JP2015013670A - Packaging bag - Google Patents

Abstract

The present invention provides a packaging bag capable of taking out medical supplies such as prefilled syringes without losing sterility. An internally sterilizable pillow-type packaging bag for packaging medical supplies is provided. The packaging bag 100 includes a double-layered airtight film 104, a slit, a breathable film 108 provided so as to close the slit, and an opening mechanism. The two-layer airtight film has a substantially rectangular planar shape in a state where the two sheets are overlapped, and an outer peripheral end portion in a state where the two sheets are overlapped is sealed or bent. Further, the slit is formed in the airtight film 104 in parallel with the substantially rectangular long side. The breathable film 108 has a microorganism barrier property. The unsealing mechanism is configured so that the two-layered airtight film 104 can be cut straightly in the length direction of the substantially rectangular shape. [Selection] Figure 1

Description

  The present invention relates to a packaging bag for medical supplies.

  Instead of a method of sucking a drug solution into a syringe during use, as in the case of ampules and vials conventionally used in the medical industry, a kit preparation in which a drug solution is filled in a syringe in advance is called a prefilled syringe. The prefilled syringe preparation is prefilled with a chemical solution, so that it not only reduces the risk of a medical accident, but also has sterility, safety and workability, and economy. However, prefilled syringes require advanced manufacturing techniques and need to be filled under stricter hygiene control. Here, not only when prefilled syringes are filled with a medicine, but also hygiene management when individually packing prefilled syringes is equally important. For this reason, various research and development have been conducted on techniques for hygienic individual packaging of prefilled syringes.

  For example, an injection pack in which a medicine-filled syringe is enclosed in a packaging container, the packaging container being integrally formed into a long and thin container shape with a transparent resin and having a bottom opened, and sterilization And a sterilized paper that seals the bottom surface of the container main body, and the container main body includes a first bulge that accommodates a syringe needle mounting portion of a syringe containing a medicine. Combining these bulges with the bulge, the second bulge that accommodates the substantially central portion of the syringe containing the medicine, the third bulge that accommodates the flange of the syringe barrel and the pusher of the piston rod A so-called blister-type packaging container having a third bulging portion formed in a hook-like shape with a recessed central portion when viewed from the side of the container body in the side view. Is known (Patent Document 1).

  Patent Document 2 describes a pillow-type syringe packaging bag including a transparent airtight resin film and a breathable resin film having a microbial barrier property. The planar shape of the syringe packaging bag is substantially rectangular, and an opening start portion for opening the pillow type syringe packaging bag is disposed on any one of a pair of long sides of the substantially rectangular shape. . In addition, the breathable resin film is arranged in a strip shape along a substantially rectangular long axis in a planar shape of any one of the front and back surfaces of the syringe packaging bag. The strip-shaped region does not include the central axis in the length direction of the substantially rectangular shape, and is provided close to one side of the pair of long sides of the substantially rectangular shape facing the opening start portion. Therefore, according to this document, it is described that it is difficult to drop a sterilized prefilled syringe and that a syringe packaging bag designed to have excellent gas sterilization properties can be obtained.

Japanese Patent Laid-Open No. 11-155948 JP 2010-136981 A

  However, the prior art described in the above literature has room for improvement in the following points.

  First, the so-called blister-type injection pack described in Patent Document 1 is, for the time being, although the container itself uses a transparent resin, the content of the sterilizing gas-permeable sheet is opaque. It was not always satisfactory in practice, such as poor visibility of the state of things and bulkiness during transportation.

  Secondly, the so-called pillow-type syringe packaging bag described in Patent Document 2 has room for further improvement in terms of openability. This syringe packaging bag is excellent in that it is difficult for a user (doctor, nurse, etc.) to drop a sterilized prefilled syringe when opening the syringe packaging bag. However, from another point of view, when opening the tear, the tears run straight and hit the belt-like region of the breathable resin film, so that both sides of the tear of the syringe packaging bag are clean. It will remain connected in a dull state without breaking up into two. As a result, when pulling out the prefilled syringe after opening, the surface of the prefilled syringe may come into contact with the outer surface of the portion hanging from the dangle and the sterility may be lost.

  This invention is made | formed in view of the said situation, and it aims at providing the packaging bag which can take out medical supplies, such as a prefilled syringe, without losing sterility.

  According to the present invention, a pillow-type packaging bag capable of being internally sterilized for packaging medical supplies is provided. The packaging bag includes a double-layered airtight film, a slit, a breathable film provided so as to close the slit, and an opening mechanism. The two-layer airtight film has a substantially rectangular planar shape in a state where the two sheets are overlapped, and an outer peripheral end portion in a state where the two sheets are overlapped is sealed or bent. Further, the slit is formed in parallel to the long side of the substantially rectangular shape in the airtight film. Moreover, this air permeable film has a microbial barrier property. The unsealing mechanism is configured so that the two-layered airtight film can be cut straightly in the substantially rectangular length direction.

