Package of sterilized object

Abstract

A package 4 includes: an air filter 5 which is a sterilized object; a first sealing bag 61 for vacuum-packaging the air filter 5; and a second sealing bag 62 for packaging a vacuum package 40 formed by packaging the air filter 5 with the first sealing bag 61. Therefore, in the event of any unexpected circumstances, a broken sealing state of the first sealing bag 61 can be easily noticed by visual observation or touch. Therefore, it is possible to reduce the risk of contamination caused by carrying the package 4 without noticing that the sterilization state of the air filter 5 is not maintained.

Description

Sterile packaging

[0001] The present disclosure relates to packaging of sterile items that are brought into near-sterile or sterile controlled areas such as bioclean rooms.

[0002] In factories and research facilities that handle pharmaceuticals, food, cosmetics, etc., biological clean rooms (BCRs) are used, which are controlled to be near-sterile or sterile, to prevent contamination by microorganisms such as mold and viruses that are present in the general environment. Biological clean rooms are divided into multiple areas according to the level of cleanliness (air purity), with the cleanliness increasing the further inside. The final area, which is the cleanest, is composed of equipment such as biological safety cabinets (BSCs), isolators, clean benches, and CO2 incubators.

[0003] The safety cabinets and other equipment described above are equipped with air filters that are replaced as needed. When replacing an air filter, it is preferable that a new air filter be brought in from outside as a package containing a sterile item that has been pre-sterilized to prevent contamination of the bioclean room. Regarding such a package containing a sterile item, Patent Document 1 describes a method of sterilizing the package containing an air filter wrapped in a radiation-resistant bag by irradiating it with an electron beam. Patent Document 2 also describes a package in which sterile items such as pipette tips are multi-packaged using a sterile bag whose inside and outside are sterilized.

[0004] JP 2005-212827 A JP 2008-239168 A

[0005] The air filter packages, which are sterile items as described above, are not necessarily brought into a bioclean room immediately after delivery to the user, but are sometimes stored in a general environment (sometimes for a long period of time) until an opportunity to replace them arises. If an unexpected event occurs in which the sealed state of the package is broken due to an impact during storage or transportation, there is a risk that the air filter brought in by the user without realizing that it is no longer sterile may contaminate the bioclean room. While the probability of such an event occurring is not particularly high, it is desirable to take measures to prepare for the unlikely event in order to reduce the risk of contamination.

[0006] In addition to air filters, other sterilized items that can be placed in the package include chemical filters, cleaning tools such as cloths, and protective gear such as gowns (coveralls). As with air filters, these items also pose a risk of contamination if brought in without being kept in a sterile state.

[0007] The present disclosure has been made in consideration of the above-mentioned circumstances, and its purpose is to provide a package for sterilized items that can reduce the risk of contamination caused by items being brought in without realizing that the sterilization state has not been maintained.

[0008] The package of a sterilized object of the present disclosure comprises a sterilized object, a first sealed bag for vacuum-packaging the sterilized object, and a second sealed bag for packaging a vacuum-packaged object formed by packaging the sterilized object in the first sealed bag.

[0009] Schematic diagram showing an example of the configuration of a bio-clean room. Schematic diagram showing an example of the configuration of a safety cabinet. Schematic diagram showing an example of a decontamination device. A diagram showing a package of sterilized objects according to an embodiment of the present disclosure. A perspective view showing an example of the configuration of an air filter. A diagram showing a modified example of a contact-preventing member. A schematic diagram showing an example of a method for manufacturing a package of sterilized objects. A schematic diagram showing an example of a method for manufacturing a package of sterilized objects. A diagram showing a package of sterilized objects according to another embodiment of the present disclosure.

[0010] An embodiment of the present disclosure will be described with reference to the drawings.

[0011] FIG. 1 is a schematic diagram showing an example of the configuration of a bio-clean room. Bio-clean room 1 is used in factories and research facilities that handle pharmaceuticals, food, cosmetics, etc., to prevent the introduction of microorganisms such as mold and viruses that are present in the general environment. Bio-clean room 1 is divided into multiple areas according to the cleanliness level (air cleanliness), and in this embodiment, it is divided into three areas A1 to A3. Areas A1 to A3 are each controlled to a near-sterile or sterile state, and the cleanliness level increases stepwise as you go further in (i.e., from area A3 to area A1).

[0012] Area A1, which has the highest level of cleanliness, is composed of a workroom containing a safety cabinet 10 and other equipment. Area A1 is not limited to a safety cabinet, and can also be composed of a workroom containing an isolator, clean bench, CO2 incubator, and other equipment. Area A2 is composed of a room 20 in which a safety cabinet 10 is installed. Area A3 is composed of a room 30 adjacent to the outside of room 20, and the outside of room 30 is a general environment. Passrooms 21 and 31 are provided at the entrances to rooms 20 and 30, respectively. Passrooms 21 and 31 have double doors to form sealed spaces where cleaning work such as air blowing, UV irradiation, and wiping with alcohol can be performed.

