CN109533418A - It is a kind of to guarantee the reagent container of sterile replacement in non-clean environment - Google Patents

It is a kind of to guarantee the reagent container of sterile replacement in non-clean environment Download PDF

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Publication number
CN109533418A
CN109533418A CN201811397066.3A CN201811397066A CN109533418A CN 109533418 A CN109533418 A CN 109533418A CN 201811397066 A CN201811397066 A CN 201811397066A CN 109533418 A CN109533418 A CN 109533418A
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CN
China
Prior art keywords
reagent
bottle
container
reagent container
pumped
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN201811397066.3A
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Chinese (zh)
Inventor
余春
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Innovil Intelligent Technology (suzhou) Co Ltd
Original Assignee
Innovil Intelligent Technology (suzhou) Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Innovil Intelligent Technology (suzhou) Co Ltd filed Critical Innovil Intelligent Technology (suzhou) Co Ltd
Priority to CN201811397066.3A priority Critical patent/CN109533418A/en
Publication of CN109533418A publication Critical patent/CN109533418A/en
Pending legal-status Critical Current

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Classifications

    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B3/00Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B3/04Methods of, or means for, filling the material into the containers or receptacles
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B55/00Preserving, protecting or purifying packages or package contents in association with packaging
    • B65B55/02Sterilising, e.g. of complete packages
    • B65B55/04Sterilising wrappers or receptacles prior to, or during, packaging

Abstract

The present invention relates to the reagent container technical fields that non-clean environment guarantees sterile replacement, it is in particular a kind of to guarantee the reagent container of sterile replacement in non-clean environment, the following steps are included: S1, reagent container is connected to the system of being pumped into and started and is pumped into system, the system of being pumped into can successively clean this section of pipeline between the pump housing-filling head by the switching on the road Beng Hefa using cleaning solution, thimerosal etc.;S2 injects reagent: after one bottle of reagent is used up, when needing replacing new reagent, reagent container is connected to the system of being pumped into, the container of new reagent is put into agent bin by the reagent bottle more renewed, if it is the reagent for needing temperature control, need to open the temperature control module of agent bin;S3, not being due to installation environment is gnotobasis, after connecting in such a case.The present invention does not need the reagent container installed under high-level gnotobasis (such as grade A environment), and the reagent container can guarantee sterile injection reagent after installation, effectively raise the efficiency of production.

