CN109481709B - Sterilization method and sealing ring for connecting device of isolator and dryer - Google Patents
Sterilization method and sealing ring for connecting device of isolator and dryer Download PDFInfo
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- CN109481709B CN109481709B CN201811341630.XA CN201811341630A CN109481709B CN 109481709 B CN109481709 B CN 109481709B CN 201811341630 A CN201811341630 A CN 201811341630A CN 109481709 B CN109481709 B CN 109481709B
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- Prior art keywords
- sealing ring
- dryer
- isolator
- air inlet
- sealing
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- 238000007789 sealing Methods 0.000 title claims abstract description 118
- 230000001954 sterilising effect Effects 0.000 title claims abstract description 48
- 238000004659 sterilization and disinfection Methods 0.000 title claims abstract description 29
- 238000000034 method Methods 0.000 title claims abstract description 19
- 239000007789 gas Substances 0.000 claims description 16
- MHAJPDPJQMAIIY-UHFFFAOYSA-N Hydrogen peroxide Chemical compound OO MHAJPDPJQMAIIY-UHFFFAOYSA-N 0.000 claims description 14
- 230000006835 compression Effects 0.000 claims description 6
- 238000007906 compression Methods 0.000 claims description 6
- 239000011810 insulating material Substances 0.000 claims description 2
- 238000010438 heat treatment Methods 0.000 description 5
- 238000001816 cooling Methods 0.000 description 4
- 230000000694 effects Effects 0.000 description 2
- 239000012774 insulation material Substances 0.000 description 2
- 239000003595 mist Substances 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000000712 assembly Effects 0.000 description 1
- 238000000429 assembly Methods 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 239000000284 extract Substances 0.000 description 1
- 238000009434 installation Methods 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 238000001179 sorption measurement Methods 0.000 description 1
- 229910001220 stainless steel Inorganic materials 0.000 description 1
- 239000010935 stainless steel Substances 0.000 description 1
- 238000012414 sterilization procedure Methods 0.000 description 1
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
- A61L2/20—Gaseous substances, e.g. vapours
- A61L2/208—Hydrogen peroxide
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
- A61L2/04—Heat
- A61L2/06—Hot gas
- A61L2/07—Steam
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/26—Accessories or devices or components used for biocidal treatment
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F26—DRYING
- F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
- F26B25/00—Details of general application not covered by group F26B21/00 or F26B23/00
- F26B25/008—Seals, locks, e.g. gas barriers or air curtains, for drying enclosures
Landscapes
- Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- Mechanical Engineering (AREA)
- General Engineering & Computer Science (AREA)
- Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Apparatus For Disinfection Or Sterilisation (AREA)
Abstract
The invention relates to a sterilization method and a sealing ring for connecting equipment of an isolator and a dryer, wherein the sterilization method comprises the following steps of closing a sealing door between the isolator and the dryer, sterilizing the dryer at high temperature, and sterilizing the sealing ring by high-temperature steam through an air inlet of the sealing ring on the sealing door; after the dryer and the sealing ring are sterilized, the sealing ring is inflated through the air inlet of the sealing ring to be attached to the sealing door body; the isolator is sterilized. The sterilization method can solve the problem and risk that the sealing ring on the automatic sealing door between the isolator and the dryer cannot be effectively sterilized, and the high-temperature gas for sterilizing the sealing ring comes from the high-temperature gas source in the dryer, so that the high-temperature gas source is not required to be additionally provided, and the sterilization cost is further reduced.
Description
Technical Field
The invention relates to the technical field of sterilization, in particular to a sterilization method and a sealing ring for connecting equipment of an isolator and a dryer.