[0013] FIG. 2 is a schematic diagram showing an example of the configuration of a safety cabinet 10. The safety cabinet 10 is a box-shaped facility having a work area, designated area A1, inside. Workers can insert their hands into the work area to perform various tasks. The safety cabinet 10 includes a fan 11, air filters 12 and 13 that capture particles such as viruses, and a shutter 14 that can be opened and closed. By operating the fan 11 to generate an airflow, clean air is supplied to the work area (area A1) through the air filter 12, and clean air is exhausted outside the facility through the air filter 13.

[0014] The air filters 12 and 13 are consumables that are replaced as needed. When replacing them, it is preferable that a new air filter 5 (see FIG. 4) to be installed in the safety cabinet 10 is brought in from outside as a pre-sterilized package 4 (see FIG. 4) so ​​as to avoid contaminating the bioclean room 1. The air filters 12 and 13 and the air filter 5 are not particularly limited as long as they have the required particle collection performance, but filters with a high particle collection rate, such as HEPA (High Efficiency Particulate Air) filters or ULPA (Ultra Low Penetration Air) filters, are preferably used.

[0015] A bottom plate 15 that functions as a mounting table is installed inside the safety cabinet 10. The bottom plate 15 is formed with an intake port 16 that draws in air that flows in through an air supply port 18. The air drawn in through the intake port 16 passes through an internal passage 17 of the safety cabinet 10 and moves above the work area (area A1). A portion of the air that moves above the work area passes through an air filter 12 and is sent into the work area as clean air. A portion of the air that moves above the work area passes through an air filter 13 and is discharged to the outside of the cabinet through an exhaust port 19 as clean air.

[0016] The safety cabinet 10 is subjected to decontamination treatment every time work is completed or periodically. The decontamination treatment is performed using a decontamination apparatus 3 as shown in FIG. 3 , for example. The decontamination apparatus 3 includes a supply unit 31 that supplies decontamination gas, an inlet flow path 32 that feeds the decontamination gas into the safety cabinet 10, and an outlet flow path 33 that discharges the decontamination gas from the safety cabinet 10. The supply unit 31 supplies a gasified decontamination agent, such as decontamination agent vapor or mist. The decontamination agent may be, for example, a chemical agent containing peracetic acid, hydrogen peroxide, or chlorine dioxide. The inlet flow path 32 and the outlet flow path 33 are each provided by a hose, pipe, duct, or the like.

[0017] The decontamination apparatus 3 is configured to circulate decontamination gas through a circulation path formed including the safety cabinet 10. A blower 36 is disposed upstream of a switching valve 35, which will be described later. Air can be circulated through the circulation path by operating the blower 36 to generate an airflow. The blower 36 may be provided as a blower unit including a blower. The introduction flow path 32 is airtightly connected to the air inlet 18, and the discharge flow path 33 is airtightly connected to the exhaust port 19. If there are gaps around the shutter 14, the air inlet 18, the exhaust port 19, or other locations, it is desirable to seal them with masking tape or the like.

[0018] The circulation path includes a first path passing through the supply unit 31, a second path passing through the collection unit 34, and a switching valve 35 for selectively switching between the first and second paths. The collection unit 34 is configured to be able to collect decontamination gas. The collection unit 34 is provided as a filter unit including a chemical filter. The chemical filter is a consumable item that is replaced as needed. When replacing the chemical filter, it is preferable that a new chemical filter 9 (see FIG. 9) to be installed in the safety cabinet 10 be brought in from outside as a pre-sterilized package 4 (see FIG. 9) of a sterile material that has been subjected to a sterilization process, so as not to contaminate the bioclean room 1.

[0019] During decontamination processing, the switching valve 35 is operated to select the first path, and decontamination gas is released into the safety cabinet 10, distributing it throughout the entire interior, including the air filters 12 and 13. The decontamination gas flows through the circulation path together with the air, filling the interior and killing microorganisms. Once decontamination is complete, the switching valve 35 is operated to select the second path, and aeration is performed to remove the decontamination gas from the interior. The decontamination gas flowing through the circulation path is collected by the collection unit 34, thereby suppressing the concentration of the chemical agent inside the interior. The decontamination device 3 is not limited to this configuration, and various modifications are possible, such as installing a supply unit 31 inside the safety cabinet 10.

