CN102295083B - Method and device for transferring material - Google Patents
Method and device for transferring material Download PDFInfo
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- CN102295083B CN102295083B CN 201110124315 CN201110124315A CN102295083B CN 102295083 B CN102295083 B CN 102295083B CN 201110124315 CN201110124315 CN 201110124315 CN 201110124315 A CN201110124315 A CN 201110124315A CN 102295083 B CN102295083 B CN 102295083B
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Abstract
The invention relates to a method and device for transferring a material, aiming at solving the problem that a controlled limited environment is easy to damage in the process of transferring the material out from the controlled limited environment and solving the problem that the online cleaning and online sterilization during application of the prior art are hard to verify. The device comprises an annular support fixed at the bottom of the controlled limited environment or a side platform, a material transferring bag, an outer fixing ring sleeved along a bottom of the material transferring bag and air-tightly matched with an outer side of the annular support, and an inner fixing ring air-tightly matched with an inner side of the annular support. The outer fixing ring, the transferring bag, a support round conic section and the inner fixing ring are in close match with one another so as to guarantee the airtightness of the controlled limited environment and realize the online replacement of the material transferring bag. The method and device provided by the invention have the beneficial effects of reducing the risks in damaging the controlled limited environment, and being simple and convenient in operation, and can be widely applied to sterile production, product test, sample preparation, biosafety protection and other aspects in the medicine field.
Description
Technical field
The present invention relates generally to a kind of method and device thereof of handling material, especially a kind of method and device for migrate out material from controlled limitation environment.
Background technology
Controlled limitation environment such as isolator, glove box etc., in many applications, such as sterile production, product testing, the sample preparation of field of medicaments, and the biological safety protection operation.Controlled limitation environment like this can reach a specific environmental index usually, such as the special control such as aseptic, clean.Between controlled environment and uncontrolled environment, usually do not allow the direct exchange of material, air, to prevent from destroying controlled limitation environment.Yet in actual use, material is migrated out from controlled limitation environment and not allowing to destroy this controlled limitation environment, is requisite link in the operation in many cases.
For solving such difficult problem, certain methods and device are developed, technology the most typical and that be widely used is that a kind of device with two-door forwarding function (transmits port fast, RTP), DPTE transfer gate such as clean Ding-La Kelin company, can realize in the situation of not destroying controlled limitation environment, material being transferred to another controlled limitation environment from a controlled limitation environment, then take out material.
Yet adopt the method for transmitting fast port (RTP) to have following problem: the structure of two-door transfer system is comparatively complicated, and volume, weight are larger, make operating difficulties.Because Shortcomings on the structure design, after two-door docking operation, exposed seal ring is still source of pollution, has the risk of destroying controlled limitation environment.Another kind of improved plan is to adopt a kind of device of aseptic separation butterfly valve, and the technology as described in the patent WO2007/107500 is mainly used in the transfer of aseptic powdery.
Above-mentioned two kinds of technology and to install common characteristics be that manufacturing cost is higher, manufacture difficulty is larger, and after controlled limitation environment is connected, need to carry out on-line cleaning (CIP) and online sterilization (SIP), device for this type of inner structure complexity, usually on-line cleaning and online sterilization all are difficulties relatively, and the effect of cleaning with sterilization is difficult to checking, easily accumulate residue in the seal ring junction and have the dead angle of sterilizing.On the other hand, above-mentioned two kinds of devices need in actual use the container that holds material is changed online and do not affect the environment of confined space, although also can be realized complicated operation, need more complete like this devices to carry out integral replacing, costly.Therefore, need a kind of can the low-risk operation, can realize cheaply that material holds online replacing of container and the material transferring device that do not destroy the confined space environment is realized this process.
Summary of the invention
The purpose of this invention is to provide a kind of can the realization material is migrated out from controlled limitation environment, and do not destroy controlled limitation environment, do not clean and the sterilization dead angle, and can hold online material transfer method and the lane device thereof of changing of container to material.
