CN1123521A - A device and a process for aseptic mixing of liquid products - Google Patents
A device and a process for aseptic mixing of liquid products Download PDFInfo
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- CN1123521A CN1123521A CN95190123A CN95190123A CN1123521A CN 1123521 A CN1123521 A CN 1123521A CN 95190123 A CN95190123 A CN 95190123A CN 95190123 A CN95190123 A CN 95190123A CN 1123521 A CN1123521 A CN 1123521A
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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
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2089—Containers or vials which are to be joined to each other in order to mix their contents
-
- 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
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
- A61J1/2006—Piercing means
- A61J1/201—Piercing means having one piercing end
-
- 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
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
- A61J1/2006—Piercing means
- A61J1/2013—Piercing means having two piercing ends
-
- 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
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
- A61J1/2048—Connecting means
- A61J1/2058—Connecting means having multiple connecting ports
-
- 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
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
- A61J1/2068—Venting means
- A61J1/2075—Venting means for external venting
-
- 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
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
- A61J1/2079—Filtering means
- A61J1/2082—Filtering means for gas filtration
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- Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Accessories For Mixers (AREA)
- Filling Of Jars Or Cans And Processes For Cleaning And Sealing Jars (AREA)
Abstract
The invention relates to an apparatus for mixing aseptically three or more liquid products (51, 53, 55) and includes at least two pointed connection devices (1, 21, 41) which are provided with through-passing flow passageways (3, 4, 24, 25, 43, 44) and are connected in series by means of a connecting line (61) and are intended to be inserted through penetrable closure means (58, 59, 60) of product containers (52, 54, 56). A first of these connection devices (1) functions to place the first container (52) in communication with the surroundings via a sterilizing filter (7), and connects the first container with the second container (54) through the connecting line (61), wherein the product containers are mutually connected together successively by means of respective subsequent connection devices down to the last product container (56) in line in which the final mixture of products, including the product (55), is collected. A subpressure prevails in the last container in line, this subpressure constituting the force by means of which the products are driven through the system. The invention also relates to a connection device (21) and to a system for aseptically mixing three or more liquid products, and also to a method of mixing the products. The invention is primarily intended for application when mixing the liquid components of a preparation for parenteral nutrient supply.
Description
The present invention relates to a kind of equipment and method of aseptic liquid product mixture.Especially the apparatus and method for that relates to three kinds of aseptic mixing or more kinds of liquid drug or nutritional solution.More specifically be to the present invention relates to aseptic mixing for the parenteral input, particularly the equipment and the method for the liquid nutritional preparation of vein input.The invention still further relates to the connecting device and the system of three kinds of a kind of aseptic mixing or more kinds of fluid products.
Nutriment is normally given the patient that can't take in nutriment for a certain reason with normal mode through the parenteral approach.These nutriments are supplied with and are consisted essentially of three kinds of main nutriment types: i.e. carbohydrate, aminoacid and fat.But,, must supply with the about altogether 50 kinds of different nutriments of patient in one day in order to reach good nutritional status.Carbohydrate and aminoacid are supplied with the form of solution, and is fatty then with the form supply of Emulsion.This preparation also comprises the nutriment that other are essential, as electrolyte, and trace element and water solublity and fatsoluble vitamin., can not prepare the storage mixed liquor that contains all three kinds of liquid components under the normal condition, because this mixed liquor does not have enough bin stabilities.Because different courses of reaction can generate unsuitable product, when these product when the parenteral approach is defeated by patient, may be deleterious sometimes.For example: carbohydrate and aminoacid can generate Mai Er rad (Maillard) product, and they can cause the toxicity secondary action.Mai Er rad (Maillard) product usually makes the solution flavescence, and this phenomenon does not meet needs, and national health mechanism is unacceptable under many circumstances.The other composition easily makes the lipomul instability, causes Emulsion to decompose, and forms big lipochondrion, as the one-tenth butyrous, or forms fatty separation fully.
Once attempted to reach by the branch pipeline, near the transfusion place, mixed these compositions, to avoid the problems referred to above by being defeated by these three kinds of compositions of patient respectively., this method is very complicated, and is difficult to supply with various compositions according to correct dose.
