JP4615165B2 - Manufacturing method for liquid bag - Google Patents

Description

[0001]
BACKGROUND OF THE INVENTION
The present invention relates to a method for producing a liquid bag in which contamination of germs and the like is prevented, and more particularly to an infusion bag, particularly a multi-chamber infusion bag.
[0002]
[Prior art]
In the case of infusions for injecting medicinal solutions such as nutrients into blood vessels, heat-sterilized infusion bags may be used, but vitamins and other unstable drugs should be stored in a form with excellent storage stability. An operation such as making a mixed solution immediately before infusion is performed. For example, vitamin preparations are dissolved in physiological saline and used for infusion, but if dissolved, there is a risk of deterioration, so immediately before the infusion, doctors, nurses, etc. use syringes at medical sites. It is used to inject a small amount from a mixed injection port into an infusion bag and administer it to a patient.
However, it is not desirable to perform such mixed injection from the mixed injection port in a hospital from the viewpoint of nosocomial infection. In addition, there is a possibility of causing an administration error of the medicine to be mixed.
Therefore, in order to prevent hospital infection and administration errors, the use of a multi-chamber infusion bag (full kit type) having a plurality of filling chambers is encouraged in order to perform aseptic mixed injection operation. This multi-chamber infusion bag is one in which each filling chamber is filled with a plurality of types of drugs, and immediately before the infusion, by removing the partition of each filling chamber by pressurization etc., each drug solution is mixed, It is excellent in handleability.
[0003]
[Problems to be solved by the invention]
It is important that the drug solution filled in the infusion bag is highly sterilized. Therefore, regarding the manufacture of the infusion bag, it is necessary to prevent germs and the like from entering the infusion bag during the operation of filling the infusion bag with the chemical solution. In particular, if the drug solution itself has high heat resistance and can withstand heat treatment, it is effective to heat sterilize the entire infusion bag in a state filled with the drug solution, but in the case of a drug solution with low heat resistance Such heat sterilization after filling cannot be performed. Therefore, an expensive aseptic filling apparatus is required in order to perform the filling operation at room temperature while maintaining the sterile state of the chemical solution. Furthermore, work in a highly clean aseptic room of class 1000 or less and complicated work are also required.
Therefore, the manufacturing cost of the infusion bag is very high, and there is a problem that it is practically limited to application to expensive drugs such as antibiotics.
[0004]
The present invention has been made to solve the above-mentioned problems, and aims at a method for manufacturing a bag for liquid that prevents contamination of germs, in particular, an infusion bag, particularly a multi-chamber infusion bag, in a simple and inexpensive manner. It is.
[0005]
[Means for Solving the Problems]
The method for producing a liquid bag according to the present invention includes a filling step of filling a liquid bag having a sterilization filter at the inlet for filling the filling chamber with the liquid through the sterilization filter, and in the vicinity of the inlet. And a removal step of welding the liquid bag and separating the sterilization filter.
INDUSTRIAL APPLICABILITY The present invention is suitable for manufacturing a medical infusion bag, particularly a multi-chamber infusion bag provided with a plurality of filling chambers.
For example, it can be applied to a multi-chamber infusion bag in which each filling chamber is filled with a non-heatable chemical solution. In this case, the liquid bag has a plurality of filling chambers partitioned by isolation means, and is removed from the inlet for each filling chamber. A multi-chamber bag equipped with a fungus filter may be applied.
Moreover, it is applicable also to the multi-chamber infusion bag which fills one multi-chamber infusion bag with a heat-resistant chemical | medical agent and a non-heatable chemical | medical solution, In that case, manufacturing by the following process is desirable.
First, it has a plurality of filling chambers partitioned by separating means, an inlet is formed for each filling chamber, and at least one of the plurality of filling chambers is a non-heatable chemical solution filling chamber, A multi-chamber bag equipped with a sterilization filter is prepared at the inlet of the filling chamber for the heated chemical solution.
A first sterilization step for sterilizing the multi-chamber bag.
A first filling step of filling a medicine into a filling chamber other than the non-heatable chemical solution filling chamber.
The 2nd sterilization process which heat-sterilizes a multi-chamber bag after the 1st filling process.
A second filling step of filling the non-heatable chemical solution into the non-heatable chemical solution filling chamber through the sterilization filter after the second sterilization step.