For realizing purpose of the present invention, need the design following apparatus to realize: the bearing (3) of installing at bottom platform (2) or the side coaming plate of limitation environment (1), bearing (3) is cirque structure, the lower end is equipped with openable end cap (4), extend in the limitation environment space in bearing (3) upper end, the outside of extension is the circular outer tapering (5) of bearing, outer tapering top, tapering to the tapering end of this circle is no more than 10 °, the inboard of bearing extension is the round interior tapering (13) of bearing, this round interior tapering is inverted cone-shaped structure, and open top end (large mouthful) to tapering end is no more than 10 °.
For realizing that material is migrated out from controlled limitation environment, also need design a kind of material transfer bag (6) of disposal type.Material transfer bag edge of opening part (7) cooperatively interacts with the circular outer tapering of bearing (5), the edge of opening of bag partly can be inserted in the tapering.The bottom of material transfer bag (6-1) is enclosed construction, and mode realizes can to adopt heat-sealing, tighten etc.Material transfer bag (6) adopts the materials such as high molecular polymer such as polyethylene film to make, and is packaged in advance in another sterile barrier system (8), sterilizes by the gamma rays radiation mode that cobalt-60 or electron ray produce, and is the transporting sterile materials bag.
In addition, material transfer bag (6) is fixed in the circular outer tapering of bearing (5), needs a design outer set collar (9), for guaranteeing sealing, the circular outer tapering of set collar medial surface and bearing (5) cooperatively interacts, and outer set collar adopts elastomeric material to make.
For realizing that disposal type material transfer bag holds the laggard row of material and changes, and the process of changing is not destroyed the limitation environment, need a design interior set collar (10), for guaranteeing sealing, the lateral surface of interior set collar is designed to cooperatively interact with the circular interior tapering of bearing (5), interior set collar adopts deformable elastomeric material to make, and can utilize its deformability that interior set collar is taken out from the lower end of bearing.
A kind of method that migrates out material from controlled limitation environment, described method comprise the annular ledge (3) that is fixed on controlled limitation environment bottom or the side platform; Material transfer bag (6), it is made by the Polymer flexible material; And the outer set collar (9) that is inserted in along material transfer bag bottom and is sealed and matched with the annular ledge lateral surface, and along the airtight cooperation of annular ledge medial surface, be used for the online interior set collar (10) of changing the material transfer bag, described outer set collar is designed to coat to compress to the bearing lower end device that also can seal with fixing material transfer bag edge of opening part (7), said method comprising the steps of:
The material transfer bag that a) will contain in advance the sterile barrier system is put into controlled limitation environment, and adopts bio-decontaminated or the process for purifying decontamination of confirming;
B) open the sterile barrier system of material transfer bag outside, material transfer bag open end is opened and is inserted in the lateral border of annular ledge upper end extension;
C) direction that outer set collar is matched with its medial margin tapering and annular ledge upper end extension lateral border tapering, be inserted in outer set collar from the end of material transfer bag, lower end along from the lateral border of annular ledge upper end extension to annular ledge promotes, the upper part that the open end of material transfer bag is inserted in annular ledge is coated between outer set collar and the annular ledge, continues to enforce to reach airtight to the lower end;
D) end cover of annular ledge lower end is opened, and the upset of the bottom of material transfer bag and the outside direction along the medial margin of annular ledge to controlled limitation environment are extended, the material transfer bag can be hold material state;
E) behind the material transfer bag inner stuffing material, make material concentrate on the bottom of bag by natural gravity, upper end position along weighting material, mode by heat-sealing or machinery wrapping seals, again along this potted line upwards along exhibition, again seal in an identical manner, then along the midway location of twice potted line, the material transfer bag is cut off, and made it to separate;
When f) changing online the material transfer bag, the direction that interior set collar is matched with its lateral border tapering and annular ledge upper end extension medial margin tapering, be fixed bag and make it airtight, take off outer set collar from annular ledge, with the inwardly fixedly anchor ring upset of sack of material transfer bag; Other gets a material transfer bag to be used, from the annular ledge upper end opening is inserted in, and use outer set collar to wrap on annular ledge, utilize the flexibility of material transfer bag to be used, with the upper end pulling of interior set collar to annular ledge, and make it to separate with bearing, the material transfer bag that has held material and needs replacing this moment takes out from the outlet of bearing lower end, and the deformability of set collar in utilizing is taken out interior set collar in the downward mode of pushing or drawing outside the outlet of bearing lower end of vertical direction above the bag of new replacing.