  Further, this airtight film has an outward film curl property in the length direction of the substantially rectangular shape of −10 mm to −20 mm by the Batten check method of 50 mm × 50 mm, and the outward direction of the substantially rectangular shape in the lateral direction. The film curling property of the film is +5 mm to −5 mm according to the Batten check method of 50 mm × 50 mm.

  According to this structure, both sides of the tear of the packaging bag are separated into two neatly, the opening is greatly opened in an oval shape, and a beard-like structure is hardly formed in the opening, and the edge of the opening Is hard to curl inward. Therefore, when pulling out the medical supplies, the surface of the medical supplies can be prevented from coming into contact with the outside of the packaging bag or the beard-like structure, which is not aseptic, so the medical supplies such as prefilled syringes are sterilized. Can be taken out without losing sex.

  According to the packaging bag of the present invention, a medical product such as a prefilled syringe can be taken out without losing sterility.

It is a top view for demonstrating the bag for syringe packaging which concerns on embodiment. 3 is a plan view of an airtight resin film 104. FIG. It is explanatory drawing which shows the state of the curl of the triangular piece formed by the x mark 152 at the time of performing the batten check method with respect to the airtight resin film of FIG. 2a, and is the center of the x mark 152 in the front view of FIG. It is a longitudinal cross-sectional view of a part. It is a conceptual diagram for demonstrating the state after opening of the bag for syringe packaging which concerns on embodiment. It is sectional drawing for demonstrating the airtight resin film of the bag for syringe packaging which concerns on embodiment. It is a conceptual diagram which illustrates each deformation | transformation perforation of (a)-(f) used for the bag for syringe packaging which concerns on embodiment.

  Hereinafter, embodiments of the present invention will be described with reference to the drawings. In all the drawings, the same reference numerals are given to the same components, and the description will be omitted as appropriate.

<Background of the invention>
In order to remove the prefilled syringe aseptically and easily, the inventors of the present invention originally thought that it would be sufficient to design the two parts of the two sides of the syringe packaging bag to be cleanly separated into two parts. It was. However, when the present inventors actually tackle the design of the improved product, the prefilled syringe can be aseptically removed simply by making the two parts of the tear to be separated into two cleanly. I realized it was difficult. And this problem was not a problem peculiar to the syringe packaging bag of patent document 2, but noticed that it was a problem common to a general syringe packaging bag. Then, the present inventors have sought the cause, so that the opening of the syringe packaging bag is likely to have a beard-like structure as a result of the tearing, and the edge of the opening further falls inward. When pulling out a prefilled syringe to curl, the surface of the prefilled syringe often comes into contact with the outer surface of the beveled structure or the edge of the opening that curls inward. I noticed. Thus, the present inventors have completed the present invention by designing a syringe packaging bag that is unlikely to bend in the opening of the syringe packaging bag and that is difficult to curl so that the opening falls down inside.

<Syringe packaging bag>
FIG. 1 is a plan view for explaining a syringe packaging bag according to an embodiment. The syringe packaging bag according to this embodiment is a pillow-type syringe packaging bag 100 that can be internally sterilized for packaging the prefilled syringe 102. The syringe packaging bag 100 includes a double-layered airtight resin film 104. The two-layer airtight film 104 has a substantially rectangular planar shape when the two sheets are overlapped, and the outer peripheral end portion when the two sheets are overlapped is sealed or bent. If it demonstrates from another viewpoint, this bag 100 for syringe packaging will be provided with the three-sided sealing bag 136 comprised with the airtight resin film 104 folded in half. The three-sided seal bag 136 is bent at the bent side 126. Therefore, the three-sided seal bag 136 has a structure in which the planar shape in a state of being stacked on two sheets is substantially rectangular, and the outer peripheral end in the state of being stacked on two sheets is sealed or bent. ing. The remaining three sides of the three-side seal bag 136 other than the substantially rectangular bent side 126 are sealed by the short-side seal portions 124a and 124b and the long-side seal portion 122 (that is, the three-side openings are joined to each other). Sealed).

  The syringe packaging bag 100 includes a slit (not shown because it is blocked by the breathable resin film 108). This slit is formed in parallel to the substantially rectangular long side 126 of the two-layer airtight resin film 104. The syringe packaging bag 100 includes a breathable resin film 108 provided to close the slit. This breathable resin film 108 has a microbial barrier property. The syringe packaging bag 100 includes an opening mechanism 138. The unsealing mechanism 138 is configured so that the two-layered airtight film 104 can be cut straightly in a substantially rectangular length direction 140. That is, the unsealing mechanism 138 has a belt-like straight cut region 134 having a plurality of parallel perforations formed in the airtight film 104 and a cutting process for starting the tearing of the airtight film 104. An opening start portion 132. The syringe packaging bag 100 has a prefilled syringe 102 therein.

