DK2628474T3

DK2628474T3 - BAG FOR STORAGE AND DISPENSING A LIQUID ADDITIVE UNDER ASEPTIC CONDITIONS

Info

Publication number: DK2628474T3
Application number: DK12007290.5T
Authority: DK
Inventors: Fleischner Wilhelm; Edgar Weichhard
Original assignee: optiferm GmbH
Priority date: 2011-10-28
Filing date: 2012-10-24
Publication date: 2019-03-25
Also published as: ES2712926T3; EP2628474B1; PT3326605T; PT2628474T; DE102011117268A1; EP3326605A1; DK3326605T3; PL3326605T3; EP3326605B1; PL2628474T3; EP2628474A1; ES2847277T3

Description

Method for filling a bag with a liquid additive for storing the additive in the bag and dispensing the additive from the bag

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

TECHNICAL FIELD

The bag is filled with a liquid additive for storing the additive in the bag and dispensing the additive from the bag under aseptic conditions. At least two connections that are arranged on the bag are provided, along with means for hanging the bag in a hung position, that are positioned such that the additive is supplied on the gravity side to one of the connections, and with a dispensing assembly that on the one hand is connected to one of the connections for the purpose of dispensing the additive from the bag, and is fluidically connectable as needed, and that on the other hand discharges into an injection needle for dosing into a basic product, wherein the bag and the dispensing assembly unit are sterilized before filling the bag with the additive. Such a method is for example described in EP 0 315 740 A2.

STATE OF THE ART

Liquid additives such as enzymes, aromas, dyes, lipids, probiotic bacteria and other nutrients are dosed into a food functioning as a basic product in order to provide it with special properties. Since these additives can be heat-sensitive, they are fed to the basic product directly before its bottling and its heat treatment to kill undesirable germs, such as an ultrahigh temperature treatment (UHT heat treatment), and preferably in the context of so-called in-line dosing. Dosing must be under aseptic conditions and with a sterile additive that is also stored under aseptic conditions so that the basic product which is made sterile during the heat treatment does not become infected with germs in the dosing phase.

Lactose-reduced or lactose-free production of products is a widespread application in which an enzyme is used as the additive. Lactase is used in this case to enzymatically split the lactose. These products are primarily consumed by humans who suffer from a deficiency of β-galactosidase in the intestinal tract. Another possible use for lactose-reduced milk and related substances is the market for low-calorie products. When lactose is split, one molecule of D-glucose and one molecule of β-D-galactose arises [TOPEL, 2004, p. 99; [1] JEKLE; Lebensmitteltechnologisches Seminar, Lactosefreie und -reduzierte Milchprodukte, 2004]. Each of these molecules has a greater sweetness than lactose so that a significantly sweeter product can be produced with unchanged nutrition. To ensure nearly complete hydrolysis of the lactose, the enzyme β-galactosidase can for example be used in production. In order to be able to reduce the processing costs of hydrolysis, methods have been developed in which the enzyme is added directly before bottling [1]. The advantage of this is that the distribution phase can be used as the hydrolysis time, and lower enzyme doses are therefore feasible. The dosing rate of the relevant enzyme moves within a range of 0.2 to 4 mL enzyme/L basic product.

The document by the company Tetra Pak Processing GmbH, Tetra FlexDos™, Flexibles aseptisches Dosiersystem fur fliissige Zusatzstoffe, PD 10080 de 2007-02, describes a dosing apparatus in which aseptic in-line dosing of this liquid additive into a basic product is carried out using a bag of the generic type in which an additive of the relevant type is stored. For this purpose, the ready-to-use 5 or 10 L bag that is filled with the sterile additive under aseptic conditions and for its part is accommodated in a bucket-like exterior packaging is hung in the dosing apparatus. During dosing, a separate hose assembly functioning as the dispensing assembly is used to transfer the additive from the bag into the basic product and is connected before dosing by a special adapter to the bag. The hose assembly and bag are produced and provided separate from each other; they generally originate from different manufacturers and are only joined and securely connected to each other in the dosing apparatus. An injection needle is arranged on the end of the hose assembly facing away from the adapter through which the additive is dosed into the basic product at an injection point by means of a peristaltic pump acting from the outside on the hose assembly. The injection point is located at a pipe stub of a pipeline sealed by a sterile membrane into which the basic product flows.

