CN107952280A - A kind of live vaccine sterile ultrafiltration enrichment facility and method - Google Patents
A kind of live vaccine sterile ultrafiltration enrichment facility and method Download PDFInfo
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- CN107952280A CN107952280A CN201711210929.7A CN201711210929A CN107952280A CN 107952280 A CN107952280 A CN 107952280A CN 201711210929 A CN201711210929 A CN 201711210929A CN 107952280 A CN107952280 A CN 107952280A
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D36/00—Filter circuits or combinations of filters with other separating devices
-
- 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
- A61L2/04—Heat
-
- 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
- A61L2/04—Heat
- A61L2/06—Hot gas
- A61L2/07—Steam
-
- 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
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
- B01D61/14—Ultrafiltration; Microfiltration
- B01D61/145—Ultrafiltration
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D65/00—Accessories or auxiliary operations, in general, for separation processes or apparatus using semi-permeable membranes
- B01D65/02—Membrane cleaning or sterilisation ; Membrane regeneration
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D65/00—Accessories or auxiliary operations, in general, for separation processes or apparatus using semi-permeable membranes
- B01D65/02—Membrane cleaning or sterilisation ; Membrane regeneration
- B01D65/022—Membrane sterilisation
Abstract
The invention discloses a kind of live vaccine sterile ultrafiltration enrichment facility, including medium tank, sterilizing filter, ultrafiltration concentration machine, some valves；The medium tank includes antigen tank, PBS tanks, alkali liquid tank, and mutual pipeline connection between three, the sterilizing filter are removably mounted at the outlet of PBS tanks；The antigen tank is connected with machine circulation line is concentrated by ultrafiltration, and alkali liquid tank is connected with machine circulation line is concentrated by ultrafiltration；At least two valves are respectively provided with connecting pipe in the antigen tank, PBS tanks, alkali liquid tank, sterilizing filter, ultrafiltration concentration machine between any two.The present invention also provides the method for concentration using the device, beneficial effects of the present invention：Set using cleverly pipeline, controllable valve switching sequence so that whole concentration process all accomplishes that 100% is sterile controllable, lifts the utilization rate of antigen, lifts the effect of antigen, cost-effective, can be widely used in live vaccine, inactivated vaccine.
Description
Technical field
The present invention relates to a kind of vaccine enrichment facility and method, more particularly to a kind of live vaccine sterile ultrafiltration to concentrate
Device and method.
Background technology
Ultrafiltration concentration is one very crucial technology of live vaccine industry, is concentrated by high magnification numbe, improves containing for antigen
Amount, so as to improve the quality of product, widely uses in inactivated vaccine workshop now.
The pollution rate of antigen reaches more than 60% after ultrafiltration at present, is widely used in inactivated vaccine workshop, due to super
Filter concentration aseptic controlling is more difficult, but is not suitable for the production of live vaccine.The present invention accomplishes each step of ultrafiltration concentration
100% is sterile controllable, so that it is sterile to reach 100%.
The content of the invention
The technical problems to be solved by the invention are the provision of a kind of production process gnotobasis and reach fully controllable
Live vaccine sterile ultrafiltration enrichment facility and method.
The present invention is to solve above-mentioned technical problem by the following technical programs：The present invention includes medium tank, is sterile filtered
Device, be concentrated by ultrafiltration machine, some valves；The medium tank includes antigen tank, PBS tanks, alkali liquid tank, and mutual pipeline connects between three
Logical, the sterilizing filter is removably mounted at the outlet of PBS tanks；The antigen tank is connected with machine circulation line is concentrated by ultrafiltration, alkali
Flow container is connected with machine circulation line is concentrated by ultrafiltration；In the antigen tank, PBS tanks, alkali liquid tank, sterilizing filter, ultrafiltration concentration machine
At least two valves are respectively provided with connecting pipe between any two.
Preferably, it is interconnected between the antigen tank, PBS tanks, alkali liquid tank and ultrafiltration concentration machine using cross pipeline；
One T font pipeline is set between the antigen tank, alkali liquid tank and ultrafiltration concentration machine, between alkali liquid tank and the ultrafiltration concentration machine
One direct pipeline is set.
