EP2628474B1 - Bag for storing and dispensing a liquid additive under aseptic conditions - Google Patents

Description

The invention relates to a method for filling a bag with a liquid additive, for storing the additive in the bag and for removing the additive from the bag according to claim 1.

TECHNICAL AREA

The filling of the bag with a liquid additive, for storing the additive in the bag and for removing the additive from the bag, each should be done under aseptic conditions. There are provided at least two ports arranged on the bag, and means for suspending the bag in a suspension position, which are positioned so that a gravity feed of the additive to one of the terminals, and with a removal arrangement, on the one hand for the purpose of removal of the additive from the bag connected to one of the connections and fluidly connectable when needed and the other on the other hand opens into an injection needle for dosing into a base product, wherein bag and removal assembly unit are sterilized before filling the bag with the additive. Such a method is for example in EP 0 315 740 A2 described.

STATE OF THE ART

Liquid additives such as enzymes, flavors, colors, lipids, probiotic bacteria and other nutrients are dosed into a basic food product to provide it with special properties. Since these additives may be sensitive to heat, the supply of these additives in the base product immediately before filling and after the heat treatment to kill unwanted germs, such as an ultra-high-temperature treatment (UHT heat treatment), and preferably in the context of a so-called. in-line dosing. The dosing must be carried out under aseptic conditions and with a sterile additive also stored under aseptic conditions, so that the basic product produced without germs during the heat treatment is not infected with germs in the dosing phase.

A widespread application in which an enzyme is used as an additive is the production of lactose-reduced or lactose-free products Here Lactase is used for enzymatic cleavage of lactose. These products are mainly consumed by people who suffer from a deficiency of ß-galactosidase in the digestive tract. Another possible use for lactose-reduced milk and related substances is the market for calorie-reduced products. Lactose cleavage produces one molecule each of D-glucose and β-D-galactose [ TÖPEL , 2004, p. 99 ; [1] JEKLE; Food Technology Seminar, Lactose Free and Reduced Dairy Products, 2004 ]. Each of these molecules has greater sweetening power than lactose, so that a much sweeter product can be produced with the same nutritional value. To ensure almost complete hydrolysis of the lactose, for example, the enzyme β-galactosidase can be used in the production. In order to be able to reduce the process costs of hydrolysis, processes have been developed in which the enzyme is added immediately before bottling [1] . One has the advantage here that the distribution phase can be used as the hydrolysis time and thus lower enzyme dosages can be realized. The dosage rate of the enzyme in question ranges from 0.2 to 4 ml of enzyme / liter of the base product.

In the document Tetra Pak Processing GmbH , Tetra FlexDos ™, flexible aseptic dosing system for liquid additives, PD 10080 de 2007-02, a metering device is described, with the use of a bag of the generic type in which an additive of the in question standing stock type, an aseptic in-line dosage of this liquid additive is made into a base product. For this purpose, the ready-to-use 5 or 10-liter bag filled with the sterile additive under aseptic conditions, which in turn is accommodated in a bucket-like outer packaging, is suspended in the metering device. In the course of dosing, a separate hose arrangement acting as a removal arrangement is used to transfer the additive from the bag into the base product, which tube is connected to the bag via a special adapter prior to dosing. Hose arrangement and bags are prepared and provided separately from each other, they are usually from different manufacturers and are brought together only in the metering device and firmly connected. At the end of the hose assembly facing away from the adapter, an injection needle is arranged, via which the additive is metered into the base product at an injection point by means of a peristaltic pump acting on the hose assembly from the outside. The injection point is located on a sealed by a sterile membrane pipe socket of a pipeline in which the base product flows.

