CN106726576A - A kind of supensoid agent prepares induction system - Google Patents
A kind of supensoid agent prepares induction system Download PDFInfo
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- CN106726576A CN106726576A CN201611224499.XA CN201611224499A CN106726576A CN 106726576 A CN106726576 A CN 106726576A CN 201611224499 A CN201611224499 A CN 201611224499A CN 106726576 A CN106726576 A CN 106726576A
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- liquid
- filter
- feedway
- water
- dispensing device
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
-
- 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
- A61L2/26—Accessories or devices or components used for biocidal treatment
- A61L2/28—Devices for testing the effectiveness or completeness of sterilisation, e.g. indicators which change colour
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J2200/00—General characteristics or adaptations
- A61J2200/40—Heating or cooling means; Combinations thereof
- A61J2200/42—Heating means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J2200/00—General characteristics or adaptations
- A61J2200/70—Device provided with specific sensor or indicating means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J2200/00—General characteristics or adaptations
- A61J2200/70—Device provided with specific sensor or indicating means
- A61J2200/72—Device provided with specific sensor or indicating means for temperature
-
- 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
- A61L2202/14—Means for controlling sterilisation processes, data processing, presentation and storage means, e.g. sensors, controllers, programs
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Apparatus For Disinfection Or Sterilisation (AREA)
Abstract
Induction system is prepared the invention discloses a kind of supensoid agent, including:Feeding device, liquid dispensing device, filter, the buffer unit of setting are sequentially communicated, and connect the tapping equipment of setting with feeding device, liquid dispensing device, filter, buffer unit respectively;Feeding device includes being supplied to switch board the first compressed air feedway of compressed air, the steam feedway of steam is supplied to liquid dispensing device, filter, buffer unit, the second compressed air feedway of compressed air is supplied to liquid dispensing device, to the water for injection feedway of liquid dispensing device supply water, the apparatus for supplying cool water of cooling water is supplied to liquid dispensing device, the industrial steam feedway of industrial steam is supplied to liquid dispensing device.Steam is provided to liquid dispensing device, filter, buffer unit in the present invention, for cleaning or sterilizing;So as to thoroughly be carried out disinfection to liquid dispensing device, filter, buffer unit, cleaned, sterilized automatically;Reduce labour intensity, improve operating efficiency.
Description
Technical field
The invention belongs to medical manufacturing technology field, more particularly to supensoid agent prepares induction system.
Background technology
In bio-pharmaceuticals production system, for example:Omeprazole dry suspensoid agent is prepared, it is necessary to liquid in induction system
Tank, pipeline and other equipment carry out periodic cleaning and sterilization, and life is met with Agitation Tank, pipeline and other equipment in ensuring system
The requirement that production. art specifies.
At present, to the cleaning and sterilization of Agitation Tank liquid, pipeline and other equipment, typically completed by artificial.However,
This artificial cleaning and sterilization have the following disadvantages:Sterilization, cleaning, sterilizing be not thorough, and in cleaning process, the dismounting of pipeline
Connection will bring artificially-contaminated risk.Meanwhile, also increase the labour intensity of operating personnel, operating efficiency of cutting interest rate.
The content of the invention
The technical scheme that the present invention is provided is as follows:
The present invention provides a kind of supensoid agent and prepares induction system, including:It is sequentially communicated the feeding device of setting, is filled with liquid
Put, filter, buffer unit, and connected with the feeding device, liquid dispensing device, filter, buffer unit set respectively
The tapping equipment put;The feeding device includes being supplied to switch board the first compressed air feedway of compressed air, to institute
The steam feedway that liquid dispensing device, filter, buffer unit supply steam is stated, compressed air is supplied to the liquid dispensing device
The second compressed air feedway, to the water for injection feedway of the liquid dispensing device supply water, filled with liquid to described
The apparatus for supplying cool water of supply cooling water is put, the industrial steam feedway of industrial steam is supplied to the liquid dispensing device.
Further, the liquid dispensing device includes:Two Agitation Tanks, each Agitation Tank is matched somebody with somebody with liquid branch pipe by first with first
Liquid house steward connection is set;Described first with being provided with first on liquid branch pipe with hydraulic pneumatic valve, described first with liquid house steward with it is described
The connection of steam feedway is set;Each Agitation Tank also connects setting with second with liquid branch pipe by second with liquid house steward;It is described
Second with being provided with second with hydraulic pneumatic valve on liquid branch pipe, described second connects with liquid house steward with the water for injection feedway
Set.