Preferably, the sterilizing filter is 0.2 micron of sterilizing filter, in sterilizing filter inlet and outlet pipeline point
Not She Zhi a fast interface, be respectively first to connect connect soon with second soon, the ultrafiltration concentration machine includes three ports, including film
Bag import, film bag return port, film bag pass through port, and the film bag import connects medium tank, film bag return port connection antigen
Tank, alkali liquid tank, film bag is through port connection alkali liquid tank.
Preferably, a valve is respectively provided with four branches of the cross pipeline, in sterilizing filter outlet conduit
On, and before the second fast interface for the first valve, be arranged on antigen tank outlet conduit for the 3rd valve, be arranged on alkali
On flow container outlet conduit for the 5th valve, be arranged on the film bag inlet pipeline of ultrafiltration concentration machine for the 4th valve.
Preferably, a drain water piping and the second valve being arranged on pipeline are further included, the drain water piping is arranged on
First valve and with first connect soon between.
Preferably, a valve is respectively provided with three branches of the T fonts pipeline, be arranged on alkali liquid tank reflux line
For the 7th valve, be arranged on antigen tank reflux line for the 8th valve, be arranged on ultrafiltration concentration machine film bag reflux line
On for the 9th valve.
Preferably, one article of drain water piping and the 6th valve being placed on drain water piping are further included, the drain water piping is set
Put in the junction of each branch of T fonts pipeline.
Preferably, the direct pipeline is that the pipeline at end is passed through by alkali liquid tank connection ultrafiltration concentration machine film bag, described straight
Take over and two valves are set on road, be respectively the tenth valve and the 11st valve.
Preferably, one article of drain water piping and the 12nd valve being placed on drain water piping, the drain water piping are further included
It is arranged between the tenth valve and the 11st valve.
The present invention also provides a kind of method using live vaccine sterile ultrafiltration enrichment facility, the method step are as follows：
(1) sterilizing filter sterilizes offline, first connects to connect soon with second soon by first and dismantles, related first valve and the second valve
Door is removed together as an entirety, detects filter core integrality, with double at the first fast interface and the second fast interface and drain port
Layer clean-cloth encases, and the first valve, the second valve are opened, and is integrally placed on 121 DEG C of sterilizing cabinet and sterilizes more than 40 minutes, sterilizing
After, the first valve, the second valve are closed, and be connected to by sterile working in whole device；
(2) film bag sterilizes：The 5th valve, the 4th valve, the 9th valve, the 7th valve are opened in order, remaining valve is equal
Close, open ultrafiltration concentration machine, using the sodium hydroxide solution circulation disinfection film bag reflux line of 0.4-0.6mol/L concentration, hold
Continuous more than 60 minutes of time, the 7th valve, the 9th valve, the 4th valve are closed, open the second valve, lye in alkali liquid tank is arranged
Go out, close the 5th valve and the second valve；Again the sodium hydroxide solution of new 0.4-0.6mol/L concentration is prepared to alkali liquid tank,
The 5th valve, the 4th valve, the 11st valve, the tenth valve are opened, partially opens the 9th valve and the 7th valve, remaining valve
It is turned off, opens ultrafiltration concentration machine, lye circulation disinfection film bag passes through pipeline, more than 60 minutes duration, closes all valves
Door, disinfection terminate；
(3) antigen tank sterilizes online：Connect pure steam pipeline from antigen upper end, open the 8th valve, the 6th valve,
3rd valve, the second valve, remaining valve are turned off, and open pure steam, and 121 DEG C sterilize more than 30 minutes, two drain port temperature
Degree will reach 121 DEG C and be kept for more than 30 minutes, and all valves are closed after sterilizing, antigen tank is cooled to room temperature, lead to
Cross sterile working and antigen is added to antigen tank；
(4) film bag is cleaned：Open the first valve, the 4th valve, the 9th valve, the 6th valve, the 11st valve, the 12nd
Valve, remaining valve are turned off, and give the pressurization of PBS tanks, make PBS after 0.2 micron of sterilizing filter filters, by film bag, from
The reflux end of film bag and the PBS solution pH value discharged through end discharge, two ports of moment monitoring, when PBS is molten in pH value and tank
When liquid is consistent, all valves are closed, cleaning terminates；
(5) it is concentrated by ultrafiltration：Open the 3rd valve, the 4th valve, the 9th valve, the 8th valve, the 11st valve, the 12nd
Valve, opens ultrafiltration concentration machine, starts to concentrate, and until being concentrated into required multiple, stops concentration.
