CN102530324A - Purification isolating device of aseptic powder needle split-charging production line - Google Patents
Purification isolating device of aseptic powder needle split-charging production line Download PDFInfo
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- CN102530324A CN102530324A CN2011103874598A CN201110387459A CN102530324A CN 102530324 A CN102530324 A CN 102530324A CN 2011103874598 A CN2011103874598 A CN 2011103874598A CN 201110387459 A CN201110387459 A CN 201110387459A CN 102530324 A CN102530324 A CN 102530324A
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Abstract
The invention discloses a purification isolating device of an aseptic powder needle split-charging production line, which aims at solving the problem that the operation mode of an existing powder needle split-charging production line possibly damages aseptic environment and is high in construction cost. The purification isolating device of the aseptic powder needle split-charging production line directly integrates an isolating device on a powder needle split-charging production line by arranging an isolating device cabin body, a built-in split-charging production line, a glove operating system, a static pressure box, a one-way laminar flow air supply system, an air return system, an exhaust system, an integration interface board and the like, has the beneficial effects that operators can be isolated from the production process of split charging and stopper adding of medicines and the like, and split-charging aseptic environment of the medicines can be more effectively guaranteed.
Description
Technical field
The present invention relates to the purification spacer assembly that a kind of aseptic powder injection divides assembling production lines.
Background technology
The powder pin divide assembling production lines be with the packing of product with bottle after bottle washing machine cleans with purified water, water for injection; Dry up residual water with the degerming pressurized air,, then the bottle transfer is sorted through tunnel baking oven hot air sterilization, except that behind the thermal source; Again it is carried out powder and irritate (branch) dress; After immediately to the bottle tamponade, at last bottle is delivered to Cover-rolling machine and rolls lid, accomplish aseptic powder injection and irritate the production of (branchs) dress.Sterile powder injection is meant the injection sterile powder that adopts aseptic technology to process; The terminally sterilised injection of powder-injection right and wrong; Have characteristics such as aseptic, no thermal source and high purity; For other formulations, the highest to the requirements for quality of product, its inherent quality depends on the aseptic assurance level of supplementary material, technology and environment control to a great extent.According to the requirement of " GMP (revision in 2010) ", the packing of sterile powder injection should be carried out at A level clean area environment.
With regard to prior art; At first the powder pin divides assembling production lines not accomplish people and medicine are kept apart fully; Aseptic powder injection still carries out associative operation by the operating personal of wearing aseptic working clothes around dividing assembling production lines at present; And human body itself is source of pollution maximum in the gnotobasis, and under the condition of defined A level cleanliness class, such operating mode very likely causes the destruction to gnotobasis in 2010 editions GMP appendix 1; Secondly; Cost, the maintenance cost of prior art are higher; Common aseptic powder injection divides assembling production lines still to utilize clean room's in-to-in cleanup system, just hangs holding court from behind a screen of plastics or places dividing plate as barrier in the key core zone, is necessary at the cleanliness class that requires whole clean room under the condition of A level; Construct large-area A level clean room and involve great expense, and operation expense is higher.
Summary of the invention
The present invention addresses the above problem to provide a kind of and can divide aseptic subpackaged production facilitiess such as assembling production lines transfer ordering system, powder pin racking machine, Cover-rolling machine integrated with the powder pin, and the purification spacer assembly of crucial Production Regional may command environment can be provided;
For realizing above-mentioned purpose, a kind of purification spacer assembly of the present invention comprises spacer assembly cabin body, built-in minute assembling production lines, gloves operating system, plenum chamber, unidirectional ply air supply stream system, air return system, exhaust system and integrated interface plate.
As further improvement of the present invention, described spacer assembly cabin body comprises that into bottle cushions cabin 1, filling and stopper-adding cabin 2, rolls and cover cabin 3, transferring cabin 4, and body front, cabin is provided with hatch door 8 and gloves operating system 9, each cabin butt flange and gate.
As further improvement of the present invention, describedly advance that bottle buffering cabin 1 is built-in advances bottle machine 5, and be provided with guide rail, conveniently enter a bottle buffering cabin and dock with sterilization tunnel.