The known metering device with the bag used for the purpose and the separate hose arrangement have disadvantages, in particular in the area of the bag and the coupling of the hose arrangement, which can call into question the absolutely required safety of the sterility of the metering process. The extraction port on the bag may be exposed to harmful environmental influences and / or possible faulty actions prior to the coupling of the hose assembly, which may affect the sterility of the critical surfaces leading to the metered additive in the course of the coupling process. A sterilization of these critical surfaces after completion of the coupling process is no longer possible. Since the bag and the hose assembly are separated from one another in each case in an outer packaging, resulting solely by this storage and handling situation, a relatively costly and less user-friendly starting position and a not only theoretical possibility for contamination of the critical surfaces with germs. In addition, the known bag does not provide a way to remove a sterile sample from the bag as part of a quality assurance. Sampling of the bag by means of proximal puncturing is ruled out, as the sampled contents of the bag remain sustainably unadulterated and, if so desired, can still be safely supplied to a dose after sampling. Furthermore, it has been found that the known bag can not be completely emptied.

The DE 33 19 633 A1 describes a blood bag device that includes a flexible blood bag for receiving donor blood with a flexible tubing connection and attached to the blood bag outlet with zippers. The flexible tubing connector consists of a hub located at the top of the blood bag and a donor tube. One Cannula Cutlery is attached to the flexible tubing connector and allows venipuncture on the arm of the dispenser. The blood bag device may consist only of a donor or collection bag, or it may comprise a donor bag and one or more other bags (satellite bags) for collecting the blood and processing the bled blood to recover ingredients. Each of the outlet ports could be fitted with flexible hoses for internal connection to other blood bags in a blood bag system. The blood bag has at its bottom an opening by means of which it can be hung upside down. The flexible tube with a conventional clamp is connected at one end in one piece to the blood bag and carries the cannula cutlery at its opposite end. The blood bag system can be sterilized after assembly by means common in the art.

The known blood bag and also the described blood bag system with more than one blood bag are, starting from the cannula cutlery, filled with blood via the donor tube and this blood is stored there. Although the dispenser or collection bag has outlet sockets, which may be connected to a satellite bag, if necessary. The respective outlet nozzle thus serves at most the transfer or the forwarding of the blood from the donor or collecting bag in the associated satellite bag. In principle, the cannula cutlery is suitable for acting as a removal arrangement.

Out EP 0 315 740 A2 a system for storage, preparation and application of infusion solutions for parenteral nutrition has become known in which infusion solutions are filled in individual containers for the storage of individual components, wherein sterilizable connecting elements are provided between connecting pieces of at least two individual containers, wherein the connecting pieces of the filled individual container with Closing valves are sealed, which can be opened for preparation and application by hand. The individual containers as well as the main container are suspended, the latter being filled in a position from below.

It is an object of the present invention to further develop a method of the generic type and in such a way that the entire dosing process and the handling of its components are made safer and more user-friendly.

SUMMARY OF THE INVENTION

The object is achieved by a method having the features of claim 1. Advantageous embodiments of the method according to the invention are described in the subclaims.

The inventive idea is that even before the filling of the bag with the additive which ends in the injection needle removal device is firmly and tightly connected to the second port serving for removal. This connection can preferably be realized positively and / or non-positively, for example in the form of an elastically ductile coupling, so that a joining of the bag with the removal arrangement is given to a tight and tightly connected unit in the simplest way. But the connection can also be made cohesively, for example by welding.

In any case, the unit, consisting of the bag and the withdrawal device preferably fixed on it, can be exposed in its entirety, for the purpose of sterilization, to a suitable treatment, for example by sterilizing radiation. This embodiment of the method certainly eliminates the otherwise existing possibility of impairing the sterility of the compound when the latter is prepared after filling the bag with the additive and before metering the additive into the base product. The method according to the invention is further characterized by the steps a) to i) of claim 1 and is described in the following description of the figures and, where necessary, annotated.

An advantageous embodiment of the method provides that for the purpose of quality assurance via a third port on the bag the latter a sterile sample can be removed by the fact that the third port is closed by a sealing plug, which after the means of a withdrawal needle reseal sample taken from the bag. The sampled bag may then be dosed or discarded.

In order to achieve a secure suspension and clear positional fixation, which ensures in particular a trouble-free emptying of the bag, the means for suspending the bag are designed as a three-point suspension.

In order to fill the bag more easily under the effect or with the help of gravity, it is placed in an inclined position, in the at least the second terminal represents a high point of the arrangement.