The present invention has the following advantages compared with prior art：Whole ultrafiltration concentration device of the invention, antigen tank, PBS tanks, alkali
It is interconnected between flow container and ultrafiltration concentration machine using cross pipeline；Between the antigen tank, alkali liquid tank and ultrafiltration concentration machine
One T font pipeline is set, a direct pipeline is set between alkali liquid tank and the ultrafiltration concentration machine, so cleverly pipeline is set
Put, can effective control valve switching sequence, can then control whole concentration process so that whole concentration process is accomplished
100% is sterile controllable, lifts the utilization rate of antigen, lifts the effect of antigen, cost-effective, can be wide in live vaccine, inactivated vaccine
General use.
Brief description of the drawings
Fig. 1 is a kind of structure diagram of live vaccine sterile ultrafiltration enrichment facility of the present invention.
Medium tank 1, antigen tank 11, the 3rd valve 111, pure steam pipeline 112, PBS tanks 12, alkali liquid tank 13, the 5th valve
131st, the 6th valve 132, the 7th valve 133, the 8th valve 134, the tenth valve 135, the 12nd valve 136
Sterilizing filter 2, first connects 21, second and connects the 22, first valve 23, the second valve 24 soon soon
Ultrafiltration concentration machine 3, film bag import 31, film bag return port 32, film bag are through port 33, the 4th valve the 34, the 9th
Valve 35, the 11st valve 36,
Embodiment
Elaborate below to the embodiment of the present invention, the present embodiment is carried out lower premised on technical solution of the present invention
Implement, give detailed embodiment and specific operating process, but protection scope of the present invention is not limited to following implementation
Example.
As shown in Figure 1, a kind of live vaccine sterile ultrafiltration enrichment facility of the present embodiment includes medium tank 1, sterilizing filter
2nd, machine 3, some valves is concentrated by ultrafiltration；The medium tank 1 includes antigen tank 11, PBS tanks 12, alkali liquid tank 13, and phase between three
Mutual pipeline connection, the sterilizing filter 2 are removably mounted at PBS tanks 12 and export；The antigen tank 11 is followed with ultrafiltration concentration machine 3
Endless tube road connects, and alkali liquid tank 13 is connected with 3 circulation line of machine is concentrated by ultrafiltration；The antigen tank 11, PBS tanks 12, alkali liquid tank 13, nothing
At least two valves are respectively provided with connecting pipe in bacterium filter 2, ultrafiltration concentration machine 3 between any two.
It is interconnected between the antigen tank 11, PBS tanks 12, alkali liquid tank 13 and ultrafiltration concentration machine 3 using cross pipeline；
A T font pipeline is set between the antigen tank 11, alkali liquid tank 13 and ultrafiltration concentration machine 3, the alkali liquid tank 13 and ultrafiltration are dense
One direct pipeline is set between contracting machine 3.
The sterilizing filter 2 is 0.2 micron of sterilizing filter, is set respectively in the sterilizing filter 2 inlet and outlet pipeline
A fast interface is put, respectively first connects 21 and second soon connects 22 soon, and the ultrafiltration concentration machine 3 includes three ports, including
Film bag import 31, film bag return port 32, film bag pass through port 33, and the film bag import 31 connects medium tank 1, film bag reflux end
Mouth 32 connects antigen tanks 11, alkali liquid tank 13, and film bag connects alkali liquid tank 13 through port 33.
A valve is respectively provided with four branches of the cross pipeline, on 2 outlet conduit of sterilizing filter, and
Before second quick 22 interface for the first valve 23, be arranged on 11 outlet conduit of antigen tank for the 3rd valve 111, be arranged on
On 13 outlet conduit of alkali liquid tank for the 5th valve 131, be arranged on the film bag inlet pipeline of ultrafiltration concentration machine 3 for the 4th valve
Door 34.
