CN104353282A - Filling closed system sterile-filtration equipment - Google Patents
Filling closed system sterile-filtration equipment Download PDFInfo
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- CN104353282A CN104353282A CN201410637857.4A CN201410637857A CN104353282A CN 104353282 A CN104353282 A CN 104353282A CN 201410637857 A CN201410637857 A CN 201410637857A CN 104353282 A CN104353282 A CN 104353282A
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- filter
- glass tube
- filtration equipment
- aseptic filtration
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Abstract
The invention relates to the field of pharmaceutical engineering, and particularly relates to filling closed system sterile-filtration equipment. The filling closed system sterile-filtration equipment comprises a mixing tank, a pressure device, a two-stage filter device and a buffer device, wherein the mixing tank, the pressure device and the two-stage filter device are sequentially connected; the mixing tank and the two-stage filter device are connected with each other through a guide pipe, and the guide pipe positioned between the mixing tank and the two-stage filter device partially extends into the pressure device; the pressure device is a peristaltic pump; the buffer device is connected with the two-stage filter device through the guide pipe; and the two-stage filter device comprises a redundant filter and a main filter which is connected in series with the redundant filter. The filling closed system sterile-filtration equipment provided by the invention has the advantages of miniaturization in structure, simple material, convenience for disassembly and assembly, easiness for operation, low cost, less liquid medicine residue, high sterile guarantee level, high safety property and suitability for laboratories, small scale production and pilot scale production.
Description
Technical field
The present invention relates to pharmaceutical engineering field, particularly relate to a kind of loading sealing system aseptic filtration equipment.
Background technology
Pharmaceuticals industry typical dosing aseptic filtration system and device is primarily of material-compound tank, pressurization or the auxiliary equipment such as pressure regulating equipment, two-stage filtering device, receiver and pipeline, valve, instrument composition.There is following defect in dosing aseptic filtration system and device of the prior art:
(1) pharmaceutical factory is high to the aseptic filtration system requirements of non-final sterilising prods in producing, and design is complicated, and equipment is huge, and require high to plant area, cost is high;
(2) operating procedure is complicated, high to personnel requirement.Because equipment operating is loaded down with trivial details, not easily sterilization, therefore all should design in non-A level clean area except final receiver external equipment parts and operation, and fillingly must to carry out at A level clean area, inconvenient operation;
(3) be main equipment, pipeline is many, and dead volume is large, and liquor residue is many, is not suitable for use for laboratory or little trial production, scale up test uses.
(4) Agitation Tank, receiver, pipeline etc. cannot be dismantled, and need online design cleaning, sterilization system on line sterilizing, increase cost.Agitation Tank, receiver, pipeline are metal material, and chemical temperatures, anticorrosive property are poor.Production different cultivars pipeline can not be changed, and pollutes confusion risk large.Pipeline, valve damage changes trouble.
(5) filter power and adopt compressed air, nitrogen pressurization, or decompressor, all have contacting of medium and liquid, need aseptic process to medium, comparatively complicated, cost is high.Agitation Tank is required to be pressure-tight tank, requires high.Adopt high-order static pressure to filter, namely receiver is installed on a roof high position, filters by pressure itself, long to filling district pipeline, and strengthen pollution risk, cost is high.
(6) when filtering, flow velocity can not intuitively visible and adjustment in real time.
(7) aseptic filtration system is obturator, and the integrity test of filter core needs complete with liquid medicine filling in a pre-installation, carries out after dismounting filter core.Once filter core integrity test cannot be passed through after filling end, then this product can only be scrapped, and loses huge, and cannot avoid.
(8) filter core price is high, needs frequent clean, sterilizing, and filter element filtering liquor residue is many, and uses in the useful life through checking.
Because above-mentioned defect, the design people, actively in addition research and innovation, to founding a kind of loading sealing system aseptic filtration equipment of new structure, make it have more value in industry.
Summary of the invention
Object of the present invention is intended to solve prior art Problems existing, a kind of loading sealing system aseptic filtration equipment is provided, miniaturized structure, material is simple, easy accessibility, simple to operate, cost is low, and liquor residue is few, and sterility assurance level is high, security performance is high, is applicable to use for laboratory or little trial production, scale up test uses.
The present invention relates to a kind of loading sealing system aseptic filtration equipment, comprise the material-compound tank, pressure apparatus, the two-stage filtering device that connect successively, tubes connection is passed through between described material-compound tank and two-stage filtering device, conduit portion between described material-compound tank and two-stage filtering device stretches into the inside of described pressure apparatus, and described pressure apparatus is peristaltic pump; Described loading sealing system aseptic filtration equipment also comprises and the buffer unit of described two-stage filtering device by tubes connection; The main filter that described two-stage filtering device comprises redundant filter and connects with described redundant filter.
