CN109364279A - It is a kind of can online CIP/SIP thimerosal filtration sterilization and cleaning system - Google Patents
It is a kind of can online CIP/SIP thimerosal filtration sterilization and cleaning system Download PDFInfo
- Publication number
- CN109364279A CN109364279A CN201811058972.0A CN201811058972A CN109364279A CN 109364279 A CN109364279 A CN 109364279A CN 201811058972 A CN201811058972 A CN 201811058972A CN 109364279 A CN109364279 A CN 109364279A
- Authority
- CN
- China
- Prior art keywords
- valve
- thimerosal
- cip
- injection
- water
- 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
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
- A61L2/18—Liquid substances or solutions comprising solids or dissolved gases
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
- A61L2/022—Filtration
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/26—Accessories or devices or components used for biocidal treatment
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
- B01F23/00—Mixing according to the phases to be mixed, e.g. dispersing or emulsifying
- B01F23/70—Pre-treatment of the materials to be mixed
- B01F23/708—Filtering materials
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B08—CLEANING
- B08B—CLEANING IN GENERAL; PREVENTION OF FOULING IN GENERAL
- B08B9/00—Cleaning hollow articles by methods or apparatus specially adapted thereto
- B08B9/08—Cleaning containers, e.g. tanks
- B08B9/093—Cleaning containers, e.g. tanks by the force of jets or sprays
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
- A61L2202/10—Apparatus features
- A61L2202/17—Combination with washing or cleaning means
Landscapes
- Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Mechanical Engineering (AREA)
- Respiratory Apparatuses And Protective Means (AREA)
Abstract
The present invention provides a kind of filtering of thimerosal and on-line cleaning disinfection system, it includes (4) heat exchanger, (5) respirator, (6) preparing tank, (7) water for injection sterilizing filter, (8) thimerosal sterilizing filter, (11) CIP/SIP connecting tube；This system 1) using medium auxiliary conveying, the thimerosal rate of filtration can be accelerated, thimerosal filtering dosage is bigger, is suitable for the biggish workshop of aseptic area area；2) using medium auxiliary conveying, thimerosal filtering can be made more complete, loss is less；3) CIP/SIP can be carried out online, operator is reduced and dismantles the workload to sterilize offline, also be can avoid system and frequently dismantled the phenomenon that leading to easy leakage；4) this system can be used for, thimerosal dosage big workshop high to the requirement of thimerosal preparation filtration.
Description
Technical field
The present invention relates to industrial systems, and in particular to a kind of thimerosal preparation filtration system.
Background technique
In pharmaceutical industry, thimerosal is usually used in the disinfection of the equipment, ground, personnel of clean area, therefore thimerosal itself is micro-
The amount of biology should be by stringent control.To avoid thimerosal itself from polluting clean area, according to 2010 editions GMP annex without
Bacterium drug chapter 9 regulation: A/B grades of clean areas should use disinfectant and detergent sterile or through aseptic process.Thimerosal
Preparation filtration system in regulation due to not providing explicitly, therefore respectively to use producer to require different for thimerosal preparation filtration system
It causes, the systematic comparison of thimerosal preparation filtration is rare in the market, is mostly used using producer's designed, designed.Thimerosal used at present
Preparation filtration system is mostly more simple, not can be carried out online CIP/SIP, needs to be sterilized offline after dismantling.Pacify after sterilizing
It is carried out mounted in B grades of environment or under the conditions of A grades of laminar flows are blown.On the one hand complicated for operation, efficiency is influenced, on the other hand, is gone out offline
Installation process has the risk of microbiological contamination to bacterium again, and filter pipe must pass through B grades and C grades of areas, and there are certain risks.The present invention exists
On the basis of conventional thimerosal preparation filtration system, preparation filtration mode is advanced optimized, water for injection and mistake can be filtered
Thimerosal is filtered, while by the way of online CIP/SIP, thimerosal preparation filtration system on-line cleaning can be enable to sterilize, subtracted
Lack the workload of operator, while also preventing the risk of thimerosal preparation filtration system off-line installation process microbiological contamination.Disappear
Venom preparation filtration system is shown in attached drawing.
