A kind of full closed aseptic liquid ultrafiltration tank arrangement
Technical field
The present invention relates to a kind of sterile liquid medicine case for ultrafiltration, specifically refer in medicine and biologic product production, for a kind of full closed aseptic liquid ultrafiltration tank arrangement of sterile liquid medicine ultrafiltration concentration and ultrafiltration dialysis.
Background technology
Ultrafiltration (Ultrafiltratoin) refers in the production of active liquid and biologically active agents, in the production of vaccine, by being called as the filter membrane isolation technics of molecular sieve, stoste small molecular solute and water is leached, thereby obtains concentrated liquid; In ultrafiltration system, the stoste of preparation enters the ultrafilter filter membrane surface of flowing through by ultrafiltration concentration container under the promotion of pump pressure, the aqueous solvent and the little molecule solute that are less than filter membrane fenestra are called through liquid (Permeate) through filter membrane, see through liquid and discharge ultrafilter as liquid waste processing, than the large solute of filter membrane fenestra and solute group, be trapped and become concentrate, concentrate is back to and in ultrafiltration concentration container, is again pumped into ultrafilter and filter, so circulation, stoste in ultrafiltration concentration container is progressively concentrated, thereby obtains concentrated purifying liquid.
Prior art adopts uncovered large vertical bottle or stainless steel cask as ultrafiltration concentration container, under efficient laminar flow hood, carry out the operation of non-seal, because the inlet and outlet piping of ultrafiltration concentration container is more, operate complicated, very easily contaminated, Chinese new edition GMP requirement, pollution or cross pollution for fear of liquid, should " adopt closed system produce ", if medicine be the biological products of " can not final sterilization or degerming ", the quality of its end article is just difficult to assurance.Yet prior art there is no and meets the airtight ultrafiltration concentration case that is specifically designed to ultrafiltration system circular flow that new edition GMP requires, therefore, there are the problems and shortcomings that do not meet the airtight requirement of new edition GMP in prior art.
Summary of the invention
The problems and shortcomings that exist for above-mentioned prior art, the present invention adopts by ultrafiltration tank, electronic scale, supporting station, the whole closing appliance that controller forms, wherein, ultrafiltration tank consists of tank body and cover, tank body is provided with carrying handle, rotating shaft, locking closure device, liquid feed valve, liquid valve, return liquid valve, in tank body, be provided with ring-type injector, interior long tube, cover is provided with glass window, air cleaner, ultrafiltration tank be positioned at electronic scale above, electronic scale be fixed on supporting station above, controller is fixed on the technical scheme of a side of supporting station, a kind of full closed aseptic liquid ultrafiltration tank arrangement is provided, be intended to be connected with ultrafiltration system by full-closed structure, make the operation of ultrafiltration system reach the object that meets the airtight requirement of new edition GMP.
The object of the present invention is achieved like this: a kind of full closed aseptic liquid ultrafiltration tank arrangement, comprise ultrafiltration tank, electronic scale, supporting station, controller, wherein: described ultrafiltration tank consists of tank body and cover, described tank body is the stainless steel vessel of hollow and thin-walled drum-shaped, the symmetrical carrying handle that is provided with of outside bucket wall of tank body, before and after the outside bucket wall of tank body, be arranged with the columniform rotating shaft of protrusion, the upper port of tank body is laid with the locking closure device of knob along place; The outer barrel wall place, front side on the top of tank body is provided with the triplet commutation diaphragm valve communicating with tank inner chamber and is called back liquid valve, one end that described time liquid valve is arranged in tank inner chamber connect one downwards the long tube of straight-through tank inner chamber bottom be called long tube, the bottom of interior long tube is horizontal curved near tank skin, and the bottom end opening of interior long tube is horizontal along tank skin circumferencial direction; The rear side outer barrel wall place on the top of tank body is provided with the two-way diaphragm valve communicating with tank inner chamber and is called liquid feed valve, and one of one end connection that described liquid feed valve is arranged in tank inner chamber is called ring-type injector around the annular pipe that is laid with some manholes on tank body top internal chamber wall, tube wall; The rear side outer barrel wall place of the bottom of tank body is provided with the two-way diaphragm valve communicating with tank inner chamber and is called liquid valve; Described cover is the end cap of the circular stainless steel matter of the airtight thin-walled coordinating of the upper edge hole with tank body, the outer rim place of cover is provided with the snap close for coordinating with the described locking closure device of tank body, on cover, be also provided with the glass window consisting of adpting flange and clear glass, the top of cover is provided with air cleaner protruding upward; Below the outer rim of cover, be provided with the O-ring seal for the upper edge hole sealing with tank body;