Further, described buffer unit is surge flask, described surge flask comprises head and body, three inner port that are provided with described head stretch into the glass tube outlet that described body is inner, external port stretches out surge flask outside, be respectively the air ports glass tube being connected breathing circuit filter with the filtrate import glass tube of the output tubes connection of described main filter, inner port close to the filtrate (liquid glass tube at the bottom of bottle, external port, described air ports glass tube is connected with described breathing circuit filter by conduit, and described breathing circuit filter is disposable air filter for removing bacteria.
Further, described head and body are separated from each other, and joining place adopts frosted interface.
Further, be the taper shape that intermediate point is minimum bottom described body, circle arc support mechanism is arranged at body bottom.
Further, described filtrate import glass tube, filtrate (liquid glass tube and air ports glass tube at right angles bend to horizontal direction after stretching out the outside certain distance of described surge flask.
Further, what described filtrate import glass tube, filtrate (liquid glass tube and air ports glass tube stretched in described surge flask is different in size.
Further, described redundant filter connects the input of described material-compound tank, the described main filter of rear end connection by catheter proximal end, described redundant filter is disposable miillpore filter syringe filters, described main filter is single-layer board type millipore filter, and the filter membrane of described main filter is single use.
Further, described conduit is sanitary hose.
Further, described material-compound tank is made by beaker.
By such scheme, the present invention at least has the following advantages: loading sealing system aseptic filtration equipment provided by the present invention, and because pressue device is peristaltic pump, directly do not contact with liquid, Sterility Assurance degree is high, and can regulate in real time the filtrate rate of filtration; Owing to comprising the two-stage filtering device be made up of redundant filter and main filter, can sterilizing separately, cost is low, and security performance is high, and liquor residue is few, and Sterility Assurance degree is high; Owing to comprising buffer unit, whole system pressure is steady, and Sterility Assurance degree is high, can be stored in buffer unit temporarily before filtrate is filling, first carries out integrity of filtration membranes test, filling again after qualified, avoids causing unnecessary loss; Whole device miniaturization, material is simple, and easy accessibility, all can carry out separately cleaning and sterilization, cost is low, liquor residue is few, and Sterility Assurance degree is high, and security performance is high, simple to operate, operating personnel are few, can carry out the dosing of liquid, filtration and filling at formulation core district A level clean area simultaneously, be applicable to use for laboratory or little trial production, scale up test uses.
Above-mentioned explanation is only the general introduction of technical solution of the present invention, in order to better understand technological means of the present invention, and can be implemented according to the content of description, coordinates accompanying drawing to be described in detail as follows below with preferred embodiment of the present invention.
Accompanying drawing explanation
Fig. 1 is the structural representation of loading sealing system aseptic filtration equipment of the present invention;
Detailed description of the invention
Below in conjunction with drawings and Examples, the specific embodiment of the present invention is described in further detail.Following examples for illustration of the present invention, but are not used for limiting the scope of the invention.
See Fig. 1, loading sealing system aseptic filtration equipment of the present invention comprises the material-compound tank 1, pressure apparatus 2, the two-stage filtering device 3 that connect successively, and described material-compound tank 1 is made by beaker, described material-compound tank 1 is connected by conduit 4 with between two-stage filtering device 3, and conduit 4 part between described material-compound tank 1 and two-stage filtering device 3 stretches into the inside of described pressure apparatus 2, and described pressure apparatus 2 is peristaltic pump 2, described loading sealing system aseptic filtration equipment also comprises the buffer unit 5 be connected by conduit 4 with described two-stage filtering device 3, described buffer unit 5 is surge flask 5, described surge flask 5 comprises head 51 and body 52, described head 51 and body 52 are separated from each other, joining place adopts frosted interface, it is inner that three inner port that are provided with described head 51 stretch into described body, external port stretches out the glass tube outlet of surge flask outside, be respectively the filtrate import glass tube 53 with the output tubes connection of described main filter, inner port is close to the filtrate (liquid glass tube 54 at the bottom of bottle, external port connects the air ports glass tube 55 of breathing circuit filter 6, described air ports glass tube 55 is connected with described breathing circuit filter 6 by conduit 4, described breathing circuit filter 6 is disposable air filter for removing bacteria 6, described filtrate import glass tube 53, filtrate (liquid glass tube 54 and air ports glass tube 55 stretch into different in size in surge flask 5 and at right angles bend to horizontal direction after stretching out the outside certain distance of surge flask 5, be the taper shape that intermediate point is minimum bottom described body 52, circle arc support mechanism 7 is arranged at body 52 bottom, the main filter 32 that described two-stage filtering device 3 comprises redundant filter 31 and connects with described redundant filter, described redundant filter 31 connects the input of described material-compound tank 1, the described main filter 32 of rear end connection by conduit 4 front end, described redundant filter 31 is disposable miillpore filter syringe filters 31, described main filter 32 is single-layer board type millipore filter 32, and the filter membrane of described main filter 32 is single use, described conduit 4 is sanitary hose 4.