The known dosing apparatus with the bag that is used and the separate hose assembly can have problems, especially in the region of the bag and the coupling of the hose assembly that can endanger the reliable sterility of the dosing process that is absolutely necessary. The dispensing connection on the bag can be exposed to harmful environmental influences and/or potential faulty handling before the hose assembly is coupled, which may impair the sterility of the critical surfaces that are joined during the coupling process and conduct the additive to be dosed. Sterilization of these critical surfaces after the coupling process is over is no longer possible. Since the bag and hose assembly are each located separate from each other in an exterior packaging, this storage and handling situation alone yields a relatively expensive and not very user-friendly initial situation, as well as the possibility of contaminating the critical surfaces with germs that is not just theoretical. Moreover, the known bag does not offer any way of dispensing a sterile sample from the bag during quality assurance. Sampling the bag by obviously puncturing is not possible since the sampled bag content must remain consistently unadulterated and, if desired, must be able to be confidently supplied for dosing after sampling. In addition, it has been revealed that the known bag cannot be completely drained. DE 33 19 633 Al describes a blood bag device which comprises a flexible blood bag for holding donor blood with a flexible hose connection and drain ports with tear-off seals attached to the blood bag. The flexible hose connection consists of an attachment that is arranged on the top end of the blood bag, and a donor hose. A cannula unit is fastened to the flexible hose connection and enables a vein in the arm of donor to be punctured. The blood bag device can consist of just a donor or collection bag, or it can comprise a donor bag and one or more additional bags (satellite bags) for collecting the blood and processing the drawn blood to obtain components. Each of the drain ports can be provided with flexible hoses for internally connecting to other blood bags in a blood bag system. The blood bag possesses an opening in its bottom by means of which it can be hung upside down. The flexible hose with a conventional clamp is connected at its one end to the blood bag in one section and bears the cannula unit at its opposite end. After it is assembled, the blood bag system can be sterilized using conventional methods in the field.

Proceeding from the cannula unit, the known blood bag, and the described blood bag system as well with more than one blood bag, are filled with blood through the donor hose, and this blood is stored therein. The donor or a collection bag does have drain ports that if applicable can be connected to a satellite bag. The respective drain port may also serve to pass on, or respectively transfer the blood from the donor or collection bag into the associated satellite bag. In principle, the cannula unit is suitable to also function as a dispensing assembly. A system for storing, preparing and applying infusion solutions for parenteral nutrition is disclosed in EP 0 315 740 A2, wherein infusion solutions are filled into individual containers for storing individual components, wherein sterilizable connecting elements are provided between connection ports of at least two individual containers, wherein the connection ports of the filled individual containers are sealed tight by closing valves which can be manually opened for preparing and applying. Individual containers as well as the main container are hung, wherein the latter is filled in a position from below.

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

SUMMARY OF THE INVENTION

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

The basic inventive concept is to securely and tightly connect the dispensing assembly ending in the injection needle to the second connection serving for dispensing before filling the bag with the additive. This connection can preferably be realized by a form and/or force fit, for example in the form of an elastically ductile coupling so that it is extremely easy to join the bag to the dispensing assembly into a secure and tightly connected unit. The connection can however also be accomplished by integrally bonding, for example by welding.

In any case, the unit consisting of the bag and the dispensing assembly preferably fixed thereto can be exposed as a whole to a suitable treatment for the purpose of sterilizing it, for example by sterilizing irradiation. This embodiment of the method reliably overcomes the possibility of compromising the sterility of the connection that otherwise exists when the latter is produced after filling the bag with the additive and before dosing the additive into the basic product. The method according to the invention is moreover characterized by steps a) to i) of claim 1, and is described in the following description of the figures and explained where necessary.

An advantageous embodiment of the method provides that a sterile sample can be removed from the bag through a third connection for the purpose of quality assurance such that the third connection is sealed by a plug which re-closes after the sample removed from the bag by means of a dispensing needle. The sample bag can then be supplied for dosing, or it can be discarded.

To achieve secure hanging and straightforward positional fixation that in particular ensures trouble-free drainage of the bag, the means for hanging the bag are designed as a three-point suspension.