A removal step in which a multi-chamber bag is welded in the vicinity of the inlet of the non-heatable chemical solution filling chamber and the sterilization filter is separated.
In addition, as a disinfection filter, it is desirable that the maximum pore diameter is 1.0 μm or less.
It is desirable that the separating means be a partition member that can communicate by weak heat sealing or by applying external pressure.
[0006]
DETAILED DESCRIPTION OF THE INVENTION
Hereinafter, a multi-chamber infusion bag using the present invention for medical purposes will be described as an example.
In this embodiment, a multi-chamber bag 10 as shown in FIG. 1 is used. This multi-chamber bag 10 is a bag that can seal liquid and is made of a material having flexibility, transparency for content confirmation, heat resistance for high-pressure steam sterilization, etc. And polyolefin resins such as polypropylene, polyesters such as polyethylene terephthalate and polybutylene terephthalate, thermoplastic resins such as vinyl chloride resins, polyvinyl alcohol resins, polyamide resins, and polyvinylidene chloride.
In order to prevent alteration, it is more desirable to have oxygen and water vapor barrier properties. Specifically, it is preferable to use a laminated film in which a barrier layer is provided on at least one layer. As the material of the barrier layer, for example, ethylene-vinyl alcohol copolymer, polyamide, polyvinyl chloride, polyvinylidene chloride, polyethylene, polypropylene, polyester, aluminum foil, a resin film on which silicon oxide is deposited, aluminum oxide is deposited. Examples thereof include a resin film, a resin film on which aluminum is deposited, and an aluminum foil. The barrier layer may be a single type of these or a laminate of two types. Such a barrier layer is provided in the entire multi-chamber bag 10 or a part of the filling chambers as necessary. For example, the barrier layer can be provided only in the filling chamber 12.
The illustrated multi-chamber bag 10 is obtained by heat-sealing the periphery of two films obtained by T-die molding, lamination molding, or the like, but is not limited to this, inflation molding, blow molding, vacuum molding, etc. It may be a cylindrical film obtained by the following. Moreover, if the film to be used is a laminated film, multilayer inflation molding, multilayer T-die molding, lamination molding or the like can be applied.
[0007]
In the multi-chamber bag 10, two filling chambers 12 and 14 are formed and separated by a separating means. In this example, the weak heat seal part 16 is formed as a separating means. Weak heat seal is a film in which the film on the front and back of the bag is usually welded by heat seal, but it can be easily peeled off by applying manual force to intentionally peel it off. The state that is welded. In this example, the filling chamber 14 exhibits a peeling strength to such an extent that it is peeled by applying a pressure to crush it (preferably 0.02 to 0.15 kg / cm ² ) from the outside. .
In the multi-chamber bag 10 of this embodiment, the filling chamber 12 is a filling chamber for non-heatable chemicals, and the filling chamber 14 is a filling chamber for heat resistant chemicals. Drugs or drug solutions are applied according to the purpose.
For example, examples of heat resistant chemicals include amino acid, glucose, fructose, xylitol, glycolose, high-calorie infusions mainly composed of fat, physiological saline, 5% glucose solution, various electrolyte solutions, and the like.
In addition, as non-heatable chemicals, one or more of vitamin A, vitamin B1, vitamin B2, vitamin B6, vitamin B12, vitamin C, vitamin D, vitamin E, vitamin K, nicotinic acid, pantetonic acid, folic acid, bition, etc. Vitamin preparations that combine seeds, correction elements that combine one or more compounds such as trace elements, calcium, and phosphoric acid that combine one or more of zinc, copper, manganese, cobalt, molybdenum, selenium, etc. Examples thereof include a drug solution in which a drug selected from electrolyte insulin drugs, antibiotic drugs, anticancer drugs, and the like is dissolved in a solution.
In each filling chamber 12, 14, intakes 18, 20 are formed, and mouth members 22, 24 are attached to the respective intakes 18, 20. These mouth members 22 and 24 are formed of a general-purpose resin in a cylindrical shape, and are heat-sealed and liquid-tightly fixed together with the heat seal at the periphery of the multi-chamber bag 10.