An embodiment of the method according to the invention provides that the filling serving first terminal is welded after the filling of the bag. This is a completely safe measure to create sustainable sterile conditions at this critical point.

BRIEF DESCRIPTION OF THE DRAWINGS

Figur 1

in der Vorderansicht einen ersten Beutel mit einem Fassungsvermögen von beispielweise 10 Liter;

Figur 2

gleichfalls in der Vorderansicht einen zweiten Beutel mit einem Fassungsvermögen von beispielsweise 5 Liter

A more detailed description of the invention will become apparent from the following description and the accompanying drawings. Show it

FIG. 1

in front view, a first bag with a capacity of for example 10 liters;

FIG. 2

also in the front view, a second bag with a capacity of, for example, 5 liters

DETAILED DESCRIPTION

A bag 10, wherein it is in FIG. 1 is a first bag 10.1 with a capacity of, for example, 10 liters, for the sterile storage of liquid additives Z, such as enzymes, flavors, colors, lipids, probiotic bacteria and other nutrients is in its unfilled state, a flat, rectangular, from a suitable plastic existing structure, as it finds application in its basic form in medical technology. As a starting form usually a tubular film is used with a suitable diameter, which is assembled to a required axial length and then closed at the two open ends by welding, at or in these ends then the respective application-specific precautions, peculiarities or requirements are realized.

The first bag 10, 10.1 is preferably made of semi-transparent ethylene vinyl acetate (EVA) with light protection. He has at a first upper edge 10.1a provided with transverse and longitudinal ribs strip-shaped upper edge reinforcement 10.4, which by welding the two in contact with each other coming foil surfaces of the folded Hose is made. In this upper edge reinforcement 10.4 is preferably centrally an elongated, Axis L shorter than the first bag 10.1 formed. This has only a minor effect on the formation of a second upper edge 10.2a and a second lower edge 10.2b, wherein the upper edge reinforcement 10.4 inevitably shorter and the lower edge reinforcement 10.5 is also shorter, and the second lower edge 10.2b preferably parallel to the removal side Inner contour 10.3 runs, while the relevant course in the first bag 10.1 is oriented perpendicular to the longitudinal axis L. The distance between the fixing openings 24 is adapted to the smaller transverse dimension of the second bag 10.2 and is smaller than in the case of the first bag 10.1. The vorg. Differences are only due to optimization aspects with regard to the shape design of the bags 10.1, 10.2 with their different capacities; they have no influence on the storage with the additive Z and on the general function of the respective bag 10.1, 10.2 in the aseptic dosing process. In its other features, the second bag 10.2 adequately corresponds to that of the first bag 10.1. The above description of the first bag 10.1 is therefore fully applicable to the second bag 10.2.