Further, the tank deck of each Agitation Tank is provided with first with liquid passage and second with liquid passage;Described first is logical with liquid
Road or second is with, equipped with a spray ball, the spray ball is used to send the water for injection and/or purified water on liquid passage
Enter the liquor charging passage in the Agitation Tank.
Further, be provided with each Agitation Tank it is in communication with liquid respirator, it is described with liquid respirator and the steaming
Vapour feedway, the connection of the second compressed air feedway are set, and described also connection with the tapping equipment with liquid respirator sets
Put;The tank bottom of each Agitation Tank offers the liquid outlet for being connected with the filter and being set.
Further, the chuck that can accommodate liquid is arranged with each Agitation Tank, is provided with the chuck and the cooling
Import, outlet that water feeder connection is set, the chuck are also supplied with second compressed air feedway, industrial steam
Connected to device and set.
Further, the filter includes:Four filters, two filters are sequentially communicated for setting and being formed
Filter element, each Agitation Tank is connected with the filter in a filter element near the Agitation Tank side by delivery pipe and set
Put;The first filtering pneumatic operated valve, the first filter pressure sensor are provided with the delivery pipe;On the output channel of each filter
It is provided with the second filter pressure sensor.
Further, the discharge duct for being connected with the tapping equipment and being set, the row are provided with the top of each filter
The second filtering pneumatic operated valve is provided with feed channel.
Further, the buffer unit includes:Near described in two surge tanks, each surge tank and a filter element
The filter connection of surge tank side is set, and each surge tank also connects setting with the steam feedway.
Further, buffering respirator is provided with and communicated with each surge tank, is set between the buffering respirator and surge tank
It is equipped with the first buffering hand-operated valve;Buffering liquid level gauge, buffering pressure meter are additionally provided with the surge tank.
Further, the tapping equipment includes:Discharge of wastewater passage and cooling-water drain passage, the discharge of wastewater passage
On be provided with centrifugal pump, be provided with the discharge of wastewater passage discharge hand-operated valve, conductivity meter, the conductivity meter be used for survey
The electrical conductivity of examination institute waste discharge;Be respectively arranged with the discharge of wastewater passage and cooling-water drain passage temperature transmitter,
Check-valves.
Compared with prior art, a kind of supensoid agent that the present invention is provided prepares induction system, has the advantages that:
1) feeding device, liquid dispensing device, filter, buffer unit, and tapping equipment are set gradually in the present invention;Its
In, feeding device not only can provide water for injection to liquid dispensing device, for making up a prescription;Can also be to liquid dispensing device, filter, slow
Flushing device provides steam, for cleaning liquid dispensing device, filter, buffer unit, or it is sterilized;So as to automatic to matching somebody with somebody
Liquid device, filter, buffer unit thoroughly carry out disinfection, clean, sterilize;Reduce the labour intensity of operating personnel, improve
Operating efficiency.
2) two sets of liquid mixing systems are designed in the present invention, when a set of liquid mixing system is when filling, another set of liquid mixing system is clear
Wash or sterilize, using bivalve cut-off mode (first matches somebody with somebody hydraulic pneumatic valve with hydraulic pneumatic valve, second), duplicate protection avoids being
Occurs cross pollution in system.
3) it is provided with liquid respirator on Agitation Tank in the present invention, the air and external air pressure in Agitation Tank can be made
Balance, is unlikely to make the pressure in Agitation Tank excessive or too small, causes Agitation Tank to explode or deflated.And enter in Agitation Tank
Air, when by with liquid respirator, its air has reached degerming purpose, will not there is any pollution to liquid.
4) chuck is arranged with the present invention on Agitation Tank, apparatus for supplying cool water, industrial steam feedway are supplied to chuck
To cooling water, industrial steam, so as to meet different liquids in configuration process, difference configures the demand of temperature.
5) top design in the present invention in filter has special discharge duct to be sterilized, and is set before and after filter
It is equipped with pressure sensor (first pressure sensor, second pressure sensor), the pressure difference before and after real time record filter, according to pressure
The poor amount of filling into adjust steam, reaches the effect of filter sterilised.