Can also before transfusion, mix three kinds of compositions immediately, import medicine immediately before why not good reaction in office then may take place according to required ratio., in this case, usually must under the condition of integral asepsis, mix these compositions, yet not have aseptic place again, also not be subjected to the staff's of this special training help.Therefore, on the angle of physics and chemistry, can both correctly mix these solution, simultaneously can prevent contamination by micro again, this staff to hospital is a serious problem, up to now, a kind of equipment that is used for two kinds of fluid products of aseptic mixing is developed into together with other achievements and is applied.This equipment is used for a kind of lipomul of aseptic mixing and a kind of aminoacid that has mixed and the mixed liquor of carbohydrate in aqueous solution.But based on above-mentioned reason, the storage mixed liquor of aminoacid and carbohydrate is actually inappropriate.Still do not have at present a kind of can three kinds of aseptic mixing or the equipment of more kinds of fluid products.The present invention has overcome this shortcoming.
The invention provides and a kind of three kinds of fluid products are carried out aseptic blended equipment.This equipment comprises:
A) one first have a connecting device of most advanced and sophisticated transparent capping in order to the container that inserts one first product, it comprises that two are separated, normally parallel penetrating via, an end opening of first passage is in the tip portion of connecting device; And its other end communicates by a sterilizing filter and atmosphere on every side; One end of second passage also is opened on the tip portion of connecting device, and its other end then is connected on the connecting duct; And
B) one second connecting device that has two tips, transparent capping of one second product container can be inserted in its first tip, it comprises that two separate, normally parallel penetrating via, wherein an end opening of a first passage is in first tip portion of connecting device, and the other end of this passage is connected to from first connecting device and extends on the connecting duct of coming; And an end of second channel also is opened on first tip portion of this connecting device, its other end then is opened on second tip portion of connecting device, this second tip portion is used to insert transparent capping of a three products container, and the mixture of all products all is collected in the 3rd container.
When present device is used for four kinds of aseptic mixing or more kinds of fluid product, connecting duct between first and second connecting devices is even connect the connecting device of one or more additional, intermediary band tip portions, and each such connecting device all has the capping of a penetrable containers for liquid products and inserts the tip portion of container.This tip portion comprises two passages that separate, normally parallel, the terminal of the tip portion of both in an end opening in connecting device, their other end then is connected respectively to extend from last connecting device and comes, or extends on the connecting duct of next connecting device.
According to the present invention, also provide one to be used to mix three kinds or more I plant the connecting device of fluid product.It comprises that one is used to insert the first hollow tip part of transparent capping of containers for liquid products.This tip portion comprises two penetrating vias that separate, normally parallel, the tip portion of both in an end opening in connecting device, and first passage is connected on the connecting duct, in order to provide treat with container in mutually blended fluid product of fluid product or product mixture; And an end opening of second channel is in another tip portion, its penetrable transparent capping that the container of another product is housed, and other fluid products are mixed mutually with product in this container, thus obtain final mixed liquor.
The invention still further relates to and a kind of three kinds or more kinds of fluid product are carried out aseptic blended method.Every kind of product all is contained in the product container separately that in series connects together mutually.First container from this series, product in each container or product mixture one after the other flow into the next container in the series under aseptic condition, and mix with product in this container, to the last the final mixed liquor with all products is collected in last container of this series.
According to preferred embodiment of this method, the product to last product container of major general is packaged in the container under subatmospheric condition in advance, and first product container communicates by a sterilizing filter and ambient atmosphere.Under so just can externally atmospheric influence, drive or draw product in succession by product container series, and mix mutually, be collected in last product container as final mixture at last.Best, all products are packaged in its container separately under subatmospheric condition in advance.
The invention still further relates to and a kind of three kinds of fluid products are carried out aseptic blended system.This system comprises:
A) one is equipped with container one first fluid product and that have transparent capping;
B) one first have the connecting device of tip portion, it comprises first penetrating via, an end opening of this passage is in the tip portion of connecting device; Its other end communicates by a sterilizing filter and ambient atmosphere; It also comprises one second penetrating via, and this passage is usually parallel with first passage and separate.One end opening of second channel is in the tip portion that connects, and its other end then is connected in connecting duct.Wherein the tip portion of first connecting device inserts transparent capping of first container to realize liquid mixing.