In order to be able to fill the bag more easily under the effect, or with the additional assistance of gravity, it is moved into an oblique position in which at least the second connection represents a high point of the assembly.

One embodiment of the method according to the invention provides welding the first connection that is for filling after the bag is filled. This is an absolutely reliable measure for permanently establishing sterile conditions at this critical point.

BRIEF DESCRIPTION OF THE DRAWINGS A detailed representation of the invention is given in the following description and the accompanying figures of the drawing. In the figures:

Fig. 1 shows the front view of a first bag with a capacity of for example 10 liters;

Fig. 2 also shows the front view of a second bag with a capacity of for example 5 liters.

DETAILED DESCRIPTION A bag 10, which is a first bag 10.1 with a capacity of for example 10 L in Fig. 1, for sterile storage of liquid additives Z such as enzymes, aromas, dyes, lipids, probiotic bacteria and other nutrients is, in its unfilled state, a flat, rectangular object consisting of a suitable plastic as is used in medical technology in its basic form. As the initial form, generally a tubular film with a suitable diameter is used which is fabricated to a required axial length and closed at both open ends by welding, wherein the respective use-specific precautionary measures, special features or requirements are realized at or in these ends.

The first bag 10, 10.1 preferably consists of semitransparent ethylene vinyl acetate (EVA) with light protection. It has a strip-shaped top edge reinforcement 10.4 provided with transverse and longitudinal ribs on a first, top edge 10.1a that is produced by welding the film surfaces of the folded tube that come into contact with each other. Preferably in the middle, an elongated axis L is made shorter than the first bag 10.1 in this top edge reinforcement 10.4. This only has a slight influence on the design of a second top edge 10.2a and a second bottom edge 10.2b, wherein the top edge reinforcement 10.4 is necessarily shorter and the bottom edge reinforcement 10.5 is also shorter, and the second bottom edge 10.2b preferably runs parallel to the dispensing-side inner contour 10.3, whereas its contour in the first bag 10.1 is oriented perpendicular to the longitudinal axis L. The spacing of the fixation openings 24 is adapted to the smaller transverse dimension of the second bag 10.2 and is designed smaller than with the first bag 10.1. The above-described differences are only because of optimization considerations regarding the shape of the bags 10.1, 10.2 with their different capacities; they do not influence the storage of the additive Z and the general functioning of the respective bag 10.1, 10.2 in the aseptic dosing process. The other features of the second bag 10.2 generally correspond to those of the first bag 10.1. In this regard, the above description of the first bag 10.1 can therefore be transferred without restriction to the second bag 10.2. A method for filling the bag 10, or respectively 10.1, 10.2 with the liquid additive Z, for storing the additive Z in the bag 10.1, 10.2, and for dispensing the additive Z from the bag 10.1, 10.2 under aseptic conditions in each case and performed using a bag 10.1, 10.2 as described above is performed in the steps a) to i) presented below. The steps are preceded by a method step that is known per se, i.e., that the bag 10.1, 10.2 and the dispensing assembly 100 are already sterilized as a unit before filling the bag 10.1, 10.2 with the additive Z. a) The bag 10.1, 10.2 and the dispensing assembly 100 affixed thereupon that is connected thereto by the second connection 14 are first inserted in a sterile state relative to hanging position A by the top end of the bag 10.1, 10.2 into an outer packaging bag open on one side and serving as outer packaging. Coupling the dispensing assembly 100 to the bag 10.1, 10.2 in the dosing apparatus and shortly before starting dosing with the sources of error known from the prior art is avoided. b) The assembly consisting of the outside packaging bag and bag 10.1, 10.2 is moved into an oblique position while being fixed by the two fixation openings 24 such that at least the first connection 12 represents the high point of the assembly. c) The bag 10.1, 10.2 is filled through the first connection 12 with the liquid additive Z. d) After the bag 10.1, 10.2 is completely filled, the first connection 12 is welded. The additive Z is then hermetically and sterilely enclosed by the bag 10.1, 10.2. e) The outside packaging bag is completely hermetically closed by welding its still open side around the bag 10.1, 10.2. f) The packaged bag 10.1, 10.2 is moved to a dosing apparatus, removed there from the outside packaging bag, and positioned in its hanging position A by the three-point suspension 20 in the dosing apparatus. To protect from damage during transport, the outside packaging bag can be accommodated in a transport packaging such as a box. g) The injection needle 100.5 at the end of the dispensing assembly 100 is moved into its dosing position under aseptic conditions where vapor or steam condensation barriers maintain the aseptic conditions during the dosing process. h) In terms of time, shortly before dosing the liquid additive Z into the basic product P flowing in a line, a fluidic connection is established between the interior of the bag 10.1, 10.2 and the dispensing assembly 100 by breaking the barrier at the predetermined breaking point B in the kink valve 18. i) The liquid additive Z is forcibly conveyed from the bag 10.1, 10.2 to the injection needle 100.5 by means acting from the outside on the dispensing assembly 100. REFERENCE LIST OF THE ABBREVIATIONS 10 Bag, general 10.1 First bag 10.1a First top edge 10.1b First bottom edge 10.2 Second bag 10.2a Second top edge 10.2b Second bottom edge 10.3 (dispensing-side) inner contour 10.4 Top edge reinforcement 10.5 Bottom edge reinforcement 12 First connection (filling) 14 Second connection (dispensing) 16 Third connection (sampling) 20 Means for hanging 20.1 Hanging opening 20.2 (slotted) recess 20.2a Bulge 22 Grip plate 24 Fixation opening 100 Dispensing assembly 100.1 Dispensing hose 100.2 Coupling 100.3 Filter 100.4 Non-return valve 100.5 Injection needle 110 Plug A Hanging position B Predetermined breaking point L Longitudinal axis P Basic product Z Additive