6) present invention increases conductivity probe and temp probe in floss hole, and conductivity value is converted into 4-20 milliamperes of mould
Analog quantity signal, being sent in PLC system carries out data record and storage, after terminating for the production of liquid batch, cleaning pipeline,
Equipment, or to system SIP (online sterilizing), conductivity value and temperature value can be monitored on-line, reach cleaning validation and go out
The data needed in bacterium checking.
Brief description of the drawings
Below by clearly understandable mode, preferred embodiment is described with reference to the drawings, a kind of supensoid agent is prepared and is conveyed
The above-mentioned characteristic of system, technical characteristic, advantage and its implementation are further described.
Fig. 1 is the part mark chart lattice that a kind of supensoid agent of the invention prepares induction system;
Fig. 2 is another part mark chart lattice that a kind of supensoid agent of the invention prepares induction system;
Fig. 3 is another portion identification chart lattice that a kind of supensoid agent of the invention prepares induction system;
Fig. 4 is that a kind of supensoid agent of the invention is prepared feeding device in induction system, liquid dispensing device, the structure of tapping equipment and shown
It is intended to;
Fig. 5 is the structural representation that a kind of supensoid agent of the invention prepares liquid dispensing device in induction system;
Fig. 6 is that a kind of supensoid agent of the invention prepares filter, the structural representation of buffer unit in induction system;
Fig. 7 is the structural representation that a kind of supensoid agent of the invention prepares switch board in induction system;
Fig. 8 is the structural representation that a kind of supensoid agent of the invention prepares filling apparatus in induction system.
Specific embodiment
In order to illustrate more clearly about the embodiment of the present invention or technical scheme of the prior art, control is illustrated below
Specific embodiment of the invention.It should be evident that drawings in the following description are only some embodiments of the present invention, for
For those of ordinary skill in the art, on the premise of not paying creative work, other can also be obtained according to these accompanying drawings
Accompanying drawing, and obtain other implementation methods.
To make simplified form, part related to the present invention is only schematically show in each figure, they are not represented
Its as product practical structures.In addition, so that simplified form is readily appreciated, there is identical structure or function in some figures
Part, only symbolically depicts one of those, or has only marked one of those.Herein, " one " is not only represented
" only this ", it is also possible to represent the situation of " more than one ".
As shown in Fig. 1~8, according to one embodiment of present invention, a kind of supensoid agent prepares induction system, including:Successively
Feeding device, liquid dispensing device, filter, the buffer unit for setting are connected, and is filled respectively with the feeding device, with liquid
Put, filter, buffer unit connect the tapping equipment for setting;The feeding device is included to switch board supply compressed air
First compressed air feedway, be provided between first compressed air feedway and switch board electro connecting pressure gauge,
Air composition element, the compressed air of the first compressed air feedway output, the work for controlling trigger valve in switch board
State;The steam feedway of steam, the steam feedway are supplied to the liquid dispensing device, filter, buffer unit
The steam of (PS feedways) output, for being cleaned to the liquid dispensing device, filter, buffer unit or sterilized;To
The liquid dispensing device supplies the second compressed air feedway of compressed air, the output of second compressed air feedway
Air composition element is provided with pipeline;To the water for injection feedway of the liquid dispensing device supply water, water for injection is supplied
To the water for injection of device output, for making up a prescription;The apparatus for supplying cool water of cooling water, the note are supplied to the liquid dispensing device
Penetrate and also connect setting with heat exchanger respectively with water feeder, apparatus for supplying cool water;Industry is supplied to the liquid dispensing device
The industrial steam feedway of steam.Air cleaner is provided with and communicated with the output channel of the steam feedway, institute
State air cleaner and setting is also connected with second compressed air feedway, the air cleaner is also filled with the discharge
Connection is put to set.This supensoid agent prepares induction system, also including filling apparatus, for the filling liquid for having prepared, public one
Bottle placer, and the time is more nervous, to be equipped with one day filling 3 batch materials.