The mouth member 24 is sealed so that it can be opened. The mouth member 24 can be filled with the medicine into the filling chamber 14 and can be discharged from the filling chamber 14, and is provided with a heat-resistant rubber stopper (not shown). ing. This rubber stopper is designed to allow a drip needle to pierce. The rubber stopper is attached to the mouth member 24 by various known methods. For example, it can be sealed by a heat sealing method, a dielectric heating welding method, an ultrasonic welding method, or the like. As described in JP-A-8-317961, a method of attaching the rubber plug in a state where the diameter of the rubber plug is reduced by insert injection molding is preferable.
[0008]
On the other hand, the sterilization filter 26 is provided in the mouth member 22, and the sterilization filter 26 is provided in the intake 18 via the mouth member 22.
The sterilizing filter 26 is a membrane filter having a maximum pore size of 1.0 μm or less, and can pass the solution, but bacteria and the like cannot pass through it. Desirably, the maximum pore diameter is less than 0.1 μm. However, as the sterilization property, it is desirable that the pore size is smaller, but if the size is smaller than necessary, the filling efficiency of the chemical solution is lowered, so that the maximum pore size is preferably 0.01 μm or more. Examples of the material for the sterilization filter include cellulose resins such as cellulose acetate, cellulose triacetate, and regenerated cellulose, polycarbonate resins, polyamide resins, fluororesins, vinylidene chloride resins, and polyolefin resins such as polyethylene and polyethylene.
[0009]
A method of manufacturing a multi-chamber infusion bag filled with a heat-resistant chemical and a non-heatable chemical using the multi-chamber bag 10 will be described.
First, it is desirable to sterilize the multi-chamber bag 10 before starting the filling process (first sterilization process). Various treatments such as heat sterilization, electron beam irradiation sterilization, γ-ray irradiation sterilization, and ethylene oxide gas sterilization treatment can be applied to the sterilization treatment. In the case of heat sterilization treatment, the heating temperature is preferably 100 to 121 ° C. If the temperature is lower than 100 ° C., a long time is required for sufficient sterilization, and if it exceeds 121 ° C., the bag itself may be altered or deformed. In the first sterilization step, since no chemical solution is filled, various desired sterilization treatments such as heating can be performed, and the heat sterilization treatment can be applied.
Then, a predetermined amount of a predetermined medicine is filled into the filling chamber 14 from the mouth member 24 and sealed with a rubber plug (first filling step). This chemical | medical agent should just have heat resistance which can endure the heat sterilization process of a post process, and does not ask | require liquid or solid (for example, granular form).
After sealing the mouth member 24, it is desired that the entire multi-chamber bag 10 is again heat sterilized (second sterilization step). By performing this second sterilization step, even if bacteria or the like are mixed in the filling chamber 14 during the first filling step, it can be sterilized. In this heat sterilization treatment, it is preferable to perform the heat sterilization treatment in a temperature range of 100 to 121 ° C, particularly 105 to 121 ° C. This is because if it is lower than 100 ° C., it takes a long time for sufficient sterilization, and if it is higher than 121 ° C., there is a possibility of causing thermal deformation of the multi-chamber bag.
And the non-heatable chemical | medical solution is filled in the filling chamber 12 (2nd filling process). In the second filling step, a predetermined chemical solution is filled so as to pass through the sterilization filter 26. In the second filling step, it is desirable to perform pressure filling using a pressure pump or the like.
When a predetermined amount of chemical solution is filled, a fusing seal is performed in the vicinity of the inlet 18 of the filling chamber 12 to weld the front and back surfaces of the multi-chamber bag 10, and the mouth member 22 and the sterilization filter 26 are separated. (Removal step), the multi-chamber infusion bag 30 shown in FIG. 2 is manufactured.
In the removal step, it is preferable to perform fusing in which welding and cutting are performed at the same time. However, the present invention is not limited to this, and after the vicinity of the inlet 18 of the filling chamber 12 is heat-sealed, it may be cut after a while. good. Further, the welding is not limited to heat sealing, and a dielectric heating welding method, an ultrasonic welding method, or the like can be applied.
[0010]
By such a method, a multi-chamber infusion bag can be easily manufactured while preventing contamination of germs and the like. In particular, even when a chemical solution with low heat resistance is filled, a special aseptic filling apparatus, work in a sterile room, and complicated work are unnecessary. For example, a sufficiently high-quality multi-chamber infusion bag can be manufactured even under conditions of class 100,000 or less.
Therefore, the manufacturing cost is low, and it can be applied to many inexpensive and general-purpose chemical solutions.