  FIG. 2 a is a plan view of the airtight resin film 104. FIG. 2b is an explanatory view showing a curled state of a triangular piece formed by a cross mark 152 when the batten check method is applied to the airtight resin film of FIG. 2a. It is a longitudinal cross-sectional view of the center part of the mark 152. The measurement of the film curling batten check is a method of obtaining the side height 156 when the airtight resin film 104 is curled by cutting an X mark 152 of 50 mm × 50 mm into the airtight resin film 104. If the direction of the curl 154 is outward, the value is positive. If the direction of the curl 158 is inward, the value is negative (note that the X mark 152 is cut to make a triangular piece, However, if the triangle piece falls down, it cannot be measured if it is placed on the pedestal, so the airtight resin film 104 is removed from the pedestal and turned over. Will be measured). The airtight resin film 104 has an outward film curl property of about −10 mm to −20 mm in the substantially rectangular length direction 140, and an outward film curl property of the substantially rectangular lateral direction 142 of +5 mm. It is preferable to use one having a thickness of -5 mm.

  Drawing 3 is a key map for explaining the state after opening of the bag for syringe packaging concerning an embodiment. In the syringe packaging bag 100 according to the present embodiment, the three-sided sealing bag 136 formed by the two-layered airtight film 104 is straightly cut in the substantially rectangular length direction 140, and the three-sided sealing bag 136 is cut. Since it is configured so that it can be divided into two, the edge of the tear of the syringe packaging bag 100 is straight, and the beard-like structure 146 is hardly formed in the opening 144.

  Since this airtight resin film 104 has a film curlability to the outside in the substantially rectangular length direction 140 of −10 mm to −20 mm according to the Batten check method of 50 mm × 50 mm, the opening 144 is greatly elliptical. Will open. Further, since the outward film curl property in the substantially rectangular lateral direction 142 is +5 mm to −5 mm in the 50 mm × 50 mm batten check method, the edge 148 of the opening is curled inward (inward in FIG. 3). It is difficult to collapse 150). Therefore, when pulling out the prefilled syringe 102, the surface of the prefilled syringe 102 can be prevented from coming into contact with the outside of the syringe packaging bag 100 or the bearded structure 146, which is not sterile. Can be removed without losing sterility.

  The breathable resin film 108 used in this embodiment is permeable to hydrogen peroxide gas. Therefore, when hydrogen peroxide gas is introduced from the outside after the prefilled syringe 102 is packaged using the syringe packaging bag 100, the breathable resin film 108 provided in the syringe packaging bag 100 is removed from the hydrogen peroxide gas. It penetrates inside. Therefore, the inside of the syringe packaging bag 100 and the outside of the prefilled syringe 102 can be sterilized with hydrogen peroxide gas. The breathable resin film 108 is not particularly limited, and is a resin film having a certain level of toughness and breathability, and any resin film can be used as long as it has resistance to gas sterilization with hydrogen peroxide gas or the like. However, it is preferable to use, for example, Tyvek (registered trademark, made of high-density polyethylene) having excellent microbial barrier properties and air permeability.

  The syringe packaging bag 100 includes a band-shaped gap (slit). This slit is formed in parallel to the substantially rectangular long side 126 of the two-layer airtight resin film 104. For this reason, the gas inside and outside the syringe packaging bag 100 can communicate with each other through the breathable resin film 108. The breathable resin film 108 is provided so as to close the slit. Therefore, the breathable resin film 108 can communicate the gas inside and outside the syringe packaging bag 100. Therefore, the inside of the syringe packaging bag 100 and the outside of the prefilled syringe 102 can be sterilized by the hydrogen peroxide gas introduced from the outside of the syringe packaging bag 100 after the prefilled syringe 102 is packaged. If the position and area of Tyvek (registered trademark) having such good air permeability and microbial barrier properties are defined as described later, excellent visibility, transportability and openability of the syringe packaging bag 100 can be realized. However, gas sterilization outside the packaged prefilled syringe 102 can also be suitably performed.

  In addition, the air-permeable resin film 108 used in the present embodiment is an air-tight resin film 104 on any one surface (the back surface in FIG. 1) of the front and back surfaces of the three-side seal bag 136 formed by the two-layer air-tight film 104. It is provided so as to close the belt-like gap (slit). This slit is provided in the length direction 140 of the three-side seal bag 136. For this reason, the gas inside and outside the syringe packaging bag 100 can communicate with each other through the breathable resin film 108. Specifically, when Tyvek (registered trademark) is used as the breathable resin film 108, for example, the seal width of the breathable resin film 108: 1 to 10 mm and the ventilation width: 1 to 10 mm are preferable. In addition, it is preferable that the breathable resin film 108 be provided at a position 1 mm to 20 mm away from the long side (the bent side 126 in FIG. 1) on the side facing the opening mechanism 138.