Background
With the continuous development of the pharmaceutical industry, many pharmaceutical enterprises or pharmaceutical equipment enterprises continuously improve the technology thereof. Where the sterile environment has a profound effect on the products or equipment of the pharmaceutical industry. At present, the inner environments of an isolator and a dryer can reach a sterile environment, but a connecting device (an automatic sealing door) between the isolator and the dryer has a sterilization dead angle, when the dryer is sterilized, because a laminar flow dead zone at the outlet position of a cooling section is longer, the heat convection and the heat conducted to the position of a sealing ring are limited, and the heat conductivity of a rubber material of the sealing ring on the automatic sealing door is poorer than that of stainless steel, the sterilization temperature point of the sealing ring can hardly reach a required value; when the isolator adopted hydrogen peroxide to disinfect, sealing door closed also led to the sealing washer to fail effectual sterilization, had contaminated risk when the medicine bottle production had been led to in the not complete sterilization of the sealing washer itself.
Disclosure of Invention
In view of the above, it is necessary to provide a sterilization method and a gasket for a connection device between an isolator and a dryer, aiming at the technical problem that an automatic sealing door between the isolator and the dryer has a sterilization dead angle.
A method for sterilizing a connecting device of an isolator and a dryer, comprising the steps of:
s1, closing a sealing door between the isolator and the dryer, sterilizing the dryer at high temperature, and sterilizing the sealing ring by high-temperature steam through an air inlet of the sealing ring on the sealing door;
s2, after the dryer and the sealing ring are sterilized, inflating the sealing ring through the air inlet of the sealing ring to enable the sealing ring to be attached to the sealing door body;
and S3, sterilizing the isolator.
In one embodiment, the temperature for sterilizing the sealing ring is above 150 ℃ in step S1.
In one embodiment, in step S3, sterilizing the isolator uses hydrogen peroxide gas.
In one embodiment, the hydrogen peroxide gas has a concentration of 400ppm or more.
In one embodiment, the pressure inside the isolator is maintained to 100pa, and the internal pressure within 3min of sterilization is not lower than 76 pa.
In one embodiment, in step S2, the device for inflating the gasket is an air compression tank.
The invention also provides the sealing ring, the sealing ring is provided with a cavity, the sealing ring is provided with an air inlet and an air outlet, the cavity is communicated with the air inlet and the air outlet, the air inlet is provided with a three-way valve, the air outlet of the three-way valve is communicated with the air inlet of the sealing ring, and the air outlet is provided with an exhaust valve.
In one embodiment, a first air inlet of the three-way valve is communicated with the steam sterilizer, and a second air inlet of the three-way valve is communicated with the air compression tank.
In one embodiment, the three-way valve is coated with a thermal insulation material.
The sterilization method can solve the problem and risk that the sealing ring on the automatic sealing door between the isolator and the dryer cannot be effectively sterilized, and the high-temperature gas for sterilizing the sealing ring comes from the high-temperature gas source in the dryer, so that the high-temperature gas source is not required to be additionally provided, and the sterilization cost is further reduced.
Drawings
FIG. 1 is a schematic flow chart illustrating a sterilization method for a connection device of an isolator and a dryer according to the present invention;
FIG. 2 is a schematic structural diagram of a sealing ring according to the present disclosure;
FIG. 3 is a schematic structural view of the automatic sealing door disclosed in the present invention;
FIG. 4 is a schematic view and a partial enlarged view I of the sealing ring sealing door body disclosed in the present invention;
FIG. 5 is a schematic structural view of a connecting apparatus of an isolator and a dryer according to the present invention;
FIG. 6 is a schematic view of sterilization and sealing ring inflation of the dryer disclosed in the present invention;
description of reference numerals:
1 sealing ring, 11 air inlets, 12 air outlets, 2 automatic sealing doors, 21 electric cylinders, 22 joints, 23 guide rails, 24 sliding blocks, 25 sealing door bodies, 26 sealing ring installation seats, 3 dryers, 31 laminar flow fans, 32 fan housings, 33 filters, 34 bottle conveying net belts, 35 cooling boxes, 36 air return assemblies, 37 heating devices, 38 surface cooling devices, 4 filling machines with isolators, 51 centrifugal fans, 52 three-way electromagnetic valves, 53 compressed air branch two-way electromagnetic valves, 54 pressure monitors, 55 micro-mist separators, 56 pressure reducing valves, 57 air leakage two-way electromagnetic valves and 58 high-temperature air branch two-way electromagnetic valves.