In addition, since the filling chamber 12 is welded and the mouth member 22 and the sterilizing filter 26 are separated from each other, the intake port is lost, so there is no risk of leakage of chemicals or contamination from the outside environment such as air. , Quality and handleability can be further improved.
[0011]
In the multi-chamber infusion bag described above, a weak heat seal is used as an isolation means for partitioning the filling chamber, but the invention is not limited to this. For example, a partition member 31 as shown in FIG. 3 can be applied.
The partition member 31 is a hollow body that is long in the width direction of the multi-chamber infusion bag and flat in the thickness direction. As shown in FIG. 4, the partition member 31 is formed with a hollow portion 39 that communicates from the top surface to the bottom surface, and a band-shaped lid body 32 that seals the bottom surface side of the hollow portion 39. A thin portion 34 and a thick portion 35 are formed at the connecting portion with the member main body 33, and a support 36 is inserted into the hollow portion 39 of the partition member 31. Moreover, the width direction end part 38 of the partition member 31 is boat-shaped.
[0012]
Examples of the material of the partition member 31 include polyolefin resins such as polyethylene and polypropylene, styrene resins such as ABS resin, AS resin, and MBS resin, polyvinyl chloride, polyester, polystyrene, and polycarbonate.
[0013]
The thin portion 34 formed in the connecting portion between the lid 32 and the partition member main body 33 is a portion that can be broken by an external deformation operation on the partition member 31, and the thick portion 35 is from the outside. The lid 32 and the partition member main body 33 are connected to each other without being broken even by a deformation operation. The thickness of the thin portion 34 is preferably 0.1 to 0.2 mm. If the thickness of the thin portion 34 is less than 0.1 mm, it may break due to the weight of the drug or the internal pressure during retort sterilization, and if it exceeds 0.2 mm, an unnecessarily high force is applied during the deformation operation of the partition member 31. Is not appropriate because it is necessary.
[0014]
The support 36 includes a plurality of ribs 36a along the width direction of the hollow portion 39, and a connecting member 36b extending in the longitudinal direction of the hollow portion 39 so as to connect the central portion of the rib 36a. When heat-sealing both surfaces of the partition member 31 with the film of the liquid bag, the shape of the hollow portion 39 is maintained to prevent distortion of both surfaces of the partition member 31 due to the heat seal pressure, and there are no spots or gaps on the heat seal surface. It is for doing so.
The support 36 is not limited to the illustrated example as long as it has a plurality of ribs 36 a along the width direction of the hollow portion 39 and can be bent in the width direction of the hollow portion 39.
[0015]
For example, when the partition member 31 and the liquid bag are heat-sealed, the inclined surface formed in the width direction end portion 38 of the partition member 31 has a larger gap between the two synthetic resin films and the partition member 31. It can be welded without any problems.
Ribs 37 are formed on the lid 32. The rib 37 increases the strength in the width direction of the lid 32, increases the difference in stress generated from the lid 32 and the partition member body 33 with respect to external force applied by an external deformation operation, and opens the lid 32. It is for encouraging. In addition, the rib 37 contacts the end surface of the partition member main body 33 after the lid 32 is opened, and becomes caught, thereby preventing the lid 32 from being closed when the medicine is mixed.
[0016]
In such a partition member 31, as shown in FIG. 4, a force in the same direction is applied to the width direction end portions 38 on both sides of the partition member 31 in the thickness direction of the multi-chamber infusion bag. By applying force in the direction opposite to the width direction end portion 38 to the width direction center portion of 31 and bending the partition member 31 into a dogleg shape, the lid body 32 and the partition member main body 33 are respectively subjected to external force. Different stresses are generated, and the thin portion 34 formed at the connecting portion between the lid body 32 and the partition member main body 33 can be broken by the difference in the stress, and the lid body 32 is opened outside the partition member 31. Can do. In this way, the filling chamber 12 and the filling chamber 14 communicate with each other, and the medicines filled in each can be mixed. At this time, the lid body 32 is connected to the partition member main body 33 by the thick portion 35 and thus does not fall off.
[0017]
In addition, the partition member in which such a hollow portion and a lid body that seals at least one end of the hollow portion are formed, and a thin portion is formed at a connection portion between the lid body and the main body of the partition member, It is not limited to the above.
