WO2014112113A1

WO2014112113A1 - Container for housing syringe barrels

Info

Publication number: WO2014112113A1
Application number: PCT/JP2013/051050
Authority: WO
Inventors: 等沖原
Original assignee: テルモ株式会社
Priority date: 2013-01-21
Filing date: 2013-01-21
Publication date: 2014-07-24

Abstract

Provided is a container for housing syringe barrels, whereby when syringe barrels made of a cyclic polyolefin are subjected to high-pressure steam sterilization while housed in a housing container made of resin, blocking does not occur at locations of contact between the syringe barrels and constituent members of the housing container. The container for housing syringe barrels (10) is designed to house a plurality of syringe barrels (26) which are to be filled with a pharmacological agent, and which have a cylindrical drum part, and a flange (30) furnished along the outer perimeter of the drum part, while the syringe barrels (26) undergo sterilization with high-pressure steam; and is provided with: a container body (12) having a bottom part at the lower end, a peripheral wall part continuous with the perimeter of the bottom part, and extending towards a top end, and a rack (14) furnished to the peripheral wall part; and a nesting panel (16) which is designed to rest on the rack (14), and in which a plurality of cradle tubes (18) capable of detaining the flange (30) of a syringe barrel (26) removably inserted therein to thereby suspend the syringe barrel (26) are arrayed at intervals. The syringe barrels (26) are made from cyclic polyolefin resin, and the nesting panel (16) is formed of polypropylene resin.

Description

Syringe storage container

The present invention relates to a syringe barrel container for storing a plurality of empty syringe barrels for filling a chemical solution that is sterilized with high-pressure steam.

Since an empty syringe barrel for filling a chemical solution, such as a prefillable syringe, must be kept in a clean and sterile state until filling with the chemical solution, it is sterilized in a state of being previously stored in a packaging material. This syringe is made of resin. As a sterilization treatment of a resin syringe, for example, in Patent Document 1 below, a polypropylene syringe is stored in a deoxygenated state in a packaging material made of a polyethylene sheet material and subjected to radiation sterilization. In addition, it is described that a sterile prefillable syringe which is difficult to elute a decomposition product of polypropylene can be produced.

JP 2004-275616 A

By the way, in recent years, a syringe made of cyclic polyolefin having a high transparency, a high refractive index, and a small optical anisotropy has been used as a resin syringe. For this sterilization, high-pressure steam sterilization is performed in an autoclave. The high-pressure steam sterilization treatment of such a plastic syringe barrel is carried out by inserting a cyclic polyolefin syringe barrel into a receiving barrel on a polyvinyl chloride nesting plate and storing it in a plastic container. The film is sealed with a gas-permeable and liquid-impermeable membrane, and the container together with the syringe barrel is housed in an autoclave, and then high-pressure steam is introduced into the autoclave to sterilize.

The injection tube made of cyclic polyolefin subjected to high-pressure steam sterilization is likely to cause blocking at the point of contact with the components of the storage container, particularly the nesting plate made of polyvinyl chloride. For this reason, the syringe barrel in which blocking has occurred is not easily handled in the process of lifting and removing it from the nesting plate in the storage container, or if the blocking occurrence portion is forcibly removed, the syringe barrel may be scratched or peeled off. . Scratched parts of syringe barrels and fragile parts due to peeling cannot maintain the expected strength, and cause indirect accidents such as damage during use. Occurrence of blocking in a high pressure steam sterilization treatment for a syringe made of cyclic polyolefin is a problem to be solved not only for productivity reduction but also for safety improvement. In this case, it is particularly useful to consider a raw material that is an upstream stage of production because it can cope with a change in production conditions.

The present invention has been made in order to solve the above-described problem. Even when a syringe made of cyclic polyolefin is accommodated in a resin container and subjected to high-pressure steam sterilization, the syringe and the components of the container are provided. An object of the present invention is to provide a syringe barrel container in which blocking is unlikely to occur at the contact point.