1. a) Der Beutel 10.1, 10.2 und die mit diesem über den zweiten Anschluss 14 verbundene und auf diesem fixierte Entnahmeanordnung 100 werden in sterilisiertem Zustand, bezogen auf die Aufhängeposition A, mit dem oberen Ende des Beutels 10.1, 10.2 zuerst in einen auf einer Seite offenen, als Umverpackung dienenden Umverpackungsbeutel eingeführt. Ein Ankoppeln der Entnahmeanordnung 100 an den Beutel 10.1, 10.2 in der Dosiereinrichtung und kurz vor der Inbetriebnahme der Dosierung mit den aus dem Stand der Technik bekannten Fehlerquellen wird vermieden.
2. b) Die Anordnung aus Umverpackungsbeutel und Beutel 10.1, 10.2 wird unter Fixierung über die beiden Fixieröffnungen 24 derart in eine Schräglage verbracht, dass wenigstens der erste Anschluss 12 den Hochpunkt der Anordnung darstellt.
3. c) Der Beutel 10.1, 10.2 wird über den ersten Anschluss 12 mit dem flüssigen Zusatzstoff Z befüllt.
4. d) Nach der vollständigen Befüllung des Beutels 10.1, 10.2 wird der erste Anschluss 12 verschweißt. Der Zusatzstoff Z ist nun hermetisch und steril von dem Beutel 10.1, 10.2 umschlossen.
5. e) Der Umverpackungsbeutel wird durch Verschweißung seiner noch offenen Seite um den Beutel 10.1, 10.2 herum vollständig hermetisch abgeschlossen.
6. f) Der umverpackte Beutel 10.1, 10.2 wird an eine Dosiereinrichtung verbracht, dort aus dem Umverpackungsbeutel entnommen und in der Dosiereinrichtung über die Dreipunktaufhängung 20 in seiner Aufhängeposition A positioniert. Zum Schutz vor Beschädigungen beim Transport kann der Umverpackungsbeutel wiederum in einer Transportverpackung, beispielsweise in einem Karton, Aufnahme finden.
7. g) Die Injektionsnadel 100.5 am Ende der Entnahmeanordnung 100 wird unter aseptischen Bedingungen in ihre Dosierposition verbracht, wo Dampf- oder Wasserdampfkondensat-Barrieren die aseptischen Bedingungen während des Dosierprozesses aufrechterhalten.
8. h) Zeitlich gesehen wird kurz vor der Dosierung des flüssigen Zusatzstoffes Z in das in einer Leitung strömende Basisprodukt P eine fluidgängige Verbindung zwischen dem Innenraum des Beutels 10.1, 10.2 und der Entnahmeanordnung 100 durch Brechen der Barriere an der Sollbruchstelle B in dem Knickventil 18 hergestellt.
9. i) Der flüssige Zusatzstoff Z wird von dem Beutel 10.1, 10.2 zur Injektionsnadel 100.5 durch von außen auf die Entnahmeanordnung 100 einwirkende Mittel zwangsweise gefördert.

A method for filling the bag 10 or 10.1, 10.2 with the liquid additive Z, for storing the additive Z in the bag 10.1, 10.2 and for removing the additive Z from the bag 10.1, 10.2, each under aseptic conditions and performed with a Bag 10.1, 10.2, as described above, is used in the following steps a) to i) carried out. These steps are preceded by a method step known per se, namely that the bag 10.1, 10.2 and the removal arrangement 100 are sterilized as a unit already before filling the bag 10.1, 10.2 with the additive Z.

1. a) The bag 10.1, 10.2 and connected thereto via the second terminal 14 and fixed thereto removal assembly 100 are in a sterilized state, based on the suspension position A, with the upper end of the bag 10.1, 10.2 first in one on one side open , introduced as outer packaging bag serving. A coupling of the removal assembly 100 to the bag 10.1, 10.2 in the metering device and shortly before the start of the dosage with the error sources known from the prior art is avoided.
2. b) The arrangement of outer packaging bag and bag 10.1, 10.2 is placed under fixation on the two fixing holes 24 in such a skew that at least the first terminal 12 represents the high point of the arrangement.
3. c) The bag 10.1, 10.2 is filled via the first port 12 with the liquid additive Z.
4. d) After the complete filling of the bag 10.1, 10.2, the first terminal 12 is welded. The additive Z is now enclosed hermetically and sterile by the bag 10.1, 10.2.
5. e) The overwrap bag is completely hermetically sealed by welding its still open side around the bag 10.1, 10.2.
6. f) The repackaged bag 10.1, 10.2 is brought to a metering device, removed there from the outer packaging bag and positioned in the metering device via the three-point suspension 20 in its suspension position A. In order to protect against damage during transport, the outer packaging bag can again be accommodated in a transport packaging, for example in a cardboard box.
7. g) The injection needle 100.5 at the end of the extraction assembly 100 is placed under aseptic conditions in its dosing position where vapor or water vapor barrier barriers maintain the aseptic conditions during the dosing process.
8. h) In terms of time, shortly before the metering of the liquid additive Z into the basic product P flowing in a line, a fluid-permeable connection between the interior of the bag 10.1, 10.2 and the removal arrangement 100 is established by breaking the barrier at the predetermined breaking point B in the buckling valve 18.
9. i) The liquid additive Z is forcibly conveyed from the bag 10.1, 10.2 to the injection needle 100.5 by means acting externally on the removal arrangement 100.