Adopt the said structure device, realize that by following method material is shifted out from the limitation environment: will put in advance controlled limitation environment with the transporting sterile materials bag (6) of sterile barrier system, outer set collar (9), interior set collar (10), the end cap (4) of sealing bearing lower end.After the bio-decontaminated confirmed or decontamination procedure processed controlled limitation environment, by specific operation port such as work gloves etc., take out transporting sterile materials bag (6) after opening the sterile barrier system, sack (7) is inserted in the circular tapering of bearing (5), be inserted in outer set collar (9) from transporting sterile materials bag outside, the inner conical surface of outer set collar is coated the outside face of transporting sterile materials bag sack (7), to the lower extreme direction compression of bearing.At this moment, close fit between the circular tapering of outer set collar, transhipment bag and bearing guarantees the leakproofness of controlled limitation environment.Open the end cap of bearing lower end and the bottom of transporting sterile materials bag is stretched to the bearing lower end, make the medial surface of aseptic transhipment bag be exposed to the outside of controlled limitation environment, the contact surface that the lateral surface of transporting sterile materials bag then stores for material.After material enters the bag bottom, holds material in the bag, tighten mode by heat-sealing or machinery, carry out double sealing in the lower end of transporting sterile materials bag, in the middle of the double sealing line, cut off, take the material that shifts out away with the method.
When needs integral replacing transporting sterile materials bag, at first with interior set collar (10) with bearing (5) circular in the tapering direction of agreeing with sealing put into bearing and be fixed the transporting sterile materials bag, this moment is mobile with outer set collar upper end, tapering outside the circle of bearing, and makes it to break away from bearing.The sack of the transporting sterile materials bag that this moment is to be used with another is inserted in the circular outer tapering of bearing (5), be inserted in outer set collar and be fixed, utilize the flexibility of material transfer bag to be used, the circular interior tapering large end of interior set collar to bearing spurred, and make it to separate with bearing, the material transfer bag that has held material and needs replacing this moment takes out from the outlet of bearing lower end, and the deformability of set collar in utilizing is taken out interior set collar in the downward mode of pushing or drawing outside the lower end outlet of literary composition seat of vertical direction above the bag of new replacing.
Effective effect of using this device to bring is: adopt disposal type pocket type structure owing to holding the transporting sterile materials bag of material, in advance through the gamma rays sterilization, and material does not contact other parts, therefore need not the material transfering channel is cleaned and sterilizes, also reduced thus and polluted or the destroyed risk of controlled limitation environment.This material transfering channel structure is all comparatively simple with operation, can realize the online replacing of material transfer bag, and component processing requires relatively easy the realization, and is with low cost, when realizing the sterile material forwarding function, and the production cost of reduction.