  Within this range, a so-called “play” region can be ensured even when a normal packaging device is used, so that the prefilled syringe 102 can be quickly packaged with good sealing performance and productivity. Moreover, if it is in this range, since the area | region excellent in transparency can be ensured in the center part in the substantially rectangular surface of one side of the syringe packaging bag 100, the inside of the syringe packaging bag 100 should be confirmed with the naked eye. Becomes easier. Further, if the distance is within this range, the smaller the distance, the larger the area on the substantially rectangular surface of the syringe packaging bag 100 on which the unsealing mechanism 138 is located can be secured. Therefore, the opening of the syringe packaging bag 100 is facilitated. Within this range, the breathable resin film 108 made of Tyvek (registered trademark) with a sufficient area can secure an area in which the gas inside and outside the syringe packaging bag 100 can be communicated. The gas sterilization outside the prefilled syringe 102 packaged by 100 is improved.

  FIG. 4 is a cross-sectional view for explaining an airtight resin film of the syringe packaging bag according to the embodiment. As shown in FIG. 4, the airtight resin film 104 used in this embodiment is not particularly limited, and is a resin film having a certain level of toughness and airtightness, and has resistance to gas sterilization with hydrogen peroxide gas or the like. Any resin film can be used as long as it satisfies the above-mentioned curling conditions.

  That is, the airtight resin film 104 has an outward film curl property in the substantially rectangular length direction 140 (also referred to as “Machine Direction”) of −10 mm to −20 mm by a batten check method of 50 mm × 50 mm. . If the outward curl property of the substantially rectangular length direction 140 is −10 mm to −20 mm by the batten check method of 50 mm × 50 mm, the opening 144 is greatly opened in an oval shape (from −10 mm). When approaching 0, the opening is too small, and it is difficult to take out the prefilled syringe while maintaining sterility, and when it is farther from 0 mm than -20 mm, it opens too much and microorganisms in the air enter the syringe packaging bag 100. It becomes easy to enter and is not preferable). In addition, this film curl property is in the range of any two values among −10 mm, −11 mm, −12 mm, −13 mm, −14 mm, −15 mm, −16 mm, −17 mm, −18 mm, −19 mm, and −20 mm. It may be.

  On the other hand, the airtight resin film 104 has an outward film curl property of +5 mm to −5 mm in a substantially rectangular lateral direction 142 (also referred to as “Transform Machine Direction”) by a Batten check method of 50 mm × 50 mm. If the outward film curl property in the lateral direction 142 of the substantially rectangular shape is +5 mm to −5 mm by the batten check method of 50 mm × 50 mm, the edge 148 of the opening is curled inward (in FIG. It is difficult to remove the prefilled syringe while maintaining the sterility because the edge 148 of the opening is curled inward when it is farther from 0 mm than −5 mm. Then, the edge 148 of the opening is curled outward, and microorganisms in the air easily enter the syringe packaging bag 100, which is not preferable). In addition, this film curl property may be in the range of arbitrary two values among +5 mm, +4 mm, +3 mm, +2 mm, +1 mm, 0 mm, −1 mm, −2 mm, −3 mm, −4 mm, and −5 mm.

  More specifically, as shown in FIG. 4, the airtight resin film 104 includes a sealant layer 110 made of a polyethylene resin film on the innermost side. Further, the airtight resin film 104 includes an intermediate PET layer 114 made of a uniaxially stretched polyethylene terephthalate resin film that is easy to cut in a substantially rectangular shape in the length direction, outside the sealant layer 110. Further, the airtight resin film 104 includes a surface PET layer 118 made of a polyethylene terephthalate resin film outside the intermediate PET layer 114. When the syringe packaging bag 100 is configured, the sealant layers 110 are overlapped and heat-sealed so that the sealant layers 110 are located on the inner edges of the airtight resin film 104 in a state where the two are stacked.

  The sealant layer 110 and the intermediate PET layer 114 can be dry laminated by a dry laminate layer 112 made of, for example, a polyethylene adhesive. Further, the intermediate PET layer 114 and the surface PET layer 118 can be dry-laminated by a dry laminate layer 116 made of a polystyrene-based adhesive. That is, the airtight resin film 104 is a laminated film obtained by laminating a sealant layer 110, an intermediate PET layer 114, and a surface PET layer 118 in order from the inside by a dry laminating method.

  The intermediate PET layer 114 is preferably a longitudinally uniaxially stretched resin film that can be easily cut in one direction. Since the longitudinal uniaxially stretched resin film has the property of being easily cut in one direction, the laminated film itself formed by laminating a plurality of resin films including the longitudinally uniaxially stretched resin film also has the property of being easily torn in one direction. become. As a result, the opening of the syringe packaging bag 100 that is torn by the unsealing mechanism 138 is also easy to tear in one direction.

  The longitudinally uniaxially stretched resin film is preferably arranged so that one direction that is easy to tear is parallel to the length direction of the substantially rectangular planar shape of the pillow-type syringe packaging bag 100. If this arrangement is adopted, when opening the syringe packaging bag 100 by the opening mechanism 138, the longitudinal uniaxially stretched resin film is cut straight by the opening mechanism 138, and the longitudinally uniaxially stretched resin film is included along the tear. A laminated film itself formed by laminating a plurality of resin films is also torn straight in one direction. Therefore, the person opening the syringe packaging bag 100 easily tears the syringe packaging bag 100 in a direction parallel to the length direction of the substantially rectangular planar shape of the pillow type syringe packaging bag 100 without applying a large force. be able to.