As further improvement of the present invention; Described filling and stopper-adding cabin 2 built-in racking machines 6 and plug stopper-adding machine, and be provided with plug transport carriage and dolly slippage guide rail, after plug is sterilized through the sterilization cabinet; Via going in the transferring cabin on the plug transport carriage, directly be transported to plug vibrations hopper.
As further improvement of the present invention, described rolling covered cabin 3 built-in Cover-rolling machines 7, rolls to cover the cabin and dock with the filling and stopper-adding cabin, and is provided with continuous tilting aluminium lid delivery pipe, and aluminium lid is directly toppled over by the filling and stopper-adding cabin and is delivered to aluminium lid vibrations hopper.
As further improvement of the present invention; Described transferring cabin 4 connects with the sterilization cabinet; And be provided with and slippage guide rail that the cabinet guide rail of sterilizing connects, transferring cabin also is provided with the interface 38 that is connected with the hydrogen peroxide gas producer in addition, and dolly can directly get into transferring cabin; Avoided sterilization material in the traditional handicraft to be transported to the risk of manufacturing line, just be in controlled environment after can making material get into the sterilization cabinet always via intermediate links such as laminar flow cars.
As further improvement of the present invention, described gloves operating system 9 is located on the hatch door 8, and gloves operating system 9 is provided with oversleeve mounting ring, oversleeve, gloves oversleeve adapter sleeve, operation gloves and gloves support that can be for convenience detach.
As further improvement of the present invention, described unidirectional ply air supply stream system 10 comprises frequency conversion fan, and below blower fan, is provided with high efficiency particle air filter 11, and the high efficiency particulate air filter below is provided with current-sharing membrane module 12, to guarantee that air-flow is uniform and stable in the cabin everywhere.
As further improvement of the present invention, described air return system forms 15 by outer backwind tube 13, interior backwind tube 14, high efficiency particle air filter, and air return system is formed the inner complete laminar flow circulating system of clean-up device with unidirectional ply air supply stream system.
As further improvement of the present invention, the air draft filter element that described exhaust system 16 is made up of air draft blower fan, air draft electric control valve 17 and air draft high efficiency particle air filter can be arranged the row's of acceleration residual effect rate when residual, residual time of the row of saving at bactericidal agent.
As further improvement of the present invention; Body top, described spacer assembly cabin is provided with and plenum chamber 18, air-intaking box 19 successively; Plenum chamber is provided with and is used to detect the DOP detection tabs 20 that high efficiency particulate air filter is used; And on the plenum chamber front panel, be provided with tracheae and connect air-supply high efficiency particulate air filter and return air high efficiency particulate air filter upstream and downstream two ends respectively; And be connected to each differential pressure indicator 21, so that the difference of pressure at each high efficiency particulate air filter upstream and downstream two ends of on-line real time monitoring is established new air-valve 22 to connect external new wind air conditioner unit on the air-intaking box.
As further improvement of the present invention, be provided with by gate chute 23 fix screw 24 on the body of said spacer assembly cabin; Gate 25, the gate structure that safety door switch 26 is formed moves on the gate during production; The manufacturing line interlock, the sterilization time gating student moves, and seals hole; Can independently be sterilized in each cabin, be independent of each other.
As further improvement of the present invention, described safety door switch 26 has the mechanical self-latching switch, and each safety door can electrical interlocks, guarantees each cabin orderly safety of sterilizing.
As further improvement of the present invention, the required air gun interface 28 of described integrated interface plate 27 is integrated manufacturing line and spacer assembly cleaning with hydraulic giant interface 29, produce required humidity sensor interface 30 and temperature sensor interface 31, air velocity transducer interface 32, the power interface 33 of realizing the electrical interlocks device, the corpuscular counter interface 34 that on-line monitoring is used, the bacterium that swims sampling interface 35, detect the low concentration sensor interface 36 that hydrogen peroxide uses and the cabin pressure sensor interface 37 of monitoring in real time.
Compared with prior art; The present invention directly divides integrated spacer assembly on the assembling production lines at the powder pin, and operator and drugs packaging, production process such as jump a queue are kept apart, and makes the drugs packaging gnotobasis obtain better assurance; Fundamentally solved the pollution problem that the people brings; Simultaneously protect personnel not receive influence poisonous, the sensitization medicine again, with respect to making up the tradition clean zone of A level on a large scale, reduced construction, maintenance cost effectively in addition.
