CN102698997B - 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 PDF

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CN102698997B
CN102698997B CN201210169850.5A CN201210169850A CN102698997B CN 102698997 B CN102698997 B CN 102698997B CN 201210169850 A CN201210169850 A CN 201210169850A CN 102698997 B CN102698997 B CN 102698997B
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valve
sterilizing
washing
material barrel
hand valve
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CN102698997A (en
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郑效东
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Shanghai Tofflon Pharmaceutical Equipment Manufacturing Co Ltd
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Shanghai Tofflon Pharmaceutical Equipment Manufacturing Co Ltd
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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

A kind of method of the material barrel on-line cleaning sterilizing for sterile production
Technical field
The present invention relates to a kind of method that (particularly in sterile bulk drug production process for the material barrel of aseptic transhipment and storage) carries out on-line cleaning sterilizing to the material barrel in production process.
Background technology
In field of pharmaceutical machinery, material barrel is generally used for transhipment and the storage of material, and particularly, in sterile bulk drug production technology, material barrel is mainly used in aseptic transhipment and the storage of sterile bulk drug.After production finishes, material barrel all needs washing and sterilizing, then proceeds to the production of next batch.
Traditional material barrel is non-pressure vessel, and the mode of washing and sterilizing mainly contains following several: the one, and manual cleaning wiping sterilization, the 2nd, push 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, due to just manual wipping sterilization, cannot reach sterilization effect.Second method need to increase a set of washing and sterilizing cabinet, and the region of placing washing and sterilizing cabinet need to be cooked up in workshop, increases cost.Meanwhile, while shifting out washing and sterilizing cabinet after material barrel washing and sterilizing finishes, be still exposed to personnel activity's region, particularly in sterile bulk drug production technology, cannot meet aseptic requirement.The third method need to increase the region of chuck and chuck placement, and after while washing and sterilizing completes, charging basket is exposed to personnel activity's region equally, cannot meet aseptic requirement.
Summary of the invention
The object of this invention is to provide the method for a kind of material barrel on-line cleaning sterilizing, the method can be that user is cost-saving, can reach again washing and sterilizing effect.
In order to achieve the above object, technical scheme of the present invention has been to provide a kind of method of the material barrel on-line cleaning sterilizing for sterile production, it is characterized in that:
Step 1, in toilet, arrange washing and sterilizing hand valve and dry hand valve, washing and sterilizing hand valve is connected with cleaning main valve and sterilizing main valve in original washing and sterilizing system, dry hand valve is connected with the dry main valve in original washing and sterilizing system, washing and sterilizing aggressive valve and passive valve are set in the open top of material barrel, on the outlet of material barrel bottom, install and discharge hand valve;
Step 2, the material barrel of sterilizing to be cleaned after using is placed on transport carriage and is pushed in toilet, one end of the first flexible pipe is connected 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 rotation spray ball, rotation spray ball is connected with washing and sterilizing aggressive valve, one end of the second flexible pipe is connected and discharges hand valve, the other end with in original washing and sterilizing system between valve and inline valve be connected;
Step 3, cleaning: open washing and sterilizing aggressive valve, passive valve, washing and sterilizing hand valve and discharge hand valve, open and clean main valve and inline valve by the control module in original washing and sterilizing system, material barrel inside is cleaned by rotation spray ball by cleansing medium, after end, close and clean main valve, inline valve and washing and sterilizing hand valve, rotation spray ball is split out in material barrel;
Step 4, drying process: open dry hand valve, open dry main valve and inline valve by the control module in original washing and sterilizing system, automatically complete drying process, after being dried, close dry hand valve, dry main valve and inline valve;
Step 5, sterilization process: open washing and sterilizing hand valve, open sterilizing main valve and a valve by the control module in original washing and sterilizing system, automatically complete the sterilization process to material barrel, after sterilizing, close washing and sterilizing hand valve, open sterilizing main valve and a valve;
Step 6, drying process: open dry hand valve, open dry main valve and inline valve by the control module in original washing and sterilizing system, automatically complete drying process, after being dried, close dry hand valve, dry main valve and inline valve;
Step 7, close and discharge hand valve, washing and sterilizing aggressive valve and passive valve, remove the first flexible pipe and the second flexible pipe, shift washing and sterilizing and dried material barrel onto staging area and deposit, prepare to drop into the production of next batch.
Preferably, in step 1, in toilet, also arrange safety hand valve, on safety hand valve, be connected with safety valve; In step 2, one end of described the first flexible pipe is also connected with safety hand valve; In step 5, carrying out before sterilization process, open described washing and sterilizing hand valve and safety hand valve simultaneously, after sterilization process, safety hand valve cuts out.
The present invention, by the connection of a series of valves and pipeline, installs passive valve at the water inlet air inlet of material barrel, at the outlet of material barrel, passive valve or manually-operated gate is installed, and adopts automatic program control, has effectively guaranteed aseptic.
Advantage of the present invention is to have solved when traditional material barrel carries out washing and sterilizing by other equipment as washing and sterilizing cabinet or chuck, both to have improved cost and also cannot guarantee aseptic requirement; material barrel after assurance washing and sterilizing is in sterility protection state; aseptic is high, meets the requirement of international pharmaceuticals industry cGMP.
Accompanying drawing explanation
The layout drawing that Fig. 1 is the equipment that uses in the present invention.
The specific embodiment
For the present invention is become apparent, hereby with a preferred embodiment, and coordinate accompanying drawing to be described in detail below.
In conjunction with Fig. 1, the invention provides a kind of method of the material barrel on-line cleaning sterilizing for sterile production, the steps include:
Step 1, in toilet, arrange washing and sterilizing hand valve 1, dry hand valve 2 and safety hand valve 16, on safety hand valve 16, be connected with safety valve 17, washing and sterilizing hand valve 1 is connected with cleaning main valve 3 and sterilizing main valve 4 in original washing and sterilizing system, dry hand valve 2 is connected with the dry main valve 5 in 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 bottoms, install and discharge hand valve 9;
Step 2, the material barrel 6 of sterilizing to be cleaned after using is placed on transport carriage 10 and is pushed in toilet, one end of the first flexible pipe 11 is connected 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, at the interior placement rotation spray of material barrel 6 ball 12, rotation spray ball 12 is connected with washing and sterilizing aggressive valve 7, one end of the second flexible pipe 13 is connected and discharges hand valve 9, the other end with in original washing and sterilizing system between valve 14 and inline valve 15 be connected;
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 and clean main valve 3 and inline valve 15 by the control module in original washing and sterilizing system, material barrel 6 inside are cleaned by rotation spray ball 12 by cleansing medium, after end, close and clean main valve 3, inline valve 15 and washing and sterilizing hand valve 1, rotation spray 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 by the control module in original washing and sterilizing system, automatically complete drying process, after being dried, close dry hand valve 2, dry main valve 5 and inline valve 15;
Step 5, sterilization process: open washing and sterilizing hand valve 1 and safety hand valve 16, open sterilizing main valve 4 and a valve 14 by the control module in original washing and sterilizing system, automatically complete the sterilization process to material barrel 6, after sterilizing, close washing and sterilizing hand valve 1, safety hand valve 16, open sterilizing main valve 4 and a valve 14;
Step 6, drying process: open dry hand valve 2, open dry main valve 5 and inline valve 15 by the control module in original washing and sterilizing system, automatically complete drying process, after being dried, close dry hand valve 2, dry main valve 5 and inline valve 15;
Step 7, close and discharge hand valve 9, washing and sterilizing aggressive valve 7 and passive valve 8, remove the first flexible pipe 11 and the 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.

