CN106310302A - RTP container and online sterilization and online drying device comprising RTP container and use method thereof - Google Patents
RTP container and online sterilization and online drying device comprising RTP container and use method thereof Download PDFInfo
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- CN106310302A CN106310302A CN201510341503.XA CN201510341503A CN106310302A CN 106310302 A CN106310302 A CN 106310302A CN 201510341503 A CN201510341503 A CN 201510341503A CN 106310302 A CN106310302 A CN 106310302A
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Abstract
The invention discloses a RTP container and an online sterilization and online drying device comprising the RTP container and a use method thereof. In the prior art, a whole RTP container must be put into a sterilization cabinet for off-line sterilization, the RTP container cannot be completely dried by a drying system brought by the sterilization cabinet, the technological requirements of strictly controlled dryness of objects cannot be met. The RTP container is characterized in that a gas inlet is arranged on a cavity near a passive door, the cavity is connected with a gas inlet diaphragm valve, the bottom of the gas inlet is provided with an exhaust port, is connected with an exhaust port diaphragm valve; the outer wall of the cavity is covered with a removable insulation layer, and the passive door is covered with a pressure protection cover resisting high pressure steam sterilization pressure. The RTP container is suitable for on-line sterilization and on-line drying, and the online sterilization and online drying device comprising the RTP container can thoroughly dry sterilized objects, and can meet the technological requirements of strictly controlled dryness of the sterilized objects.
Description
Technical field
The present invention relates to pharmaceutical machine steam sterilization techniques field, RTP container, the online sterilizing comprising RTP container and the online dry device of a kind of aseptic material transmission being applied to the industries such as pharmacy, biology, food and using method thereof.
Background technology
In the process of producing product of the industries such as pharmacy, biology, food, it is frequently necessary under non-sterile production environment, article after sterilizing are transferred to another sterilized space from a sterilized space, in transmittance process, also need to maintain the aseptic condition of article, such as the aseptic material in sterilizing cabinet is delivered in sterile filling isolator.
At present, most widely used is RTP (Rapid Transfer Port) fast transfer gate technique.The RTP door of complete set is made up of alpha door (also referred to as active door) and beta door (also referred to as passive door), wherein alpha door is typically mounted on the wall of isolator, RABS or Biohazard Safety Equipment, beta door is then arranged on the discharging opening of the container holding article, and therefore this container is also referred to as RTP container.
The bottom of RTP container is provided with a hydrophobicity aseptic level filter, and saturated vapor can be allowed to pass through, and the most whole RTP container just can put into sterilizing in sterilizing cabinet.
At present the disinfecting action flow process of RTP container is as follows: first, it would be desirable to the article of sterile transfer (include the tool of production, glass drying oven, packaging material etc. are any can be with the article of steam sterilization) load in RTP container, cover beta door；
Secondly, whole RTP container is put into devaporation sterilizing in sterilizing cabinet；
Then, take out the most sterilized good RTP container, the beta door of its discharging opening is docked on the alpha door of isolator (isolator sterilizing in advance is good, stand-by), and locks；
Finally, by the glove on isolator, inside isolator, open a whole set of RTP door, thus connect two sterilized spaces, sterilizing article is quickly transferred in isolator in RTP container.
Although said method has been widely used, but have a disadvantage in that RTP container must whole be put in sterilizing cabinet and do off-line sterilizing, these article (such as plug and vial etc.) that some are needed to make thorough dried after sterilization, the drying system carried by sterilizing cabinet is difficult to accomplish to be completely dried, it is impossible to meet the technological requirement having strict control to article aridity.
Summary of the invention
The technical problem to be solved is the defect overcoming above-mentioned prior art to exist, it is provided that the RTP container that a kind of structure is improved, and makes RTP container can be appropriate to online sterilizing and online dry.
For this, the present invention adopts the following technical scheme that: a kind of RTP container, cavity and the passive door being arranged on cavity discharge outlet including high pressure resistant steam sterilization pressure, it is characterized in that, having an air inlet and connect an air inlet diaphragm valve on the cavity of passive door, the bottom of cavity has an air vent and connects an air vent diaphragm valve；
The lateral wall of described cavity covers a detachable heat-insulating layer, and described passive door is stamped the pressure protection cap of a high pressure resistant steam sterilization pressure.