  As described above, when the syringe packaging bag 100 is configured, the opposing sealant layers 110 are heat-sealed to form a bag at the edge of the airtight resin film 104 in a state where the two are stacked. Therefore, by using a polyethylene resin film as the sealant layer 110, it is possible to improve heat weldability when heat-sealing the sealant layers 110 facing each other. Further, by using a polyethylene terephthalate film as the surface PET layer 118, the gas-tight resin film 104 can have a gas barrier property, and the printability can be made relatively good. That is, by using such a three-layer structure, different properties are imparted to the back layer, the intermediate layer, and the surface layer, respectively, and the airtight resin film 104 as a whole is imparted with a property that combines these three properties in a well-balanced manner. It becomes possible. Furthermore, by adjusting the manufacturing conditions such as the tension when dry lamination is performed after having such a three-layer structure, the above-described curling condition can be satisfied.

<Opening mechanism>
The unsealing mechanism 138 used in the syringe packaging bag 100 of the present embodiment includes a belt-like straight cut region 134 having one or a plurality of parallel perforations formed on the surface PET layer 118 described above. In FIG. 3, one or a plurality of parallel perforations in the straight cut region 134 pass through the surface PET layer 118 of the airtight resin film 104, but do not pass through the intermediate PET layer 114. Therefore, these one or more parallel perforations do not impair the airtightness of the airtight resin film 104.

  The rectilinear cut region 134 is provided between a pair of short sides (short-side seal portions 124a and 124b in FIG. 1) on both the front and back surfaces of the three-side seal bag 136. Further, the rectilinear cut regions 134 overlap each other on the front and back sides over the entire length of the substantially rectangular length direction 140. The straight cut area 134 is provided at a position parallel to the central axis 130 in the longitudinal direction 140 of the substantially rectangular shape of the two-layered airtight film and not overlapping the central axis 130.

  Further, the opening mechanism 138 includes an opening start portion 132 having a cutting process for starting the tearing of the airtight resin film 104. And this opening start part 132 is in arbitrary one side (short side seal part 124a in FIG. 1) among a pair of short sides (short side seal part 124a and 124b in FIG. 1) of the substantially rectangular shape of the three-side seal bag 136. It is provided at a position that intersects the straight cut area 134.

  And as mentioned above, if the above-mentioned airtight resin film 104 is a laminated film formed by laminating a plurality of resin films including the intermediate PET layer 114 which is a longitudinally uniaxially stretched resin film that is easy to tear in one direction, Using the cutting process (for example, I notch, V notch, U notch, etc.) of the opening start portion 132, the airtight resin film 104 is torn in one direction along the straight cut region 134 with a small force. This is because if the short-side seal portion 124a, which is a margin (sealing portion) obtained by bonding the air-tight resin films 104 to each other, can be torn, the entire length in the longitudinal direction 140 of the substantially rectangular shape can be reduced with a small force thereafter. The reason why the front and back surfaces overlap each other is to cut the airtight resin film 104 straight in one direction along the straight cut region 134.

  FIG. 5 is a conceptual diagram illustrating each modified perforation of (a) to (f) used for the syringe packaging bag according to the embodiment. One or a plurality of parallel perforations used in the above-described straight cut region 134 may be one, but is a modified perforation having two or more (particularly preferably four or more) perforations. It is preferable. As this deformation perforation, in addition to the normal mere straight cut, the perforation forming a deformation perforation that maintains the straight cut performance of tearing from the opening start portion 132 as shown in FIG. It can be suitably used. As this deformed perforated cut line 5, for example, as shown in FIG. 5A, a pair of perforations (almost V) in which two cuts inclined in opposite directions have a line-symmetric relationship with respect to the longitudinal direction. Perforations), substantially Y-shaped incisions parallel to each other as shown in FIGS. 5B and 5C, and incisions inclined in opposite directions as in FIG. 5D are staggered. In addition to those arranged in parallel to each other, as well as those formed so as to face each other in an arc-shaped cut as shown in FIGS. 5 (e) and 5 (f), the straight cut ability in the tearing direction from one cut can be maintained. Any cut shape may be used. Thereby, it can tear and open to a predetermined shape along the score line 5 reliably.

  The number of perforations used in the above-described straight cut area 134 may be one or more, but two or more (particularly preferably three, four, five, six, seven, nine, ten, More than this, or within the range of any two of these values), even if the front and back surfaces of the syringe packaging bag 100 are sealed with a slight deviation when sealed, Since the rectilinear cut region 134 overlaps with each other over the entire length of the substantially rectangular length direction 140, the front and back surfaces of the three-side seal bag 136 are torn straight in one direction, which is preferable.

  The material of the airtight resin film 104 may be a material having airtightness, and there are metals such as an aluminum film and copper other than the resin. Further, the configuration of the airtight resin film 104 may be a configuration other than the configuration in which the sealant layer, the intermediate PET layer, and the surface PET layer are laminated in this order as long as the film curl characteristics are the same.