[0020] 4 is a diagram showing a package of a sterilized object according to this embodiment. This package 4 of a sterilized object (hereinafter sometimes simply referred to as "package 4") includes a sterilized object, a sealed bag 61 as a first sealed bag for vacuum-packaging the sterilized object, and a sealed bag 62 as a second sealed bag for packaging a vacuum package 40 formed by packaging the sterilized object in the sealed bag 61. In this embodiment, an example is shown in which the sterilized object is a sterilized air filter 5 (an example of a filter). The inner surface of the sealed bag 61 faces the air filter 5, and the outer surface faces the inner surface of the sealed bag 62. The inner surface of the sealed bag 61 is in intimate contact with the air filter 5. The package 4 is a product formed by multi-packaging the air filter 5 in this manner, and may be packaged in an outer packaging 63 to prevent dust from adhering during transport.

[0021] When replacing the air filters 12, 13 with air filter 5, the package 4 is first brought into the pass room 31, where the sealed bag 62 is opened and the contents (vacuum package 40) are removed. The sealed bag 62, which has been exposed to the general environment, is not brought into area A3, so the cleanliness of area A3 is maintained. The vacuum package 40 is then brought into the pass room 21, where the sealed bag 61 is opened and the contents (air filter 5) are removed. The sealed bag 61, which has been exposed to the atmosphere of area A3, is not brought into area A2, so the cleanliness of area A2 is maintained. In this way, the air filter 5, which has been kept sterile, is carried from outside the bioclean room 1 toward the safety cabinet 10.

[0022] By packaging the air filter 5 in the sealed bags 61, 62, when the air filter 5 is brought from an area with a relatively low level of cleanliness to an area with a high level of cleanliness (i.e., from the outside to area A3, or from area A3 to area A2), the contents of the outermost sealed bag can be removed in the area with a relatively low level of cleanliness and the filter can be brought into the area with a relatively high level of cleanliness. In this embodiment, this process of bringing the air filter 5, which remains sterile, into area A2 and attaching it to the safety cabinet 10, is repeated multiple times.

[0023] Due to the structure of the bio-clean room 1, it may seem that cleaning the air filter 5 in the pass room 21 would maintain the cleanliness of area A2, but this is unrealistic. As will be described later, the air filter 5 includes a filter media pack 51 with an uneven shape, and it is practically difficult to evenly treat the filter media pack 51 by cleaning in the pass room 21. In particular, if the filter media sheet 53 included in the filter media pack 51 is made of a material containing glass fiber, it is easily damaged by impact, making treatment particularly difficult. Therefore, the air filter 5 needs to be transported as a pre-sterilized item, and the above-mentioned multi-packaging is useful.

[0024] Incidentally, although the probability of this occurring is not particularly high, if an unexpected event occurs in which the sealed state of the package 4 is broken due to an impact during storage or transportation, there is a risk that a user may bring in an air filter 5 without realizing that the sterilization state is no longer being maintained, thereby contaminating the bio-clean room 1. Since it is particularly important to avoid contamination of area A1, which has the highest level of cleanliness, it is necessary to prevent air filters 5 from being brought in without realizing that the sealed state of the sealed bag 61 has been broken. Of course, such a situation can be avoided if the user notices something unusual before bringing it in, but there may also be cases where the tear in the sealed bag 61 is extremely small and cannot be detected at a glance.

[0025] In contrast, in this embodiment, the air filter 5 is vacuum-packaged in the sealed bag 61, so if the sealed bag 61 is torn, air will enter the bag, causing it to swell, or the sealed bag 61 will lose its seal on the air filter 5, changing its shape. This makes it easier for a user to notice, by sight or touch, that the sealed state of the sealed bag 61 has been broken, which can happen as early as before bringing it into the pass room 31, or at the latest before bringing it from the pass room 21 into area A2. Therefore, even if such an emergency occurs, the risk of contamination caused by bringing it in without realizing that the sterility has not been maintained can be reduced.

[0026] In this embodiment, the sealed bag 62 is non-vacuum packaged. That is, the sealed bag 61 is sealed in a vacuumed state, while the sealed bag 62 is sealed in a non-vacuumed state. Because the sealed bag 62 contains a gas such as air along with the vacuum package 40, the degree of vacuum (pressure) inside is lower than that of the sealed bag 61. Therefore, before opening the sealed bag 62 or immediately after opening the sealed bag 62, it is easy to notice by visual inspection or touch any abnormalities that may occur when the sealed bag 61 is no longer sealed (e.g., a bulge in the sealed bag 61). This is advantageous in reducing the risk of contamination due to the introduction of an air filter 5 that is not kept sterile.