C) one one second container fluid product and that have transparent capping is housed;
D) one second connecting device that has two tip portions, it comprises first penetrating via, the one end is opened on first tip portion of connecting device; And its other end is connected in the connecting duct that is extended out by first connecting device; It also comprises second penetrating via parallel with first passage usually, and the one end opening is in first tip portion of connecting device; And its other end is opened on second tip portion of this connecting device; First tip portion inserts in second product container to realize liquid mixing by transparent capping;
E) product is kept at subatmospheric three products container, and it comprises a transparent capping, and second tip portion of second connecting device inserts this capping makes liquid be communicated with this container, and the volume of this container is enough to the mixture of receiving fluids product.
Be used for obtaining the aseptic mixed liquor of four kinds or more kinds of fluid products according to an embodiment of this system, the connecting device of one or more additional, intermediary band tip portions is connected on the connecting duct between first and second connecting device.Each so additional connecting device all comprises two normally parallel penetrating vias, and the one end opening is in the tip portion of connecting device, and its other end is connected on the connecting duct; Wherein, the tip portion of connecting device in the middle of each is inserted transparent capping of an additional containers for liquid products.
At this, will be able to characteristics of the present invention, structure, method and other purposes are given more detailed description by means of accompanying drawing.In the accompanying drawing,
Fig. 1 is the profile of the connecting device of first kind of band tip portion of the present invention;
Fig. 2 is the side view of connecting device shown in Figure 1;
Fig. 3 is the profile of the connecting device of second kind of band tip portion of the present invention;
Fig. 4 is the side view of second kind of connecting device;
The additional middle connecting device that the one embodiment of the present of invention of expressing Fig. 5 adopt; And
Fig. 6 schematically shows system structure of the present invention.
Fig. 1 and Fig. 2 represent first connecting device, represent with label 1 generally.It comprises a tip portion 2 and two separated, normally parallel penetrating vias 3 and 4.One end of first passage 3 is opened on tip portion 2 in 5 places, and the other end of first passage communicates with ambient atmosphere in 6 places by a sterilizing filter 7.The sterilizing filter 7 that this figure shows is to be placed in the cell 8, is fixed by a capping 9 that has the perforate 10 that communicates with ambient atmosphere, certainly, can also have additive method that sterilizing filter is installed.
One end of second channel 4 also is opened on tip portion 2 in 11 places, and the other end of second channel 4 is connected to by joint 13 on the connecting duct (not showing) in 12 places.
Fig. 3 and Fig. 4 represent second connecting device, represent with 21 generally, and it comprises one first tip portion 22 and one second tip portion 23, and these two tip portions extend usually in the opposite direction, but this is not strict necessary.Second connecting device 21 comprises that two are separated from each other, and normally parallel passage 24 and 25.One end of first passage 24 is opened on first tip portion 22 in 26 places, and the other end of this passage, is connected to from first connecting device 1 and extends on the connecting duct (not showing) of coming by means of joint 28 in 27 places.First end of second channel 25 also is opened on first tip portion 22 in 29 places, and the other end of this passage is opened on the second contiguous tip portion 23 in 30 places.
Fig. 5 is one intermediary, has the profile of most advanced and sophisticated connecting device, represents with label 41 generally, and it is the embodiments of the invention that are used to mix four kinds or more kinds of fluid products.Middle connecting device 41 comprises that a tip portion 42 and two are separated from each other normally parallel penetrating via 43 and 44.The other end 47 and 48 that two passages 43 and an end 45 and 46 of 44 all are opened on tip portion 42, two passages then is connected to this centre connecting device on the connecting duct between first and second connecting devices 1 and 21 (not showing) by joint 49 and 50 respectively.
Can understand like this, can connect several middle connecting devices 41 continuously on connecting duct, except that above-mentioned three kinds of products of touching upon, every increase is a kind of will just to need so middle connecting device according to the blended fluid product of the present invention.
The tip portion of the connecting device shown in Fig. 1-5 and the passage that includes will more mainly, prevent microbial contamination by means of placing the head protector on each tip portion to prevent mechanical damage.In a single day these head protectors are preferably air-locked, also can comprise a device that promptly damages after head protector takes off, and just show obviously that head protector is removed, just can not place (preventing reuse) to head protector again so that take off.All people with the normal technical ability in this area can design such head protector and such safety device.Head protector should be when being about to insert the product container capping takes off on just by its tip.For the purpose of clear, head protector does not show on figure.