  Moreover, in the said embodiment, although the airtight resin film 104 was set as the structure laminated | stacked by the dry laminating method in order from an inner side, it is not the meaning to specifically limit. For example, a single dry laminate may be laminated at a time, or a dry laminate in order from the outside.

  In the above embodiment, the rectilinear cut region 134 is provided at a position that is parallel to the central axis in the length direction of the substantially rectangular shape and does not overlap the central axis. However, the present invention is not particularly limited. If the packaging bag 100 is large, there is no particular problem even if the rectilinear cut region 134 exists at a position overlapping the central axis.

  Moreover, in the said embodiment, although the airtight resin film 104 was folded in two and it was set as the structure in which the three-sided sealing bag 136 was formed, it is not the meaning to specifically limit. For example, there may be a configuration in which there are two airtight films, the two airtight resin films are sealed in four directions, and the outer circumferences overlapped are airtight.

  Moreover, although it was set as the syringe packaging bag 100 which puts the prefilled syringe 102 in an inside in the said embodiment, it is not the meaning to specifically limit. For example, it may be a packaging bag for storing other types of medical supplies such as sterilized medicines and medical tools.

  EXAMPLES Hereinafter, although an Example demonstrates this invention further, this invention is not limited to these.

<Examples 1-5>
This inventor manufactured the syringe packaging bag 100 which consists of a structure shown in FIG. As the planar shape of the syringe packaging bag 100, an airtight resin film 104 having a length direction (Machine Direction (MD)) of 185 mm × transverse direction (Transform Machine Direction (TD)) of 150 mm was used before being folded. The airtight resin film 104 was previously provided with slits (width: 4 ± 1 mm) in the length direction.

  As shown in FIG. 4, the cross-sectional shape of the airtight resin film 104 is as follows. Surface PET layer 118 (polyethylene terephthalate 16 μm thick) / dry laminate layer 116 (polystyrene adhesive) 2 μm thick / intermediate PET layer 114 (in order from the outside) Vertical uniaxially stretched polyethylene terephthalate 12 μm thick) / dry laminate layer 112 (polyethylene adhesive) 2 μm thick / sealant layer 110 (linear low density polyethylene 30 μm thick). At this time, five kinds of airtight resin films 104 having different film curling properties were manufactured as shown in Table 1 to be described later by appropriately adjusting manufacturing conditions such as tension when performing dry lamination.

  As the breathable resin film 108, Tyvek (registered trademark) having a thickness of 155 μm was used. The size of the breathable resin film 108 was 14 mm in width / seal part; 5 ± 1 mm × 2, and the ventilation part was 4 ± 1 mm. The air-permeable resin film 108 was disposed so as to close the slit (width: 4 ± 1 mm) of the air-tight resin film 104 therebelow. At this time, the air-permeable resin film 108 was disposed at a distance of 3 mm from the position to be the long side (bending side 126) on the opposite side of the opening mechanism 138.

  And the side (long side seal part 122) is centered on a position that is 20 ± 2 mm away from the side (long side seal part 122) having a length of 185 mm in the length direction (MD) of the breathable resin film 108. A straight cut region 134 having a width of 12 mm was formed on the front and back one by one so as to be parallel to each other. Each of the straight cut areas 134 was formed in such a manner that six parallel deformation perforations were intermittently provided (six together). As shown in FIG. 4, the perforations of these straight-cut regions 134 were formed so as to penetrate only the outermost polyethylene terephthalate thickness of 16 μm and not penetrate the longitudinally uniaxially stretched polyethylene thickness of 12 μm.

  And this airtight resin film 104 was bent in the middle, and it was set as the rectangular three-way seal bag 136 which bonded the front and back. The size of one side of the rectangular three-side seal bag 136 was a film of length direction (MD) 185 mm × transverse direction (TD) 75 mm.

  As described above, the air-tight resin film 104 is bent halfway to form the three-side sealed bag 136. As a result, the breathable resin film 108 made of Tyvek is 3 mm away from the long side (folded side 126) on the opposite side of the opening mechanism 138. Therefore, the three-way seal bag 136 is provided at a position not including the central axis 130 in the longitudinal direction 140 of the rectangular shape.

  Thereafter, as the opening start portion 132, a position of 20 ± 2 mm from the corner on the long-side seal portion 122 side in one rectangular short-side seal portion 124a of the three-side seal bag 136 (that is, the short-side seal portion 124a is straight cut) A V-notch process was formed at a position intersecting the region 134 to obtain a pillow-type syringe packaging bag 100.

<Example 6>
As shown in Table 1 and Table 3, the packaging bag of Example 6 is the same material as Example 1 except that the intermediate layer of the airtight resin film 104 is different, and is manufactured by the same manufacturing method. .

<Comparative Examples 1-4>
As shown in Table 1 and Table 2, the packaging bags of Comparative Examples 1 to 4 are the same materials as in Example 1 except that the film curl properties are different, and are manufactured by the same manufacturing method.