Description

It is a kind of to guarantee the reagent container of sterile replacement in non-clean environment
Technical field
The present invention relates to the reagent container technical field that non-clean environment guarantees sterile replacement, it is specially a kind of can be non-clean The reagent container of the sterile replacement of net conditions warrant.
Background technique
In industries such as drug production, filling, the cell productions of drug, need that entire production environment is maintained to be in germ-free condition Under.Space of the entire production environment in a sealing, isolation.And the reagent of some large capacities is since volume is larger, it is difficult To be placed directly into sterile insulating space.Usually these medicaments are placed on the outside of an insulating space, then pass through pump Enter system to be pumped into shielding system medicament.Since medicament is placed on outside shielding system, be in ambient non-sterile, how Drug-injecting system simultaneously guarantees sterile, is the challenge of industry, the container of conventional splendid attire medicament, it is necessary to open under clean environment Lid uses, or combines using disposable pipeline and with sterile bulb-tubulating machine.When using this container, in order to guarantee reagent Piping connection, the gnotobasis in use process, common practice has so several: a kind of factory to build high-cleanness, high Room allows outside isolator and is also maintained at higher gnotobasis, such as B grades of environment.Use disposable piping connection reagent bottle (bag) And injection carries out disinfection after each replacement.This scheme needs the workshop of high-cleanness, high, expenditure of construction and maintenance Expense is all more high;Another method is the container of splendid attire medicament to be connected to the fixing pipe road with decontamination system, often Using purified water, compressed air, injection water, steam etc. after the completion of the production of one batch, successively carry out disinfection sterilizing to pipeline.This Kind scheme needs a sterilization module, and cost is not low, and occupied area is huge.
In conclusion how to design a kind of container of new installed reagents, can easily make in ambient non-sterile With, and guarantee it is sterile in use process, become at present need urgently solve the problems, such as.
Summary of the invention
It can guarantee the reagent container of sterile replacement in non-clean environment the purpose of the present invention is to provide a kind of, on solving State the problem of proposing in background technique.
To achieve the above object, the invention provides the following technical scheme:
It is a kind of to guarantee the reagent container of sterile replacement in non-clean environment, comprising the following steps:
Reagent container is connected to the system of being pumped into and starting is pumped into system by S1, and the system of being pumped into can cutting by the road Beng Hefa It changes, this section of pipeline between the pump housing-filling head is successively cleaned using cleaning solution, thimerosal etc.;
S2 injects reagent: after one bottle of reagent is used up, when needing replacing new reagent, reagent container being connected to and is pumped into The container of new reagent is put into agent bin by system, the reagent bottle more renewed, if it is the reagent for needing temperature control, needs to open The temperature control module of agent bin;
S3, not being due to installation environment is gnotobasis, after connecting in such a case, agent bin, patch panel, pump This part pipeline between body will receive pollution, open back flush program, after program starting, pumping system meeting switching valve road, Successively using this section of pipeline between the reagents cleaning reagent storehouse-patch panel-pump housings such as thimerosal, cleaning solution;
S4, reagent it is canned: reversal valve connection pass joint and reagent bottle under initial conditions, reagent manufacturer by reagent by After connector is filled into reagent bottle, the direction of switch valve;
S5, install reagent bottle: user, can be under non-clean state, by reagent container when using reagent Connector is connected in patch panel;
S6, the irrigation and disinfection of pipeline: due to being installed under non-clean state, this section of reagent container reversal valve to connector Pipeline is contaminated, only needs to invert pumping system at this time, using this section of pipeline of liquid wash, so that this part pipeline be allowed to reach To germ-free condition;
S7, switch valve, normal to inject: after the completion of flushing, switch valve is connected to connector with reagent bottle.
Preferably, the S1, reagent container are made of reagent bottle, rubbish bottle, reversal valve, connector.The reagent container is The containers such as sack, bottle, bucket and first filling reagent are to reagent bag (bottle) in, then with pipe-connecting modes such as sterile bulb-tubulating machines, trying Agent and reversal valve, rubbish bottle connect together.