Fig. 6 is the graphic extension of three kinds of fluid product inventions of aseptic mixing system.First kind of product 51 is contained in first product container 52.Second kind of product 53 is contained in second product container 54.The third product 55 is contained in the three products container 56, and its sky volume 57 should be enough to hold respectively the product 51 and 53 from container 52 and 54.
Three containers 52,54 and 56 are sealed by transparent capping 58,59 and 60 respectively.These cappings can come the closed container opening, and be fixed by a metal cap with general general type, as rubber membrane.Metal cap is provided with an opening at the center of capping can expose rubber membrane, so that the connecting device of band tip portion can penetrate this rubber membrane.The central opening of metal cap can prevent that it is damaged and germ contamination by means of the head protector of a metal or plastics in storing and transporting.Obviously, those skilled in the art can also imagine the transparent capping that other types.
What Fig. 6 represented is that first connecting device 1 of being with tip portion of one among Fig. 1 and Fig. 2 is by in transparent capping 58 insertion containers 52.Two passages 3 of connecting device 1 and 4 are in the internal switching of an end at tip portion 2 with the container 52 of device.The other end of passage 3 communicates with ambient atmosphere in 6 places, one sterilizing filter, and the other end of passage 4 then is communicated on the connecting duct 61 that extends to one second connecting device 21 (as shown in Figure 3 and Figure 4) in 12 places.
The tip portion 22 of connecting device 21 inserts in the container 54 by transparent capping 59, and the tip portion 23 of connecting device 21 inserts in the container 56 through transparent capping 60.The opening 27 of first passage 24 of connecting device 21 is communicated in by first container 52 and extends and next connecting duct 61.Its second passage 25 gets up the inside of second container 54 and the internal communication of the 3rd container 56.Like this, have the connecting duct of an opening to communicate with surrounding by sterilizing filter 7 (see figure 1)s, and sequentially arrive the 3rd container by preceding two containers, promptly the container of last shown in this figure 56.Therefore, if any suitable driving force effect, fluid product 51 just can mix with the fluid product 53 in that morning through container 54 mutually from container 52, arrives container 56 at last, and all three kinds of products obtain mixing at this, and form final mixture.
When mixing four kinds or more kinds of fluid product, can be with the middle connecting device of or multiple type as shown in Figure 5 by means of two joints 49 and 50 and be connected on the connecting duct 61.Then, the tip portion 42 that comprises this connecting device of two passages 43 and 44 just inserts in the product container that is similar to container 52 and 54 by transparent capping.
Hold last container 56 of the final mixture (comprising product 55) of described fluid product in the container series, should have enough capacity to hold final mixture.Therefore, before component of mixture arrived final container 56, its sky volume 57 was very big.This sky volume should be vacuum or pressure is lower than atmospheric pressure.Just produced the driving force in the mixed process just because of this negative pressure, will be described in detail below.
Product in any other additive vessel of the upstream of container 52,54 and final container 56 preferably all is under vacuum or the negative pressure.Yet the negative pressure in these containers is not essential, can be atmospheric pressure in the container, even a little higher than atmospheric pressure.Except that last container, when being malleation or negative pressure in one or more containers, must make malleation become equipressure by sterilizing filter.In order to realize this point, the tip portion of connecting device must place on the liquid level of liquid in container separately.In order to prevent the oxidation of some sensitive composition, product encapsulates under suitable protective gas usually, as nitrogen, rather than air.
The connecting duct 61 that extends between two connecting devices 1 and 21 can the form with flexible pipe connect between joint 13 and 28 separately; And have additional, middle connecting device 41 to be connected on the connecting duct alternatively.Yet, preferably with connecting duct 61 and two connecting devices 1 and 21 when mixing apparatus is made, just for good and all link together, as make a composite set.The composite set of this connecting device and connecting duct can also reconnect the proper container fixture, thereby with the form of composite set, fixes three product containers 52,54 and 56 and connector separately and connecting duct.In mixed process, such composite set product container that separates that operates is much easy.