[0027] Although not adopted in this embodiment, the packaging using the sealed bag 62 may be vacuum-packaged. If the sealed bag 62 is torn, air will enter the inside, causing the sealed bag 62 to swell, or the sealed bag 62 will lose its seal with the vacuum packaged body 40, changing its shape. This makes it easy to notice by sight or touch that the sealed state of the sealed bag 62 has been broken. In such a case, after opening the sealed bag 62 in the pass room 31, it is preferable to leave the vacuum packaged body 40 for a while before bringing it into area A3. If the sealed bag 62 is torn, the abnormality described above (e.g., the sealed bag 61 will bulge) will appear, making it easy to notice that the sealed state of the sealed bag 61 has been broken.

[0028] The sealed bags 61, 62 are preferably made of a tear-resistant material, although not particularly limited thereto. Examples of materials that can be used for the sealed bags 61, 62 include polyethylene bags, polypropylene bags, PET (polyethylene terephthalate) bags, nylon bags, polyvinyl chloride bags, and aluminum-evaporated bags. The thickness of the sealed bags 61, 62 is, for example, 0.005 mm or more, but is preferably 0.02 mm or more from the perspective of tear resistance, and is preferably 0.1 mm or less from the perspective of ease of handling. Furthermore, the sealed bags 61, 62 are preferably sealed by heat sealing using a sealer or the like, and the width of the heat-sealed portion is preferably 1 mm or more to ensure sealing performance, but 10 mm is sufficient.

[0029] It is preferable that at least a portion of the sealed bag 62 is transparent or semi-transparent so that the inside can be seen. With this configuration, it is possible to check for abnormalities that occur when the sealed state of the sealed bag 61 is broken (for example, bulging of the sealed bag 61) without opening the sealed bag 62. In this embodiment, an example is shown in which the entire sealed bag 62 is transparent. The sealed bag 61 may be transparent, semi-transparent, or opaque.

[0030] The package 4 is not necessarily brought into the bioclean room 1 immediately after delivery to the user, but may be stored until an opportunity for replacement arises. However, if the package 4 is stored for a long period of time, there is a risk that gas such as air may penetrate the sealed bag 61 during that time, causing the sealed state of the sealed bag 61 to appear as if it has been unsealed, leading to a misidentification by the user. Therefore, to prevent such a misidentification, the sealed bag 61 may have gas barrier properties. In such a case, the sealed bag 61 may have a structure including a film layer with excellent gas barrier properties, such as an aluminum vapor deposition film, a silica vapor deposition film, an alumina vapor deposition film, or aluminum foil.

[0031] FIG. 5 is a perspective view showing an example of the configuration of the air filter 5. The air filter 5 includes a filter media pack 51 and a filter frame 52 to which the filter media pack 51 is attached. In this embodiment, the filter frame 52 is formed as a rectangular frame having four corners 52c. The components of the filter frame 52 are preferably formed from a metal material such as aluminum, stainless steel, zinc steel, or galvalume steel. If the filter frame 52 is formed from wood or paper, it may serve as nutrients for microorganisms. Furthermore, if the filter frame 52 is formed from a plastic material, it may generate a sterilization odor due to gamma ray irradiation, as described below.

[0032] The filter media pack 51 has a rectangular shape slightly smaller than the filter frame 52 and is attached to the inside of the filter frame 52. To maintain airtightness between the filter media pack 51 and the filter frame 52, the gap between them is sealed with a sealant (not shown) such as urethane. The filter media pack 51 includes a filter media sheet 53 folded in a pleated shape (accordion-like, zigzag-like). From the perspective of suppressing sterilization odor, the filter media sheet 53 is preferably made of a material containing glass fiber. However, this is not limited thereto, and the filter media sheet 53 may also be made of a material containing polyester fiber, polypropylene fiber, or the like.

[0033] As shown in FIG. 5 , the filter pack 51 has a separator 54 extending in a direction intersecting the fold direction (the direction in which the folds extend) of the filter sheet 53. The separator 54 is provided not only on the front of the filter sheet 53 shown in FIG. 5 , but also on the back of the filter sheet 53 (not shown in FIG. 5 ). The separator 54 is a thread separator in which the outer periphery of the thread is coated with an adhesive such as a synthetic resin, and the separators 54 are bonded to each other between adjacent peaks of the filter sheet 53. By providing such a separator 54, an appropriate pleat spacing (fold spacing) can be maintained to ensure collection performance. Note that various forms of separators can be applied, such as those made of thermoplastic resin or those with unevenness on the filter sheet 53.

