CN102698997A - Method for cleaning and sterilizing material barrel on line for aseptic production - Google Patents
Method for cleaning and sterilizing material barrel on line for aseptic production Download PDFInfo
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- CN102698997A CN102698997A CN2012101698505A CN201210169850A CN102698997A CN 102698997 A CN102698997 A CN 102698997A CN 2012101698505 A CN2012101698505 A CN 2012101698505A CN 201210169850 A CN201210169850 A CN 201210169850A CN 102698997 A CN102698997 A CN 102698997A
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Abstract
The invention provides a method for cleaning and sterilizing a material barrel on line for aseptic production. The method is characterized by comprising the steps of: connecting an auxiliary device on a particular position of the material barrel which is to be cleaned and sterilized after being used; finishing an online cleaning and sterilizing process and a drying process for the material barrel according to a predetermined procedure through terminal control; closing valves for water and gas inlet and outlet after cleaning, sterilizing and drying; and dismounting the auxiliary device, pushing the cleaned and sterilized material barrel to a staging area for storage, so as to be ready for a next batch production. According to the method provided by the invention, the method has the advantages of solving the problem that cost is improved and aseptic requirements cannot be guaranteed when a traditional material barrel adopts other devices including a cleaning and sterilizing cabinet to clean and sterilize, the cleaned and sterilized material barrel is enabled to be in an aseptic protection status with high sterility, and the requirements of the international pharmacy industry cGMP (Good Manufacturing Practice) can be met.
Description
Technical field
The present invention relates to a kind of method of the material barrel in the production process (material barrel that particularly is used for aseptic transhipment and storage in the sterile bulk drug production process) being carried out the on-line cleaning sterilization.
Background technology
In field of pharmaceutical machinery, material barrel generally is used for the transhipment and the storage of material, and particularly in the sterile bulk drug production technology, material barrel is mainly used in the aseptic transhipment and the storage of sterile bulk drug.After producing end, material barrel all needs washing and sterilizing, changes the production of next batch then over to.
Traditional material barrel is a non-pressure vessel, and the mode of washing and sterilizing mainly contains following several kinds: the one, artificial clean wiping and sterilization, and the 2nd, push the washing and sterilizing cabinet and carry out washing and sterilizing, the 3rd, shift the washing and sterilizing station of appointment onto, put chuck and carry out washing and sterilizing.
First method is because just manual wipping sterilization can't reach sterilization effect.Second method need increase by a cover washing and sterilizing cabinet, and the zone of placing the washing and sterilizing cabinet need be cooked up in the workshop, increases cost.Simultaneously, still be exposed to personnel activity's zone when shifting out the washing and sterilizing cabinet after the material barrel washing and sterilizing finishes, particularly in the sterile bulk drug production technology, can't satisfy aseptic requirement.The third method need increase the zone of chuck and chuck placement, and charging basket was exposed to personnel activity's zone equally after washing and sterilizing was accomplished simultaneously, can't satisfy aseptic requirement.
Summary of the invention
The purpose of this invention is to provide a kind of method of material barrel on-line cleaning sterilization, this method can be practiced thrift cost for the user, can reach the washing and sterilizing effect again.
In order to achieve the above object, technical scheme of the present invention has provided a kind of method that is used for the material barrel on-line cleaning sterilization of sterile production, it is characterized in that:
Step 2, will use the material barrel of back sterilization to be cleaned to be placed on and to be pushed in the toilet on the transport carriage; One end of first flexible pipe is linked to each other with washing and sterilizing hand valve and dry hand valve; The other end connects washing and sterilizing aggressive valve and passive valve; In material barrel, place the rotating spraying ball; The rotating spraying ball links to each other with the washing and sterilizing aggressive valve; One end of second flexible pipe connected discharges the hand valve, in the other end and the original washing and sterilizing system between valve and inline valve link to each other;
Preferably, in step 1, in the toilet, also arrange safe hand valve, on safety hand valve, be connected with safety valve; In step 2, an end of said first flexible pipe also links to each other with safety hand valve; In step 5, before carrying out sterilization process, open said washing and sterilizing hand valve and safe hand valve simultaneously, behind sterilization process, safe hand valve cuts out.
The present invention is connected through a series of valves and pipeline, at the water inlet air inlet of material barrel passive valve is installed, and at the outlet of material barrel passive valve or manually-operated gate is installed, and adopts automatic program control, has guaranteed aseptic effectively.