The present invention eliminates the filter being arranged on RTP container bottom in existing RTP structure of container, and aerofluxus and draining are all carried out by air vent diaphragm valve.
Further, described cavity and pressure protection cap are all resistant to more than 0.1MPa saturated vapor sterilization pressure.
Further, described detachable heat-insulating layer is common heat-insulation layer or electric heating type heat-insulation layer.
It is a further object of the present invention to provide online sterilizing and the online dry device comprising above-mentioned RTP container, RTP container can be carried out the device of online sterilizing and online dry, it can carry out thorough dried to article after sterilizing, to meet the technological requirement having strict control to the aridity of article after sterilizing.
For this, the technical scheme that another object of the present invention uses is as follows: the online sterilizing of RTP container and online dry device, comprise above-mentioned RTP container, it is characterized in that, it also comprises conveyance conduit, clean steam system, clean pressure air system, vacuum system, air heating system, sterile air filtration system, safe pressure relief device and hydrophobic, draining and gas extraction system, and described hydrophobic, draining and gas extraction system comprise discharge tube；
The air vent diaphragm valve of described RTP container is by silica gel hose and connects clip soon and is connected with discharge tube；
The input of described conveyance conduit sets described vacuum system and clean pressure air system, the outfan of conveyance conduit is by silica gel hose and connects clip soon and is connected with the air inlet diaphragm valve of RTP container, sets described air heating system, sterile air filtration system, clean steam system and safe pressure relief device between input and the outfan of conveyance conduit successively；
Described clean pressure air system is for providing clean compressed air to RTP container, clean compressed air is heated by described air heating system, sterile air filtration system carries out aseptic filtration to the clean compressed air after heating, described clean steam system is for providing clean steam to RTP container and sterile air filtration system, described is hydrophobic, draining and gas extraction system are for the condensed water that will produce during sterile air filtration system sterilizing, the condensed water that produces during sterilizing in RTP container and dry time the clean compressed air that is passed through in RTP container discharge, described vacuum system is vacuum dried for the vacuum controlled in RTP container；Described safe pressure relief device pressure release when superpressure, it is ensured that safety when the online sterilizing of RTP container and online dry device use.
Further, described clean pressure air system includes clean compressed air conveyance conduit and the air relief valve being arranged on clean compressed air conveyance conduit and the first diaphragm valve.
Further, described clean compressed air can use clean nitrogen to replace, it would however also be possible to employ the inert gas of other cleanings replaces.
Further, described vacuum system includes vacuum handling pipeline and the vacuum pump, check-valves and the second diaphragm valve that are arranged on vacuum handling pipeline.
Further, described air heating system uses steam indirect heat exchange mode to carry out heating or being directly electrically heated.
Further, described sterile air filtration system includes stainless steel filter housing, be placed in housing degerming level hydrophobicity filter element and the Pressure gauge being arranged on housing.
Further, described clean steam system includes clean steam conveyance conduit and the steam rates regulation valve being arranged on clean steam conveyance conduit.
Further, described safe pressure relief device is relief valve or rupture disk.
Further, described hydrophobic, draining and gas extraction system also comprise condensed water drain water piping, is arranged on condensed water drain water piping the first drain valve and the 3rd diaphragm valve and the drain valve being arranged on discharge tube and the second drain valve, described sterile air filtration system is connected with discharge tube by described condensed water drain water piping.
Further, described online sterilizing and online dry device also comprise a switch board, this switch board band PLC, man machine operation interface and control software, described conveyance conduit is provided with pressure probe and pressure transducer, it is respectively equipped with the whole operation of temperature probe and sensor, online sterilizing and online dry device on described discharge tube and condensed water drain water piping and automatically controls valves such as (use air-driven type) all of diaphragm valve, drain valve, regulation valves by PLC.