For the improvement of above-described embodiment, in the present embodiment, the liquid dispensing device includes:Two Agitation Tanks, each matches somebody with somebody liquid
Tank connects setting with first with liquid branch pipe by first with liquid house steward;Described first matches somebody with somebody hydraulic pneumatic with being provided with first on liquid branch pipe
Valve, first could be arranged to multiple (such as 2,3) with hydraulic pneumatic valve, and described first supplies dress with liquid house steward with the steam
Connection is put to set;Each Agitation Tank also connects setting with second with liquid branch pipe by second with liquid house steward;Described second with liquid branch
Second is provided with pipe with hydraulic pneumatic valve, second could be arranged to multiple (such as 2,3) with hydraulic pneumatic valve, and described second matches somebody with somebody
Liquid house steward connects setting with the water for injection feedway.300L Agitation Tank TK-01,300L Agitation Tank TK-02 (Agitation Tank bodies
Product can determine according to the need for each various processes), material passes through compressed air.
The tank deck of each Agitation Tank is provided with first with liquid passage and second with liquid passage;Described first with liquid passage with it is described
First connects setting with liquid branch pipe, and described second connects setting with described second with liquid passage with liquid branch pipe;Described first matches somebody with somebody liquid
Passage and/or second is with, equipped with a spray ball, the spray ball is used for the water for injection and/or purifying on liquid passage
Water sends into the liquor charging passage in the Agitation Tank.The bottom of each Agitation Tank is provided with and communicated with magnetic stirrer, becomes with liquid temperature degree
Device, Weighing module are sent, pressure transmitter, pressure gauge, rupture disk are additionally provided with each Agitation Tank.
Agitation Tank TK-01 tank decks access tank deck spray ball jointly equipped with water for injection and purified water interface, are separately further added by one
Individual pipeline does not spray ball and is directly entered in tank by tank deck, and in conventional blending process, the operation sprayed by abhiseca is can
With satisfactory.But in emerging field of biological pharmacy, some special materials are for the requirement of proportioning process condition extremely
Strictly, if using Normal practice (i.e. dispensing when injection water directly by spray enter, without in addition increase entrance directly enter
Enter in tank), then easily cause foam in blending process, material conveying is not easy to, or feed liquid is splashed, for these materials
For, this may cause material characteristic to change.This point can be determined the need for according to specific pharmaceutical field.
Be provided with each Agitation Tank it is in communication with liquid respirator, it is described pneumatic by the first breathing with liquid respirator
Valve connects setting with the steam feedway, the second compressed air feedway, described also to be exhaled by second with liquid respirator
Inhale pneumatic operated valve and connect setting with the tapping equipment;The tank bottom of each Agitation Tank is offered and connects what is set with the filter
Liquid outlet.
With liquid respirator air in Agitation Tank can balance with external air pressure, be unlikely to make the pressure in Agitation Tank
Power is excessive or too small, causes Agitation Tank to explode or deflated.And the air entered in Agitation Tank, when by with liquid respirator,
Its air has reached degerming purpose, will not there is any pollution to liquid.Heating is had additional in the respirator with liquid
Device, with increased heating function in liquid respirator, pure steam is needed to use during online sterilizing, and pure steam easily produces condensation
Water, and condensed water can be blocked with the filter core in liquid respirator, now using mode of heating, liquid respirator is matched somebody with somebody in heating, makes condensed water
Evaporation, is unlikely to cause filter core to block.
Being arranged with each Agitation Tank can accommodate the chuck of liquid, be provided with the chuck and filled with the cooling water supply
Import, outlet that connection is set are put, the cooling water of apparatus for supplying cool water output is flowed into by heat exchanger or directly from import
Chuck, then from outlet outflow chuck, apparatus for supplying cool water is returned to, Agitation Tank is cooled down so as to recycle water resource;
The chuck also connects setting with second compressed air feedway, industrial steam feedway;Second compressed air is supplied
Compressed air to device output enters chuck from entrance, may be such that the liquid in chuck is expelled to tapping equipment;Industrial steam
The industrial steam of feedway output flows into chuck from entrance, then from outlet outflow chuck, is emitted into tapping equipment.
For the improvement of above-described embodiment, in the present embodiment, the filter includes:Four filters, two filterings
Device is sequentially communicated the filter element for setting and being formed, and each Agitation Tank in delivery pipe and a filter element by being close to institute
The filter connection for stating Agitation Tank side is set;The first filtering pneumatic operated valve, the first filter pressure is provided with the delivery pipe to pass
Sensor.The filtering accuracy of the first filter F L-04 or FL-05 is 0.45 μm, the mistake of the second sterilizing filter FL-04 or FL-05
Filter precision is 0.22 μm, and each accessory on tank.Wherein, accessory includes the diaphragm valve of safety valve and various sizes, ball valve, dredges
Water valve and pipe fitting etc..