Summary of the invention
The present invention is to advanced optimize preparation filtration mode on the basis of conventional thimerosal preparation filtration system, can
To filter water for injection and filtering thimerosal, while by the way of online CIP/SIP, thimerosal preparation filtration system can be enable
Enough on-line cleaning sterilizings.
Present system structural schematic diagram is attached drawing, and system includes: (1) pure steam, (2) compressed air, (3) injection
Water, (4) heat exchanger, (5) respirator, (6) preparing tank, (7) water for injection sterilizing filter, (8) thimerosal sterilizing filter,
(9) bucket is received, (10) receive bucket, (11) CIP/SIP connecting tube, (12) compressed air pressure reducing valve A, (13) valve B, (14) valve
C, (15) valve D, (16) valve E, (17) valve F, (18) valve G, (19) drain valve H, (20) valve I, (21) valve J,
(22) valve K, (23) valve L, (24) valve M, (25) valve N, (26) valve O, (27) drain valve P, (28) sample tap Q.
CIP is i.e.: on-line cleaning system.
SIP is i.e.: online disinfection system.
The course of work:
Water for injection filtering:
It opens heat exchanger (4), water for injection temperature is down to required temperature, opens valve (D), valve (F), valve (I),
For water for injection after water for injection sterilizing filter (7), filtering to water for injection receives bucket (9).
Thimerosal filtering:
Preparing tank is put into after thimerosal is prepared, or by after thimerosal addition preparing tank, is proportionally added into a certain amount of
Water for injection is prepared.After preparing thimerosal, compressed air pressure reducing valve (A), valve (C), valve (L), thimerosal are opened
Under the promotion of compressed air after thimerosal sterilizing filter (8), filtering to thimerosal receives bucket (10).
Online CIP:
Water for injection filtration system is because filtering is water for injection, and the ejected wash water that CIP is used is also water for injection, institute
It can not need to carry out CIP with water for injection filtration system, CIP can also be carried out simultaneously with the configurating filtered system of thimerosal.
After thimerosal filters, disconnects valve (I) and water for injection receives the connection of bucket (9), disconnect valve (L) and disappear
Venom receives the connection of bucket (10).CIP/SIP connecting tube (11) is connected to valve (I), valve (L) and valve (M) respectively
Together.
Water for injection filtration system CIP: after connecting each pipeline, valve (F), valve (I), valve (M), valve are opened
(N) it after, opens valve (D), CIP is carried out to water for injection pipeline as required, room temperature or hot water for injection can be used to be cleaned.
After CIP, above-mentioned valve is closed.
Thimerosal filtration system CIP: after connecting each pipeline, open valve (E), valve (J), valve (K), valve (M),
After valve (N), open valve (D), CIP carried out to thimerosal compounding system as required, can be used room temperature or hot water for injection into
Row cleaning, preparing tank (6) import are contemplated that the cleaning for being conducive to preparing tank (6) using spray ball.After CIP, close above-mentioned
Valve.
Online SIP:
SIP is carried out after CIP
Water for injection filtration system SIP: after opening valve (F), valve (I), valve (M), valve (O), valve is opened
(D), SIP is carried out to water for injection pipeline as required using pure steam (1), after SIP, closes above-mentioned valve.
Thimerosal filtration system SIP: after connecting each pipeline, open valve (E), valve (J), valve (K), valve (M),
After valve (N), open valve (D), CIP carried out to thimerosal compounding system as required, can be used room temperature or hot water for injection into
Row cleaning, preparing tank (6) import are contemplated that the cleaning for being conducive to preparing tank (6) using spray ball.After CIP, close above-mentioned
Valve.