REFERENCE LIST OF ABBREVIATIONS USED

• 10 bags, general
• 10.1 first bag
• 10.1a first upper edge
• 10.1b first lower edge
• 10.2 second bag
• 10.2a second upper edge
• 10.2b second lower edge
• 10.3 (removal side) inner contour
• 10.4 upper edge reinforcement
• 10.5 lower edge reinforcement
• 12 first connection (filling)
• 14 second connection (removal)
• 16 third connection (sampling)
• 20 means of suspension
• 20.1 suspension opening
• 20.2 (slot-shaped) recess
• 20.2a bulge
• 22 handle plate
• 24 fixing opening
• 100 removal arrangement
• 100.1 withdrawal hose
• 100.2 coupling
• 100.3 filters
• 100.4 Check valve
• 100.5 injection needle
• 110 sealing plugs
• A suspension position
• B breaking point
• L longitudinal axis
• P basic product
• Z additive

Claims (3)

1. A method for filling a bag with a liquid additive, for storing the additive (Z) in the bag (10; 10.1, 10.2) and for dispensing the additive (Z) from the bag (10; 10.1, 10.2), respectively under aseptic conditions, with at least two connections (12, 14) arranged on the bag (10; 10.1, 10.2), with means for mounting (20) the bag (10; 10.1, 10.2) in a mounting position (A), which is positioned such that a gravity-side supply of the additive (Z) to one of the connections (12, 14) takes place, and with a dispensing arrangement (100), which is connected on one side with one of the connections (12, 14) for the purpose of dispensing the additive (Z) from the bag (10; 10.1, 10.2) and can be connected in a fluid-accessible manner as needed, and which on the other side leads into an injection needle (100.5) for dosing into a base product (P), wherein the bag (10; 10.1, 10.2) and the dispensing arrangement (100) are already sterilized as one unit before the filling of the bag (10; 10.1, 10.2) with the additive (Z),
   characterized by the following steps a) through i):

   a) the bag (10; 10.1, 10.2) and the dispensing arrangement (100) connected with it via the second connection (14) and fastened on it are inserted in the sterilized state, with respect to the mounting position (A), first with the upper end of the bag into an outer packaging bag that is open on one side and that serves as an outer packaging;

   b) the arrangement made up of the outer packaging and the bag (10; 10.1, 10.2) is placed while fastened in an inclined position such that the first connection (12) represents the high point of the arrangement;

   c) the bag (10; 10.1, 10.2) is filled with the liquid additive (Z) via the first connection (12);

   d) after the complete filling of the bag (10; 10.1, 10.2), the first connection (12) is heat-sealed;

   e) the outer packaging bag is hermetically sealed in full around the bag (10; 10.1, 10.2) through the heat-sealing of its still open side;

   f) the outer-packaged bag (10; 10.1, 10.2) is supplied to a dosing apparatus, removed there from the outer-packaging bag and positioned in its mounting position (A) in the dosing apparatus with the means for mounting (20), which is designed as a three-point mounting;

   g) the injection needle (100.5) on the discharge-side end of the dispensing arrangement (100) is brought into its dosing position under aseptic conditions;

   h) chronologically just before the dosing of the liquid additive (Z) into the base product (P) flowing in a line, a fluid-accessible connection between the interior of the bag (10; 10.1, 10.2) and the dispensing arrangement (100) is established through the irreversible breaking of a barrier at a predetermined breaking point (B) in a kink valve (18) arranged in the second connection (14);

   i) the liquid additive (Z) is forcibly delivered from the bag (10; 10.1, 10.2) to the injection needle (100.5) through means acting on the dispensing arrangement (100) from the outside.
2. The method according to claim 1,
   characterized in that
   the bag and the dispensing arrangement are sterilized as one unit with sterilizing radiation before the bag is filled with the additive.
3. The method according to one of the preceding claims,
   characterized in that
   via a third connection (16) on the bag (10; 10.1, 10.2), a sterile sample can be taken from the latter in that the third connection (16) is closed via a closing plug, which closes again after the sample taken from the bag (10; 10.1, 10.2) by means of a dispensing needle.

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