Description of drawings
Fig. 1 is cutaway view of the present invention;
Fig. 2 is material transfer bag packing schematic diagram of the present invention;
Fig. 3 is the assembling schematic diagram of bearing of the present invention tapering and outer set collar, interior set collar;
The specific embodiment
Within being used for the operate isolator of sterility test, use this material transferring device.Bearing is fixedly installed on the service platform of isolator, encapsulation process is made in the junction, and the lower end end cap with bearing before using seals.To all put into for all materials of aseptic test support, pallet or the hook of isolator inside, and prepare at least 1 of outer set collar, interior set collar at least 1 only reaches at least 2 bags through polyethylene (PE) the material transfer bags of irradiation sterilizations, this material transfer bag opening is slightly larger than the outer tapering of the circle external diameter of annular ledge.Mode with regulation is carried out bio-decontaminated to isolator inside.Exhaust is opened the external packing of transporting sterile materials bag after finishing, and sack is inserted in the circular outer tapering of bearing.From the bottom of bag outer set collar is inserted in, makes fixing around the sack and make it airtight with the circular outer tapering contact surface of bearing.During use, overturn to isolator is outside in bearing in the bag bottom, be used for holding the material that need to shift out.After holding material in the transhipment bag, with heat sealing machine with the material plastic packaging in bag, adopt the two pass heat-sealing, between the two pass hot-sealing line, the part of holding material cut off with bag separates, continue to use this material transfer bag in isolator, to collect the material that need to shift out.
Need online when changing the material transfer bag, first with interior set collar to put into the circular inner conical surface of bearing with the direction of bearing opening level and to compress airtightly, take out outer set collar, will overturn in the inside set collar of sack.Other gets a stand-by material transfer bag, after unpacking sack is inserted in the circular outer tapering of bearing, outer set collar is inserted in compression and makes it airtight.Utilize iris action and the flexibility of bag this moment, with hand interior set collar is taken off, bag to be replaced is taken out from the lower end of bearing, and little set collar, by the elasticity of himself, in the situation that torsional deflection also takes out by the lower port of bearing, extend with new bag upset and to the lower end of bearing, namely make to hold material and use.
Claims (6)
1. the device of a handling material comprises the annular ledge (3) that is fixed on controlled limitation environment bottom or the side platform; Material transfer bag (6), it is made by the Polymer flexible material; And be inserted in along material transfer bag bottom and with the airtight outer set collar (9) that cooperates of annular ledge lateral surface, and along the interior set collar (10) of the airtight cooperation of annular ledge medial surface, described outer set collar is designed to coat to the bearing lower end and compresses the device that also can seal with fixing material transfer bag edge of opening part (7); When described interior set collar is designed to change online the material transfer bag from the inboard fixedly device of bag of annular ledge.
2. device according to claim 1, described bearing upper end extension lateral border is to be no more than 10 ° tapered configuration, the inboard of annular ledge can hold the material transfer bag and extend to the lower end, the seal cover board of end portion for opening.
3. device according to claim 1, described material transfer bag opening internal diameter is slightly larger than the upper end lateral border diameter of annular ledge, and the bottom is hermetically-sealed construction; The flexible high molecular material that bag adopts thickness to be no more than 1mm is made, and the use of material transfer bag is prepended in the sterile barrier system and adopts the gamma rays irradiation technique to make sterilization treatment.
4. device according to claim 1, described outer set collar medial margin is to be no more than 10 ° tapered configuration, is made by elastomeric material, cooperatively interacts airtight with annular ledge, material transfer bag opening portion.
5. device according to claim 1, described interior set collar lateral border is to be no more than 10 ° tapered configuration, made by elastomeric material,, material transfer bag inboard with annular ledge cooperatively interacts airtight, and can take out from the annular ledge lower end by the mode of twist distortion.