A drain water piping and the second valve 24 being arranged on pipeline are further included, the drain water piping is arranged on the first valve
Door 23 and is connect between 21 soon with first.
Be respectively provided with a valve in three branches of the T fonts pipeline, be arranged on alkali liquid tank reflux line for
Seven valves 133, be arranged on antigen tank reflux line for the 8th valve 134, be arranged on ultrafiltration concentration machine film bag reflux line
On for the 9th valve 35.
One article of drain water piping and the 6th valve 132 being placed on drain water piping are further included, the drain water piping is arranged on
The junction of each branch of T fonts pipeline.
The direct pipeline is to connect pipeline of the ultrafiltration concentration machine film bag through end by alkali liquid tank 13, in the direct pipeline
Two valves of upper setting, are respectively the tenth valve 135 and the 11st valve 36.
One article of drain water piping and the 12nd valve 136 being placed on drain water piping are further included, the drain water piping is set
Between the tenth valve 135 and the 11st valve 36.
The present invention also provides a kind of live vaccine sterile ultrafiltration method for concentration, the method embodiment step are as follows：
Embodiment one：
(1) sterilizing filter sterilizes offline, first connects 21 and second soon by first and connects 22 soon and dismantle, related first valve, 23 He
Second valve 24 is removed together as an entirety, detects filter core integrality, in the first fast interface and the second fast interface and hydrophobic
Encased at mouthful with double-deck clean-cloth, and the first valve 23, the second valve 24 are opened, be integrally placed on 121 DEG C of sterilizings 40 of sterilizing cabinet
More than minute, after sterilizing, the first valve 23, the second valve 24 are closed, and be connected to whole device by sterile working
On.
(2) film bag sterilizes：Disinfection lye is sodium hydroxide solution, its concentration is 0.5mol/L, opens the 5th valve in order
The 131, the 4th valve 34 of door, the 9th valve 35, the 7th valve 133, remaining valve are turned off, and open ultrafiltration concentration machine 3, lye follows
Ring sterilizes film bag reflux line, and 60 minutes duration, close the 7th valve 133, the 9th valve 35, the 4th valve 34, opens
Second valve 24, sodium hydroxide in alkali liquid tank 13 is discharged, and closes the 5th valve 131 and the second valve 24；Again prepare newly
Sodium hydroxide is 0.5mol/L to alkali liquid tank 13, new naoh concentration, opens the 5th valve 131, the 4th valve 34, the
11 valves 36, the tenth valve 135, partially open the 9th valve 35 and the 7th valve 133, remaining valve is turned off, and open super
Thickener 3 is filtered, lye circulation disinfection film bag passes through pipeline, 60 minutes duration, closes all valves, disinfection terminates.
(3) antigen tank sterilizes online：Connect pure steam pipeline 112 from 11 top of antigen tank, open the 8th valve 134,
6th valve 132, the 3rd valve 111, the second valve 24, remaining valve are turned off, and open pure steam, and 121 DEG C sterilize 30 minutes,
Two drain port temperature will reach 121 DEG C and keep 30 minutes, thus can by antigen tank 11, antigen tank 11 to film bag into
Pipeline, the pipeline of film bag reflux end 32 to antigen tank 11 of mouth 31 sterilize together, ensure in contact with antigen ultrafiltration concentration process
The pipeline arrived is all sterile.All valves are closed after sterilizing, antigen tank 11 is cooled to room temperature, will be anti-by sterile working
Original is added to antigen tank.
(4) film bag is cleaned：Open the first valve 23, the 4th valve 34, the 9th valve 35, the 6th valve the 132, the 11st
Valve 36, the 12nd valve 136, remaining valve are turned off, and are pressurizeed to PBS tanks 12, PBS is passed through 0.2 micron of sterilizing filter
After filtering, by film bag, to be discharged from the reflux end of film bag and through end, the moment monitors the PBS solution pH value of two port discharges,
When pH value is consistent with PBS solution in tank, all valves are closed, cleaning terminates, and all pipelines are in the range of aseptic controlling.
(5) it is concentrated by ultrafiltration：Open the 3rd valve 111, the 4th valve 34, the 9th valve 35, the 8th valve the 134, the 11st
Valve 36, the 12nd valve 136, open ultrafiltration concentration machine 3, start to concentrate, and until being concentrated into required multiple, stop concentration, whole
A concentration process is in aseptic condition control range.