For example, as shown in FIG. 5, a hollow portion and a circular lid body 42 that seals the bottom surface side of the hollow portion are formed, and a thin portion 44 is formed at a connection portion between the lid body 42 and the partition member main body 43. Examples thereof include a cylindrical partition member 40 in which the thick part 45 is formed.
In this partition member 40, as shown in FIG. 6, by crushing the peripheral wall of the partition member 40, different stresses are generated from the lid body 42 and the partition member main body 43 with respect to the external force. The thin portion 44 formed at the connecting portion between the lid body 42 and the partition member main body 43 can be broken, and the lid body 42 can be opened outside the partition member 40.
By applying the weak heat seal and partitioning member as described above as separation means, it is possible to easily produce a multi-chamber infusion bag and to easily communicate with a plurality of filling chambers, and to mix the drugs quickly. it can.
[0018]
In the above description, a multi-chamber infusion bag filled with a heat resistant chemical and a non-heatable chemical is described as an example, but the present invention is not limited to this. For example, the present invention can also be applied to a multi-chamber infusion bag in which all the filling chambers are filled with non-heatable chemical solutions.
[0019]
In the above description, a multi-chamber infusion bag has been described as an example, but the present invention is not limited to this. For example, the present invention can be applied to an infusion bag having only one filling chamber, or various bags for containing a liquid other than an infusion bag.
[0020]
【The invention's effect】
According to the present invention, various liquid bags such as a multi-chamber infusion bag can be easily and inexpensively manufactured while preventing contamination of bacteria and the like. In particular, even when a chemical solution with low heat resistance is filled, a special aseptic filling apparatus, work in a sterile room, and complicated work are unnecessary. For example, a sufficiently high-quality multi-chamber infusion bag can be manufactured even under conditions of class 100,000 or less.
Therefore, the manufacturing cost is low, and it can be applied to many inexpensive and general-purpose chemical solutions.
[Brief description of the drawings]
FIG. 1 is a perspective view showing an example of a multi-chamber bag.
FIG. 2 is a perspective view showing an example of a multi-chamber infusion bag.
FIG. 3 is a perspective view showing an example of another multi-chamber bag.
FIG. 4 is a perspective view showing an example of a partition member.
FIG. 5 is a perspective view showing an example of another partition member.
6 is a perspective view showing a state where the partition member shown in FIG. 5 is opened. FIG.
[Explanation of symbols]
DESCRIPTION OF SYMBOLS 10 Multi-chamber bag 12 Filling chamber 14 Filling chamber 16 Weak heat seal part 18 Intake port 20 Inlet port 22 Opening member 24 Opening member 26 Sanitization filter 31 Partition member 40 Partition member

Claims (6)

A filling step of filling a liquid bag having a sterilization filter at an inlet for filling the filling chamber with the liquid through the sterilization filter;
A method for manufacturing a liquid bag, comprising: a step of welding a liquid bag in the vicinity of an intake port, and removing a disinfecting filter. 2. The liquid bag according to claim 1, wherein the liquid bag is a multi-chamber bag having a plurality of filling chambers partitioned by isolation means and having a sterilization filter at an inlet for each of the filling chambers. Bag manufacturing method. There are a plurality of filling chambers partitioned by the separating means, an intake is formed for each filling chamber, and at least one of the plurality of filling chambers is a filling chamber for non-heatable chemical liquid, and the non-heatable chemical liquid A first sterilization step of sterilizing a multi-chamber bag equipped with a sterilization filter at the inlet of the filling chamber for
A first filling step of filling the filling chamber other than the non-heatable chemical solution filling chamber;
A second sterilization step of heat-sterilizing the multi-chamber bag after the first filling step;
After the second sterilization step, a second filling step of filling the non-heatable chemical solution into the non-heatable chemical solution filling chamber through the sterilization filter;
A method for producing a multi-chamber infusion bag, comprising: a removal step of welding the multi-chamber bag in the vicinity of the inlet of the non-heatable chemical solution filling chamber and separating the sterilization filter. The method for producing a multi-chamber infusion bag according to claim 3, wherein the sterilization filter has a maximum pore diameter of 1.0 µm or less. The method for producing a multi-chamber infusion bag according to claim 3 or 4, wherein the isolating means is weak heat sealing. The method of manufacturing a multi-chamber infusion bag according to claim 3 or 4, wherein the isolating means is a partition member that can communicate with an external pressure.

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