In the present embodiment, material-compound tank 1 is made by 2L beaker, and glass material stability is better, not easily produces chemical reaction with liquid.Sanitary hose 4 is No. 17 pipes, external diameter 7.9mm.Disposable miillpore filter syringe filters 31 is diameter 50mm, 0.22 μm, aperture, flow velocity 500mL/ minute, hot pressing sterilizing, single use; Single-layer board type millipore filter 32 is 316L stainless steel, diameter 150mm, filter sizes 0.22um, flow velocity 200mL/ minute, equal hot pressing sterilizing, filter membrane single use, can change unlike material filter membrane according to liquid character at every turn.Surge flask 5 is glass material, and head 51 separates with body 52 and designs, joining place frosted interface, was both easy to dismounting, keep seal again, body 52 is circular, diameter 150mm, clear height 170mm, more than shoulder portion high 8mm, volume 2L, the high 20mm of circle arc support mechanism 7, is convenient to the placement of surge flask 5 and takes.The pipe diameter of filtrate import glass tube 53, filtrate (liquid glass tube 54 and air ports glass tube 55 is 7mm, internal diameter 5mm, and filtrate import glass tube 53 stretches into 110mm in bottle, and filtrate enters surge flask by this glass tube; Filtrate (liquid glass tube 54 stretches into 295mm in bottle, and filtrate flows out surge flask 5 by this glass tube; Air ports glass tube 55 stretches into 50mm in bottle, and three glass tubes stretched in bottle are different in size, ensure that filtrate flows does not interfere with each other.Apart from one another by 2mm between three glass tubes, be convenient to clean, and at right angles bend to horizontal direction 40mm after stretching out the outer 20mm of bottle, when preventing from using, foreign matter enters in bottle by the mouth of pipe, is also convenient to install sanitary hose 4.The interface external diameter of the sanitary hose 4 be connected with three glass tube outputs is 5mm, and increasing gradually slightly has diameter 10mm to heave to external diameter 7mm, distance interface 7mm place, has both been convenient to the installation of sanitary hose 4, can have prevented again mounted sanitary hose 4 from coming off.Disposable air filter for removing bacteria 6 is diameter 50mm, 0.22 μm, aperture, hot pressing sterilizing, and gas can freely pass through, and intercepts bacterium and contaminant particles, and the balance flowing of reason gas is not subject to extraneous pollution.
By above setting, first at A level clean area, loading sealing system aseptic filtration equipment is installed.During use, dosing, filtration, fillingly can to carry out in same place.Dosing is complete directly carries out aseptic filtration.After filtration, filtrate is stored in surge flask 5, can first airtight main filter 32 and the connection of surge flask 5, pulls down the integrity test that main filter 32 carries out filter membrane.After test passes, then carry out the filling of filtrate.
In material-compound tank 1, add raw material and water for injection stirring and dissolving, preparating liquid 2L, material-compound tank 1 is transparent visible, can carry out the intermediate detection such as clarity test simultaneously.Drug solution preparing is complete, material-compound tank 1 adds lid and prevents foreign matter from entering and reduce germ contamination risk.After dosing, open peristaltic pump 2, liquid is flowed out from Agitation Tank 1 by sanitary hose 4, centre provides pressure through peristaltic pump 2, utilize the elasticity of sanitary hose 4, the turning cylinder of peristaltic pump 2 constantly extrudes the liquid promoted in sanitary hose 4 and advances, and produce pressure, this pressure apparatus 2 can avoid equipment to the direct contact of liquid, reduce aseptic and risk that is chemical reaction, because do not have pressure, Agitation Tank 1 does not need to adopt pressure-tight tank, and peristaltic pump 2 rotating speed is adjustable, as required the rate of filtration of liquid is regulated in real time.
First liquid filters through redundant filter 31, and redundant filter 31 can remove the more impurity in liquid in advance, and carries out first aseptic filtration, improves the filter efficiency of main filter 32.Liquid carries out further aseptic filtration through main filter 32 afterwards.Two cover positioned inline carry out twice aseptic filtration of liquid, meet the requirement of non-final sterilizing aseptic medicine production to positioned inline progression, adopt double-stage filtering pattern, improve sterility barrier degree, syringe needle and membrane filter liquor residue few, liquid total residue is less than 30mL, be applicable to the aseptic filtration of a small amount of liquid, easy accessibility, can clean, sterilizing repeatedly, and two cover filters all can sterilizing separately, cheap, for single use, cost is low, and security is high.
