CN208065489U - A kind of novel bulk pharmaceutical chemicals sterile processing systems - Google Patents
A kind of novel bulk pharmaceutical chemicals sterile processing systems Download PDFInfo
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- CN208065489U CN208065489U CN201721756289.5U CN201721756289U CN208065489U CN 208065489 U CN208065489 U CN 208065489U CN 201721756289 U CN201721756289 U CN 201721756289U CN 208065489 U CN208065489 U CN 208065489U
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- pharmaceutical chemicals
- bulk pharmaceutical
- tank
- filter
- sterile
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Abstract
The utility model is a kind of novel bulk pharmaceutical chemicals sterile processing systems, including poor solvent aseptic process module, bulk pharmaceutical chemicals aseptic process module, sterile bulk drug output module, online temperature monitoring system, pure steam disinfection system, compressed air conveying system（Containing air filter for removing bacteria）.Wherein, the poor solvent aseptic process module is sequentially connected by the conveyance conduit between No. 1 poor solvent storage tank, 0.22 μm of filter, No. 2 poor solvent storage tanks, 0.22 μm of cartridge filter and each tank, filter and is formed.The bulk pharmaceutical chemicals aseptic process module, the conveyance conduit being heated to reflux between dissolving tank, 1 grade of 0.45 μm of filter, 2 grades of 0.22 μm of filters and each tank, filter by bulk pharmaceutical chemicals, which is sequentially connected, to be formed.The output channel of conveyance conduit and Sterilized isolator between the sterile bulk drug output module, including crystallisation by cooling tank, Sterilized isolator, crystallisation by cooling tank and Sterilized isolator between above-mentioned two module.
Description
Technical field
The utility model is related to medical production equipment technology, more particularly to one kind are right in pharmaceutical preparation production process
The system that bulk pharmaceutical chemicals carry out aseptic process.
Background technology
In pharmaceutical preparation production process, moist heat sterilization is generally taken to the method that bulk pharmaceutical chemicals carry out sterilization processing, is done
Heat sterilization, radiation sterilization, gaseous sterilization and filtration sterilization method.But these methods, there are many shortcoming, many bulk pharmaceutical chemicals exist
It is very unstable under high temperature and radiation source radiation, easily cause active ingredient breaks down failure；Gaseous sterilization is often carried out with toxic gas, easily
It is remained in bulk pharmaceutical chemicals and the active constituent of bulk pharmaceutical chemicals is had an impact；It is filtration sterilization long flow path, of long duration, and its filter device
After use after a period of time, needs to shut down once obstruction and be rebuild, replace filter device, influence the production schedule, increase
Cost is added.Therefore, the sterilization processing of bulk pharmaceutical chemicals also needs to technically be improved.
Utility model content
The utility model aims to solve the problem that the deficiencies in the prior art, and provides a kind of novel bulk pharmaceutical chemicals sterile processing systems.
The utility model to achieve the above object, using following technical scheme：The bulk pharmaceutical chemicals sterile processing systems, packet
Include poor solvent aseptic process module, bulk pharmaceutical chemicals aseptic process module, sterile bulk drug output module, online monitoring temperature system
System, pure steam disinfection system, compressed air conveying system（Containing air filter for removing bacteria）.Wherein, the poor solvent is sterile
Processing module, by No. 1 poor solvent storage tank, 0.22 μm of filter, No. 2 poor solvent storage tanks, 0.22 μm of cartridge filter and
Conveyance conduit between each tank, filter is sequentially connected composition.The bulk pharmaceutical chemicals aseptic process module, is heated by bulk pharmaceutical chemicals
Conveyance conduit between reflux dissolving tank, 1 grade of 0.45 μm of filter, 2 grades of 0.22 μm of filters and each tank, filter is successively
Connection composition.The sterile bulk drug output module, including crystallisation by cooling tank, Sterilized isolator, crystallisation by cooling tank with it is sterile
The output channel of conveyance conduit and Sterilized isolator between isolator between above-mentioned two module.
Preferably, bulk pharmaceutical chemicals are heated to reflux sterilized magnetic blender built in dissolving tank.
Preferably, sterilized magnetic blender built in crystallisation by cooling tank.
Preferably, suction filtration system, drying system, airflow comminution system are integrated in Sterilized isolator.
Preferably, the conveyance conduit between No. 2 poor solvent storage tanks and 0.22 μm of cartridge filter is equipped with valve.