Described electronic scale is the electronic scale for weighing;
Described supporting station is the stainless steel platform of rectangle, and the Si Ge corner below of supporting station is respectively equipped with castor;
Described controller is for to connect by wire, for controlling ultrafiltration tank and electronic scale, the Pump for giving-out in ultrafiltration tank and ultrafiltration system, liquid feeding pump, magnetic valve carry out coordinated operation electric apparatus control apparatus;
Cover be positioned at tank body above by described locking closure device and tank body is airtight connects and composes airtight ultrafiltration tank, ultrafiltration tank be positioned at electronic scale above, electronic scale be fixed on supporting station above, controller is fixed on the column of a side of supporting station;
The direction face of structure representation is divided into up, down, left, right, front, rear side, wherein, before be the face in the face of institute's statement main body, after be with described before relative face.
Operation principle and beneficial effect
During application, in ultrafiltration system, liquid feed valve is connected with diluent tank with original fluid container through liquid feeding pump; Two ports that commutate each other that return liquid valve are connected with liquid medicine collecting tank with the output of ultrafilter respectively; Liquid valve is connected with the input of ultrafilter through Pump for giving-out;
During work, medicament stoste in original fluid container enters in ultrafiltration tank by liquid feed valve and ring-type injector, enter medicament stoste in ultrafiltration tank through liquid valve and Pump for giving-out enters ultrafilter and the ultrafiltration membrance filter of flowing through, stoste small molecular solute and solvent see through milipore filter to be become through liquid discharge ultrafilter as liquid waste processing, than the large solute of milipore filter fenestra and solute group, be trapped and become concentrate, concentrate with not and the stoste of filtering together through returning liquid valve and interior long tube, get back in ultrafiltration tank, now, the stoste in ultrafiltration tank is concentrated one time; Medicament is again pumped into ultrafilter and is carried out ultrafiltration, again concentrated, and so circulation, the little molecule solute in ultrafiltration tank stoste is by progressively filtering, thus acquisition is through the concentrated and purified liquid of dialysis; When dialysis completes, close liquid feed valve, time liquid valve switches to and cuts out the state that ultrafiltration tank is opened liquid medicine collecting tank, the concentrated and purified liquid in ultrafiltration tank and in ultrafilter is all pumped in liquid medicine collecting tank;
The opening direction of interior long tube bottom is beneficial to and forms the stoste that whirlpool allows cracked ends liquid feed valve not enter ultrafiltration tank and fully mix with concentrate; The effect of ring-type injector is, while needing ultrafiltration dialysis after ultrafiltration tank completes ultrafiltration concentration, diluent in diluent tank (being sterile buffer, physiological saline or water for injection) enters ultrafiltration tank through liquid feed valve, by ring-type injector, the liquid that is attached to inner tank wall is washed away to ultrafiltration tank intracavity bottom participation ultrafiltration dialysis; The effect of electronic scale is, in the process of ultrafiltration, to monitor the state of ultrafiltration by the changes in weight of the ultrafiltration tank of liquid is housed; The effect of glass window is, in the process of ultrafiltration, and the situation in can visualization ultrafiltration tank inner chamber; The effect of air cleaner is, keeps germ-free condition in ultrafiltration tank and the air pressure balance inside and outside tank in the process of ultrafiltration; The effect of carrying handle and rotating shaft is, when cleaning ultrafiltration tank, to be convenient to carrying, to topple over and clean; The effect that is provided with the supporting station of castor is to be convenient to the movement of ultrafiltration tank.
This device is connected with ultrafiltration system by full-closed structure, makes the operation of ultrafiltration system meet the airtight requirement of new edition GMP.