[0034] In this embodiment, a contact prevention member 55 (see FIG. 4 ) is interposed between the corner 52c of the filter frame 52 and the inner surface of the sealing bag 61 to prevent contact therebetween. The contact prevention member 55 is positioned so as to cover the sharp portion of the corner 52c. This prevents damage to the inner surface of the sealing bag 61, which is in close contact with the corner 52c, due to vacuuming, thereby maintaining a good sealed state of the sealing bag 61. The contact prevention member 55 is formed from a cushioning material (cushioning material) such as, but not limited to, sponge, bubble wrap, polystyrene foam, or polyethylene sheet. Instead of or in addition to using the contact prevention member 55, it is also possible to prevent damage to the sealing bag 61 by rounding the corner 52c (for example, with a radius of curvature of 1 mm or more).

[0035] In the example shown in FIG. 4 , the contact prevention members 55 are partially attached to cover the corners 52 c of the filter frame 52. Four contact prevention members 55 are attached to the corners 52 c of the filter frame 52, respectively. However, this is not limited to this. For example, as shown in FIG. 6 , the contact prevention members 55 may be attached to cover the periphery of the filter frame 52. The contact prevention members 55 shown in FIG. 6 are members that are longer than one side of the filter frame 52 and are arranged to surround the filter frame 52 while covering each of the corners 52 c. This reduces the number of parts required for the contact prevention members 55 and simplifies the attachment process. At least one such long contact prevention member 55 is required, and multiple members may be used.

[0036] A protective member 56 (see FIG. 5 ) may be interposed between the filter media pack 51 and the inner surface of the sealed bag 61 to prevent contact between them and protect the filter media pack 51. This configuration prevents damage to the filter media pack 51 due to the tight contact of the vacuum-sealed bag 61. This measure is particularly useful when the filter media sheet 53 is made of a material containing glass fiber, as it is prone to damage due to the tight contact of the sealed bag 61. The protective member 56 shown in FIG. 5 is a plate material that is not fixed to the filter frame 52 and is arranged in pairs to cover the front and back of the filter media pack 51. The protective member 56 may be fixed to the filter frame 52 with an adhesive or the like. In this case, it is considered to be formed of a mesh to ensure breathability of the air filter 5.

[0037] The packaging body 4 of this embodiment can be manufactured by a method including a step of vacuum-packaging the air filter 5 in a sealed bag 61 (first packaging step), a step of packaging the first packaging body obtained by packaging the air filter 5 in the sealed bag 61 in a sealed bag 62 (second packaging step), and a step of sterilizing the second packaging body obtained by packaging the first packaging body in the sealed bag 62 (sterilization step).

[0038] An example of a method for manufacturing the package 4 will be described with reference to Figures 7 and 8. As shown in Figure 7, first, the air filter 5 is placed in a sealed bag 61, and the opening 61a of the sealed bag 61 is sealed by heat sealing using a sealer or the like. Then, a portion of the sealed bag 61 is cut to form a small opening 61b, and the inside of the sealed bag 61 is evacuated through the opening 61b. The vacuum evacuating should be sufficient to bring the sealed bag 61 into close contact with the air filter 5. These steps may be performed in a general manufacturing environment, but a microorganism-controlled environment such as a clean room is preferable.

[0039] In this embodiment, the opening 61b is formed at a position opposite the corner 52c of the filter frame 52, so that when vacuuming, the suction nozzle (not shown) of the suction machine can be brought into contact with the contact-preventing member 55 made of sponge. This prevents the suction nozzle from sucking the inner surface of the sealed bag 61, improving workability. Once vacuuming is complete, the opening 61b is heat-sealed to seal it. This results in a vacuum packaged product 40p, in which the unsterilized air filter 5 is vacuum-packaged in the sealed bag 61.

[0040] Next, as shown in Figure 8, the vacuum package 40p is placed in a sealed bag 62, and the opening of the sealed bag 62 is heat-sealed to seal it. This results in a package 4p, in which the vacuum package 40p is packaged in the sealed bag 62. Next, the package 4p is subjected to a sterilization treatment. Therefore, the air filter 5 is sterilized after being packaged in the sealed bags 61, 62. In this example, multiple packages 4p packaged in outer packaging 63 are packed in a case 7 such as a cardboard box, and are sterilized all at once. Through these steps, a package 4 of air filters 5 (see Figure 4), which is a sterilized product, is obtained.

[0041] In this embodiment, the air filter 5 included in the package 4 is sterilized by gamma ray irradiation. In the step shown in the lower part of Figure 8, the sterilization process is performed using a gamma ray irradiation device (not shown). The fact that the air filter 5 has been sterilized by gamma ray irradiation can be confirmed, for example, by a gamma ray indicator 8 (a chemical indicator for sterilization). In Figure 8, the indicator 8 is attached to the sealed bag 62, but this is not a limitation and the indicator 8 may be attached to the air filter 5 or the sealed bag 61.