This system advantage: 1) using medium (compressed air) auxiliary conveying, the thimerosal rate of filtration, thimerosal mistake can be accelerated
It is bigger to filter dosage, is suitable for the biggish workshop of aseptic area area.2) using the conveying of medium (compressed air) auxiliary, thimerosal can be made
Filtering is more complete, and loss is less.3) CIP/SIP can be carried out online, reduced operator and dismantled the workload to sterilize offline.It can also
Avoiding system from frequently dismantling leads to the phenomenon that being easy leakage.4) this system can be used for, disinfection high to the requirement of thimerosal preparation filtration
The big workshop of liquid dosage.
Detailed description of the invention
Thimerosal preparation filtration system
Specific embodiment
Embodiment 1
According to shown in attached drawing, various parts are connected, comprising: (1) pure steam, (2) compressed air, (3) water for injection,
(4) heat exchanger, (5) respirator, (6) preparing tank, (7) water for injection sterilizing filter, (8) thimerosal sterilizing filter, (9) connect
Receive bucket, (10) receive bucket, (11) CIP/SIP connecting tube, (12) compressed air pressure reducing valve A, (13) valve B, (14) valve C,
(15) valve D, (16) valve E, (17) valve F, (18) valve G, (19) drain valve H, (20) valve I, (21) valve J, (22)
Valve K, (23) valve L, (24) valve M, (25) valve N, (26) valve O, (27) drain valve P, (28) sample tap Q.
The filtering of 2 water for injection of embodiment:
It opens heat exchanger (4), water for injection temperature is down to required temperature, opens valve (D), valve (F), valve (I),
For water for injection after water for injection sterilizing filter (7), filtering to water for injection receives bucket (9).
The filtering of 3 thimerosal of embodiment:
Preparing tank is put into after thimerosal is prepared, or by after thimerosal addition preparing tank, is proportionally added into a certain amount of
Water for injection is prepared.After preparing thimerosal, compressed air pressure reducing valve (A), valve (C), valve (L), thimerosal are opened
Under the promotion of compressed air after thimerosal sterilizing filter (8), filtering to thimerosal receives bucket (10).
4 water for injection filtration system CIP of embodiment
It after connecting each pipeline, opens valve (F), valve (I), valve (M), after valve (N), open valve (D), by wanting
It asks and CIP is carried out to water for injection pipeline, room temperature or hot water for injection can be used to be cleaned.After CIP, above-mentioned valve is closed
Door.
5 thimerosal filtration system CIP of embodiment
After connecting each pipeline, after opening valve (E), valve (J), valve (K), valve (M), valve (N), valve is opened
(D), CIP is carried out to thimerosal compounding system as required, room temperature or hot water for injection can be used to be cleaned, preparing tank (6) into
Mouth is it is contemplated that be conducive to the cleaning of preparing tank (6) using spray ball.After CIP, above-mentioned valve is closed.
6 water for injection filtration system SIP of embodiment
After opening valve (F), valve (I), valve (M), valve (O), open valve (D), as required using pure steam (1)
After to the progress of water for injection pipeline SIP, SIP, above-mentioned valve is closed.
7 thimerosal filtration system SIP of embodiment
After connecting each pipeline, after opening valve (E), valve (J), valve (K), valve (M), valve (N), valve is opened
(D), CIP is carried out to thimerosal compounding system as required, room temperature or hot water for injection can be used to be cleaned, preparing tank (6) into
Mouth is it is contemplated that be conducive to the cleaning of preparing tank (6) using spray ball.After CIP, above-mentioned valve is closed.
Claims (8)
1. a kind of filtering of thimerosal and on-line cleaning disinfection system, it is characterised in that: it include (4) heat exchanger, (5) respirator,
(6) preparing tank, (7) water for injection sterilizing filter, (8) thimerosal sterilizing filter, (11) CIP/SIP connecting tube.