Claims (2)

1. for a method for the material barrel on-line cleaning sterilizing of sterile production, it is characterized in that:
Step 1, in toilet, arrange washing and sterilizing hand valve (1) and dry hand valve (2), washing and sterilizing hand valve (1) is connected with cleaning main valve (3) and sterilizing main valve (4) in original washing and sterilizing system, dry hand valve (2) is connected with the dry main valve (5) in 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, the material barrel (6) of sterilizing to be cleaned after using is placed on transport carriage (10) and is pushed in toilet, one end of the first flexible pipe (11) is connected 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 rotation spray ball (12), rotation spray ball (12) is connected with washing and sterilizing aggressive valve (7), one end of the second flexible pipe (13) is connected and discharges hand valve (9), the other end with in original washing and sterilizing system between valve (14) and inline valve (15) be connected,
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 and clean main valve (3) and inline valve (15) by the control module in original washing and sterilizing system, material barrel (6) inside is cleaned by rotation spray ball (12) by cleansing medium, after end, close and clean main valve (3), inline valve (15) and washing and sterilizing hand valve (1), rotation spray 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) by the control module in original washing and sterilizing system, automatically complete drying process, after being dried, close dry hand valve (2), dry main valve (5) and inline valve (15);
Step 5, sterilization process: open washing and sterilizing hand valve (1), open sterilizing main valve (4) and a valve (14) by the control module in original washing and sterilizing system, automatically complete the sterilization process to material barrel (6), after sterilizing, close washing and sterilizing hand valve (1), sterilizing main valve (4) and a valve (14);
Step 6, drying process: open dry hand valve (2), open dry main valve (5) and inline valve (15) by the control module in original washing and sterilizing system, automatically complete drying process, after being dried, close dry hand valve (2), dry main valve (5) and inline valve (15);
Step 7, close and discharge hand valve (9), washing and sterilizing aggressive valve (7) and passive valve (8), remove the first flexible pipe (11) and the 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. the method for a kind of material barrel on-line cleaning sterilizing for sterile production as claimed in claim 1, is characterized in that: in step 1, also arrange safety hand valve (16) in toilet, be connected with safety valve (17) on safety hand valve (16); In step 2, one end of described the first flexible pipe (11) is also connected with safety hand valve (16); In step 5, carrying out before sterilization process, open described washing and sterilizing hand valve (1) and safety hand valve (16) simultaneously, after sterilization process, safety hand valve (16) cuts out.
CN201210169850.5A 2012-05-28 2012-05-28 Method for cleaning and sterilizing material barrel on line for aseptic production Active CN102698997B (en)

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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
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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CN201906730U (en) * 2010-12-27 2011-07-27 土明林 Oil drum washing device

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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
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
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CN201906730U (en) * 2010-12-27 2011-07-27 土明林 Oil drum washing device

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