) and side at the frame assembly (5) bottom comprising, the glove box assembly (4) be located on frame assembly (5), top.
2. sterility test technique isolator as claimed in claim 1, it is characterized in that, described air treatment system (3) comprises air treatment system mounting bracket (6) and is located at the illuminating lamp (7) on air treatment system mounting bracket (6), current-sharing film (8), new wind assembly (9), new air-valve assembly (10), inner loop catalytic decomposition unit (11), circulating fan assembly (12), exhaust valve assembly (13), air draft assembly (14), flume seal filter (15), illuminating lamp (7) is fixed on mounting bracket by the illuminating lamp mount pad be arranged on air treatment system support (6), current-sharing film (8), new wind assembly (9), new air-valve assembly (10), inner loop catalytic decomposition unit (11), circulating fan assembly (12), exhaust valve assembly (13), air draft assembly (14) is bolted to be fixed on air treatment system mounting bracket (6), and flume seal filter (15) adopts the mode of bolt presses to be fixed on mounting bracket (6) by compact heap.
3. sterility test technique isolator as claimed in claim 1, it is characterized in that, described glove box assembly (4) comprises rustless steel casing (16), and rustless steel casing (16) is provided with operation window (18), and operation window (18) is provided with at least one group of operation glove mechanism (17).
4. sterility test technique isolator as claimed in claim 3, it is characterized in that, the left and right sides of described operation window (18) is connected with rustless steel casing (16) by nitrogen spring (22), upside is connected by hinge (20) with rustless steel casing (16), is provided with door latch assembly (19) between downside and rustless steel casing (16).
5. sterility test technique isolator as claimed in claim 4, it is characterized in that, described door latch assembly (19) is provided with alarm device.
6. as the sterility test technique isolator in claim 3-5 as described in any one, it is characterized in that, when described operation window (18) is closed, itself and rustless steel casing (16) contact position are provided with door sealing system (21).
7. sterility test technique isolator as claimed in claim 6, it is characterized in that, described door sealing system (21) comprises I shape hermetic seal mounting groove (24), the side of hermetic seal mounting groove (24) is connected with operation window (18), be provided with air inflation sealing device (25) between operation window (18) and hermetic seal mounting groove (24), the inflation end of air inflation sealing device (25) is connected with hermetic seal gas charging system (23) after the opposite side of hermetic seal mounting groove (24) exposes.
8. sterility test technique isolator as claimed in claim 7, is characterized in that, be provided with vacuum protection system (26) between described air inflation sealing device (25) and operation window (18).
9. sterility test technique isolator as claimed in claim 1, it is characterized in that, described hydrogen peroxide vapor sterilization system (1) comprises on-line weighting system (28), on-line weighting system (28) is provided with hydrogen peroxide container (29), hydrogen peroxide is pumped on hydrogen peroxide steam flash distillation dish (31) by pumping system (30) by hydrogen peroxide container (29), produces the hydrogen peroxide steam be used for the isolator cavity sterilizing that air treatment system (3) and glove box assemblies (4) interior surface are formed.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201420650075.XU CN204319339U (en) | 2014-11-03 | 2014-11-03 | Sterility test technique isolator |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201420650075.XU CN204319339U (en) | 2014-11-03 | 2014-11-03 | Sterility test technique isolator |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN204319339U true CN204319339U (en) | 2015-05-13 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201420650075.XU Active CN204319339U (en) | 2014-11-03 | 2014-11-03 | Sterility test technique isolator |
Country Status (1)
| Country | Link |
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| CN (1) | CN204319339U (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP3127664A1 (en) * | 2015-08-07 | 2017-02-08 | INDAG Gesellschaft für Industriebedarf mbH & Co. Betriebs KG | Machine for aseptic filling of liquids, method for opening and a method of closing an opening window in a machine for aseptic filling of liquids |
-
2014
- 2014-11-03 CN CN201420650075.XU patent/CN204319339U/en active Active
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP3127664A1 (en) * | 2015-08-07 | 2017-02-08 | INDAG Gesellschaft für Industriebedarf mbH & Co. Betriebs KG | Machine for aseptic filling of liquids, method for opening and a method of closing an opening window in a machine for aseptic filling of liquids |
| WO2017025461A1 (en) * | 2015-08-07 | 2017-02-16 | Indag Gesellschaft für Industriebedarf mbH & Co. Betriebs KG | Machine for the aseptic filling of liquids, method for opening and method for closing an opening window in a machine for the aseptic filling of liquids |
| US10836054B2 (en) | 2015-08-07 | 2020-11-17 | Indag Pouch Partners Gmbh | Machine for the aseptic filling of liquids, method for opening and method for closing an opening window in a machine for the aseptic filling of liquids |
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