[0042] Sterilization by electron beam irradiation is also applicable, but because electron beams are blocked by aluminum, if the filter frame 52 constituting the air filter 5 is made of aluminum, it becomes difficult to thoroughly sterilize the air filter 5. Similar problems may arise when the sealed bags 61, 62 have a structure including an aluminum-deposited film or aluminum foil. In contrast, gamma rays have the property of penetrating aluminum, so the air filter 5 can be sterilized without any problems.

[0043] When gamma ray irradiation is performed, the dose of gamma rays is set to, for example, 10 kGy or more from the viewpoint of killing microorganisms attached to the package 4, but considering the industrial killing of spore-forming bacteria used in biological indicators (BI), which are indicators of death, the dose is preferably 25 kGy or more. On the other hand, considering damage to organic matter contained in the package 4, the dose of gamma rays is preferably 50 kGy or less.

[0044] 9 is a diagram showing a package of a sterilized object in another embodiment. In the above-described embodiment, an example was shown in which the sterilized filter serving as the sterilized object was an air filter 5 that captures airborne particulate matter, but in this other embodiment, an example is shown in which the sterilized filter is a chemical filter 9 that captures gaseous pollutants. Because this embodiment using the chemical filter 9 can be configured in a similar manner to the above-described embodiment using the air filter 5, a description of the commonalities will be omitted and differences will be mainly described. Components already described will be assigned the same reference numerals, and duplicate explanations will be omitted.

[0045] The chemical filter 9 includes a filter media pack 91 and a filter frame 92 to which the filter media pack 91 is attached. The filter media pack 91 is rectangular and slightly smaller than the filter frame 92, and is attached to the inside of the filter frame 92. To maintain airtightness between the filter media pack 91 and the filter frame 92, the gap between them may be sealed with a sealant (not shown) such as urethane. Examples of sealants that may be used include hot-melt resin and two-component curing urethane resin. The filter frame 92 may have a similar configuration to the filter frame 52, and therefore a detailed description thereof will be omitted.

[0046] The filter pack 91 includes a filter sheet 93 folded into a pleated shape (bellows or zigzag). The filter sheet 93 has a filter structure in which a sheet-like material, made of an adsorbent such as activated carbon held by an adhesive, is sandwiched between nonwoven fabric sheets. A hot-melt resin is preferably used as the adhesive. Examples of hot-melt resins include EVA (ethylene vinyl acetate), polyolefin, polyamide, polyester, and polyurethane. The nonwoven fabric sheet is made of polyethylene or polypropylene, for example.

[0047] 9, package 4 includes sterilized chemical filter 9, which is a sterilized item, a sealed bag 61 in which it is vacuum-packaged, and a sealed bag 62 in which vacuum-packaged product 40, which is the sterilized item packaged in sealed bag 61, is packaged. Package 4 is a product in which chemical filter 9 is multi-packaged in this way, and may be packaged in an outer packaging 63 to prevent dust from adhering during transport. For the same reasons as air filter 5, it is difficult to wipe chemical filter 9 with bathroom 21. For this reason, it is convenient to transport chemical filter 9 as a pre-sterilized item, making the above-mentioned multi-packaging useful.

[0048] The above-described matters regarding the packaging body 4 of the air filter 5, such as the packaging method using the sealed bags 61, 62, the material and structure of the sealed bags 61, 62, the use of the contact prevention member 55 and the protective member 56 (see Figure 5), the manufacturing method of the packaging body 4, and the sterilization treatment by gamma ray irradiation, can also be applied without any particular restrictions to the packaging body of the chemical filter 9.

[0049] The chemical filter 9 shown in Fig. 9 is sterilized by gamma ray irradiation, similar to the air filter 5. As described above, the filter medium sheet 93 of the chemical filter 9 uses a resin material as the adhesive that holds the adsorbent. In an example in which activated carbon is used as the adsorbent, polyester is used as the adhesive, and urethane is used as the sealant, the weight of the resin material accounts for approximately 52% of the weight of the chemical filter 9 excluding the filter frame 92. In this case, there is a concern that an operator may smell a strong sterilization odor caused by gamma ray irradiation when removing the chemical filter 9 from the sealed bag 61.

[0050] A mat-type chemical filter can be used instead of the pleated-type chemical filter 9. A mat-type chemical filter has a filter structure in which an adsorbent is held by applying an adhesive to a three-dimensional filament-structured foam. A sealant to seal the gap with the filter frame is not required. In an example using activated carbon as the adsorbent, urethane as the foam material, and a urethane-based adhesive, the weight of the resin material accounted for approximately 60% of the weight of the chemical filter excluding the filter frame. Therefore, even with this type, there is concern that workers may be exposed to a strong sterilization odor.