Embodiment two：
It is with one difference of embodiment：The concentration of sodium hydroxide, and sterilization time.
(1) sterilizing filter sterilizes offline, first connects 21 and second soon by first and connects 22 soon and dismantle, related first valve, 23 He
Second valve 24 is removed together as an entirety, detects filter core integrality, in the first fast interface and the second fast interface and hydrophobic
Encased at mouthful with double-deck clean-cloth, and the first valve 23, the second valve 24 are opened, be integrally placed on 121 DEG C of sterilizings 45 of sterilizing cabinet
Minute, after sterilizing, the first valve 23, the second valve 24 are closed, and be connected to by sterile working in whole device.
(2) film bag sterilizes：Disinfection lye is sodium hydroxide solution, its concentration is 0.4mol/L, opens the 5th valve in order
The 131, the 4th valve 34 of door, the 9th valve 35, the 7th valve 133, remaining valve are turned off, and open ultrafiltration concentration machine 3, lye follows
Ring sterilizes film bag reflux line, and 70 minutes duration, close the 7th valve 133, the 9th valve 35, the 4th valve 34, opens
Second valve 24, sodium hydroxide in alkali liquid tank 13 is discharged, and closes the 5th valve 131 and the second valve 24；Again prepare newly
Sodium hydroxide is 0.4mol/L to alkali liquid tank 13, new naoh concentration, opens the 5th valve 131, the 4th valve 34, the
11 valves 36, the tenth valve 135, partially open the 9th valve 35 and the 7th valve 133, remaining valve is turned off, and open super
Thickener 3 is filtered, lye circulation disinfection film bag passes through pipeline, 70 minutes duration, closes all valves, disinfection terminates.
(3) antigen tank sterilizes online：Connect pure steam pipeline 112 from 11 top of antigen tank, open the 8th valve 134,
6th valve 132, the 3rd valve 111, the second valve 24, remaining valve are turned off, and open pure steam, and 121 DEG C sterilize 45 minutes,
Two drain port temperature will reach 121 DEG C and keep 35 minutes, thus can by antigen tank 11, antigen tank 11 to film bag into
Pipeline, the pipeline of film bag reflux end 32 to antigen tank 11 of mouth 31 sterilize together, ensure in contact with antigen ultrafiltration concentration process
The pipeline arrived is all sterile.All valves are closed after sterilizing, antigen tank 11 is cooled to room temperature, will be anti-by sterile working
Original is added to antigen tank.
(4) film bag is cleaned：Open the first valve 23, the 4th valve 34, the 9th valve 35, the 6th valve the 132, the 11st
Valve 36, the 12nd valve 136, remaining valve are turned off, and are pressurizeed to PBS tanks 12, PBS is passed through 0.2 micron of sterilizing filter
After filtering, by film bag, to be discharged from the reflux end of film bag and through end, the moment monitors the PBS solution pH value of two port discharges,
When pH value is consistent with PBS solution in tank, all valves are closed, cleaning terminates, and all pipelines are in the range of aseptic controlling.
(5) it is concentrated by ultrafiltration：Open the 3rd valve 111, the 4th valve 34, the 9th valve 35, the 8th valve the 134, the 11st
Valve 36, the 12nd valve 136, open ultrafiltration concentration machine 3, start to concentrate, and until being concentrated into required multiple, stop concentration, whole
A concentration process is in the range of aseptic controlling.
Embodiment three：
It is with one difference of embodiment：The concentration of sodium hydroxide, and sterilization time.
(1) sterilizing filter sterilizes offline, first connects 21 and second soon by first and connects 22 soon and dismantle, related first valve, 23 He
Second valve 24 is removed together as an entirety, detects filter core integrality, in the first fast interface and the second fast interface and hydrophobic
Encased at mouthful with double-deck clean-cloth, and the first valve 23, the second valve 24 are opened, be integrally placed on 121 DEG C of sterilizings 45 of sterilizing cabinet
Minute, after sterilizing, the first valve 23, the second valve 24 are closed, and be connected to by sterile working in whole device.