After miillpore filter syringe filters 31 and single-layer board type nuclepore membrane filter 32 twice filtration, filtrate flows into glass surge flask 5 by filtrate import glass tube 53, now in bottle, gas is flowed outside bottle by air ports glass tube 55, keeping system atmospheric pressure state.Liquid flows out from Agitation Tank 1, then through the aseptic filtration of two-stage filtering device 3, finally enters surge flask 5 and store, about 11 minutes consuming time altogether.After filtration, filtrate can be stored in surge flask 5 temporarily, first carry out the integrity test of main filter 32 filter membrane: clamp the sanitary hose 4 be connected between main filter 32 with filtrate import glass tube 53, thus the connection of airtight main filter 32 and surge flask 5, pull down the integrity test that main filter 32 carries out filter membrane, after test passes, then carry out the filling of filtrate, can prevent filling after carry out integrity of filtration membranes test again, avoid the loss that test failure causes.
After filter membrane test passes, the filtrate that surge flask 5 is stored can be directly used in filling.Time filling, filtrate is flowed out from surge flask 5 by filtrate (liquid glass tube 54, gas is through breathing circuit filter 6 aseptic filtration and flow by the export-oriented bottle of bottle, intercept bacterium and contaminant particles, the balance flowing of reason gas is not subject to extraneous pollution, and ensures seal and the keeping system atmospheric pressure state of system.Bottom design due to surge flask 5 is the pyramid type that intermediate point is minimum, and filtrate (liquid glass tube 54 close to bottle at the bottom of, make filling at the end of reduce filtrate remaining.
In sum, the less space of loading sealing system aseptic filtration equipment utilization provided by the present invention can complete the aseptic filtration of liquid, and the whole pouring process that is filled into is closed system, and liquid direct exposed environments, improves sterility barrier degree; Because pressue device 2 is peristaltic pump 2, directly do not contact with liquid, Sterility Assurance degree is high, and can regulate in real time the filtrate rate of filtration; Owing to comprising the two-stage filtering device 3 be made up of disposable miillpore filter syringe filters 31 and single-layer board type millipore filter 32, can sterilizing separately, cost is low, and security performance is high, and liquor residue is few, and Sterility Assurance degree is high; Owing to comprising surge flask 5, whole system pressure is steady, and Sterility Assurance degree is high, can be stored in surge flask 5 temporarily, carry out integrity of filtration membranes test before filtrate is filling, filling again after qualified, avoids causing unnecessary loss; Because all connecting ducts 4 adopt sanitation-grade flexible pipe 4, easy accessibility, cheap; Whole device miniaturization, material is simple, and easy accessibility, all can carry out separately cleaning and sterilization, cost is low, liquor residue is few, and Sterility Assurance degree is high, and security performance is high, simple to operate, operating personnel are few, can carry out the dosing of liquid, filtration and filling at formulation core district A level clean area simultaneously, be applicable to use for laboratory or little trial production, scale up test uses.
Loading sealing system aseptic filtration equipment provided by the present invention; be only the specific embodiment of the present invention; but protection scope of the present invention is not limited thereto; anyly be familiar with those skilled in the art in the technical scope that the present invention discloses; change can be expected easily or replace, all should be encompassed within scope.Therefore, protection scope of the present invention should be as the criterion with the protection domain of described claim.
Claims (9)
1. a loading sealing system aseptic filtration equipment, comprises the material-compound tank, pressure apparatus, the two-stage filtering device that connect successively, it is characterized in that:
By tubes connection between described material-compound tank and two-stage filtering device, the conduit portion between described material-compound tank and two-stage filtering device stretches into the inside of described pressure apparatus, and described pressure apparatus is peristaltic pump;
Described loading sealing system aseptic filtration equipment also comprises and the buffer unit of described two-stage filtering device by tubes connection;
The main filter that described two-stage filtering device comprises redundant filter and connects with described redundant filter.
2. loading sealing system aseptic filtration equipment according to claim 1, it is characterized in that: described buffer unit is surge flask, described surge flask comprises head and body, it is inner that three inner port that are provided with described head stretch into described body, external port stretches out the glass tube outlet of surge flask outside, be respectively the filtrate import glass tube with the output tubes connection of described main filter, inner port is close to the filtrate (liquid glass tube at the bottom of bottle, external port connects the air ports glass tube of breathing circuit filter, described air ports glass tube is connected with described breathing circuit filter by conduit, described breathing circuit filter is disposable air filter for removing bacteria.