Above-mentioned, the present invention adopts by ultrafiltration tank, electronic scale, supporting station, the whole closing appliance that controller forms, wherein, ultrafiltration tank consists of tank body and cover, tank body is provided with carrying handle, rotating shaft, locking closure device, liquid feed valve, liquid valve, return liquid valve, in tank body, be provided with ring-type injector, interior long tube, cover is provided with glass window, air cleaner, ultrafiltration tank be positioned at electronic scale above, electronic scale be fixed on supporting station above, controller is fixed on the technical scheme of a side of supporting station, overcome prior art and had the problems and shortcomings that do not meet the airtight requirement of new edition GMP, a kind of full closed aseptic liquid ultrafiltration tank arrangement providing, by full-closed structure, be connected with ultrafiltration system, make the operation of ultrafiltration system reach the object that meets the airtight requirement of new edition GMP.
Accompanying drawing explanation
Fig. 1 is the main TV structure cross-sectional schematic of a kind of full closed aseptic liquid ultrafiltration tank arrangement of the present invention;
Fig. 2 is that cross-sectional schematic is looked on Fig. 1 left side;
Fig. 3 is a kind of full closed aseptic liquid ultrafiltration tank arrangement of the present invention, the operation principle schematic diagram being connected with ultrafiltration system during application.
Below in conjunction with the embodiment in accompanying drawing, the present invention is described in further detail, but should not be construed as any limitation of the invention.
In figure: ultrafiltration tank 1, tank body 11, carrying handle 13, rotating shaft 14, locking closure device 15, liquid feed valve 16, ring-type injector 161, liquid valve 17, return liquid valve 18, interior long tube 181, cover 12, glass window 121, air cleaner 122, electronic scale 2, supporting station 3, castor 31, controller 4, Pump for giving-out 5, liquid feeding pump 6, original fluid container 7, diluent tank 8, liquid medicine collecting tank 9, ultrafilter 10, milipore filter 101, concentrate 102, see through liquid 103, liquid back pipe 01, feed tube 02, collecting pipe 03, drain pipe 04, magnetic valve 05.
The specific embodiment
Consult Fig. 1~Fig. 3, a kind of full closed aseptic liquid ultrafiltration tank arrangement of the present invention, comprise ultrafiltration tank 1, electronic scale 2, supporting station 3, controller 4, wherein: described ultrafiltration tank 1 consists of tank body 11 and cover 12, described tank body 11 is the stainless steel vessel of hollow and thin-walled drum-shaped, the symmetrical carrying handle 13 that is provided with of outside bucket wall of tank body 11, is arranged with the columniform rotating shaft 14 of protrusion before and after the outside bucket wall of tank body 11, the upper port of tank body 11 is laid with the locking closure device 15 of knob along place; The outer barrel wall place, front side on the top of tank body 11 is provided with the triplet commutation diaphragm valve communicating with tank body 11 inner chambers and is called back liquid valve 18, one end that described time liquid valve 18 is arranged in tank body 11 inner chambers connect one downwards the long tube of straight-through tank body 11 intracavity bottoms be called long tube 181, the bottom of interior long tube 181 is horizontal curved near tank skin, and the bottom end opening of interior long tube 181 is horizontal along tank skin circumferencial direction; The rear side outer barrel wall place on the top of tank body 11 is provided with the two-way diaphragm valve communicating with tank body 11 inner chambers and is called liquid feed valve 16, and one of one end connection that described liquid feed valve 16 is arranged in tank body 11 inner chambers is called ring-type injector 161 around the annular pipe that is laid with some manholes on tank body 11 top internal chamber walls, tube wall; The rear side outer barrel wall place of the bottom of tank body 11 is provided with the two-way diaphragm valve communicating with tank body 11 inner chambers and is called liquid valve 17; Described cover 12 is the end cap of the circular stainless steel matter of the airtight thin-walled coordinating of the upper edge hole with tank body 11, the outer rim place of cover 12 is provided with the snap close for coordinating with the described locking closure device 15 of tank body 11, on cover 12, be also provided with the glass window 121 consisting of adpting flange and clear glass, the top of cover 12 is provided with air cleaner protruding upward 122; Below the outer rim of cover 12, be provided with the O-ring seal for the upper edge hole sealing with tank body 11;
Described electronic scale 2 is the electronic scale for weighing;
The stainless steel platform that described supporting station 3 is rectangle, the Si Ge corner below of supporting station 3 is respectively equipped with castor 31;
Described controller 4 is for to connect by wire, for controlling ultrafiltration tank 1 and electronic scale 2, ultrafiltration tank 1 and Pump for giving-out 5, liquid feeding pump 6, magnetic valve 05 in ultrafiltration system carry out coordinated operation electric apparatus control apparatus;
What cover 12 was positioned at tank body 11 above connects and composes airtight ultrafiltration tank 1 by described locking closure device 15 and tank body 11 are airtight, ultrafiltration tank 1 be positioned at electronic scale 2 above, electronic scale 2 be fixed on supporting station 3 above, controller 4 is fixed on the column of a side of supporting station 3;
The direction face of structure representation is divided into up, down, left, right, front, rear side, wherein, before be the face in the face of institute's statement main body, after be with described before relative face.