Detailed Description
In order to make the aforementioned objects, features and advantages of the present invention comprehensible, embodiments accompanied with figures are described in detail below. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein, but rather should be construed as broadly as the present invention is capable of modification in various respects, all without departing from the spirit and scope of the present invention.
In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience of description and simplicity of description, but do not indicate or imply that the device or element being referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus, should not be construed as limiting the present invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used in the description of the invention herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention.
A method for sterilizing a connecting device of an isolator and a dryer, comprising the steps of:
s1, as shown in fig. 4 and 5, closing the automatic sealing door 2 between the isolator 4 and the dryer 3, and sterilizing the dryer 3 at high temperature, as shown in fig. 6, sterilizing the sealing ring 1 by high temperature steam through the air inlet 11 of the sealing ring 1 on the automatic sealing door 2;
specifically, referring to fig. 6, the automatic sealing door 2 is lowered to the lowest position of the stroke, that is, the window of the dryer 3 is closed, at this time, the sealing ring 1 on the automatic sealing door 2 does not perform any inflation operation, the self-sterilization procedure of the dryer 3 is started, that is, the laminar flow fan 31 and the heating device 37 are started, the hot air heated by the heating device 37 is vertically blown to the fan housing 32 under the adsorption action of the laminar flow fan 31, then is filtered by the high-temperature high-efficiency filter 33 and blown to the working chamber where the bottle conveying mesh belt 34 is located, then enters the heating device 37 after passing through the air return assembly 36 at the bottom to be heated again and enter the next cycle, the cooling box 35 is sterilized by the continuously circulating high-temperature air flow,
referring to fig. 6 and 4, high-temperature steam continuously enters the interior of the gasket 1, the gasket mounting seat 26 and the inner side of the sealing door, and conducts heat to sterilize the high-temperature steam. In order to avoid providing extra high-temperature gas, an air pipe hole is formed in the position of the box body above the heating device 37 and used for supplying high-temperature air to the inside of the sealing ring, the temperature of the high-temperature air is above 150 ℃, namely, the centrifugal fan 51 continuously extracts a proper amount of high-temperature air to fill the inflatable sealing ring 1, the two-way electromagnetic valve 58 of the high-temperature air branch is opened at the moment, the three-way electromagnetic valve 52 is switched to the state that the right channel is opened, the continuous inflation state is realized, the high-temperature air entering the sealing ring 1 can be discharged through the air outlet 12 at the other end, namely, the two-way electromagnetic valve 57 for air leakage of the sealing ring is opened in the process flow, and the two-way electromagnetic valve 53 for compressed air is also closed at the moment. To avoid heat loss. And laying heat-insulating materials on the inflation air pipes of the sealing rings.
In the seal ring in S1, as shown in fig. 2, the seal ring 1 has a cavity, the seal ring 1 has an air inlet 11 and an air outlet 12, the cavity is communicated with the air inlet 11 and the air outlet 12, a three-way valve is installed on the air inlet 11, the air outlet of the three-way valve is communicated with the air inlet 11 of the seal ring 1, and an exhaust valve is installed on the air outlet 12.