(2) film bag sterilizes：Disinfection lye is sodium hydroxide solution, its concentration is 0.6mol/L, opens the 5th valve in order
The 131, the 4th valve 34 of door, the 9th valve 35, the 7th valve 133, remaining valve are turned off, and open ultrafiltration concentration machine 3, lye follows
Ring sterilizes film bag reflux line, and 70 minutes duration, close the 7th valve 133, the 9th valve 35, the 4th valve 34, opens
Second valve 24, sodium hydroxide in alkali liquid tank 13 is discharged, and closes the 5th valve 131 and the second valve 24；Again prepare newly
Sodium hydroxide is 0.6mol/L to alkali liquid tank 13, new naoh concentration, opens the 5th valve 131, the 4th valve 34, the
11 valves 36, the tenth valve 135, partially open the 9th valve 35 and the 7th valve 133, remaining valve is turned off, and open super
Thickener 3 is filtered, lye circulation disinfection film bag passes through pipeline, 70 minutes duration, closes all valves, disinfection terminates.
(3) antigen tank sterilizes online：Connect pure steam pipeline 112 from 11 top of antigen tank, open the 8th valve 134,
6th valve 132, the 3rd valve 111, the second valve 24, remaining valve are turned off, and open pure steam, and 121 DEG C sterilize 40 minutes,
Two drain port temperature will reach 121 DEG C and keep 40 minutes, thus can by antigen tank 11, antigen tank 11 to film bag into
Pipeline, the pipeline of film bag reflux end 32 to antigen tank 11 of mouth 31 sterilize together, ensure in contact with antigen ultrafiltration concentration process
The pipeline arrived is all sterile.All valves are closed after sterilizing, antigen tank 11 is cooled to room temperature, will be anti-by sterile working
Original is added to antigen tank.
(4) film bag is cleaned：Open the first valve 23, the 4th valve 34, the 9th valve 35, the 6th valve the 132, the 11st
Valve 36, the 12nd valve 136, remaining valve are turned off, and are pressurizeed to PBS tanks 12, PBS is passed through 0.2 micron of sterilizing filter
After filtering, by film bag, to be discharged from the reflux end of film bag and through end, the moment monitors the PBS solution pH value of two port discharges,
When pH value is consistent with PBS solution in tank, all valves are closed, cleaning terminates, and all pipelines are in the range of aseptic controlling.
(5) it is concentrated by ultrafiltration：Open the 3rd valve 111, the 4th valve 34, the 9th valve 35, the 8th valve the 134, the 11st
Valve 36, the 12nd valve 136, open ultrafiltration concentration machine 3, start to concentrate, and until being concentrated into required multiple, stop concentration, whole
A concentration process is in the range of aseptic controlling.
According to apparatus and method of the present invention, tested, experiment is described as follows：
Experiment one：1000L CSFV antigens (cell source) are concentrated by ultrafiltration：According to position shown in Fig. 1, device is connected,
And method and step to specifications carries out 10 times of ultrafiltration concentrations, CSFV antigen sampling is done respectively before concentration and after concentration
Steriling test, after 7 days, observation is as a result, be sterile before and after concentration.
Experiment two：200L rabies antigens are concentrated by ultrafiltration：According to position shown in Fig. 1, device is connected, and to specifications
Method and step carry out 5 times ultrafiltration concentration, concentration before and concentration after respectively by rabies antigen sampling do steriling test, after 7 days,
Observation is as a result, be sterile before and after concentration.
Experiment three：1500L porcine circovirus 2 type antigens are concentrated by ultrafiltration：According to position shown in Fig. 1, device is connected, and press
The method and step of book carries out 10 times of ultrafiltration concentrations as directed, respectively samples porcine circovirus 2 type antigen before concentration and after concentration
Steriling test is done, after 7 days, observation is as a result, be sterile before and after concentration.
Experiment four：500L porcine circovirus 2 type antigens are concentrated by ultrafiltration：According to position shown in Fig. 1, device is connected, and press
The method and step of book carries out 5 times of ultrafiltration concentrations as directed, respectively does the sampling of porcine circovirus 2 type antigen before concentration and after concentration
Steriling test, after 7 days, observation is as a result, be sterile before and after concentration.