The discharge duct for being connected with the tapping equipment and being set is provided with the top of each filter, in steam feedway
When being input into steam to filter, steam enters from the bottom of filter, and is discharged from the blast pipe of filter top, and is emitted into
Tapping equipment, can be sterilized to filter, and the second filter pressure sensor, the first filtering are provided with the discharge duct
Pressure sensor is arranged on the porch of filter, for detecting first pressure value;Second filter pressure sensor was arranged on
The exit of filter, for detecting second pressure value;Pressure difference according to first pressure value, second pressure value adjusts steam
The amount of filling into.
For the improvement of above-described embodiment, in the present embodiment, the buffer unit includes:Two surge tanks, each buffering
Tank connects setting with the filter in a filter element near the surge tank side, and each surge tank is also supplied with the steam
Connected to device and set, the steam of steam feedway output is cleaned or sterilized to surge tank.Solution in Agitation Tank T1 or
Prepared in Agitation Tank T2, by pipeline after the completion of preparation, through two-stage bacterial filter after, be delivered to surge tank T3 or surge tank T4,
Carry out filling, whole system is controlled to Automatic Control.It is then the online sterilization process of pure steam (SIP), SIP mistakes after cleaning
Journey includes the sterilizing to tank, tank deck respirator and whole system pipeline valve filter.Increase by one 0.22 μm in the system
Sterilizing filter, multistage degerming purpose is reached, so as to more can guarantee that the quality of liquid.
Buffering respirator is provided with and communicated with each surge tank, first is provided between the buffering respirator and surge tank
Buffering hand-operated valve;The bottom of the surge tank is provided with and communicated with the second buffering hand-operated valve, is connected on the second buffering hand-operated valve
Flexible pipe is provided with, for discharging the liquid in surge tank;Buffering liquid level gauge, buffering pressure meter are additionally provided with the surge tank.
Buffering respirator can be such that air in surge tank is balanced with external air pressure, be unlikely to make the pressure in surge tank excessive or
It is too small, cause surge tank to explode or deflated.And the air entered in surge tank, when by buffering respirator, its air is
Through having reached degerming purpose, will not there is any pollution to liquid.Heater element, buffering breathing are provided with buffering respirator
Heating function is increased in device, pure steam is needed to use during online sterilizing, and pure steam easily produces condensed water, and condensed water
The filter core in buffering respirator can be blocked, now using mode of heating, heating buffering respirator makes condensate evaporation, is unlikely to
Filter core is caused to block.
For the improvement of above-described embodiment, in the present embodiment, the tapping equipment includes:Discharge of wastewater passage and cooling water
Discharge-channel, is provided with centrifugal pump on the discharge of wastewater passage, discharge hand-operated valve, electricity are provided with the discharge of wastewater passage
Conductance meter, the conductivity meter is used to test the electrical conductivity of institute's waste discharge;The discharge of wastewater passage and cooling-water drain are logical
Temperature transmitter, check-valves are respectively arranged with road.
This supensoid agent prepares induction system and is mainly and for bulk drug to enter Agitation Tank by charge door, and adds water for injection
Dilution, by magnetic stirrer;Or liquid is delivered to Agitation Tank by sanitation-grade water pump, and add corresponding injection water
Complete precisely to match somebody with somebody liquid process by Weighing module;Feed liquid is delivered into bottle placer by sterilizing filter again to encapsulate, as finished product
An induction system.
In existing Omeprazole dry suspensoid agent material-transporting system, Agitation Tank to bottle placer filter typically uses 1
The filter series connection that filtering accuracy is 0.45 μm and 2 filtering accuracies are 0.22 μm, material is by will after this two filters
Feed liquid is delivered to bottle placer.Respirator is additionally provided with tank deck simultaneously, the Main Function of respirator is to make tank in pharmaceutical industry
Interior air is balanced with external air pressure, and outside air is sterile filtered, and is unlikely to make pressure inside the tank excessive or mistake
It is small, cause tank body to explode or deflated;But because induction system needs to use pure steam in sterilizing or cleaning, and pure steam
Condensed water is easily produced, produced condensed water can block the filter core in respirator, so as to cause the pressure change in system to draw
Hair potential safety hazard.