The method of the present invention of three kinds of fluid products of aseptic mixing can be by following operation:
By means of connecting duct 61 two connecting devices 1 and 21 are linked together, and all tip portions 2,22 and 23 all are stamped the head protector (not show) of air-locked and bacteriological protection on each connecting device.As aforementioned, this head protector can prevent the passage 3,4 and 24 and 25 of air and antibacterial access to plant 1 and 21.Now, the tip portion 2 of head protector from connecting device 1 taken off, tip portion is inserted in the product container 52 by capping 58.If the products 51 in the container 52 are under negative pressure, so because ambient atmosphere can be by sterilizing filter 7 and passage 3 and access to plant 1, the inside of container will be in normal atmosphere and depress this moment.
Before the negative pressure of container 52 becomes equipressure, the head protector of inadvisable lower cover on the tip portion 22 of connecting device 21.For guarantee in the container 52 aseptic condition this be very important.Take off the head protector on most advanced and sophisticated 22 in advance if container 52 still is negative pressure, the air of filtered will suck in the container 52 by passage 24 and connecting duct 61 so, thus pollution content 51.
When the negative pressure in the container 52 becomes equipressure, the head protector of desirable lower cover on the tip portion 22 of connecting device 21, and tip portion inserted in the container 54 by transparent capping 59.Because air flows into connecting device 1 by sterilizing filter 7, flow into again in the product container 52 then, so the negative pressure in the container 54 just becomes equipressure, simultaneously, displace portioned product 51 it is flowed in the container 54.Before pressure conversion equipressure, the head protector of inadvisable lower cover on the tip portion 23 of connecting device 21.This flows into through passage 25 in the product container 54 and pollute its content 53 air that prevents filtered is very important.
When the negative pressure in the container 54 becomes equipressure, the head protector of desirable lower cover on the tip portion 23 of connecting device 21, and this tip portion inserted in last container 56 in the container series by transparent capping 60.At this moment, the negative pressure in the mixing chamber 57 in this container 56 is the product 53 in the aspiration container 54 just, simultaneously, also will flow into final container 56 by container 54 from the product 51 of container 52, and here, three kinds of products obtain mixing.Because come in and flow through container 52 and 54 and the air of connecting duct 61 by sterilizing filter 7 suction, the negative pressure in last container 56 also can become equipressure.
When four kinds of mixing or more kinds of fluid product, its mixed process is with similar as mentioned above.Connecting device by means of the band tip portion couples together containers sequentially ground, at the head protector that takes off on the tip portion of next connecting device, and liquid is touched before next container, guarantees that the interior negative pressure of container that is connected has become equipressure.
As previously mentioned, negative pressure just in the end be only in container essential.This negative pressure should enough be hanged down to driving remaining fluid product and be flowed into final container.Pressure in the preceding surface vessel begins to be atmospheric pressure, does not so just exist unfiltered air to be inhaled into the danger of container.However, preferably when being about to the penetrable capping of inserting container, just take off head protector on the tip portion of connecting device.So just, can increase the safety that does not make unfiltered air contact any product and make its pollution.
When product mixed process finished and final container 56 in pressure when being equipressure, container can take off from connecting device 21, final mixture is handled in the usual way, as transfusion or injection.For the purpose of increasing safety, suggestion is input as early as possible after mixing, to reduce the danger that reacts between each product, because these reactions may generate the untoward reaction product.In addition, before input, preferably mixture storage is existed under the shady and cool environment.
Certainly, mixed process must be carried out under the health reliable conditions.Therefore, be preferably in before the tip portion insertion of connecting device, with disinfectant such as the transparent capping of alcohol wipe.Actual used connecting device and connecting duct are preferably disposable, as being disposable use only, and are stored in before use in the sterile package, in the sterile package of crossing through the ion radiosterilization.Because method and apparatus provided by the present invention is simple, also can product mix even without the medical worker who was subjected to special training, and without any the danger of germ contamination.
The parts of present device can be made by normally used material in the known sterile liquid treatment process technology.Point product container is for conveniently being used in the simple glass or the plastic bottle of injection or transfusion.The connecting device of band tip portion can be made with in the art metal and/or plastic material by routine according to convenient.Importantly can carry out disinfection, as use high temperature and high pressure method these materials, or by means of gas or radiation etc.Because these parts are preferably disposable, the cost of parts also is important.Understand the structure that those skilled in the art are not difficult to choose suitable material and at length determine parts.
The invention provides one and solve simply under aseptic condition, pollution-free method of jeopardously mixing three kinds or more kinds of fluid product problems.This has more value when for example all required nutriments of total intravenous nutrition supply being mixed.