[0051] Reducing the resin content is effective in reducing the sterilization odor. In the case of a pleated type, it is possible to use a thin fibrous adhesive as the adhesive for holding the activated carbon or to reduce the amount of sealant. In the case of a mat type, it is also possible to use a thin fibrous adhesive as the adhesive for holding the activated carbon. In any of the pleated type, mat type, and corrugated honeycomb type described below, it is preferable that the weight of the resin material be 50% or less of the weight of the chemical filter excluding the filter frame.

[0052] Instead of pleated or mat-type chemical filters, corrugated honeycomb-type chemical filters can also be used. Corrugated honeycomb-type chemical filters have a filter structure in which a fiber sheet containing activated carbon as an adsorbent is formed into a corrugated honeycomb shape. A sealant to seal the gap with the filter frame is not required. The following two methods can be considered to reduce the content of resin materials that cause sterilization odors in corrugated honeycomb-type filters.

[0053] In the first strategy, a fiber sheet made of glass or a radiation-resistant resin material is used. Examples of radiation-resistant resin materials include polypropylene, polycarbonate, polyimide, polyether ether ketone (PEEK), and polyester. For example, a corrugated honeycomb-shaped structure can be created using such a fiber sheet, immersed in an aqueous dispersion of colloidal silica and activated carbon, and then dried to obtain a corrugated honeycomb-type activated carbon-containing filter structure. With this configuration, the weight of the resin material can be reduced to 5% or less of the weight of the chemical filter, excluding the filter frame.

[0054] In Method 2, activated carbon sheets are made as fiber sheets (activated carbon sheet production) and processed into a corrugated honeycomb shape. This activated carbon sheet can be produced, for example, by making Japanese paper using a dispersion of fiber and activated carbon. Instead of using a binder, a preferred method is to use resin fibers that are melted during drying to form an adhesive. The fiber material is preferably a resin material, more preferably a radiation-resistant resin material, and even more preferably polypropylene, which can be melted during drying and used as an adhesive. If glass is used as the fiber material, the resin content can be further reduced.

[0055] As described above, according to the above embodiment, the risk of contamination caused by bringing in a chemical filter without realizing that the sterilization state is not being maintained can be reduced. Furthermore, even if the chemical filter is sterilized by gamma ray irradiation, by reducing the resin content as described above, the worker who removes the chemical filter from the sealed bag will be less likely to smell the sterilization odor, thereby improving the health of the work environment.

[0056] In this embodiment, the sterilized object contained in the package is an air filter attached to a facility such as a safety cabinet, and a chemical filter used for decontamination of the facility such as a safety cabinet, but is not limited to this. Therefore, the sterilized object may be, for example, a cleaning tool such as a cloth used for wiping or wiping, or an attachment such as a gown (coverall), which is brought into a bioclean room in the same way as a filter such as an air filter.

[0057] It will be understood by those skilled in the art that the above-described embodiments are examples of the following aspects.

[0058] [1] A package of a sterilized object according to the present disclosure includes a sterilized object, a first sealed bag for vacuum-packaging the sterilized object, and a second sealed bag for packaging the vacuum-packaged object obtained by packaging the sterilized object in the first sealed bag. With this configuration, even if an accident occurs, it is easy to notice by sight or touch that the first sealed bag has become unsealed, thereby reducing the risk of contamination caused by bringing in an object without realizing that the sterilization state has not been maintained.

[0059] [2] In the package of the sterilized material according to [1] above, the second sealed bag may be non-vacuum packaged. This configuration makes it easier to notice, by sight or touch, any abnormality that occurs when the first sealed bag is no longer sealed (for example, a bulge in the first sealed bag) before opening the second sealed bag or immediately after opening the second sealed bag, which is advantageous in reducing the risk of contamination.

[0060] [3] In the package of the sterilized material according to [1] above, the second sealed bag may be vacuum-packaged. This configuration makes it easier to notice by sight or touch that the second sealed bag has become unsealed, which is advantageous in reducing the risk of contamination.

[0061] [4] In the package for sterilized materials according to any one of [1] to [3] above, the second sealed bag may be at least partially transparent or semi-transparent so that its interior can be seen. With this configuration, it is possible to check for abnormalities that occur when the first sealed bag is no longer sealed (for example, bulging of the first sealed bag) without opening the second sealed bag.

[0062] [5] In the package for the sterilized object according to any one of the above [1] to [4], the first sealed bag may have gas barrier properties, thereby preventing the first sealed bag from appearing to be unsealed, which can lead to a misidentification.

[0063] [6] The package of any one of the sterilized items [1] to [5] above may be configured such that the sterilized item is a sterilized filter. This configuration reduces the risk of contamination caused by unknowingly bringing in a filter that is not in a sterile state.