2. system according to claim 1, it is characterised in that: it further includes (1) pure steam, (2) compressed air, (3) note
It penetrates and receives bucket with water, (9), (10) receive bucket.
3. system according to claim 2, it is characterised in that: it further includes (12) compressed air pressure reducing valve A.
4. system according to claim 3, it is characterised in that: it further includes (28) sample tap Q.
5. system according to claim 4, which is characterized in that its further include: (13) valve B, (14) valve C, (15) valve
Door D, (16) valve E, (17) valve F, (18) valve G, (20) valve I, (21) valve J, (22) valve K, (23) valve L,
(24) valve M, (25) valve N, (26) valve O.
6. system according to claim 5, which is characterized in that its further include: (19) drain valve H.
7. system according to claim 6, which is characterized in that its further include: (27) drain valve P.
8. system according to claim 7, which is characterized in that the system can realize water for injection filtering, thimerosal filtering,
Cleaning, sterilizing.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811058972.0A CN109364279A (en) | 2018-09-06 | 2018-09-06 | It is a kind of can online CIP/SIP thimerosal filtration sterilization and cleaning system |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811058972.0A CN109364279A (en) | 2018-09-06 | 2018-09-06 | It is a kind of can online CIP/SIP thimerosal filtration sterilization and cleaning system |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN109364279A true CN109364279A (en) | 2019-02-22 |
Family
ID=65404946
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201811058972.0A Pending CN109364279A (en) | 2018-09-06 | 2018-09-06 | It is a kind of can online CIP/SIP thimerosal filtration sterilization and cleaning system |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN109364279A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112353983A (en) * | 2020-12-21 | 2021-02-12 | 迪必尔生物工程(上海)有限公司 | On-site cleaning and sterilizing device for feed supplement pipeline of multi-connected bioreactor and operation method thereof |
| CN113522073A (en) * | 2021-07-01 | 2021-10-22 | 褚培忠 | Production process of sterile disinfectant |
Citations (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103589628A (en) * | 2013-11-15 | 2014-02-19 | 河南远大生物制药有限公司 | Automatic sterilization, liquid preparation and sterile delivery system |
| CN103693791A (en) * | 2013-12-11 | 2014-04-02 | 江苏大红鹰恒顺药业有限公司 | Sterile injection water production technique and sterile compressed air preparation method |
| CN105092234A (en) * | 2015-09-11 | 2015-11-25 | 上海东富龙拓溥科技有限公司 | System and method applying isolation tank for liquid dosing system filter core on-line integrity tests |
| CN205055953U (en) * | 2015-10-16 | 2016-03-02 | 四川科伦药业股份有限公司 | Disinfectant preparation system |
| CN105536011A (en) * | 2016-03-14 | 2016-05-04 | 上海东富龙拓溥科技有限公司 | Liquid mixing system and full-automatic online sterilization control method based on same |
| CN205850732U (en) * | 2016-07-08 | 2017-01-04 | 新乡市常乐制药有限责任公司 | Automatic injection agent Agitation Tank |
| CN106421217A (en) * | 2016-11-14 | 2017-02-22 | 汕头保税区洛斯特制药有限公司 | Benzalkonium chloride solution and preparation method thereof |
| CN206880870U (en) * | 2016-12-27 | 2018-01-16 | 上海创洁科技股份有限公司 | One kind matches somebody with somebody liquid induction system |
| CN107855012A (en) * | 2017-12-29 | 2018-03-30 | 潘林 | A kind of sterile liquid mixing system |
-
2018
- 2018-09-06 CN CN201811058972.0A patent/CN109364279A/en active Pending
Patent Citations (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103589628A (en) * | 2013-11-15 | 2014-02-19 | 河南远大生物制药有限公司 | Automatic sterilization, liquid preparation and sterile delivery system |