It should be understood that described in detail and illustrated the present invention here, is some examples, and does not have the meaning of limitation.In following patent claimed range, can carry out further conversion and adjustment to the present invention.This is conspicuous for the technical staff who understands ultimate principle of the present invention.
Claims (10)
1. one kind is carried out aseptic blended equipment to three kinds of fluid products, it is characterized in that,
A) one first have a connecting device in order to transparent capping of the container that inserts one first product of tip portion, it comprises that two are separated, normally parallel penetrating via, an end opening of first passage is in the tip portion of connecting device; And its other end communicates by a sterilizing filter and atmosphere on every side; Wherein, an end of second passage also is opened on the tip portion of connecting device, and its other end then is connected on the connecting duct; And
B) one second connecting device that has two tip portions, transparent capping of one second product container can be inserted in its first tip, it comprises that two separate, normally parallel penetrating via, wherein an end opening of a first passage is in first tip portion of connecting device, and the other end of this passage is connected on the connecting duct that extends out from first connecting device; Wherein, one end of second channel also is opened on first tip portion of this connecting device, and its other end is opened on second tip portion of connecting device, this second tip portion is used to insert transparent capping of a three products container, and the mixture of all products all is collected in the 3rd container.
2. one kind is used for four kinds or more kinds of fluid product are carried out aseptic blended equipment, it is characterized in that,
A) one first have the connecting device in order to transparent capping of inserting one first product container of tip portion, it comprises two penetrating vias that separate, normally parallel, an end opening of first passage is in the tip portion of connecting device; And its other end communicates by a sterilizing filter and ambient atmosphere; Wherein an end of second passage also is opened on the tip portion of connecting device, and its other end then is connected on the connecting duct;
B) one second connecting device that has two tip portions, its first tip portion can insert transparent capping of second product container, it comprises two penetrating vias that separate, normally parallel, wherein an end opening of first passage is in first tip portion of connecting device, and the other end of this passage is connected on the connecting duct that extends out from first connecting device; Wherein, one end of second channel also is opened on first tip portion of this connecting device, its other end then is opened on second tip portion of this connecting device, this second tip portion is used to insert transparent capping of a three products container, and the mixture of all products all is collected in the 3rd container; And
C) connecting device of one or more additional, intermediary band tip portions, each all has the tip portion of a hollow, be used to insert transparent capping of intermediate liquid product container, and each described tip portion all has two penetrating vias that separate, normally parallel, one end opening of this two passage is in the tip portion of connecting device, and their other end is connected respectively to from last connecting device and extends out, or extends on the connecting duct of next connecting device.
3. connecting device that is used to mix three kinds or more kinds of fluid products, it is characterized in that, one first be used to insert the hollow tip part of transparent capping of a containers for liquid products, this tip portion comprises two penetrating vias that separate, normally parallel, two passages all are opened on tip portion, first passage is connected in a connecting duct, with provide fluid product or mixed liquor product and with this container in product mix mutually; And second channel is opened on second tip portion, and this second tip portion is used to insert transparent capping of a terminal container, and the fluid product that increases in this terminal container and other fluid products mix, to form final mixed liquor.
4. one kind is used for three kinds of fluid products are carried out aseptic blended system, it is characterized in that this system comprises:
A) one is equipped with container one first fluid product and that have transparent capping;
B) one first have the connecting device of tip portion, it comprises first penetrating via, an end opening of this passage is in the tip portion of connecting device; And its other end communicates by a sterilizing filter and ambient atmosphere; This connecting device also comprises one second penetrating via, and this passage is usually parallel with first passage and separate.The one end opening is in the tip portion of connecting device, and its other end is connected in connecting duct.And the tip portion of first connecting device inserts transparent capping of first container, to realize liquid mixing;
C) one one second container fluid product and that have transparent capping is housed;
D) one second connecting device that has two tip portions, it comprises first penetrating via, an end opening of this passage is in first tip portion of connecting device; And its other end is connected in the connecting duct that is extended out by first connecting device; It also comprises common second penetrating via parallel with first passage, and the one end opening is in first tip portion of connecting device; Its other end then is opened on second tip portion of this connecting device, and wherein, first tip portion inserts second product container by transparent capping, to realize liquid mixing; And
E) product is stored in subatmospheric three products container, and it comprises a transparent capping, and second tip portion of second connecting device inserts this capping makes liquid be communicated with this container, and the volume of this container is enough to the mixture of receiving fluids product.