Advantage of the present invention is to have solved both to have improved cost when traditional material barrel carries out washing and sterilizing by other equipment such as washing and sterilizing cabinet or chuck and also can't guarantee aseptic requirement; Guarantee that the material barrel behind the washing and sterilizing is in the sterility protection state; Aseptic is high, meets the requirement of international pharmaceuticals industry cGMP.
Description of drawings
Fig. 1 is the layout drawing of employed equipment among the present invention.
The specific embodiment
For making the present invention more obviously understandable, now with a preferred embodiment, and conjunction with figs. elaborates as follows.
In conjunction with Fig. 1, the invention provides a kind of method that is used for the material barrel on-line cleaning sterilization of sterile production, the steps include:
Step 2, will use the material barrel 6 of back sterilization to be cleaned to be placed on the transport carriage 10 and to be pushed in the toilet; One end of first flexible pipe 11 is linked to each other with washing and sterilizing hand valve 1, dry hand valve 2 and dry hand valve 2; The other end connects washing and sterilizing aggressive valve 7 and passive valve 8; In material barrel 6, place rotating spraying ball 12; Rotating spraying ball 12 links to each other with washing and sterilizing aggressive valve 7, an end of second flexible pipe 13 is connected discharges hand valve 9, in the other end and the original washing and sterilizing system between valve 14 and inline valve 15 link to each other;
Claims (2)
1. the method for a material barrel on-line cleaning sterilization that is used for sterile production is characterized in that:
Step 1, in the toilet, arrange washing and sterilizing hand valve (1) and dry hand valve (2); Washing and sterilizing hand valve (1) links to each other with cleaning main valve (3) and sterilization main valve (4) in the original washing and sterilizing system; Dry hand valve (2) links to each other with dry main valve (5) in the original washing and sterilizing system; Washing and sterilizing aggressive valve (7) and passive valve (8) are set in the open top of material barrel (6), on the outlet of material barrel (6) bottom, install and discharge hand valve (9);
Step 2, will use the material barrel (6) of back sterilization to be cleaned to be placed on the transport carriage (10) and to be pushed in the toilet; One end of first flexible pipe (11) is linked to each other with washing and sterilizing hand valve (1) and dry hand valve (2); The other end connects washing and sterilizing aggressive valve (7) and passive valve (8); In material barrel (6), place rotating spraying ball (12); Rotating spraying ball (12) links to each other with washing and sterilizing aggressive valve (7), an end of second flexible pipe (13) is connected discharges hand valve (9), in the other end and the original washing and sterilizing system between valve (14) and inline valve (15) link to each other;
Step 3, cleaning: open washing and sterilizing aggressive valve (7), passive valve (8), washing and sterilizing hand valve (1) and discharge hand valve (9); Open by the control module in the original washing and sterilizing system and to clean main valve (3) and inline valve (15); Material barrel (6) inside is cleaned through rotating spraying ball (12) by cleansing medium; After the end, close and clean main valve (3), inline valve (15) and washing and sterilizing hand valve (1), rotating spraying ball (12) is split out in material barrel (6);
Step 4, drying process: open dry hand valve (2), open dry main valve (5) and inline valve (15), accomplish drying process automatically, after the drying, close dry hand valve (2), dry main valve (5) and inline valve (15) by the control module in the original washing and sterilizing system;
Step 5, sterilization process: open washing and sterilizing hand valve (1); By the control module in the original washing and sterilizing system open sterilization main valve (4) and between valve (14); Automatically accomplish sterilization process to material barrel (6); After the sterilization, close washing and sterilizing hand valve (1), open the sterilization main valve (4) and between valve (14);
Step 6, drying process: open dry hand valve (2), open dry main valve (5) and inline valve (15), accomplish drying process automatically, after the drying, close dry hand valve (2), dry main valve (5) and inline valve (15) by the control module in the original washing and sterilizing system;
Step 7, close and discharge hand valve (9), washing and sterilizing aggressive valve (7) and passive valve (8), remove first flexible pipe (11) and second flexible pipe (13), shift washing and sterilizing and dried material barrel (6) onto staging area and deposit, prepare to drop into the production of next batch.