The foregoing is merely illustrative of the preferred embodiments of the present invention, is not intended to limit the invention, all essences in the present invention
All any modification, equivalent and improvement made within refreshing and principle etc., should all be included in the protection scope of the present invention.
Claims (10)
1. a kind of live vaccine sterile ultrafiltration enrichment facility, it is characterised in that including medium tank, sterilizing filter, ultrafiltration concentration
Machine, some valves；The medium tank includes antigen tank, PBS tanks, alkali liquid tank, and mutual pipeline connection between three, described sterile
Filter is removably mounted at the outlet of PBS tanks；The antigen tank is connected with machine circulation line is concentrated by ultrafiltration, and alkali liquid tank is dense with ultrafiltration
Contracting machine circulation line connects；In the antigen tank, PBS tanks, alkali liquid tank, sterilizing filter, ultrafiltration concentration machine between any two
Connecting pipe on be respectively provided with least two valves.
A kind of 2. live vaccine sterile ultrafiltration enrichment facility according to claim 1, it is characterised in that the antigen tank,
It is interconnected between PBS tanks, alkali liquid tank and ultrafiltration concentration machine using cross pipeline；The antigen tank, alkali liquid tank and ultrafiltration are dense
One T font pipeline is set between contracting machine, a direct pipeline is set between alkali liquid tank and the ultrafiltration concentration machine.
A kind of 3. live vaccine sterile ultrafiltration enrichment facility according to claim 2, it is characterised in that the aseptic filtration
Device is 0.2 micron of sterilizing filter, sets a fast interface respectively in sterilizing filter inlet and outlet pipeline, is respectively the
One connects connect soon with second soon, and the ultrafiltration concentration machine includes three ports, including the import of film bag, film bag return port, film bag are saturating
Port is crossed, the film bag import connects medium tank, film bag return port connection antigen tank, alkali liquid tank, and film bag is connected through port
Alkali liquid tank.
A kind of 4. live vaccine sterile ultrafiltration enrichment facility according to claim 3, it is characterised in that the cross pipe
Be respectively provided with a valve in four branches in road, on sterilizing filter outlet conduit, and before the second fast interface for
One valve, be arranged on antigen tank outlet conduit for the 3rd valve, be arranged on alkali liquid tank outlet conduit for the 5th valve,
Be arranged on the film bag inlet pipeline of ultrafiltration concentration machine for the 4th valve.
5. a kind of live vaccine sterile ultrafiltration enrichment facility according to claim 4, it is characterised in that further include one and dredge
Waterpipe and the second valve being arranged on pipeline, the drain water piping be arranged on the first valve and with first connect soon between.
A kind of 6. live vaccine sterile ultrafiltration enrichment facility according to claim 2, it is characterised in that the T fonts pipe
Be respectively provided with a valve in three branches in road, be arranged on alkali liquid tank reflux line for the 7th valve, be arranged on antigen tank
On reflux line for the 8th valve, be arranged on ultrafiltration concentration machine film bag reflux line for the 9th valve.
7. a kind of live vaccine sterile ultrafiltration enrichment facility according to claim 6, it is characterised in that further include one and dredge
Waterpipe and the 6th valve being placed on drain water piping, the drain water piping are arranged on the company of each branch of T fonts pipeline
Meet place.
A kind of 8. live vaccine sterile ultrafiltration enrichment facility according to claim 2, it is characterised in that the direct pipeline
It is the pipeline that end is passed through by alkali liquid tank connection ultrafiltration concentration machine film bag, two valves is set in the direct pipeline, are respectively
Tenth valve and the 11st valve.
9. a kind of live vaccine sterile ultrafiltration enrichment facility according to claim 8, it is characterised in that further include one and dredge
Waterpipe and the 12nd valve being placed on drain water piping, the drain water piping be arranged on the tenth valve and the 11st valve it
Between.