3. loading sealing system aseptic filtration equipment according to claim 2, is characterized in that: described head and body are separated from each other, and joining place adopts frosted interface.
4. loading sealing system aseptic filtration equipment according to claim 2, is characterized in that: be the taper shape that intermediate point is minimum bottom described body, circle arc support mechanism is arranged at body bottom.
5. loading sealing system aseptic filtration equipment according to claim 2, is characterized in that: described filtrate import glass tube, filtrate (liquid glass tube and air ports glass tube at right angles bend to horizontal direction after stretching out the outside certain distance of described surge flask.
6. loading sealing system aseptic filtration equipment according to claim 2, is characterized in that: it is different in size that described filtrate import glass tube, filtrate (liquid glass tube and air ports glass tube stretch in described surge flask.
7. loading sealing system aseptic filtration equipment according to claim 1, it is characterized in that: described redundant filter connects the input of described material-compound tank, the described main filter of rear end connection by catheter proximal end, described redundant filter is disposable miillpore filter syringe filters, described main filter is single-layer board type millipore filter, and the filter membrane of described main filter is single use.
8., according to the loading sealing system aseptic filtration equipment in claim 1-7 described in any one, it is characterized in that: described conduit is sanitary hose.
9. loading sealing system aseptic filtration equipment according to claim 1, is characterized in that: described material-compound tank is made by beaker.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410637857.4A CN104353282A (en) | 2014-11-12 | 2014-11-12 | Filling closed system sterile-filtration equipment |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201410637857.4A CN104353282A (en) | 2014-11-12 | 2014-11-12 | Filling closed system sterile-filtration equipment |
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| CN104353282A true CN104353282A (en) | 2015-02-18 |
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| CN201410637857.4A Pending CN104353282A (en) | 2014-11-12 | 2014-11-12 | Filling closed system sterile-filtration equipment |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109163841A (en) * | 2018-10-08 | 2019-01-08 | 广州达意隆包装机械股份有限公司 | Jetting pressure detection device and sterile filling production system |
| CN109927949A (en) * | 2019-03-08 | 2019-06-25 | 广西梧州制药（集团）股份有限公司 | A kind of filling delivery system of full-automatic ingredient and method |
| CN111184636A (en) * | 2018-11-14 | 2020-05-22 | 正大天晴药业集团南京顺欣制药有限公司 | Preparation of pharmaceutical composition containing recombinant protein |
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| CN2533067Y (en) * | 2000-12-22 | 2003-01-29 | 李力 | Bacterial filling device |
| CN203139787U (en) * | 2013-03-15 | 2013-08-21 | 江苏远恒药业有限公司 | Eye drops filling system with air compression device |
| CN203862017U (en) * | 2014-06-09 | 2014-10-08 | 成都中医药大学 | Constant-pressure filter constant measuring experimental apparatus with mechanical stirring function |
| CN204337902U (en) * | 2014-11-12 | 2015-05-20 | 江苏省原子医学研究所 | Loading sealing system aseptic filtration equipment |
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2014
- 2014-11-12 CN CN201410637857.4A patent/CN104353282A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN2533067Y (en) * | 2000-12-22 | 2003-01-29 | 李力 | Bacterial filling device |
| CN203139787U (en) * | 2013-03-15 | 2013-08-21 | 江苏远恒药业有限公司 | Eye drops filling system with air compression device |
| CN203862017U (en) * | 2014-06-09 | 2014-10-08 | 成都中医药大学 | Constant-pressure filter constant measuring experimental apparatus with mechanical stirring function |
| CN204337902U (en) * | 2014-11-12 | 2015-05-20 | 江苏省原子医学研究所 | Loading sealing system aseptic filtration equipment |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109163841A (en) * | 2018-10-08 | 2019-01-08 | 广州达意隆包装机械股份有限公司 | Jetting pressure detection device and sterile filling production system |
| CN109163841B (en) * | 2018-10-08 | 2023-11-21 | 广州达意隆包装机械股份有限公司 | Spray stamping force detection device and sterile filling production system |
| CN111184636A (en) * | 2018-11-14 | 2020-05-22 | 正大天晴药业集团南京顺欣制药有限公司 | Preparation of pharmaceutical composition containing recombinant protein |
| CN109927949A (en) * | 2019-03-08 | 2019-06-25 | 广西梧州制药（集团）股份有限公司 | A kind of filling delivery system of full-automatic ingredient and method |
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Application publication date: 20150218 |