With the development of current medical science, the checking in new edition GMP for material system is also increasingly stricter, wherein wrapping
Equipment, the cleaning of pipeline portions and sterilizing checking are included, and it is also more and more tighter for the filter requirement of material-transporting system
Lattice.For example:Required in new edition GMP:Sterilising temp needs control not less than 121 DEG C, sterilization time >=30min;And it is traditional
Induction system cannot be monitored on-line to temperature and water quality, and then have impact on its service behaviour and operating efficiency.
The public bottle placer of two sets of liquid mixing systems of the invention, and the time is more nervous, to be equipped with one day filling 3 batches of things
Material, causes a set of liquid mixing system when filling, and other set liquid mixing system is being cleaned or sterilized, and such system just has intersection
The risk of pollution;Reasonably designed by us, by the way of bivalve cut-off, duplicate protection avoids cross pollution.It is degerming
The traditional online sterilization method of filter is manual exhaust, and manually recorded pressure difference;During our sterilizing filter sterilizing design,
There is special discharge duct in top design, and have pressure sensor before and after filter, pressure difference before and after real time record filter,
The amount of filling into of steam is adjusted according to pressure difference, the effect of filter sterilised is reached.
The present invention increases temp probe and conductivity probe to realize temperature and water quality conductive in tank bottom floss hole
Real-time monitoring, the respirator of tank deck is respectively adopted electrical heating type respirator and (common breathing is used in conventional delivery systems
Device), the Main Function of respirator be in pharmaceutical industry, due to the strict control requirement to bacterium, and prevent whole system from
Polluted by bacterium in outside air, thus the technical program selection respectively sets one in the dispensing upper end of Agitation Tank respectively
Used as above-mentioned respirator, respirator here is actually a filter to 0.22 μm of degerming hydrophobic filter, is
Hydrophobic filter, is also degerming level filter, while also having heating function, it passes through gas, and liquid is not
Can pass through, its Main Function is exactly that tank inside and outside air pressure balance is maintained by the respirator using electrical heating type.And due to
Sterilize online can produce during (SIP) condensed water, partial condensation water of pure steam is carried out to tank body or pipeline can be gathered in and exhale
Haustorium top, causes filter core to block;For anti-problem here, then electric heating function is increased, make condensate evaporation, so as to prevent
Condensation water slug filter core.It not only plays electric heating function, and in the case where not sterilizing normally, it is big that it acts also as filtering
Gas, the effect for maintaining atmospheric pressure balance inside and outside tank.
The present invention also increases conductivity probe and temp probe in tank bottom floss hole compared with the prior art, by conductivity value
4-20 milliamperes of analog signalses are converted into, being sent in PLC system carries out data record and storage, for one batch of liquid
After production terminates, during cleaning pipeline and equipment and to system SIP (online sterilizing), can monitor on-line conductivity value and
Temperature value, reaches the data needed in cleaning validation and sterilizing checking.And in traditional cleaning checking and sterilization process
Data required for this two kinds of online monitoring instruments do not reach checking, because electrical conductivity can be carried out to the water quality after cleaning
Monitoring, and in GMP requirements, sterilising temp then needs control not less than 121 DEG C, sterilization time needs >=30min, when by temperature
Degree sensor is placed on floss hole and minimum temperature point position can then know that minimum temperature point reaches 121 DEG C of associated section
Point, and then start timing sterilizing;Thus related data can be indexed in cleaning and sterilizing checking file.
The present invention cannot be carried out online in solving traditional Omeprazole dry suspensoid agent induction system to temperature and water quality
The deficiency of monitoring;And this system can also realize automatic on-line SIP, and automatic on-line cleaning process.System realizes right
The monitoring of temperature and institute's discharging liquid electrical conductivity, and prevent from condensing water slug fluid reservoir tank by respirator heating function
Top respirator is so that tank body explosion or deflated.
It should be noted that above-described embodiment can independent assortment as needed.The above is only of the invention preferred
Implementation method, it is noted that for those skilled in the art, is not departing from the premise of the principle of the invention
Under, some improvements and modifications can also be made, these improvements and modifications also should be regarded as protection scope of the present invention.