A kind of 10. method using any live vaccine sterile ultrafiltration enrichment facilities of claim 1-9, it is characterised in that
The method step is as follows：
(1) sterilizing filter sterilizes offline, first connects to connect soon with second soon by first and dismantles, related first valve and the second valve one
Rise and removed as an entirety, detect filter core integrality, with double-deck clean at the first fast interface and the second fast interface and drain port
Net cloth encases, and the first valve, the second valve are opened, and is integrally placed on 121 DEG C of sterilizing cabinet and sterilizes more than 40 minutes, sterilizing terminates
Afterwards, the first valve, the second valve are closed, and be connected to by sterile working in whole device；
(2) film bag sterilizes：The 5th valve, the 4th valve, the 9th valve, the 7th valve are opened in order, remaining valve is turned off,
Ultrafiltration concentration machine is opened, uses the sodium hydroxide solution of 0.4-0.6mol/L concentration, circulation disinfection film bag reflux line, when continuing
Between more than 60 minutes, close the 7th valve, the 9th valve, the 4th valve, open the second valve, lye in alkali liquid tank is discharged,
Close the 5th valve and the second valve；Again the sodium hydroxide solution of new 0.4-0.6mol/L concentration is prepared to alkali liquid tank, is beaten
The 5th valve, the 4th valve, the 11st valve, the tenth valve are opened, partially opens the 9th valve and the 7th valve, remaining valve is equal
To close, open ultrafiltration concentration machine, lye circulation disinfection film bag passes through pipeline, more than 60 minutes duration, closes all valves,
Disinfection terminates；
(3) antigen tank sterilizes online：Pure steam pipeline is connected from antigen upper end, opens the 8th valve, the 6th valve, the 3rd
Valve, the second valve, remaining valve are turned off, and open pure steam, and 121 DEG C sterilize more than 30 minutes, and two drain port temperature are all
Reach 121 DEG C and kept for more than 30 minutes, all valves are closed after sterilizing, antigen tank is cooled to room temperature, passes through nothing
Antigen is added to antigen tank by bacterium operation；
(4) film bag is cleaned：Open the first valve, the 4th valve, the 9th valve, the 6th valve, the 11st valve, the 12nd valve
Door, remaining valve are turned off, and are pressurizeed to PBS tanks, make PBS after 0.2 micron of sterilizing filter filters, by film bag, from film
The reflux end of bag and the PBS solution pH value discharged through end discharge, two ports of moment monitoring, when PBS solution in pH value and tank
When consistent, all valves are closed, cleaning terminates；
(5) it is concentrated by ultrafiltration：Open the 3rd valve, the 4th valve, the 9th valve, the 8th valve, the 11st valve, the 12nd valve
Door, opens ultrafiltration concentration machine, starts to concentrate, and until being concentrated into required multiple, stops concentration.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201711210929.7A CN107952280A (en) | 2017-11-28 | 2017-11-28 | A kind of live vaccine sterile ultrafiltration enrichment facility and method |
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| CN201711210929.7A CN107952280A (en) | 2017-11-28 | 2017-11-28 | A kind of live vaccine sterile ultrafiltration enrichment facility and method |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115487582A (en) * | 2022-10-17 | 2022-12-20 | 广东百维生物科技有限公司 | Method for recovering precisely filtered collagen liquid |
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| CN101056885A (en) * | 2004-09-09 | 2007-10-17 | 健泰科生物技术公司 | Process for concentration of antibodies and therapeutic products thereof |
| CN104857857A (en) * | 2015-04-23 | 2015-08-26 | 北京科兴生物制品有限公司 | Method for cleaning ultrafiltration membrane bag |
| CN106281983A (en) * | 2015-06-09 | 2017-01-04 | 江苏诺百生物科技有限公司 | A kind of virus liquid purification, enrichment facility |
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| CA1181696A (en) * | 1981-01-12 | 1985-01-29 | Jorn D. Benedictus | Filter |
| CN101056885A (en) * | 2004-09-09 | 2007-10-17 | 健泰科生物技术公司 | Process for concentration of antibodies and therapeutic products thereof |
| CN104857857A (en) * | 2015-04-23 | 2015-08-26 | 北京科兴生物制品有限公司 | Method for cleaning ultrafiltration membrane bag |
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| CN115487582A (en) * | 2022-10-17 | 2022-12-20 | 广东百维生物科技有限公司 | Method for recovering precisely filtered collagen liquid |
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Application publication date: 20180424 |