Claims

1, Process IH filling a bag with a liquid additive for storing the additive (Z) in the bag (10; 10.1, 10.2) and dispensing the additive (Z) from the bag (10; 10.1, 10.2), each under aseptic conditions, on which bag (10; 10.1, 10.2) is arranged at least two connections (12, 14), means for suspending (20) of the bag (10; 10.1, 10.2) in a suspension position (A) arranged so that gravity feeds the additive (Z) to one of the terminals (12, 14) and to a dispensing device (100) which is connected to the terminals (12, 14) on one side and is fluidly connected when necessary to dispense the additive (Z) from the bag (10; 10.1, 10.2), which, on the other hand, opens into an injection needle! (100.5) for dosing into a base product (P), said bag (10; 10.1, 10.2) and dispensing device (100) already sterilized as a unit prior to filling said bag (10; 10.1, 10.2) with the additive (Z), characterized by the following steps (a) to (i): (a) the bag (10; 10.1, 10.2) and the dispensing groove (100) connected thereto via the second connection (14) and attached thereto are inserted in sterilized state; with respect to the suspension position (A), first with the upper end of the bag in an outer packaging bag which is open on one side and serves as an outer packaging; b) placing the device comprising the outer packaging and the bag (10; 10.1, 10.2) while being fixed in an inclined position so that the first connection (12) represents the highlight of the device; c) filling the bag (10; 10.1, 10.2) 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 welded; e) terminating the outer packaging bag completely hermetically around the bag (10; 10.1, 10.2) by welding its still open side; f) supplying the outer packing bag (10; 10.1, 10.2) to a metering device which is taken out of the outer packing bag and placed in the suspending position (A) of the metering device with the suspending means (20) designed as a three-point suspension; g) inserting the injection needle (100.5) on the outlet side of the dispensing device (100) into its dosing position under aseptic conditions; h) chronologically, just before dosing the liquid additive (Z) into the base product (P) flowing in a conduit, a fluid-accessible connection is established between the interior of the bag (10; 10.1, 10.2) and the dispensing device ( 100) through the irreversible breakdown of a barrier at a predetermined breaking point (B) in a kinck valve (18) disposed in the second connection (14); i) the liquid additive (Z) is forcibly supplied from the bag (10; 10.1, 10.2) to the injection needle (100.5) through means acting on the outside dispensing device (100).

The method according to claim 1, characterized in that the bag and dispensing device are sterilized as a unit of sterilizing radiation before the bag is filled with the additive.

Method according to one of the preceding claims, characterized in that via a third connection (18) on the bag (10; 10.1, 10.2) a sterile sample can be taken from the latter and that the third connection (16) is closed via a closure plug. which closes again after the sample is taken from the bag (10; 10.1, 10.2) using a dispensing needle.