Preferably, the S4, for reversal valve one is connection connector and reagent bottle, another kind is to be connected to connector and rubbish bottle, And when using the time, it is used to connect between patch panel.
Preferably, the S1, being pumped into system, there is special valve road to design, and be pumped into system can support multiple channels it Between switching, one be pumped into system just possess injection plurality of reagents ability.
Preferably, the S4, inside just pre- filling reagent when reagent bottle is factory.
Preferably, the S1, in reagent container the factory of rubbish bottle when be empty bag.
Preferably, the S3, agent bin have temperature control system.
Compared with prior art, the beneficial effects of the present invention are:
1, in the present invention, build the workshop of high-cleanness, high by designing to avoid, allow outside isolator be also maintained at it is higher Gnotobasis disappeared after each replacement using disposable piping connection reagent bottle (bag) and injection such as B grades of environment Poison, needs the workshop of high-cleanness, high, so that it is all more high to reduce its expenditure of construction and standing charges.
2, it in the present invention, is avoided by design and the container of splendid attire medicament is connected to the fixation pipeline with decontamination system On, using purified water, compressed air, injection water, steam etc. after the completion of the production of each batch, successively carries out disinfection and go out to pipeline Bacterium needs a sterilization module, and cost is not low, and occupied area is huge, to reduce the cost of engineering, occupied area makes With.
3, in the present invention, method is changed by design, structure is simple, and service performance is strong, and low cost, and occupied area is small, The reagent container installed under high-level gnotobasis (such as grade A environment) is not needed, and the reagent container can guarantee peace Sterile injection reagent after dress, so that high efficiency is carried out, the production of sterile mode.
Detailed description of the invention
Fig. 1 is the principle of the present invention figure;
Fig. 2 is that the present invention uses figure.
Specific embodiment
Following will be combined with the drawings in the embodiments of the present invention, and technical solution in the embodiment of the present invention carries out clear, complete Site preparation description, it is clear that described embodiments are only a part of the embodiments of the present invention, instead of all the embodiments, is based on Embodiment in the present invention, it is obtained by those of ordinary skill in the art without making creative efforts every other Embodiment shall fall within the protection scope of the present invention.
The present invention provides a kind of technical solution referring to FIG. 1-2:
It is a kind of to guarantee the reagent container of sterile replacement in non-clean environment, comprising the following steps:
Reagent container is connected to the system of being pumped into and starting is pumped into system by S1, and the system of being pumped into can cutting by the road Beng Hefa It changes, successively cleans this section of pipeline between the pump housing-filling head using cleaning solution, thimerosal etc., its role is to can guarantee It is germ-free condition before injecting reagent;
S2 injects reagent: after one bottle of reagent is used up, when needing replacing new reagent, reagent container being connected to and is pumped into The container of new reagent is put into agent bin by system, the reagent bottle more renewed, if it is the reagent for needing temperature control, needs to open The temperature control module of agent bin works and is to extend the storage time of reagent;
S3, not being due to installation environment is gnotobasis, after connecting in such a case, agent bin, patch panel, pump This part pipeline between body will receive pollution, open back flush program, after program starting, pumping system meeting switching valve road, Successively using this section of pipeline between the reagents cleaning reagent storehouse-patch panel-pump housings such as thimerosal, cleaning solution, act on Sterile injection after guaranteeing reagent replacement;
S4, reagent it is canned: reversal valve connection pass joint and reagent bottle under initial conditions, reagent manufacturer by reagent by After connector is filled into reagent bottle, the direction of switch valve completely cuts off contact of the reagent in reagent bottle with outside, guarantees the nothing of reagent Bacterium state;
S5, install reagent bottle: user, can be under non-clean state, by reagent container when using reagent Connector is connected in patch panel;
S6, the irrigation and disinfection of pipeline: due to being installed under non-clean state, this section of reagent container reversal valve to connector Pipeline is contaminated, only needs to invert pumping system at this time, using this section of pipeline of liquid wash, the contaminated fluid meeting that rinses out Into rubbish bottle;