Claims (10)
1. a kind of supensoid agent prepares induction system, it is characterised in that including:
Be sequentially communicated feeding device, liquid dispensing device, filter, the buffer unit of setting, and respectively with the feeding device,
The tapping equipment that liquid dispensing device, filter, buffer unit connection are set;
The feeding device includes being supplied to switch board the first compressed air feedway of compressed air, is filled with liquid to described
Put, filter, buffer unit supply steam steam feedway, to the liquid dispensing device supply compressed air second pressure
Contracting air feeder, to the water for injection feedway of the liquid dispensing device supply water, supplies cold to the liquid dispensing device
But the apparatus for supplying cool water of water, the industrial steam feedway of industrial steam is supplied to the liquid dispensing device.
2. supensoid agent as claimed in claim 1 prepares induction system, it is characterised in that the liquid dispensing device includes:
Two Agitation Tanks, each Agitation Tank connects setting with first with liquid branch pipe by first with liquid house steward;Described first matches somebody with somebody liquid
First is provided with branch pipe with hydraulic pneumatic valve, described first connects setting with liquid house steward with the steam feedway;
Each Agitation Tank also connects setting with second with liquid branch pipe by second with liquid house steward;Described second with setting on liquid branch pipe
Have second with hydraulic pneumatic valve, described second connects setting with liquid house steward with the water for injection feedway.
3. supensoid agent as claimed in claim 2 prepares induction system, it is characterised in that:
The tank deck of each Agitation Tank is provided with first with liquid passage and second with liquid passage;Described first matches somebody with somebody liquid with liquid passage or second
Equipped with a spray ball on passage, the spray ball is used to for the water for injection and/or purified water to send into the Agitation Tank
Interior liquor charging passage.
4. supensoid agent as claimed in claim 2 prepares induction system, it is characterised in that:
Be provided with each Agitation Tank it is in communication with liquid respirator, it is described with liquid respirator and the steam feedway,
The connection of second compressed air feedway is set, described also to connect setting with the tapping equipment with liquid respirator;Each matches somebody with somebody liquid
The tank bottom of tank offers the liquid outlet for being connected with the filter and being set.
5. supensoid agent as claimed in claim 2 prepares induction system, it is characterised in that:
Being arranged with each Agitation Tank can accommodate the chuck of liquid, be provided with the chuck and connected with the apparatus for supplying cool water
The logical import for setting, outlet, the chuck are also connected and set with second compressed air feedway, industrial steam feedway
Put.
6. supensoid agent as claimed in claim 2 prepares induction system, it is characterised in that the filter includes:
Four filters, two filters are sequentially communicated the filter element for setting and being formed, and each Agitation Tank is by conveying
Filter connection in Guan Yuyi filter element near the Agitation Tank side is set;The first mistake is provided with the delivery pipe
Filter pneumatic operated valve, the first filter pressure sensor;The second filter pressure sensor is provided with the output channel of each filter.
7. supensoid agent as claimed in claim 6 prepares induction system, it is characterised in that:
The discharge duct for being connected with the tapping equipment and being set is provided with the top of each filter, is set on the discharge duct
There is the second filtering pneumatic operated valve.
8. supensoid agent as claimed in claim 6 prepares induction system, it is characterised in that the buffer unit includes:
Two surge tanks, each surge tank connects setting with the filter in a filter element near the surge tank side,
Each surge tank also connects setting with the steam feedway.
9. supensoid agent as claimed in claim 8 prepares induction system, it is characterised in that:
Buffering respirator is provided with and communicated with each surge tank, the first buffering is provided between the buffering respirator and surge tank
Hand-operated valve;Buffering liquid level gauge, buffering pressure meter are additionally provided with the surge tank.
10. the supensoid agent as described in any one in claim 1~9 prepares induction system, it is characterised in that the discharge dress
Put including:
Discharge of wastewater passage and cooling-water drain passage, are provided with centrifugal pump, the discharge of wastewater on the discharge of wastewater passage
Discharge hand-operated valve, conductivity meter are provided with passage, the conductivity meter is used to test the electrical conductivity of institute's waste discharge;It is described useless
Temperature transmitter, check-valves are respectively arranged with water discharge passage and cooling-water drain passage.
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CN201611224499.XA CN106726576B (en) | 2016-12-27 | 2016-12-27 | Suspension preparation and conveying system |
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Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
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CN109304128A (en) * | 2017-07-26 | 2019-02-05 | 上海至纯洁净系统科技股份有限公司 | If the liquid medicine dosing system and its cleaning method of T-type liquid filter |
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