S2, after the dryer and the sealing ring are sterilized, inflating the sealing ring through the air inlet of the sealing ring to enable the sealing ring to be attached to the sealing door body;
specifically, referring to fig. 3, the automatic sealing door includes an electric cylinder 21, a door frame 20 and a sealing door body 25, the sealing door body 25 is installed on the door frame 20, the electric cylinder 21 is connected to the sealing door body 25 through a joint 22 for driving the sealing door body 25 to ascend or descend, guide rails 23 are respectively installed on two sides of the door frame 20, a slider 24 is installed on the guide rails 23, two ends of the sealing door body 25 are fixed on the slider 24 through bolts, and the up-and-down movement is realized through the electric cylinder 21. The door frame 20 is provided with a window having the same shape as the sealing door body 25, and the sealing door body 25 has a size not smaller than that of the window to seal the window. Further, a sealing ring mounting seat 26 is arranged on the door frame 20, a groove is formed in the mounting seat 26, a sealing ring 1 is mounted in the groove, a gap of 2mm is formed between the sealing ring mounting seat 26 and the sealing door body 25, and when the sealing door body 25 descends to the lowest position, the sealing ring 1 is inflated through an air compression tank to fill the gap to achieve sealing, as shown in fig. 4.
It should be noted that, in steps S1 and S2, the gas filled in the sealing ring cannot be mixed and needs to be separately provided, because the air drawn out from the inside of the dryer casing cannot reach the required pressure to seal the air-filled sealing ring by expanding the air-filled sealing ring, so that high-pressure air for connecting a client is required during air-filled sealing, and even if high-pressure and high-temperature air exists, the service life of the sealing ring is affected and the sealing ring is easily damaged when air-filled sealing is performed at high temperature.
And S3, sterilizing the isolator.
Specifically, referring to fig. 6, hydrogen peroxide gas having a concentration of 400ppm or more is filled into the isolator to sterilize the equipment inside the isolator and the automatic sealing door exposed to the inside of the isolator. In order to ensure that the hydrogen peroxide gas is not leaked, the automatic sealing door of the dryer needs to be sealed, i.e. the gas inside the isolator cannot be leaked into the dryer, thereby affecting the sterilization effect. At this time, the three-way solenoid 52 is switched to a left channel, the two-way solenoid valve 53 for compressed air is opened, the pressure inside the isolator is 100pa, compressed air with certain pressure passes through the pressure detector 54 and then flows into the sealing ring 1 after being filtered by the micro-mist separator 55, so that the sealing ring 1 is expanded and sealed, the pressure reducing valve 56 is arranged on the air path, the pressure inside the isolator is not lower than 76pa within 3min, the pressure is relieved when the pressure value exceeds the limit, the sealing ring is ensured not to be damaged by excessive pressure, and the two-way solenoid valve 57 for air leakage of the sealing ring and the two-way solenoid valve 58 for high-temperature air branch are both in a closed state.
The sterilization method can solve the problem and risk that the sealing ring on the automatic sealing door between the isolator and the dryer cannot be effectively sterilized, and the high-temperature gas for sterilizing the sealing ring comes from the high-temperature gas source in the dryer, so that the high-temperature gas source is not required to be additionally provided, and the sterilization cost is further reduced.
The invention also provides the sealing ring, as shown in fig. 2, the sealing ring 1 is provided with a cavity, the sealing ring 1 is provided with an air inlet 11 and an air outlet 12, the cavity is communicated with the air inlet 11 and the air outlet 12, the air inlet 11 is provided with a three-way valve, the air outlet of the three-way valve is communicated with the air inlet 11 of the sealing ring 1, and the air outlet 12 is provided with an exhaust valve.
Further, a steam sterilizer is communicated with a first air inlet of the three-way valve, and an air compression tank is communicated with a second air inlet of the three-way valve.
In one embodiment, the three-way valve is coated with a thermal insulation material to avoid heat loss.
The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.
The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.