In order to achieve the above object, a syringe barrel container accommodates a plurality of syringes for filling a medicine having a cylindrical barrel portion and a flange provided on an outer peripheral portion of the barrel portion, A syringe barrel container in which the syringe barrel is sterilized by water vapor, a bottom portion at a lower end, a peripheral wall portion continuous to the periphery of the bottom portion and extending toward the upper end, and a shelf provided on the peripheral wall portion, And a plurality of receiving tubes that can be suspended and suspended by engaging the flange of the syringe barrel that is placed on the shelf and is detachably inserted. And the nesting plate is formed of a cyclic polyolefin resin, and the nesting plate is formed of a polypropylene resin.

In the syringe barrel container, the inner wall surface of the receiving barrel is formed into a tapered surface whose inner diameter is gradually reduced in a locking end direction where the flange of the syringe barrel is locked, and is suspended from the receiving barrel. It is preferable that a gap is formed between the side wall surface of the syringe barrel and the inner wall surface of the receiving barrel.

It is preferable that the syringe barrel container is sterilized by the high-pressure steam.

The sterilization with high-pressure steam is preferably performed at 121 to 125 ° C. for 20 minutes.

According to the storage container of the present invention, even if the high-pressure steam sterilization is performed on the injection tube made of cyclic polyolefin resin, the flange of the injection tube and the front end surface of the polypropylene resin receiving tube that holds the flange Occurrence of blocking can be prevented. Therefore, the handling property of taking out the syringe barrel from the storage container is good, and the syringe barrel can be taken out without leaving scratches or peeling marks on the surface. As described above, even if the high-pressure steam sterilization treatment is performed on the syringe made of cyclic polyolefin resin, the occurrence of blocking can be prevented and the productivity and safety of the prefillable syringe can be improved.

It is a perspective view which shows an example of the syringe barrel container of this invention, and the syringe barrel accommodated in it. It is a fragmentary sectional view which shows the state by which the injection cylinder was accommodated in the injection cylinder storage container shown in FIG. It is a fragmentary sectional view which shows the other example of the receiving cylinder of the injection cylinder storage container of this invention.

Hereinafter, modes for carrying out the present invention will be described in detail, but the scope of the present invention is not limited to these modes.

An example of the syringe barrel container 10 of the present invention is shown in FIG. FIG. 1 is a perspective view of a syringe barrel container 10. The syringe barrel container 10 is composed of a box-shaped and resin-made container body 12 whose upper surface is opened, and a polypropylene resin nesting plate 16 having an outer dimension smaller than the inner dimension of the opening. The container body 12 has a bottom 12a at the lower end, a peripheral wall 12b extending around the bottom 12a and extending toward the upper end, an opening 19 surrounded by the upper end of the peripheral wall 12b, and a peripheral wall. Shelves 14. The area of the bottom surface is narrower and narrower than the area of the opening surface of the opening 19. The syringe barrel container 10 has a nesting plate 16 mounted on a shelf 14 of a container body 12. A plurality of cylindrical receiving cylinders 18 are arranged in the nest plate 16 so as to penetrate therethrough. The two notches 15 provided at the edge of the nesting plate 16 are used to hold the nesting plate 16 by hooking them with fingers or hooks when the nesting plate 16 is inserted into and removed from the container body 12.

1 is inserted into a cylindrical receiving tube 18 shown in FIG. 1, which is made of a cyclic polyolefin resin and is filled with a medicine, as shown in FIG. The barrel of the syringe cylinder 26 has a smaller diameter than the hollow cylinder of the receiving cylinder 18. The proximal end portion of the syringe barrel 26 has an opened proximal end opening, and a flange 30 is provided on the outer periphery of the proximal end opening. The flange 30 is locked to the upper end of the receiving tube 18. Thereby, the syringe barrel 26 is suspended from the receiving barrel 18. The flange 30 may be provided at the proximal end portion of the syringe barrel 26 on the distal end side with respect to the proximal end opening portion of the syringe barrel 26.