Another object of the present invention is to provide the above-mentioned online sterilizing of RTP container and the using method of online dry device, and its step is as follows:
A. clean pressure air system accesses clean compressed air, clean steam system access clean steam；
B. the air inlet of RTP container of article subject to sterilization and air vent will be loaded respectively by connecing clip soon and silica gel hose is connected to the outfan of conveyance conduit and hydrophobic, draining and the incoming end of gas extraction system；
C. online sterilizing and online dry program are started:
C1) whole online sterilizing and online dry device are carried out air-leakage test: be passed through clean compressed air pressurize, confirm whether air-tightness meets the requirements；
C2) open vacuum pump, RTP container and sterile air filtration system are evacuated to setting value, then pass to clean steam to setup pressure value；Evacuation again, is passed through clean steam again, is so repeated 3 times above circulation to remove the non-condensing gas in RTP container and sterile air filtration system；
C3) it is passed through clean steam heating RTP container and sterile air filtration system, after temperature reaches setting value, starts timing；
C4) after timing reaches the sterilizing setting time, close clean steam, discharge the pressure of RTP container to setting value by hydrophobic, draining and gas extraction system；
C5) opening vacuum pump to be dried RTP container vacuum-pumping to the setting time, the aseptic compressed air then passing to be heated to setting value is dried；After reaching the dryer settings time, again it is evacuated to setting value, is the most again passed through the aseptic compressed air being heated to setting value；So it is repeated 3 times above circulation to be thoroughly dried RTP container contents；
D. it is dried after terminating, takes apart and connect clip soon and disconnect silica gel hose, take off sterilized RTP container, stand-by.
The device have the advantages that as follows: achieving online sterilizing and the online dry of RTP container, sterilization effect is more preferably；Sterilizing rises gentle temperature-fall period and shortens, and sterilizing speed is faster；Vacuum drying and hot air blowing alternately, are dried more thorough, the technique being suitable for article aridity is had strict demand；Whole operating process can be automatically controlled by PLC, more meets the requirement of drugs manufacture equipment automatization.
Accompanying drawing explanation
Fig. 1 is the structural representation of RTP container of the present invention.
In figure, 100-cavity, 101-passive door (i.e. Beta door), 102-pressure protection cap, 103-air inlet diaphragm valve, 104-air vent diaphragm valve, 105-detachable heat-insulating layer.
Fig. 2 is the online sterilizing of RTP container of the present invention and the schematic diagram of online dry device.
nullIn figure，200-conveyance conduit，201-silica gel hose，202-pressure transducer，203-safe pressure relief device，204-clean steam conveyance conduit，205-sterile air filtration system，206-clean compressed air conveyance conduit，207-vacuum system，208-air heating system，209-temperature probe and sensor，210-is hydrophobic、Draining and gas extraction system，211-clean pressure air system，212-clean steam system，213-discharge tube，214-connects clip soon，215-air relief valve，216-the first diaphragm valve，217-vacuum handling pipeline，218-vacuum pump，219-check-valves，220-the second diaphragm valve，221-steam rates regulation valve，222-condensed water drain water piping，223-the first drain valve，224-the 3rd diaphragm valve，225-drain valve，226-the second drain valve.
Detailed description of the invention
Below in conjunction with specification drawings and specific embodiments, the invention will be further described.
RTP container as shown in Figure 1, cavity 100 discharge outlet of high pressure resistant steam sterilization pressure, equipped with passive door 101, has air inlet and connects air inlet diaphragm valve 103 on the cavity of passive door, and the bottom of cavity has air vent and connects air vent diaphragm valve 104.The lateral wall of cavity 100 covers detachable heat-insulating layer 105, and described passive door is stamped the pressure protection cap 102 of high pressure resistant steam sterilization pressure.Described cavity 100 and pressure protection cap 102 are all resistant to more than 0.1MPa saturated vapor sterilization pressure.Described detachable heat-insulating layer 105 is common heat-insulation layer or electric heating type heat-insulation layer.
The online sterilizing of RTP container and online dry device, hydrophobic, draining and gas extraction system 210 as shown in Figure 2 are made up of discharge tube 213, condensed water drain water piping 222, the first drain valve 223 being arranged on condensed water drain water piping and the 3rd diaphragm valve 224 and drain valve 225 and the second drain valve 226 being arranged on discharge tube.
Air vent diaphragm valve 104 is by silica gel hose 201 and connects clip 214 soon and is connected with discharge tube 213.The input of conveyance conduit 200 is provided with vacuum system 207 and clean pressure air system 211, the outfan of conveyance conduit 200 is by silica gel hose 201 and connects clip 214 soon and is connected with the air inlet diaphragm valve 103 of RTP container, is sequentially provided with air heating system 208, sterile air filtration system 205, clean steam system 212 and safe pressure relief device 203 between input and the outfan of conveyance conduit 200.