Preferably, the conveyance conduit between No. 2 poor solvent storage tanks and crystallisation by cooling tank is equipped with valve.
The utility model has the beneficial effects that：Equipment involved by the utility model can complete online pure steam sterilizing, go out
Bacterium temperature can be monitored online.It is completely closed operation after equipment sterilizing, the risk not polluted.Convey the power during material
It all is from the compressed air after aseptic filtration, safe and efficient, noresidue avoids influencing liquid medicine stability because of delivery pump heat production
The case where generate.Bulk pharmaceutical chemicals be heated to reflux dissolving tank and crystallisation by cooling tank built in sterilized magnetic blender, stir evenly, it is sterile,
Without dead angle, be conducive to uniform dissolution and the crystallization of raw material.The sterile closed operating space of separator system, using 100 grades
Laminar flow, wind speed 0.36-0.54m/s meet A grades of gnotobasis requirements, and the independent air-feeding circulatory system ensures the bulk pharmaceutical chemicals after crystallization
Without microbiological contamination risk.This bulk pharmaceutical chemicals sterile processing systems can be by the dissolving of bulk pharmaceutical chemicals, filtration sterilization, crystallization, drying, crushing closed
It is continuously finished in space, whole sterile working, pollution-free risk, can ensure that the quality of bulk pharmaceutical chemicals complies with standard.
Description of the drawings
Fig. 1 is the structural diagram of the present invention.
In figure：1-1 poor solvent storage tanks；2-0.22 μm of filter；3-2 poor solvent storage tanks；4-0.22 μm of security personnel
Filter；5- bulk pharmaceutical chemicals are heated to reflux dissolving tank；0.45 μm of filter of 6-1 grades；0.22 μm of filter of 7-2 grades；8- crystallisation by cooling
Tank；9- Sterilized isolators；The online temperature monitoring systems of 10-；11- pure steam disinfection systems；12- compressed air conveying systems.
Specific implementation mode
The utility model is described in further detail with reference to the accompanying drawings and examples.
Embodiment
As shown in Figure 1, a kind of novel bulk pharmaceutical chemicals sterile processing systems, including 1,0.22 μm of mistake of No. 1 poor solvent storage tank
Filter 2,23,0.22 μm of poor solvent storage tank cartridge filter 4, bulk pharmaceutical chemicals are heated to reflux dissolving tank（It is stirred containing sterilized magnetic
Device）5,6,2 grades of 0.22 μm of filter 7, crystallisation by cooling tanks of 1 grade of 0.45 μm of filter（Blender containing sterilized magnetic）8, sterile isolation
Device 9, online temperature monitoring system 10, pure steam disinfection system 11, compressed air conveying system（Containing air filter for removing bacteria）12.
No. 1 poor solvent storage tank 1 by 2, No. 2 poor solvent storage tanks 3 of conveyance conduit and 0.22 μm of filter successively
Connection, No. 2 poor solvent storage tanks 3 connect 8, No. 2 poor solvent storage tanks of crystallisation by cooling tank by conveyance conduit and connect one simultaneously
0.22 μm of cartridge filter, 4,0.22 μm of cartridge filter 4 is connected to crystallisation by cooling tank 8.
The bulk pharmaceutical chemicals are heated to reflux dissolving tank 5 and pass through successively with 1 grade of 0.45 μm of filter, 6,2 grades of 0.22 μm of filters 7
Conveyance conduit connects, and 2 grades of 0.22 μm of filters 7 are connected to crystallisation by cooling tank 8.
The crystallisation by cooling tank 8 is connect by conveyance conduit with Sterilized isolator 9, and suction filtration is integrated in Sterilized isolator 9
System, drying system, airflow comminution system.
This bulk pharmaceutical chemicals sterile processing systems all devices are all connected to online temperature monitoring system 10 by sensor, by corresponding
Pipeline is connected to pure steam disinfection system 11 and compressed air conveying system（Containing air filter for removing bacteria）12.
Operation principle：A kind of novel bulk pharmaceutical chemicals sterile processing systems, when work is run, poor solvent is bad molten from No. 1
Agent storage tank 1 enters back into crystallisation by cooling tank 8 via No. 2 poor solvent storage tanks 3 are entered after 0.22 μm of 2 filtration sterilization of filter；To add
Strong sterility barrier, No. 2 poor solvent storage tanks 3 are connected to 0.22 μm of cartridge filter 4 again simultaneously, bad after filtration sterilization
Solvent can be filtered degerming again, enter back into crystallisation by cooling tank 8 later, this step security personnel filter operation can if necessary into
Row.