Description of drawings
Fig. 1 is an overall structure scheme drawing of the present invention;
Fig. 2 is built-in minute of the present invention assembling production lines scheme drawing;
Fig. 3 advances bottle buffering cabin generalized section for the present invention;
Fig. 4 advances bottle buffering cabin front schematic view for the present invention;
Fig. 5 is a gate structure scheme drawing of the present invention;
Fig. 6 is an integrated interface plate scheme drawing of the present invention.
The specific embodiment
As shown in the figure, purification spacer assembly of the present invention comprises spacer assembly cabin body, enters bottle buffering cabin, filling and stopper-adding cabin, rolls and cover cabin, transferring cabin, integrated interface plate, individual layer air supply stream system, air return system and exhaust system.
Wherein enter left side, bottle buffering cabin and dock with sterilization tunnel, the transferring cabin right side connects with the sterilization cabinet.Advance that bottle buffering cabin is built-in advances bottle machine, the built-in racking machine in filling and stopper-adding cabin rolls and cover the built-in Cover-rolling machine in cabin, is provided with in the transferring cabin that guide rail is connected in guide rail and the sterilization cabinet, and the dolly of conveniently sterilizing passes in and out.Generally; The production line operation process is following: after external bottle washing machine is cleaned the packing bottle, get into into bottle buffering cabin through sterilization tunnel, advance that bottle buffering cabin is built-in advances bottle machine; The built-in racking machine in filling and stopper-adding cabin; Medicine advances to get into to roll after bottle and the packing of filling and stopper-adding cabin and cover the cabin and carry out the packing tamponade through the built-in racking machine that purifies xegregating unit through entering a bottle buffering cabin, gets into Cover-rolling machine at last and rolls the lid processing, finally accomplishes whole aseptic powder injection and divides process of assembling; Wherein purify the required plug of the built-in racking machine of spacer assembly, the required aluminium lid of Cover-rolling machine by the sterilization of sterilization cabinet after, directly be sent to racking machine and Cover-rolling machine via transferring cabin.
Claims (10)
1. an aseptic powder injection divides the purification spacer assembly of assembling production lines, comprises spacer assembly cabin body, built-in minute assembling production lines, gloves operating system, plenum chamber, unidirectional ply air supply stream system, air return system, exhaust system and integrated interface plate; Wherein, spacer assembly cabin body comprises that into bottle cushions cabin 1, filling and stopper-adding cabin 2, rolls and cover cabin 3, transferring cabin 4, and body front, cabin is provided with hatch door 8 and gloves operating system 9, each cabin butt flange and gate.
2. according to claim 1, describedly advance that bottle buffering cabin 1 is built-in advances bottle machine 5, and be provided with guide rail.
3. according to claim 1, described filling and stopper-adding cabin 2 built-in racking machines 6 and plug stopper-adding machines, and be provided with plug transport carriage and dolly slippage guide rail.
4. according to claim 1, described rolling covered cabin 3 built-in Cover-rolling machines 7, rolls to cover the cabin and dock with filling and stopper-adding cabin 2, and is provided with the tilting aluminium lid delivery pipe that links to each other with the cabin of jumping a queue.
5. according to claim 1, described transferring cabin 4 connects with the sterilization cabinet, and is provided with interface 38 that is connected with hydrogen peroxide generator and the slippage guide rail that connects with the sterilizer guide rail.
6. according to claim 1, described gloves operating system 9 is located on the hatch door 8, and gloves operating system 9 comprises oversleeve mounting ring, oversleeve, gloves oversleeve adapter sleeve, operation gloves and gloves support.
7. according to claim 1, described unidirectional ply air supply stream system 10 comprises frequency conversion fan, and below blower fan, is provided with high efficiency particle air filter 11 that the high efficiency particulate air filter below is provided with current-sharing membrane module 12; Air return system comprises outer backwind tube 13, interior backwind tube 14, high efficiency particle air filter 15; Exhaust system 16 comprises air draft blower fan, air draft electric control valve 17 and air draft high efficiency particle air filter.