Sterile air filtration system 205 is connected with discharge tube 213 by condensed water drain water piping 222.Degerming level hydrophobicity filter element and the Pressure gauge being arranged on housing that described sterile air filtration system 205 by stainless steel filter housing, is placed in housing form.
Described clean pressure air system 211 is for providing clean compressed air to RTP container, clean compressed air is heated by described air heating system 208, sterile air filtration system 205 carries out aseptic filtration to the clean compressed air after heating, described clean steam system 212 is for providing clean steam to RTP container and sterile air filtration system, described is hydrophobic, draining and gas extraction system 210 are for the condensed water that will produce during sterile air filtration system sterilizing, the condensed water that produces during sterilizing in RTP container and dry time the clean compressed air that is passed through in RTP container discharge, described vacuum system 207 is vacuum dried for the vacuum controlled in RTP container；The described safe pressure relief device 203 pressure release when superpressure, it is ensured that safety when the online sterilizing of RTP container and online dry device use.
Described clean pressure air system 211 is made up of clean compressed air conveyance conduit 206 and air relief valve 215 and the first diaphragm valve 216 being arranged on clean compressed air conveyance conduit.Clean compressed air can use clean nitrogen to replace, it would however also be possible to employ the inert gas of other cleanings replaces.
Described vacuum system 207 is made up of vacuum handling pipeline 217 and vacuum pump 218, check-valves 219 and the second diaphragm valve 220 being arranged on vacuum handling pipeline.Described air heating system 208 uses steam indirect heat exchange mode to carry out heating or being directly electrically heated.
Described clean steam system 212 is made up of clean steam conveyance conduit 204 and the steam rates regulation valve 221 being arranged on clean steam conveyance conduit.Described safe pressure relief device 203 is relief valve or rupture disk.
Described online sterilizing and online dry device also comprise a switch board, this switch board band PLC, man machine operation interface and control software, described conveyance conduit 200 is provided with pressure probe and pressure transducer 202, set the whole operation of temperature probe and sensor 209, online sterilizing and online dry device on described discharge tube 213 and condensed water drain water piping 222 respectively and automatically control valves such as (use air-driven type) all of diaphragm valve, drain valve, regulation valves by PLC.
The using method of the above-mentioned online sterilizing of RTP container and online dry device is as follows:
A. the article (include the tool of production, glass drying oven, packaging material etc. are any can be with the article of steam sterilization) needing sterile transfer are loaded in the cavity 100 of RTP container, cover beta door 101, cover pressure protection cap 102, wrap detachable heat-insulating layer 105.
B. connect clean steam, industrial steam, clean compressed air and instrument gas, connect control system power supply；
C. by sanitation-grade silica gel hose 201, the air inlet diaphragm valve 103 of the RTP container cavity 100 already loaded with article subject to sterilization and air vent diaphragm valve 104 are connected respectively to outfan and the incoming end of discharge tube 213 of conveyance conduit 200, with connecing clip 214 clamping soon；
D. the startup online sterilizing of RTP container and online dry program:
D1) open clean pressure air system 206 and respective valves, whole device is carried out air-leakage test, it is ensured that qualified；
D2) start vacuum system 207, RTP container 100 and sterile air filtration system 205 are evacuated down to setting value；
D3) open the ratio adjusting valve 221 on clean steam conveyance conduit 204, RTP container cavity 100 and filter 205 are pressurized to setting value；
D4) d2 is repeated)-d3) process 3 times, get rid of the non-condensing gas in RTP container 100 and sterile air filtration system 205；
D5) open the ratio adjusting valve 221 on clean steam conveyance conduit 204, be passed through steam and RTP container cavity 100 and sterile air filtration system 205 are heated up；When starting sterilometer after being warmed up to 121 DEG C；
D6), after terminating during sterilometer, start vacuum system 207, RTP container cavity 100 is carried out evacuation and is dried；
D7) start clean pressure air system 211 and air heating system 208, RTP container cavity 100 is carried out hot air blowing；
D8) repeat d6-d7 process 3 times, be thoroughly dried the article in RTP container cavity 100；
E. it is dried after terminating and closes all valves, take apart and connect clip soon and disconnect silica gel hose 201, take off sterilized RTP container, stand-by.