At the same time, bulk pharmaceutical chemicals are heated to reflux in dissolving tank 5 after agitating and heating reflux dissolving in bulk pharmaceutical chemicals and pass sequentially through 1 grade
0.45 μm of filter, 6,2 grades of 0.22 μm of filters 7 carry out filtration sterilizations twice, enter later crystallisation by cooling tank 8 with it is sterile not
Good solvent mixes, and crystallisation by cooling is carried out under sterilized magnetic stirring.
Suspension after being crystallized in crystallisation by cooling tank 8 is directly entered the collection of Sterilized isolator 9 by sterile conveyance conduit
At the system of suction filtration, it is separated by solid-liquid separation and is drained operation, the drying system that the solid material isolated is integrated by Sterilized isolator
It is dried, the airflow comminution system then integrated again by Sterilized isolator crushes, bulk pharmaceutical chemicals sterile at this time
It is exported from 9, carries out subsequent preparation production, entire bulk pharmaceutical chemicals aseptic process process all carries out under sealing, germ-free condition.
The utility model is exemplarily described above in conjunction with attached drawing, it is clear that the utility model specific implementation not by
The limitation of aforesaid way, if the various improvement of the methodology and technical solution progress of the utility model are used, or without
Improvement directly applies to other occasions, both is within the protection scope of the present invention.
Claims (7)
1. a kind of novel bulk pharmaceutical chemicals sterile processing systems, which is characterized in that including poor solvent aseptic process module, bulk pharmaceutical chemicals
Aseptic process module, sterile bulk drug output module, online temperature monitoring system, pure steam disinfection system, compressed air conveying
System.
2. a kind of novel bulk pharmaceutical chemicals sterile processing systems according to claim 1, which is characterized in that described is bad molten
Agent aseptic process module, by No. 1 poor solvent storage tank, 0.22 μm of filter, No. 2 poor solvent storage tanks, 0.22 μm of security personnel's filtering
Conveyance conduit between device and each tank, filter is sequentially connected composition.
3. a kind of novel bulk pharmaceutical chemicals sterile processing systems according to claim 1, which is characterized in that the bulk pharmaceutical chemicals
Aseptic process module is heated to reflux dissolving tank, 1 grade of 0.45 μm of filter, 2 grades of 0.22 μm of filters and each by bulk pharmaceutical chemicals
Conveyance conduit between tank, filter is sequentially connected composition.
4. a kind of novel bulk pharmaceutical chemicals sterile processing systems according to claim 1, which is characterized in that the sterile original
Expect medicine output module, including crystallisation by cooling tank, Sterilized isolator, crystallisation by cooling tank and Sterilized isolator between, with above-mentioned two mould
The output channel of conveyance conduit and Sterilized isolator between block.
5. a kind of novel bulk pharmaceutical chemicals sterile processing systems according to claim 3, which is characterized in that the bulk pharmaceutical chemicals
It is heated to reflux sterilized magnetic blender built in dissolving tank.
6. a kind of novel bulk pharmaceutical chemicals sterile processing systems according to claim 4, which is characterized in that the cooling knot
Sterilized magnetic blender built in brilliant tank.
7. a kind of novel bulk pharmaceutical chemicals sterile processing systems according to claim 4, which is characterized in that it is described it is sterile every
It is internally integrated suction filtration system, drying system, airflow comminution system from device.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201721756289.5U CN208065489U (en) | 2017-12-15 | 2017-12-15 | A kind of novel bulk pharmaceutical chemicals sterile processing systems |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201721756289.5U CN208065489U (en) | 2017-12-15 | 2017-12-15 | A kind of novel bulk pharmaceutical chemicals sterile processing systems |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN208065489U true CN208065489U (en) | 2018-11-09 |
Family
ID=64031964
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201721756289.5U Active CN208065489U (en) | 2017-12-15 | 2017-12-15 | A kind of novel bulk pharmaceutical chemicals sterile processing systems |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107875407A (en) * | 2017-12-15 | 2018-04-06 | 天津梅花生物医药科技有限公司 | A kind of new bulk drug sterile processing systems |
-
2017
- 2017-12-15 CN CN201721756289.5U patent/CN208065489U/en active Active
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107875407A (en) * | 2017-12-15 | 2018-04-06 | 天津梅花生物医药科技有限公司 | A kind of new bulk drug sterile processing systems |
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