S7, switch valve, normal to inject: after the completion of flushing, switch valve is connected to connector with reagent bottle, pumps at this time Reagent can be formally injected into inside isolator by system.
The S1, reagent container are made of reagent bottle, rubbish bottle, reversal valve, connector.The reagent container is sack, bottle The containers such as son, bucket and first filling reagent are in reagent bag (bottle), then with pipe-connecting modes such as sterile bulb-tubulating machines, reagent and commutation Valve, rubbish bottle connect together.
The S4, for reversal valve one is connection connector and reagent bottle, another kind is connection connector and rubbish bottle, and is used When the time, it is used to connect between patch panel.
The S1 is pumped into system and designs with special valve road, and is pumped into system to support cutting between multiple channels It changes, one is pumped into the ability that system just possesses injection plurality of reagents, works and is to switch mutually between multiple channels, together When be both able to achieve positive injection, be also able to achieve inverse injection.
The S4, inside just pre- filling reagent when reagent bottle is factory.
The S1, in reagent container the factory of rubbish bottle when be empty bag, work and be for when accommodating flushing pipeline Rubbish solution.
The S3, agent bin have temperature control system, so that large capacity reagent be allowed to be stored in agent bin for a long time, and maintain to try The potency of agent, agent bin can be bottled reagent, are also possible to packed reagent for storing large capacity reagent.
Specific embodiment:
Step 1: reagent container is connected to the system of being pumped into, the reagent bottle more renewed;
The container of new reagent: being put into agent bin by step 2, if it is the reagent for needing temperature control, needs to open agent bin Temperature control module;
Step 3: not being due to installation environment is gnotobasis, after connecting in such a case, agent bin, wiring face This part pipeline between plate, the pump housing will receive pollution, open back flush program, after program starting, pumping system can switch Valve road, successively using this section of pipeline between the reagents cleaning reagent storehouse-patch panel-pump housings such as thimerosal, cleaning solution;
Step 4: reagent it is canned: under initial conditions reversal valve connection pass joint and reagent bottle, reagent manufacturer will try After agent is filled into reagent bottle by connector, the direction of switch valve;
Step 5: installation reagent bottle: user can be held reagent under non-clean state when using reagent The connector of device is connected in patch panel;
Step 6: the irrigation and disinfection of pipeline: due to being installed under non-clean state, reagent container reversal valve to connector This section of pipeline is contaminated, only needs to invert pumping system at this time, uses this section of pipeline of liquid wash;
Step 7: switch valve, normal to inject: after the completion of flushing, switch valve is connected to connector with reagent bottle.
In this process present invention, the workshop of high-cleanness, high is built by designing to avoid, allows outside isolator and is also maintained at Higher gnotobasis is carried out after each replacement such as B grades of environment using disposable piping connection reagent bottle (bag) and injection Disinfection, needs the workshop of high-cleanness, high, so that it is all more high to reduce its expenditure of construction and standing charges, passes through design It avoids and the container of splendid attire medicament is connected to the fixing pipe road with decontamination system, used after the completion of the production of each batch Purified water, compressed air, injection water, steam etc. successively carry out disinfection sterilizing to pipeline, need a sterilization module, cost is not It is low, and occupied area is huge, to reduce the cost of engineering, the use of occupied area changes method, structure letter by design Single, service performance is strong, and low cost, and occupied area is small, does not need to be pacified under high-level gnotobasis (such as grade A environment) The reagent container of dress, and the reagent container can guarantee sterile injection reagent after installation, so that high efficiency is carried out, sterile mode Production.
The foregoing is only a preferred embodiment of the present invention, but scope of protection of the present invention is not limited thereto, Anyone skilled in the art in the technical scope disclosed by the present invention, according to the technique and scheme of the present invention and its Inventive concept is subject to equivalent substitution or change, should be covered by the protection scope of the present invention.