5. one kind is used for four kinds or more kinds of fluid product are carried out aseptic blended system, it is characterized in that this system comprises:
A) one is equipped with container one first fluid product and that have transparent capping;
B) one first have the connecting device of tip portion, it comprises first penetrating via, an end opening of this passage is in the tip portion of connecting device, and communicates by a sterilizing filter and ambient atmosphere at its other end; This connecting device also comprises one second penetrating via, this passage is normally parallel with first passage and separate, the one end opening is in the tip portion of connecting device, its other end then is connected in a bypass conduit, and the tip portion of first connecting device inserts the transparent capping of first container, to realize liquid mixing;
C) one one second container fluid product and that have transparent capping is housed;
D) one second connecting device that has two tip portions, it comprises first penetrating via, the one end opening is in first tip portion of connecting device, and its other end is connected in the connecting duct that extends out from first connecting device, it also comprises a common second channel parallel with first passage, the one end opening is in first tip portion of connecting device, its other end then is opened on second tip portion of this connecting device, wherein first tip portion inserts transparent capping of second product container, to realize liquid mixing;
E) product is kept at subatmospheric three products container, and it comprises a transparent capping, and second tip portion of second connecting device inserts this capping makes liquid be communicated with this container, and the volume of this container is enough to the mixture of receiving fluids product; And
F) one or more additional, intermediary connecting device, each connecting device all has the tip portion of a hollow, be used to insert transparent capping of intermediate liquid product container, and each described tip portion all has two to separate, normally parallel passage, this two passage is the tip portion in an end opening in connecting device all, their other end respectively with extend out from last connecting device, or the connecting duct that extends to next connecting device links to each other, and the tip portion of connecting device inserts increase in the middle of each, transparent capping of intermediary containers for liquid products is so that liquid is communicated with this product container.
6. one kind is used for three kinds or more kinds of fluid product are carried out aseptic blended method, it is characterized in that,
Each product all is contained in separately the product container, each container in series links together, begin product each container or product mixed liquor from first container of this container series and under aseptic condition, flow into next container in the container series in succession by pipeline, and mix with product in this container, in all products last container in container series, be collected, and to the end mixed liquor.
7. method according to claim 6 is characterized in that, the product in last product container in the container series is to be packaged in the container in advance under being lower than the condition of atmospheric pressure at least; First product container communicates by a sterilizing filter and ambient atmosphere, so that product is driven under the influence of air pressure around by product container series, and the product in the container is mixed mutually, all products are collected in last container in the container series, become final mixed liquor.
8. method according to claim 7 is characterized in that the product in all product containers is all packed in advance under subatmospheric condition.
9. according to any one described method among the claim 6-8, it is characterized in that, first product container at first links to each other with the connecting duct that extends to second product container, and communicate with ambient atmosphere, pressure becomes atmospheric pressure in first container when the connecting duct that leads to second container is closed, and is open-minded after being connected to the conduit of second container then pressure becoming atmospheric pressure in first container; When being connected to the closed catheter of the 3rd container, make the pressure in second container become atmospheric pressure, then, after the pressure of connecting duct in second container that extends to next container becomes atmospheric pressure by open-minded, and make the pressure in the described next container become atmospheric pressure, each product container in the container series repeats said procedure in succession, last container in container series, atmospheric pressure in the product container of front drives product and enters into last product container by these containers, to obtain final product mixture therein.