<Comparative Examples 5-8>
As shown in Table 1, Table 2, and Table 3, the packaging bags of Comparative Examples 5 to 8 are different from those in Example 1 except that the material constituting the airtight resin film 104 is different and the physical properties such as film curl are different. Are the same materials and manufactured by the same manufacturing method.

<Evaluation method>
The following items were evaluated using the pillow-type syringe packaging bags 100 of Examples 1 to 6 and Comparative Examples 1 to 8 obtained as described above.

(1) Film curl property The film curl property was judged by the Batten check method. As shown in FIG. 2, the batten check method is a method of obtaining a side height 156 when the airtight resin film 104 is curled by cutting an X mark 152 of 50 mm × 50 mm into the airtight resin film 104. A positive value is obtained when the direction of the curl 154 is upward, and a negative value is obtained when the direction of the curl 158 is downward. The values necessary for the airtight resin film 104 are −10 mm to −20 mm for the film curl property in the longitudinal direction 140 and +5 mm to −5 mm for the film curl property in the lateral direction 142.

The following evaluations (2) to (6) were evaluated after the prefilled syringe 102 was sealed in the syringe packaging bag 100 in advance and sterilized. Specifically, a prefilled syringe in which a 1% hyaluronic acid solution is injected as a medicine is stored in the syringe packaging bags of Examples 1 to 6 and Comparative Examples 1 to 8, and the opening of the syringe packaging bag is sealed. Then, sterilization was performed in the order of (i), (ii) and (iii).
(I) Conditioning is performed under conditions of 60 ° C. × 15 minutes and humidity of 5.0 RH% or less,
(Ii) sterilization with hydrogen peroxide gas under conditions of H ₂ O ₂ concentration of 1000 ppm or more and sterilization time of 0.5 to 2.5 hours,
(Iii) After sterilization, the hydrogen peroxide gas in the bag for syringe packaging was air-substituted under conditions of normal temperature and an air amount of 300 to 400 m ³ .

(2) Long side direction openability Longitudinal direction openability is a sensory evaluation in the following three stages.
○: Cut into two perforations when opened.
(Triangle | delta): Although it cuts into two at the time of opening, it remove | deviates from a perforation.
X: Cannot be cut into two (no cutting residue occurs).

(3) Beard-like structure of the opening mouth The beard-like structure of the opening mouth is a sensory evaluation of the 20 syringe packaging bags 100 by the following two stages by five adult male panelists. is there.
None: Less than 5 out of 100 bags with a beard-like structure of 3 mm or more in the opening opening Yes: More than 5 bags out of 100 with a beard-like structure of 3 mm or more in the opening opening observed

(4) Folding inward of the edge of the opening mouth Folding inward of the edge of the opening mouth is performed by the following five adult male panelists on each of the 20 syringe packaging bags 100. This is a sensory evaluation in two stages.
None: Less than 5 out of 100 bags observed to fall inside the edge of the opening. Yes: 5 out of 100 bags observed to fall inside the edge of the opening. It was more than

(5) Measurement of Maximum Value of Opening Port The maximum value of the opening port 144 (the opening obtained when the syringe packaging bag 100 is opened by tearing into two as shown in FIG. 3) is 5 adult men. The maximum value of the distance between the opening edges 148 when no force is applied to each of the 20 syringe packaging bags 100 (corresponding to the short axis length of the substantially elliptical opening 144) ) Was measured with a ruler to obtain an average value. The maximum value of the opening was set to be 15 mm or more.

(6) Aseptic extractability The method for measuring aseptic extractability is to remove the prefilled syringe 102 from the opened syringe packaging bag 100 for each of the four syringe packaging bags 20 by a panel of five adult males. In addition, the syringe was taken out with care so as not to contact the syringe as much as possible to the outside of the beard-like structure or the opening. After that, evaluation using a biological indicator for hydrogen peroxide sterilization confirmation and 106 spore bacteria (G. stearothermophilus) were directly applied to perform a challenge test, and the inner surface of the syringe packaging bag and the outer surface of the prefilled syringe The degree of sterilization was evaluated. Whether the sterilization was aseptic or not was judged as sterilized when 0 of 20 bags in which colonies of budding bacteria were confirmed. Further, in Tables 2 and 3, when N of 20 bags in which colonies of budding fungi are confirmed are indicated as spore adhesion N / 20.

<Evaluation results>
The results of performing the above evaluation items using the pillow type syringe packaging bags 100 of Examples 1 to 6 and Comparative Examples 1 to 8 are shown in Tables 1 to 3 below. As the deformation perforations shown in Tables 1 to 3, six of the shapes shown in FIG. 5A were used in parallel. That is, in FIG. 1 and FIG. 4, for the convenience of drawing, it is a chain-line perforation, but in reality, six of the shape shown in FIG. 5A are arranged in parallel.