Operation principle and beneficial effect
During application, in ultrafiltration system, liquid feed valve 16 is connected with diluent tank 8 with original fluid container 7 through liquid feeding pump 6; Two ports that commutate each other that return liquid valve 18 are connected with liquid medicine collecting tank 9 with the output of ultrafilter 10 respectively; Liquid valve 17 is connected with the input of ultrafilter 10 through Pump for giving-out 5;
During work, medicament stoste in original fluid container 7 enters in ultrafiltration tank 1 by liquid feed valve 16 and ring-type injector 161, the medicament stoste entering in ultrafiltration tank 1 enters ultrafilter 10 and flows through milipore filter 101 filtrations through liquid valve 17 and Pump for giving-out 5, stoste small molecular solute and solvent see through milipore filter 101 to be become through liquid discharge ultrafilter as liquid waste processing, than the large solute of milipore filter 101 fenestras and solute group, be trapped and become concentrate, concentrate with not and the stoste of filtering together through returning liquid valve 18 and interior long tube 181, get back in ultrafiltration tank 1, now, stoste in ultrafiltration tank 1 is concentrated one time, medicament is again pumped into ultrafilter 10 and is carried out ultrafiltration, again concentrated, and so circulation, the little molecule solute in ultrafiltration tank 1 stoste is by progressively filtering, thus acquisition is through the concentrated and purified liquid of dialysis, when dialysis completes, close liquid feed valve 16, time liquid valve 18 switches to and cuts out the state that ultrafiltration tank 1 is opened liquid medicine collecting tank 9, the concentrated and purified liquid in ultrafiltration tank 1 and in ultrafilter 10 is all pumped in liquid medicine collecting tank 9,
The opening direction of interior long tube 181 bottoms is beneficial to and forms the stoste that whirlpool allows cracked ends liquid feed valve 16 not enter ultrafiltration tank 1 and fully mix with concentrate; The effect of ring-type injector 161 is, while needing ultrafiltration dialysis after ultrafiltration tank 1 completes ultrafiltration concentration, diluent in diluent tank 8 (being sterile buffer, physiological saline or water for injection) enters ultrafiltration tank 1 through liquid feed valve 16, by ring-type injector 161, the liquid that is attached to tank body 11 inwalls is washed away to ultrafiltration tank 1 intracavity bottom participation ultrafiltration dialysis; The effect of electronic scale 2 is, in the process of ultrafiltration, to monitor the state of ultrafiltration by the changes in weight of the ultrafiltration tank 1 of liquid is housed; The effect of glass window 121 is, in the process of ultrafiltration, and the situation in can visualization ultrafiltration tank 1 inner chamber; The effect of air cleaner 122 is, keeps germ-free condition in ultrafiltration tank 1 and the air pressure balance inside and outside tank in the process of ultrafiltration; The effect of carrying handle 13 and rotating shaft 14 is, when cleaning ultrafiltration tank 1, to be convenient to carrying, to topple over and clean; The effect that is provided with the supporting station 3 of castor 31 is to be convenient to the movement of ultrafiltration tank 1.