Below only preferred embodiment of the present invention is described, but is not to be construed as limitations on claims.The present invention is not only limited to above example, and its concrete structure allows to change.All various changes made in the protection domain of independent claims of the present invention are the most within the scope of the present invention.
Claims (14)
1. a RTP container, including the cavity (100) of high pressure resistant steam sterilization pressure be arranged on the passive door (101) of cavity discharge outlet, it is characterized in that, having an air inlet and connect an air inlet diaphragm valve (103) on the cavity of passive door, the bottom of cavity has an air vent and connects an air vent diaphragm valve (104)；
The lateral wall of described cavity (100) covers a detachable heat-insulating layer (105), and described passive door is stamped the pressure protection cap (102) of a high pressure resistant steam sterilization pressure.
RTP container the most according to claim 1, it is characterised in that described cavity (100) and pressure protection cap (102) are all resistant to more than 0.1MPa saturated vapor sterilization pressure.
RTP container the most according to claim 1, it is characterised in that described detachable heat-insulating layer (105) is common heat-insulation layer or electric heating type heat-insulation layer.
The online sterilizing of 4.RTP container and online dry device, comprise the RTP container described in any one of claim 1-3, it is characterized in that, it also comprises conveyance conduit (200), clean steam system (212), clean pressure air system (211), vacuum system (207), air heating system (208), sterile air filtration system (205), safe pressure relief device (203) and hydrophobic, draining and gas extraction system (210), described hydrophobic, draining and gas extraction system (210) and comprises discharge tube (213)；
The air vent diaphragm valve (104) of described RTP container is by silica gel hose (201) and connects clip (214) soon and is connected with discharge tube (213)；
The input of described conveyance conduit (200) sets described vacuum system (207) and clean pressure air system (211), the outfan of conveyance conduit (200) is by silica gel hose (201) and connects clip (214) soon and is connected with the air inlet diaphragm valve (103) of RTP container, sets described air heating system (208), sterile air filtration system (205), clean steam system (212) and safe pressure relief device (203) between input and the outfan of conveyance conduit (200) successively；
Described clean pressure air system (211) is for providing clean compressed air to RTP container, clean compressed air is heated by described air heating system (208), sterile air filtration system (205) carries out aseptic filtration to the clean compressed air after heating, described clean steam system (212) is for providing clean steam to RTP container and sterile air filtration system (205), described is hydrophobic, draining and gas extraction system (210) are for the condensed water that will produce during sterile air filtration system (205) sterilizing, the condensed water that produces during sterilizing in RTP container and dry time the clean compressed air that is passed through in RTP container discharge, described vacuum system (207) is vacuum dried for the vacuum controlled in RTP container；The described safe pressure relief device (203) pressure release when superpressure, it is ensured that safety when the online sterilizing of RTP container and online dry device use.
The online sterilizing of RTP container the most according to claim 4 and online dry device, it is characterized in that, described clean pressure air system (211) includes clean compressed air conveyance conduit (206) and the air relief valve (215) being arranged on clean compressed air conveyance conduit and the first diaphragm valve (216).
The online sterilizing of RTP container the most according to claim 4 and online dry device, it is characterised in that described clean compressed air can use clean nitrogen to replace.
The online sterilizing of RTP container the most according to claim 4 and online dry device, it is characterized in that, described vacuum system (207) includes vacuum handling pipeline (217) and the vacuum pump (218) being arranged on vacuum handling pipeline, check-valves (219) and the second diaphragm valve (220).
The online sterilizing of RTP container the most according to claim 4 and online dry device, it is characterised in that described air heating system (208) uses steam indirect heat exchange mode to carry out heating or being directly electrically heated.
The online sterilizing of RTP container the most according to claim 4 and online dry device, it is characterized in that, described sterile air filtration system (205) includes stainless steel filter housing, the degerming level hydrophobicity filter element that is placed in housing and the Pressure gauge being arranged on housing.