| CN103693791A (en) * | 2013-12-11 | 2014-04-02 | 江苏大红鹰恒顺药业有限公司 | Sterile injection water production technique and sterile compressed air preparation method |
| CN105092234A (en) * | 2015-09-11 | 2015-11-25 | 上海东富龙拓溥科技有限公司 | System and method applying isolation tank for liquid dosing system filter core on-line integrity tests |
| CN205055953U (en) * | 2015-10-16 | 2016-03-02 | 四川科伦药业股份有限公司 | Disinfectant preparation system |
| CN105536011A (en) * | 2016-03-14 | 2016-05-04 | 上海东富龙拓溥科技有限公司 | Liquid mixing system and full-automatic online sterilization control method based on same |
| CN205850732U (en) * | 2016-07-08 | 2017-01-04 | 新乡市常乐制药有限责任公司 | Automatic injection agent Agitation Tank |
| CN106421217A (en) * | 2016-11-14 | 2017-02-22 | 汕头保税区洛斯特制药有限公司 | Benzalkonium chloride solution and preparation method thereof |
| CN206880870U (en) * | 2016-12-27 | 2018-01-16 | 上海创洁科技股份有限公司 | One kind matches somebody with somebody liquid induction system |
| CN107855012A (en) * | 2017-12-29 | 2018-03-30 | 潘林 | A kind of sterile liquid mixing system |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112353983A (en) * | 2020-12-21 | 2021-02-12 | 迪必尔生物工程(上海)有限公司 | On-site cleaning and sterilizing device for feed supplement pipeline of multi-connected bioreactor and operation method thereof |
| CN113522073A (en) * | 2021-07-01 | 2021-10-22 | 褚培忠 | Production process of sterile disinfectant |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN109364279A (en) | It is a kind of can online CIP/SIP thimerosal filtration sterilization and cleaning system | |
| CN106829000A (en) | The apparatus and its facial mask preparation method of a kind of sterile filling facial mask | |
| CN103330953A (en) | Biosafety type pulsation vacuum sterilizer | |
| CN201193988Y (en) | Micro-organism aerosol generating apparatus | |
| CN214415283U (en) | Steam-water mixing sterilizer of fermentation continuous sterilization system | |
| CN110960714A (en) | Self-cleaning smoke disinfection equipment | |
| CN106943940A (en) | A kind of fully-automatic liquid make-up modular system equipment | |
| CN103805499B (en) | Air sterilization effect pipeline evaluation system | |
| CN208395171U (en) | A kind of biopharmaceutical liquids material transmitting isolating and protecting device | |
| CN218408906U (en) | Sterile sampling butt joint device | |
| CN101579678A (en) | Method for cleaning and disinfecting process system of liquid preparation for biological product | |
| CN105031682A (en) | Static-dynamic supercritical carbon dioxide cleaning and sterilizing device | |
| CN209221126U (en) | Medical dry vacuum system | |
| CN105749633A (en) | Storage jar system | |
| CN209410840U (en) | A kind of sterile liquid storage pot system | |
| CN208213060U (en) | A kind of eye drops liquid mixing system | |
| CN207605686U (en) | A kind of improved liquid medicine dosing system for setting T-type liquid filter | |
| CN205613173U (en) | Storing jar system | |
| CN110170482A (en) | Three tank on-line cleaning work stations | |
| CN109304062A (en) | A kind of improved pipe-line system for setting air filter and its sterilizing methods | |
| CN113136322B (en) | Air phage and mixed bacteria pre-killing system for fermentation | |
| CN219377171U (en) | Sterile isolator | |
| CN105032654B (en) | A kind of intelligent decontamination Water way controller | |
| CN204972360U (en) | Water route controlling means that disappears is washed to intelligence | |
| CN205551010U (en) | Bottle cleaning machine automatically cleaning system |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| RJ01 | Rejection of invention patent application after publication | ||
| RJ01 | Rejection of invention patent application after publication |
Application publication date: 20190222 |