The abbreviations in Table 1 have the following meanings (the same applies to other tables).
PET: Polyethylene terephthalate PS: Polystyrene adhesive Longitudinal PET: Longitudinal uniaxially stretched polyethylene terephthalate PE: Polyethylene adhesive LLDPE: Linear low density polyethylene

<Consideration of results>
From the experimental results of Examples 1 to 6 above, the film curl property to the outside of the substantially rectangular length direction 140 of the airtight resin film 104 is −10 mm to −20 mm by the batten check method of 50 mm × 50 mm. The opening 144 is greatly opened in an elliptical shape. Further, since the outward film curl property in the substantially rectangular lateral direction 142 is +5 mm to −5 mm in the 50 mm × 50 mm batten check method, the edge 148 of the opening is curled inward (inward in FIG. 3). It is difficult to collapse 150). Therefore, when pulling out the prefilled syringe 102, the surface of the prefilled syringe 102 can be prevented from coming into contact with the outside of the syringe packaging bag 100 or the bearded structure 146, which is not sterile. Can be removed without losing sterility. On the other hand, in Comparative Example 3, sterilization cannot be maintained because the opening has collapsed inward. Moreover, in the comparative example 2, since the opening is too narrow, sterilization cannot be maintained.

  In the above, this invention was demonstrated based on the Example. It is to be understood by those skilled in the art that this embodiment is merely an example, and that various modifications are possible and that such modifications are within the scope of the present invention.

  For example, in the above embodiment, hydrogen peroxide gas is used for gas sterilization, but the present invention is not particularly limited. For example, you may sterilize using ethylene oxide gas instead of hydrogen peroxide gas. Also in this case, as long as the syringe packaging bag of Example 1 is used, excellent sterility and the effect of suppressing the remaining sterilized gas can be realized.

  Moreover, in the said Example, although six deformation perforations shown in FIG. 5A were used in parallel, there is no particular limitation. For example, an arbitrary number of the perforations shown in FIGS. 5B to 5F may be arranged in parallel. In this case as well, excellent sterilization and sterilization gas remaining suppression effects can be realized.

5 Cut line 100 Syringe packaging bag 102 Prefilled syringe 104 Airtight resin film 108 Breathable resin film 110 Sealant layer 112 Dry laminate layer 114 Intermediate PET layer 116 Dry laminate layer 118 Surface PET layer 122 Long side seal portions 124a and 124b Short Side seal part 126 Bending side (long side)
130 Central shaft 132 Unsealing start part 134 Straight cut region 136 Three-sided seal bag 138 Unsealing mechanism 140 Length direction 142 Lateral direction 144 Unsealing opening 146 Beard-like structure 148 Unfolding edge 150 Inward collapse 152 X mark 154 Curl 156 Side height 158 curl

Claims (7)

An internally sterilizable pillow-type packaging bag for packaging medical supplies,
Two layers of airtight film,
Slits,
A breathable film provided to close the slit;
Opening mechanism,
With
The two-layer airtight film has a substantially rectangular planar shape in a state of being stacked on two sheets, and an outer peripheral end in a state of being stacked on two sheets is sealed or bent,
The slit is formed in parallel with the substantially rectangular long side of the airtight film,
The breathable film has a microbial barrier property,
The unsealing mechanism is configured to be able to cut the two-layer airtight film straightly in the substantially rectangular length direction,
The airtight film is
The outward curl property with respect to the length direction of the substantially rectangular shape is −10 mm to −20 mm by the batten check method of 50 mm × 50 mm,
The outward curl property in the lateral direction of the substantially rectangular shape is +5 mm to −5 mm by a batten check method of 50 mm × 50 mm,
Packaging bag. In the packaging bag according to claim 1,
The airtight film is
A sealant layer made of a polyethylene resin film;
An intermediate PET layer comprising a uniaxially stretched polyethylene terephthalate resin film that is easy to tear in the substantially rectangular length direction;
A surface PET layer comprising a polyethylene terephthalate resin film;
Is a laminated film laminated in the order of
In the sealing region of the outer peripheral end in a state of being stacked on two sheets, the sealant layers are overlapped and heat sealed.
Packaging bag. The packaging bag according to claim 2,
The opening mechanism is
A belt-like straight cut region having a plurality of parallel perforations formed in the surface PET layer;
An opening start portion having a cutting process for starting the tearing of the airtight film;
With
The straight cut area is
On both the front and back sides of the two-layer airtight film,
Provided between a pair of short sides of the substantially rectangular shape,
The two sides overlap each other over the entire length of the substantially rectangular shape,
The opening start part
Provided at a position that intersects the straight cut region in any one of the pair of substantially rectangular short sides of the two-layer airtight film,
Packaging bag. In the packaging bag according to claim 3,
The plurality of parallel perforations are deformation perforations having four or more perforations per width,
Packaging bag. In the packaging bag according to claim 4,
The deformation perforations are a pair of perforations having a line-symmetric relationship with respect to four or more longitudinal directions.
Packaging bag. In the packaging bag according to any one of claims 1 to 5,
The medical product is a prefilled syringe,
Packaging bag. The packaging bag according to claim 6,
It has a prefilled syringe inside it,
Packaging bag.