10. according to any one the described method among the claim 6-9, it is characterized in that, three kinds of fluid products are mixed.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| SE9400681A SE9400681L (en) | 1994-02-28 | 1994-02-28 | Apparatus and method for aseptic mixing of three or more liquid products as well as connectors and systems for producing said mixture |
| SE94006814 | 1994-02-28 | ||
| SE9400681-4 | 1994-02-28 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1123521A true CN1123521A (en) | 1996-05-29 |
| CN1054279C CN1054279C (en) | 2000-07-12 |
Family
ID=20393107
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN95190123A Expired - Fee Related CN1054279C (en) | 1994-02-28 | 1995-02-21 | A device and a process for aseptic mixing of liquid products |
Country Status (10)
| Country | Link |
|---|---|
| EP (1) | EP0750488B1 (en) |
| CN (1) | CN1054279C (en) |
| AT (1) | ATE179589T1 (en) |
| AU (1) | AU1905295A (en) |
| CA (1) | CA2184249A1 (en) |
| DE (1) | DE69509508T2 (en) |
| HU (1) | HUT76713A (en) |
| PL (1) | PL178101B1 (en) |
| SE (1) | SE9400681L (en) |
| WO (1) | WO1995022954A1 (en) |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100471480C (en) * | 2003-06-06 | 2009-03-25 | 株式会社大塚制药工场 | Aseptic combination preparation |
| CN101081192B (en) * | 2007-07-03 | 2011-10-05 | 王建友 | Infusion bottle mouth |
| CN111032220A (en) * | 2017-08-24 | 2020-04-17 | 英纳多斯实验室有限公司 | Liquid treatment system and method |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8529502B2 (en) * | 2006-04-24 | 2013-09-10 | Novo Nordisk Healthcare Ag | Transfer system for forming a drug solution from a lyophilized drug |
| ES2545998T3 (en) | 2010-12-30 | 2015-09-17 | Ge Healthcare Limited | Multivial dispensing |
Family Cites Families (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| SE9001271D0 (en) * | 1990-04-06 | 1990-04-06 | Eric Westberg | BLOOD PASSE FOR APPLICATION FOR SEPARATION OF BLOOD IN COMPONENTS |
| US5154716A (en) * | 1990-11-06 | 1992-10-13 | Miles Inc. | Bottom blood bag separation system |
| JPH05131018A (en) * | 1991-11-11 | 1993-05-28 | Terumo Corp | Bag connection body and manufacture thereof |
-
1994
- 1994-02-28 SE SE9400681A patent/SE9400681L/en not_active IP Right Cessation
-
1995
- 1995-02-21 CN CN95190123A patent/CN1054279C/en not_active Expired - Fee Related
- 1995-02-21 CA CA 2184249 patent/CA2184249A1/en not_active Abandoned
- 1995-02-21 WO PCT/SE1995/000178 patent/WO1995022954A1/en active IP Right Grant
- 1995-02-21 DE DE69509508T patent/DE69509508T2/en not_active Expired - Fee Related
- 1995-02-21 AU AU19052/95A patent/AU1905295A/en not_active Abandoned
- 1995-02-21 HU HU9602344A patent/HUT76713A/en unknown
- 1995-02-21 PL PL95316025A patent/PL178101B1/en unknown
- 1995-02-21 EP EP95911514A patent/EP0750488B1/en not_active Expired - Lifetime
- 1995-02-21 AT AT95911514T patent/ATE179589T1/en active
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100471480C (en) * | 2003-06-06 | 2009-03-25 | 株式会社大塚制药工场 | Aseptic combination preparation |
| CN101081192B (en) * | 2007-07-03 | 2011-10-05 | 王建友 | Infusion bottle mouth |
| CN111032220A (en) * | 2017-08-24 | 2020-04-17 | 英纳多斯实验室有限公司 | Liquid treatment system and method |
| CN111032220B (en) * | 2017-08-24 | 2022-03-08 | 英纳多斯实验室有限公司 | Liquid treatment system and method |
Also Published As
| Publication number | Publication date |
|---|---|
| WO1995022954A1 (en) | 1995-08-31 |
| EP0750488A1 (en) | 1997-01-02 |
| PL178101B1 (en) | 2000-02-29 |
| CA2184249A1 (en) | 1995-08-31 |
| AU1905295A (en) | 1995-09-11 |
| CN1054279C (en) | 2000-07-12 |
| ATE179589T1 (en) | 1999-05-15 |
| HU9602344D0 (en) | 1996-10-28 |
| HUT76713A (en) | 1997-10-28 |
| EP0750488B1 (en) | 1999-05-06 |
| SE501835C2 (en) | 1995-05-22 |
| DE69509508T2 (en) | 1999-09-02 |
| DE69509508D1 (en) | 1999-06-10 |
| SE9400681L (en) | 1995-05-22 |
| PL316025A1 (en) | 1996-12-23 |
| SE9400681D0 (en) | 1994-02-28 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| C19 | Lapse of patent right due to non-payment of the annual fee | ||
| CF01 | Termination of patent right due to non-payment of annual fee |