2. a kind of method that is used for the material barrel on-line cleaning sterilization of sterile production as claimed in claim 1 is characterized in that: in step 1, in the toilet, also arrange safe hand valve (16), on safety hand valve (16), be connected with safety valve (17); In step 2, an end of said first flexible pipe (11) also links to each other with safety hand valve (16); In step 5, before carrying out sterilization process, open said washing and sterilizing hand valve (1) and safe hand valve (16) simultaneously, behind sterilization process, safe hand valve (16) cuts out.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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CN201210169850.5A CN102698997B (en) | 2012-05-28 | 2012-05-28 | Method for cleaning and sterilizing material barrel on line for aseptic production |
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CN201210169850.5A CN102698997B (en) | 2012-05-28 | 2012-05-28 | Method for cleaning and sterilizing material barrel on line for aseptic production |
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CN102698997A true CN102698997A (en) | 2012-10-03 |
CN102698997B CN102698997B (en) | 2014-05-14 |
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CN201210169850.5A Active CN102698997B (en) | 2012-05-28 | 2012-05-28 | Method for cleaning and sterilizing material barrel on line for aseptic production |
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Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN103721989A (en) * | 2013-12-05 | 2014-04-16 | 天津昭鑫电材科技有限公司 | IBC tank cleaning system |
CN103792902A (en) * | 2013-07-16 | 2014-05-14 | 上海东富龙科技股份有限公司 | Full-automatic cleaning control method |
CN104959353A (en) * | 2015-07-07 | 2015-10-07 | 山东泰邦生物制品有限公司 | Water-saving cooling type online washing method |
Citations (8)
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JPH09276811A (en) * | 1996-04-17 | 1997-10-28 | Hitachi Ltd | Washing method and its apparatus |
JP2890867B2 (en) * | 1991-02-18 | 1999-05-17 | 三菱マテリアル株式会社 | Glass ampoule cleaning equipment |
US20030015223A1 (en) * | 2001-07-17 | 2003-01-23 | American Air Liquide, Inc. | Methods of cleaning containers using ozone compositions |
CN2543615Y (en) * | 2002-05-24 | 2003-04-09 | 张康 | Medicine tank cleaner |
JP2003164825A (en) * | 2001-11-29 | 2003-06-10 | Kirin Engineering Co Ltd | Apparatus and method for washing tank |
CN1571708A (en) * | 2001-10-16 | 2005-01-26 | Icooleo动力股份公司 | Apparatus and process for washing drying and sterilising industrial plants |
CN201519687U (en) * | 2009-09-29 | 2010-07-07 | 保龄宝生物股份有限公司 | Packing barrel cleaner |
CN201906730U (en) * | 2010-12-27 | 2011-07-27 | 土明林 | Oil drum washing device |
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2012
- 2012-05-28 CN CN201210169850.5A patent/CN102698997B/en active Active
Patent Citations (8)
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JP2890867B2 (en) * | 1991-02-18 | 1999-05-17 | 三菱マテリアル株式会社 | Glass ampoule cleaning equipment |
JPH09276811A (en) * | 1996-04-17 | 1997-10-28 | Hitachi Ltd | Washing method and its apparatus |
US20030015223A1 (en) * | 2001-07-17 | 2003-01-23 | American Air Liquide, Inc. | Methods of cleaning containers using ozone compositions |
CN1571708A (en) * | 2001-10-16 | 2005-01-26 | Icooleo动力股份公司 | Apparatus and process for washing drying and sterilising industrial plants |
JP2003164825A (en) * | 2001-11-29 | 2003-06-10 | Kirin Engineering Co Ltd | Apparatus and method for washing tank |
CN2543615Y (en) * | 2002-05-24 | 2003-04-09 | 张康 | Medicine tank cleaner |
CN201519687U (en) * | 2009-09-29 | 2010-07-07 | 保龄宝生物股份有限公司 | Packing barrel cleaner |
CN201906730U (en) * | 2010-12-27 | 2011-07-27 | 土明林 | Oil drum washing device |
Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN103792902A (en) * | 2013-07-16 | 2014-05-14 | 上海东富龙科技股份有限公司 | Full-automatic cleaning control method |
CN103792902B (en) * | 2013-07-16 | 2016-09-14 | 上海东富龙科技股份有限公司 | A kind of automatic washing control method |
CN103721989A (en) * | 2013-12-05 | 2014-04-16 | 天津昭鑫电材科技有限公司 | IBC tank cleaning system |
CN104959353A (en) * | 2015-07-07 | 2015-10-07 | 山东泰邦生物制品有限公司 | Water-saving cooling type online washing method |
CN104959353B (en) * | 2015-07-07 | 2016-04-06 | 山东泰邦生物制品有限公司 | A kind of on-line cleaning method of cooling type of economizing on water |
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CN102698997B (en) | 2014-05-14 |
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