A reduced diameter cylinder tip 29 is provided at the tip of the injection cylinder 26, and a needle tube as an injection needle is fixed. The needle tube is covered with a cap 28 made of an elastic material such as isoprene rubber, and the needle tip of the needle tube is sealed with the cap 28. The cap 28 protects the needle tube while preventing leakage of the medicine filled in the syringe barrel 26 from the needle tip. When the tip of the syringe barrel 26 has a so-called luer shape or cartridge shape without an injection needle, the tip of the syringe barrel 26 is placed by an elastic cap or a plastic cap with an elastic packing inside. The drug outlet is sealed.

The syringe barrel 26 is made of a cyclic polyolefin resin. Cyclic polyolefin resin is suitable as a syringe material because of its high transparency and easy confirmation of internal color and suspension status. In addition, since the cyclic polyolefin resin is excellent in heat resistance and chemical resistance, it does not shrink due to heat during high-pressure steam sterilization in an autoclave, and impure foreign matter from the syringe barrel 26 to the drug solution contained in the hollow. Does not elute or release. As the cyclic polyolefin, a cyclic olefin homopolymer, a cyclic olefin copolymer, or a cyclic olefin alloy can be used. In these cyclic polyolefin resins, an oil component that improves the moldability of the syringe barrel 26 is added to the raw material. Examples of the oil component include a plasticizer and silicone oil. This oil component is exposed to the surface of the syringe barrel 26 during high-pressure steam sterilization, thereby preventing blocking with the nesting plate 16.

The syringe barrel container 10 for housing the syringe barrel 26 formed of a cyclic polyolefin resin containing an oil component has a nesting plate 16 having at least a receiving barrel 18 in contact with the flange 30 of the syringe barrel 26 and the distal end surface made of polypropylene resin. Form. Polypropylene resin is excellent in heat resistance and chemical resistance. Polypropylene resin can be molded with a small amount of oily additives such as plasticizers, and has good heat resistance. Since the polypropylene resin is hard even if it contains an oily additive, it is much less likely to elute the oily additive than a soft plastic such as a polyvinyl chloride resin. As a polypropylene resin, only a polypropylene may be sufficient and other general purpose resin, for example, a polyethylene resin and a vinyl chloride resin, may be contained. Moreover, as a polypropylene, any of a homopolymer, a random copolymer, and a block copolymer may be sufficient. The container body 12 is also preferably formed of a polypropylene resin like the nesting plate 16, but other general-purpose resins such as a polyolefin resin such as polyethylene; a polystyrene resin; a polycarbonate resin; a polyester resin such as polyethylene terephthalate; It can be formed of a polyamide resin.

The main body of the syringe barrel 26, the nesting plate 16, and the syringe barrel storage container 10 is formed by molding. As the molding method, an injection molding method, a blow molding method, a thermoforming method, or the like can be used, and among these, the injection molding method is preferable.

The opening 19 of the syringe barrel container 10 in which the syringe barrel 26 is inserted into the receptacle barrel 18 of the nesting plate 16 and the syringe barrel 26 is suspended and accommodated in a state where the flange 30 and the distal end surface of the receptacle barrel 18 are in contact with each other is As shown in FIG. 2, it is sealed with a gas permeable and liquid impermeable film body 20. The membrane 20 is preferably a non-woven fabric, preferably a non-woven fabric made of high-density polyethylene resin and thermocompression-bonded with continuous ultrafine fibers having a thickness of 0.5 to 10 μm, such as TYVEK (registered trademark) manufactured by DuPont. Can be used. As shown in FIG. 2, the film body 20 is bonded to the upper end of the peripheral wall portion, which is the opening edge of the container body 12, with a heat welding or thermosetting adhesive.

A syringe barrel container 10 in which each of a plurality of syringe barrels 26 made of cyclic polyolefin resin is hung on a receiving barrel 18 of a nesting plate 16 made of polypropylene resin is accommodated in an autoclave, and high-pressure steam is contained in the autoclave. And high-pressure steam sterilization. The high-pressure steam introduced into the autoclave enters the syringe barrel container 10 from the film body 20 and sterilizes the syringe barrel 26 in a state where the flange 30 and the tip end surface of the receiving barrel 18 are in contact with each other.