6. method that migrates out material from controlled limitation environment, described method comprise the annular ledge (3) that is fixed on controlled limitation environment bottom or the side platform; Material transfer bag (6), it is made by the Polymer flexible material; And the outer set collar (9) that is inserted in along material transfer bag bottom and is sealed and matched with the annular ledge lateral surface, and along the airtight cooperation of annular ledge medial surface, be used for the online interior set collar (10) of changing the material transfer bag, described outer set collar is designed to coat to compress to the bearing lower end device that also can seal with fixing material transfer bag edge of opening part (7), said method comprising the steps of:
The material transfer bag that a) will contain in advance the sterile barrier system is put into controlled limitation environment, and adopts bio-decontaminated or the process for purifying decontamination of confirming;
B) open the sterile barrier system of material transfer bag outside, material transfer bag open end is opened and is inserted in the lateral border of annular ledge upper end extension;
C) direction that outer set collar is matched with its medial margin tapering and annular ledge upper end extension lateral border tapering, be inserted in outer set collar from the end of material transfer bag, lower end along from the lateral border of annular ledge upper end extension to annular ledge promotes, the upper part that the open end of material transfer bag is inserted in annular ledge is coated between outer set collar and the annular ledge, continues to enforce to reach airtight to the lower end;
D) end cover of annular ledge lower end is opened, and the upset of the bottom of material transfer bag and the outside direction along the medial margin of annular ledge to controlled limitation environment are extended, the material transfer bag can be hold material state;
E) behind the material transfer bag inner stuffing material, make material concentrate on the bottom of bag by natural gravity, upper end position along weighting material, mode by heat-sealing or machinery wrapping seals, again along this potted line upwards along exhibition, again seal in an identical manner, then along the midway location of twice potted line, the material transfer bag is cut off, and made it to separate;
When f) changing online the material transfer bag, the direction that interior set collar is matched with its lateral border tapering and annular ledge upper end extension medial margin tapering, be fixed bag and make it airtight, take off outer set collar from annular ledge, with the inwardly fixedly anchor ring upset of sack of material transfer bag; Other gets a material transfer bag to be used, from the annular ledge upper end opening is inserted in, and use outer set collar to wrap on annular ledge, utilize the flexibility of material transfer bag to be used, with the upper end pulling of interior set collar to annular ledge, and make it to separate with bearing, the material transfer bag that has held material and needs replacing this moment takes out from the outlet of bearing lower end, and the deformability of set collar in utilizing is taken out interior set collar in the downward mode of pushing or drawing outside the outlet of bearing lower end of vertical direction above the bag of new replacing.
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CN 201110124315 CN102295083B (en) | 2011-05-13 | 2011-05-13 | Method and device for transferring material |
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CN 201110124315 CN102295083B (en) | 2011-05-13 | 2011-05-13 | Method and device for transferring material |
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Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
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CN201158461Y (en) * | 2008-01-09 | 2008-12-03 | 刘洪然 | Discharge transition bucket apparatus for powdery material quantitatively packing machine |
CN101525089A (en) * | 2008-03-03 | 2009-09-09 | 住友重机械工业株式会社 | Powder supply device and method |
CN201658416U (en) * | 2010-03-01 | 2010-12-01 | 叶大林 | Alpha and Beta interface abacterial transferring device |
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US5735609A (en) * | 1996-07-16 | 1998-04-07 | The West Company | Container for holding sterilized elements |
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Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
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CN201158461Y (en) * | 2008-01-09 | 2008-12-03 | 刘洪然 | Discharge transition bucket apparatus for powdery material quantitatively packing machine |
CN101525089A (en) * | 2008-03-03 | 2009-09-09 | 住友重机械工业株式会社 | Powder supply device and method |
CN201658416U (en) * | 2010-03-01 | 2010-12-01 | 叶大林 | Alpha and Beta interface abacterial transferring device |
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Owner name: ZHEJIANG TAILIN BIOTECHNOLOGY CO., LTD. Free format text: FORMER NAME: HANGZHOU TAILIN BIOTECHNOLOGY EQUIPMENT CO., LTD. |
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Address after: 310052 Binjiang District, Zhejiang, South Ring Road, No. 2930, No. Patentee after: ZHEJIANG TAILIN BIOENGINEERING CO., LTD. Address before: The South Ring Road of Binjiang District Hangzhou city Zhejiang province 310052 No. 2930 Hangzhou Tailin Bioengineering Equipment Co. Ltd. Patentee before: Hangzhou Tailin Biotechnology Equipment Co., Ltd. |