Claims (6)
1. A method for sterilizing a connecting device of an isolator and a dryer, comprising the steps of:
s1, closing a sealing door between an isolator and a dryer, sterilizing the dryer at high temperature, and sterilizing the sealing ring, a sealing ring mounting seat and the inner side of the sealing door by high-temperature gas through an air inlet of a sealing ring on the sealing door, wherein the sealing ring is provided with a cavity, the sealing ring is provided with an air inlet and an air outlet, the cavity is communicated with the air inlet and the air outlet, a three-way valve is mounted on the air inlet, the air outlet of the three-way valve is communicated with the air inlet of the sealing ring, an exhaust valve is mounted on the air outlet, a first air inlet of the three-way valve is communicated with a steam sterilizer, and a second air inlet of the three-way valve is communicated with an air compression tank;
s2, after the dryer and the sealing ring are sterilized, inflating the sealing ring through the air inlet of the sealing ring to enable the sealing ring to be attached to the sealing door body, wherein the device for inflating the sealing ring is an air compression tank;
and S3, sterilizing the isolator.
2. The sterilization method according to claim 1, wherein in step S1, the temperature at which the gasket is sterilized is 150 ℃ or higher.
3. The sterilization method according to claim 1, wherein in step S3, hydrogen peroxide gas is used for sterilization of the isolator.
4. The sterilization method according to claim 3, wherein the concentration of the hydrogen peroxide gas is 400ppm or more.
5. The sterilization method according to claim 1, wherein the pressure inside the separator is maintained to 100pa, and the internal pressure within 3min of sterilization is not lower than 76 pa.
6. A sterilization process according to claim 1, characterized in that said three-way valve is coated with a heat-insulating material.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811341630.XA CN109481709B (en) | 2018-11-12 | 2018-11-12 | Sterilization method and sealing ring for connecting device of isolator and dryer |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811341630.XA CN109481709B (en) | 2018-11-12 | 2018-11-12 | Sterilization method and sealing ring for connecting device of isolator and dryer |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN109481709A CN109481709A (en) | 2019-03-19 |
| CN109481709B true CN109481709B (en) | 2021-09-03 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN201811341630.XA Active CN109481709B (en) | 2018-11-12 | 2018-11-12 | Sterilization method and sealing ring for connecting device of isolator and dryer |
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE3524415A1 (en) * | 1984-07-10 | 1986-01-16 | Sando Iron Works Co., Ltd., Wakayama | High-pressure damper door |
| CN201529278U (en) * | 2009-10-09 | 2010-07-21 | 南京固延制药设备有限公司 | Device for sterilizing cooling section of tunnel drying oven |
| CN103480017A (en) * | 2013-09-18 | 2014-01-01 | 连云港佑源医药设备制造有限公司 | Online sealing steam disinfection and sterilization device |
| CN208041121U (en) * | 2018-03-22 | 2018-11-02 | 楚天科技股份有限公司 | A kind of sealing device of disinfecting drying machine |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106474505A (en) * | 2016-12-09 | 2017-03-08 | 昆山新莱洁净应用材料股份有限公司 | A kind of employing high-temperature steam promotes the Full automatic sterilizing device that sealing ring is combined with door |
-
2018
- 2018-11-12 CN CN201811341630.XA patent/CN109481709B/en active Active
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE3524415A1 (en) * | 1984-07-10 | 1986-01-16 | Sando Iron Works Co., Ltd., Wakayama | High-pressure damper door |
| CN201529278U (en) * | 2009-10-09 | 2010-07-21 | 南京固延制药设备有限公司 | Device for sterilizing cooling section of tunnel drying oven |
| CN103480017A (en) * | 2013-09-18 | 2014-01-01 | 连云港佑源医药设备制造有限公司 | Online sealing steam disinfection and sterilization device |
| CN208041121U (en) * | 2018-03-22 | 2018-11-02 | 楚天科技股份有限公司 | A kind of sealing device of disinfecting drying machine |
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| Publication number | Publication date |
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| CN109481709A (en) | 2019-03-19 |
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Application publication date: 20190319 Assignee: Changsha Pharmaceutical Equipment Industrial Technology Research Institute Co.,Ltd. Assignor: TRUKING TECHNOLOGY Ltd. Contract record no.: X2023980051833 Denomination of invention: Sterilization method and sealing ring for connecting equipment between isolators and dryers Granted publication date: 20210903 License type: Common License Record date: 20231213 |
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