The online sterilizing of RTP container the most according to claim 4 and online dry device, it is characterized in that, described clean steam system (212) includes clean steam conveyance conduit (204) and steam rates regulation valve (221) being arranged on clean steam conveyance conduit.
The 11. online sterilizing of RTP container according to claim 4 and online dry devices, it is characterised in that described safe pressure relief device is relief valve or rupture disk.
The 12. online sterilizing of RTP container according to claim 4 and online dry devices, it is characterized in that, described hydrophobic, draining and gas extraction system (210) also comprise condensed water drain water piping (222), is arranged on condensed water drain water piping the first drain valve (223) and the 3rd diaphragm valve (224) and the drain valve (225) being arranged on discharge tube and the second drain valve (226), described sterile air filtration system (205) is connected with discharge tube (213) by described condensed water drain water piping (222).
The 13. online sterilizing of RTP container according to claim 4 and online dry devices, it is characterized in that, it also comprises a switch board, this switch board band PLC, man machine operation interface and control software, described conveyance conduit (200) is provided with pressure probe and pressure transducer (202), being respectively equipped with temperature probe and sensor (209) on described discharge tube (213) and condensed water drain water piping (222), the whole operation of the online sterilizing of RTP container and online dry device is automatically controlled by PLC.
The online sterilizing of RTP container and the using method of online dry device described in 14. any one of claim 4-13, its step is as follows:
A. clean pressure air system accesses clean compressed air, clean steam system access clean steam；
B. the air inlet of RTP container of article subject to sterilization and air vent will be loaded respectively by connecing clip soon and silica gel hose is connected to the outfan of conveyance conduit and hydrophobic, draining and the incoming end of gas extraction system；
C. online sterilizing and online dry program are started:
C1) whole online sterilizing and online dry device are carried out air-leakage test: be passed through clean compressed air pressurize, confirm whether air-tightness meets the requirements；
C2) open vacuum pump, RTP container and sterile air filtration system are evacuated to setting value, then pass to clean steam to setup pressure value；Evacuation again, is passed through clean steam again, is so repeated 3 times above circulation to remove the non-condensing gas in RTP container and sterile air filtration system；
C3) it is passed through clean steam heating RTP container and sterile air filtration system, after temperature reaches setting value, starts timing；
C4) after timing reaches the sterilizing setting time, close clean steam, discharge the pressure of RTP container to setting value by hydrophobic, draining and gas extraction system；
C5) opening vacuum pump to be dried RTP container vacuum-pumping to the setting time, the aseptic compressed air then passing to be heated to setting value is dried；After reaching the dryer settings time, again it is evacuated to setting value, is the most again passed through the aseptic compressed air being heated to setting value；So it is repeated 3 times above circulation to be thoroughly dried RTP container contents；
D. it is dried after terminating, takes apart and connect clip soon and disconnect silica gel hose, take off sterilized RTP container, stand-by.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510341503.XA CN106310302A (en) | 2015-06-17 | 2015-06-17 | RTP container and online sterilization and online drying device comprising RTP container and use method thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201510341503.XA CN106310302A (en) | 2015-06-17 | 2015-06-17 | RTP container and online sterilization and online drying device comprising RTP container and use method thereof |
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| CN106310302A true CN106310302A (en) | 2017-01-11 |
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| CN201510341503.XA Pending CN106310302A (en) | 2015-06-17 | 2015-06-17 | RTP container and online sterilization and online drying device comprising RTP container and use method thereof |
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| CN106913890A (en) * | 2017-03-10 | 2017-07-04 | 洁翼流体技术（上海）有限公司 | A kind of auxiliary equipment and its method of aseptic bridging |
| CN112341266A (en) * | 2020-10-26 | 2021-02-09 | 中阿沸石承德环保科技有限公司 | Zeolite biological organic fertilizer and preparation method thereof |
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Effective date of registration: 20171208 Address after: No. 125, Yue Zhong Road, Binhai New Town, Shaoxing, Zhejiang Province Applicant after: Zhejiang Innovation Biology Co.,Ltd. Address before: No. 59, Chengguan Town, Xinchang County, Shaoxing, Zhejiang Province, around Chengguan East Road Applicant before: ZHEJIANG MEDICINE Co.,Ltd. XINCHANG PHARMACEUTICAL FACTORY |
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Application publication date: 20170111 |