After completion of high-pressure steam sterilization, the syringe barrel container 10 taken out from the autoclave is transported to a chemical solution filling factory, the film body 20 is peeled off, and each syringe barrel 26 is filled with a chemical solution. Next, the syringe barrel 26 filled with the drug solution is taken out from the receptacle barrel 18. At that time, the contact surface between the flange 30 of the syringe barrel 26 and the distal end surface of the receiving barrel 18 is not blocked, and the syringe barrel 26 can be easily taken out. Not attached. Further, during the high-pressure steam sterilization, the oil component slightly bleeds out from the cyclic polyolefin resin forming the syringe barrel 26 to prevent blocking with the nesting plate 16. Almost no components are attached. The bleed-out oil component and the polypropylene forming the receiving cylinder 18 do not react at all, and it is presumed that they are difficult to adhere to the polypropylene.

On the other hand, when the nesting plate 16 is formed of another general-purpose resin, for example, vinyl chloride resin, the syringe barrel 26 made of a cyclic polyolefin resin is inserted into the barrel 18, and the flange 30 of the syringe barrel 26 and the front end surface of the barrel 18 When the high pressure steam sterilization is performed in a state where the two are in contact with each other, both resins are easily adapted to each other, so that blocking is likely to occur on the contact surface between the flange 30 and the front end surface of the receiving tube 18. During high-pressure steam sterilization, oil components contained in cyclic polyolefin resin and oil components such as plasticizers blended in vinyl chloride resin bleed out and react with cyclic polyolefin and / or vinyl chloride resin to cause blocking. It is presumed that

In this way, the syringe barrel 26 formed of the cyclic polyolefin resin and the receiving cylinder 18 of the nesting plate 16 formed of polypropylene resin are subjected to high-pressure steam sterilization with the flange 30 and the front end surface of the receiving cylinder 18 in contact with each other. However, although blocking is unlikely to occur at the contact surfaces of the two, it is preferable to minimize the contact between the two when the syringe 26 is inserted into the receiver 18 and suspended. For this reason, when the syringe barrel 26 is suspended from the barrel 18, the inner diameter and / or injection of the barrel 18 is set so that the gap between the inner wall surface of the barrel 18 and the outer wall surface of the barrel 26 is 0.5 mm or more. It is preferable to adjust the outer diameter of the tube 26. Since the resin shrinks after heat sterilization, the diameter of the receiving tube 18 is adjusted as appropriate so that it is always smaller than the length of the flange 30 in order to maintain the suspended state of the syringe tube 26.

Further, when the inner wall surface of the receiving tube 18 is a cylindrical inner wall surface having the same diameter in the upper and lower directions, when the syringe tube 26 inserted and suspended in the receiving tube 18 is subjected to an impact by the transportation of the syringe barrel container 10 or the like, It moves in the left-right direction, and its outer wall surface is brought into contact with the inner wall surface of the receiving tube 18 in a linear or planar manner, as in the syringe barrel 26 'shown by the one-dot chain line in FIG. 2. In this state, the syringe barrel 26' May be subjected to high-pressure steam sterilization. Since the risk of blocking increases as the contact area increases, the inner wall surface of the receiving tube 18 is connected to the distal end surface that is the locking end of the flange 30 of the injection tube 26, as shown in FIG. It is preferable to form a tapered surface whose inner diameter gradually decreases in the direction. When the syringe barrel 26 is inserted into the barrel 18 whose inner wall surface is formed into a tapered surface and suspended, the rear end from the front end surface of the barrel 18 is located between the inner wall surface of the barrel 18 and the outer wall surface of the syringe barrel 26. A gap that gradually expands in the direction is formed. For this reason, even if the syringe barrel 26 moves in the left-right direction due to an impact applied to the syringe barrel container 10, it contacts the inner wall surface of the receiving barrel 18 like the syringe barrel 26 'shown by the one-dot chain line in FIG. The inner wall surface can be remarkably reduced as compared with the receiving tube 18 shown in FIG. At this time, the contact portion between the outer wall surface of the injection tube 26 and the inner wall surface of the receiving tube 18 is not blocked as well as the contact surface between the flange 30 of the injection tube 26 and the distal end surface of the receiving tube 18 is not blocked.