[0064] [7] In the package for the sterilized product of [6] above, the filter may be sterilized by gamma ray irradiation. Gamma rays have the property of penetrating aluminum, which is convenient for sterilizing the filter without any problems.

[0065] [8] In the package for sterilized material of [6] or [7] above, the filter may have a filter medium pack and a filter frame to which the filter medium pack is attached, and a contact prevention member is interposed between the corners of the filter frame and the inner surface of the first sealing bag to prevent them from coming into contact. With this configuration, it is possible to prevent damage to the inner surface of the first sealing bag that is in close contact with the corners of the filter frame due to vacuuming, and to maintain a good sealed state.

[0066] [9] In the package for sterilized materials according to the above [8], the contact-preventing member may be partially attached so as to cover the corners of the filter frame. According to this configuration, the partially attached contact-preventing member can prevent damage to the first sealing bag.

[0067]

[10] In the package for sterilized materials according to [8], the contact-preventing member may be attached so as to cover the periphery of the filter frame. With this configuration, the number of parts of the contact-preventing member can be reduced and the attachment work can be simplified.

[0068]

[11] In the package of any one of the above [6] to

[10] for the sterilized material, the filter may have a filter media pack and a filter frame to which the filter media pack is attached, and a protective member may be interposed between the filter media pack and the inner surface of the first sealed bag to prevent them from contacting each other and protect the filter media pack. With this configuration, damage to the filter media pack (especially the filter media sheet contained therein) due to tight contact of the vacuum-drawn first sealed bag can be prevented.

[0069]

[12] In the package of any one of the above [6] to

[11] for a sterile item, the filter may be an air filter. In this case, the risk of contamination caused by bringing in an air filter without realizing that the sterility of the air filter has not been maintained can be reduced.

[0070]

[13] In the package of any one of the above [6] to

[11] for a sterilized object, the filter may be a chemical filter. In this case, the risk of contamination caused by bringing in a chemical filter without realizing that the sterilized state of the chemical filter has not been maintained can be reduced.

[0071] Although the embodiment of the package for sterilized materials according to the present disclosure has been described based on the drawings, the specific configuration should not be considered to be limited to this embodiment. The scope of the present invention is indicated not only by the description of the above embodiment but also by the claims, and further includes all modifications within the meaning and scope equivalent to the claims.

[0072] The package for sterilized items according to the present disclosure is not limited to the above-described embodiment, and is not limited to the above-described effects. The package for sterilized items according to the present disclosure can be improved or modified in various ways without departing from the spirit of the present disclosure. Furthermore, the configurations employed in the above-described embodiment can be combined in any desired manner.

[0073] 1 Bioclean room, 4 Package, 5 Air filter (an example of a filter) 9 Chemical filter 9 (an example of a filter), 10 Safety cabinet (an example of a work cabinet), 40 Vacuum package 51 Filter material pack, 52 Filter frame, 52c Corner portion, 53 Filter material sheet, 55 Contact prevention member, 56 Protective member, 61 First sealing bag, 62 Second sealing bag

Claims

1. A package of a sterilized object comprising a sterilized object, a first sealed bag for vacuum-packaging the sterilized object, and a second sealed bag for packaging a vacuum-packaged product obtained by packaging the sterilized object in the first sealed bag.

2. A package of sterilized material according to claim 1, wherein the packaging in the second sealed bag is non-vacuum packaging.

3. A package of sterilized material according to claim 1, wherein the packaging in the second sealed bag is vacuum packaging.

4. A package for a sterilized item according to claim 1, wherein at least a portion of the second sealed bag is transparent or semi-transparent so that the inside of the bag can be seen.

5. A package for sterilized items according to claim 1, wherein the first sealed bag has gas barrier properties.

6. A package of a sterilized product according to any one of claims 1 to 5, wherein the sterilized product is a sterilized filter.

7. The package of sterile material according to claim 6, wherein said filter is sterilized by gamma irradiation.

8. A package of sterilized material as described in claim 6, wherein the filter has a filter media pack and a filter frame to which the filter media pack is attached, and a contact prevention member is interposed between the corners of the filter frame and the inner surface of the first sealed bag to prevent them from coming into contact.

9. The package for sterilized material according to claim 8, wherein the contact prevention member is attached partially to cover the corners of the filter frame.

10. A package for sterilized materials according to claim 8, wherein the contact prevention member is attached so as to cover the periphery of the filter frame.

11. A package of sterilized material as described in claim 6, wherein the filter has a filter media pack and a filter frame to which the filter media pack is attached, and a protective member is interposed between the filter media pack and the inner surface of the first sealed bag to prevent contact between them and protect the filter media pack.

12. The package for a sterile item according to claim 6, wherein the filter is an air filter.

13. The package for a sterile item according to claim 6, wherein the filter is a chemical filter.

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