Claims (7)

1. a kind of can guarantee the reagent container of sterile replacement in non-clean environment, which comprises the following steps:
S1, reagent container is connected to the system of being pumped into and started be pumped into system, the system of being pumped into can by the switching on the road Beng Hefa, according to Secondary this section of pipeline using between the cleaning pump housing-filling head such as cleaning solution, thimerosal;
S2 injects reagent: after one bottle of reagent is used up, when needing replacing new reagent, reagent container being connected to the system of being pumped into, The container of new reagent is put into agent bin by the reagent bottle more renewed, if it is the reagent for needing temperature control, needs to open agent bin Temperature control module;
S3, due to installation environment be not be gnotobasis, in such a case connect after, agent bin, patch panel, the pump housing it Between this part pipeline will receive pollution, open back flush program, after program starting, pumping system can switching valve road, successively Use this section of pipeline between the reagents such as thimerosal, cleaning solution cleaning reagent storehouse-patch panel-pump housing;
S4, reagent it is canned: reversal valve connection pass joint and reagent bottle under initial conditions, reagent manufacturer is by reagent by connector After being filled into reagent bottle, the direction of switch valve;
S5, install reagent bottle: user, can be under non-clean state, by the connector of reagent container when using reagent It is connected in patch panel;
S6, the irrigation and disinfection of pipeline: due to being installed under non-clean state, reagent container reversal valve to this section of pipeline of connector It is contaminated, it only needs to invert pumping system at this time, uses this section of pipeline of liquid wash;
S7, switch valve, normal to inject: after the completion of flushing, switch valve is connected to connector with reagent bottle.
A kind of it can guarantee the reagent container of sterile replacement in non-clean environment 2. according to claim 1, which is characterized in that The S1, reagent container are made of reagent bottle, rubbish bottle, reversal valve, connector.The reagent container is that sack, bottle, bucket etc. hold Device and first filling reagent are in reagent bag (bottle), then with pipe-connecting modes such as sterile bulb-tubulating machines, reagent and reversal valve, rubbish bottle It connects together.
A kind of it can guarantee the reagent container of sterile replacement in non-clean environment 3. according to claim 1, which is characterized in that The S4, reversal valve is one is connection connector and reagent bottle, and another kind is connection connector and rubbish bottle, and when the use time, It is used to connect between patch panel.
A kind of it can guarantee the reagent container of sterile replacement in non-clean environment 4. according to claim 1, which is characterized in that The S1, being pumped into system, there is special valve road to design, and is pumped into system and can support switching between multiple channels, a pump Enter the ability that system just possesses injection plurality of reagents.
A kind of it can guarantee the reagent container of sterile replacement in non-clean environment 5. according to claim 1, which is characterized in that The S4, inside just pre- filling reagent when reagent bottle is factory.
A kind of it can guarantee the reagent container of sterile replacement in non-clean environment 6. according to claim 1, which is characterized in that The S1, in reagent container the factory of rubbish bottle when be empty bag.
A kind of it can guarantee the reagent container of sterile replacement in non-clean environment 7. according to claim 1, which is characterized in that The S3, agent bin have temperature control system.
CN201811397066.3A 2018-11-22 2018-11-22 It is a kind of to guarantee the reagent container of sterile replacement in non-clean environment Pending CN109533418A (en)

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2006117310A (en) * 2004-10-25 2006-05-11 Bokuson Kogyo Kk Dispensing device for foaming beverage
CN1835887A (en) * 2003-08-11 2006-09-20 斯帕卡斯·比尔 Dispensing system for beverages and method for cleaning a dispensing system
CN202063919U (en) * 2011-05-20 2011-12-07 成都天邦生物制品有限公司 Sterile sampling system
AU2012244207A1 (en) * 2011-10-26 2013-05-09 Hoshizaki Lancer Pty Ltd Beverage Trade-Out System and Method
CN206145435U (en) * 2016-10-28 2017-05-03 内蒙古伊利实业集团股份有限公司 Aseptic connector and aseptic connecting device
CN206940913U (en) * 2017-07-10 2018-01-30 山东新华医疗器械股份有限公司 A kind of feeding pipeline cleaning and sterilizing system for high-flux cell culture systems

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1835887A (en) * 2003-08-11 2006-09-20 斯帕卡斯·比尔 Dispensing system for beverages and method for cleaning a dispensing system
JP2006117310A (en) * 2004-10-25 2006-05-11 Bokuson Kogyo Kk Dispensing device for foaming beverage
CN202063919U (en) * 2011-05-20 2011-12-07 成都天邦生物制品有限公司 Sterile sampling system
AU2012244207A1 (en) * 2011-10-26 2013-05-09 Hoshizaki Lancer Pty Ltd Beverage Trade-Out System and Method
CN206145435U (en) * 2016-10-28 2017-05-03 内蒙古伊利实业集团股份有限公司 Aseptic connector and aseptic connecting device
CN206940913U (en) * 2017-07-10 2018-01-30 山东新华医疗器械股份有限公司 A kind of feeding pipeline cleaning and sterilizing system for high-flux cell culture systems

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Application publication date: 20190329