Hereinafter, embodiments to which the present invention is applied will be described in detail.

(Example 1)
A nesting plate 16 in which the container main body 12 and the plurality of receiving cylinders 18 shown in FIG. 1 are arranged at intervals is obtained by injection molding of a polypropylene resin chip. On the shelf 14 of the obtained container main body 12, the nesting board 16 was mounted and the syringe barrel container 10 was assembled. 1 is inserted into each of the receiving cylinders 18 shown in FIG. 1, and the flange 30 and the front end surface of the receiving cylinder 18 are locked. It was hung inside and stored. The gap between the outer wall surface of the syringe barrel 26 and the inner wall surface of the receiving barrel 18 was 0.5 mm. Furthermore, TYVEK (registered trademark) manufactured by DuPont Co., Ltd. was bonded to the opening edge of the container main body 12 by the adhesive 19 and thermocompression bonding as the film body 20, and the opening 19 of the syringe barrel container 10 was sealed.

High-pressure steam was introduced into the autoclave that accommodated the syringe barrel container 10 in which a plurality of syringe barrels 26 were housed, and the syringe barrel 26 was subjected to high-pressure steam sterilization. The high-pressure steam sterilization was carried out under high-pressure steam at an autoclave temperature of 121 to 125 ° C., and the holding time was 20 minutes. After the holding time had elapsed and the high-pressure steam sterilization was completed, the inside of the autoclave was cooled to a predetermined temperature, and the syringe barrel container 10 was taken out. The taken syringe barrel container 10 is transported to a clean room, the film body 20 is peeled off, and the syringe barrel 26 is pulled out from the barrel 18, so that blocking occurs between the front end surface of the barrel 18 and the flange 30. It was easy to remove. In addition, no scratches or peeling marks are observed on the surface of the syringe barrel 26 taken out, there is no oil component or a blocking component that is an oil-based additive, and it is sufficiently transparent and not deformed. Met.

The syringe barrel container of the present invention can be used when a plurality of syringe barrels are accommodated and subjected to high-pressure steam sterilization.

10: Syringe container, 12: Container body, 12a: Bottom, 12b: Peripheral wall, 14: Shelf, 15: Notch, 16: Nesting plate, 18: Cylinder, 19: Opening, 20: Membrane 26: syringe barrel, 28: cap, 29: reduced diameter barrel tip, 30: flange

Claims

A syringe barrel containing a plurality of syringes for filling a medicine having a cylindrical barrel portion and a flange provided on an outer peripheral portion of the barrel portion, and sterilization by high-pressure steam is performed on the syringe barrel. There,
A container body having a bottom at the lower end, a peripheral wall portion extending around the bottom and extending toward the upper end, and a shelf provided on the peripheral wall portion;
A nesting plate in which a plurality of receiving tubes, which are placed on the shelf and can be suspended and hung by engaging the flange of the syringe barrel inserted detachably, are arranged at intervals. And
A syringe barrel container, wherein the syringe barrel is formed of a cyclic polyolefin resin, and the nesting plate is formed of a polypropylene resin.
An inner wall surface of the receiving tube is formed in a tapered surface whose inner diameter gradually decreases in a locking end direction where the flange of the injection tube is locked, and a side wall surface of the injection tube suspended from the receiving tube, The syringe barrel container according to claim 1, wherein a gap is formed between the inner wall surface of the receiving barrel.
The syringe barrel container according to claim 1, wherein sterilization with the high-pressure steam is performed.
The syringe barrel container according to claim 3, wherein the sterilization with high-pressure steam is performed at 121 to 125 ° C for 20 minutes.