8. according to claim 1; Body top, described spacer assembly cabin is provided with plenum chamber 18, air-intaking box 19 successively; Wherein, Plenum chamber 18 is provided with the DOP that is used to detect the high efficiency particulate air filter integraty and detects interface 20, and on the plenum chamber front panel, is provided with tracheae and connects air-supply high efficiency particulate air filter and return air high efficiency particulate air filter upstream and downstream two ends respectively, and is connected to each differential pressure indicator 21; Establish new air-valve 22 on the air-intaking box 19 and connect external new wind air conditioner unit.
9. according to claim 1, said spacer assembly cabin body is provided with the gate structure of being made up of gate chute 23, fix screw 24, gate 25, safety door switch 26, and wherein safety door switch 26 has the mechanical self-latching switch.
10. according to claim 1, described integrated interface plate 27 is integrated air gun interface 28, hydraulic giant interface 29, humidity sensor interface 30, temperature sensor interface 31, air velocity transducer interface 32, the power interface 33 of realizing the electrical interlocks device, the corpuscular counter interface 34 that on-line monitoring is used, the bacterium that swims sampling interface 35, detect the low concentration sensor interface 36 that hydrogen peroxide uses and the cabin pressure sensor interface 37 of monitoring in real time.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2011103874598A CN102530324A (en) | 2011-11-25 | 2011-11-25 | Purification isolating device of aseptic powder needle split-charging production line |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2011103874598A CN102530324A (en) | 2011-11-25 | 2011-11-25 | Purification isolating device of aseptic powder needle split-charging production line |
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| CN102530324A true CN102530324A (en) | 2012-07-04 |
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| CN2011103874598A Pending CN102530324A (en) | 2011-11-25 | 2011-11-25 | Purification isolating device of aseptic powder needle split-charging production line |
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102718036A (en) * | 2012-07-06 | 2012-10-10 | 温州亚光机械制造有限公司 | Sterile material transport device |
| CN103041417A (en) * | 2013-01-30 | 2013-04-17 | 杭州盈天科学仪器有限公司 | Transfer cabin with sterilization function |
| CN103465943A (en) * | 2013-09-25 | 2013-12-25 | 杭州盈天科学仪器有限公司 | Transfer trolley |
| CN103641048A (en) * | 2013-12-11 | 2014-03-19 | 上海新旭发机械科技有限公司 | Cleaning and protecting system for plugging device |
| CN106016978A (en) * | 2016-07-06 | 2016-10-12 | 山东新华医疗器械股份有限公司 | Drug sterile freeze-drying isolator system for laboratory |
| CN112625886A (en) * | 2020-12-31 | 2021-04-09 | 无锡市第五人民医院 | A automatic partial shipment device of nasopharynx swab for new coronary pneumonia virus detects |
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| CN202414227U (en) * | 2011-11-25 | 2012-09-05 | 杭州泰林生物技术设备有限公司 | Purification and isolation device for aseptic powder injection sub-packaging production line |
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| US5488811A (en) * | 1995-02-21 | 1996-02-06 | Abbott Laboratories | On-line air filter integrity testing apparatus |
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Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102718036A (en) * | 2012-07-06 | 2012-10-10 | 温州亚光机械制造有限公司 | Sterile material transport device |
| CN102718036B (en) * | 2012-07-06 | 2014-04-16 | 温州亚光机械制造有限公司 | Sterile material transport device |
| CN103041417A (en) * | 2013-01-30 | 2013-04-17 | 杭州盈天科学仪器有限公司 | Transfer cabin with sterilization function |
| CN103465943A (en) * | 2013-09-25 | 2013-12-25 | 杭州盈天科学仪器有限公司 | Transfer trolley |
| CN103641048A (en) * | 2013-12-11 | 2014-03-19 | 上海新旭发机械科技有限公司 | Cleaning and protecting system for plugging device |
| CN106016978A (en) * | 2016-07-06 | 2016-10-12 | 山东新华医疗器械股份有限公司 | Drug sterile freeze-drying isolator system for laboratory |
| CN112625886A (en) * | 2020-12-31 | 2021-04-09 | 无锡市第五人民医院 | A automatic partial shipment device of nasopharynx swab for new coronary pneumonia virus detects |
| CN112625886B (en) * | 2020-12-31 | 2024-04-05 | 无锡市第五人民医院 | Automatic nasopharynx swab split charging device for detecting novel coronavirus |
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Application publication date: 20120704 |