Sterilized packaging systems

Abstract

A packaging system (10), including an outer bag (36) constructed from a gas-impervious material, the outer bag including a valve (44) in fluid communication with an interior cavity (40) of the outer bag; one or more bags (24) positioned in the interior cavity of the outer bag, wherein each of the one or more bags includes a gas-impervious portion (32) and a porous portion (34) configured to allow a sterilizing gas to penetrate therein; one or more containers (12) positioned inside each of the one or more bags, wherein each of the one or more containers includes a porous portion configured to allow a sterilizing gas to penetrate therein; and one or more sterilizable items (18) positioned inside each of the one or more containers.

Description

FIELD OF THE INVENTION

[0001] The present disclosure relates generally to packaging, storage, and transport systems for sterilizable items, and features and methods for detecting a loss of sterilization integrity of such packaging and systems.BACKGROUND OF THE INVENTION

[0002] Various medical devices and related components may be transported from one site to another during manufacturing, assembly, and / or ultimate delivery to a healthcare facility for use. Such devices and components, which may include syringes, medical or surgical instruments, medicine vials or containers, bandaging, or other healthcare items, may be placed inside a bag, sealed, and sterilized prior to transportation or storage. These sterilization bags are intended to provide a barrier to prevent contaminants, including microorganisms, from entering the bag. The integrity of the sterilization bag has to be maintained until opening for final use of the medical devices or components therein. Otherwise, there exists a risk that contamination of the medical devices occurs, with possibly hazardous consequences for the patient.

[0003] A loss of integrity of an individual sterilization bag may not be easily visible, e.g., in the case of a small breach formed in a wall of a single bag in a container with multiple sterilization bags therein. Thus, even if one or more sterilization bags in larger container are seemingly undamaged, the medical devices in one or more of the sterilization bags may have, in fact, been contaminated through even a small breach with limited visibility. Out of an abundance of caution and in order to counteract such possible contamination of the medical devices, a second sterilization or decontamination process may be carried out at the point of use. However, such potentially-duplicative procedures, which may be applied to all the medical devices contained in multiple bags, is expensive and time-consuming. The present disclosure provides systems, devices, and methods of use thereof for sterile storage, transport, and visible indication of a compromised environment within one or more containers having multiple individual sterilization bags therein.SUMMARY OF THE INVENTION

[0004] In accordance with one aspect, the present disclosure is directed to a packaging system, comprising an outer bag constructed from a gas-impervious material, the outer bag including a valve in fluid communication with an interior cavity of the outer bag; one or more bags positioned in the interior cavity of the outer bag, wherein each of the one or more bags includes a gas-impervious portion and a porous portion configured to allow a sterilizing gas to penetrate therein; one or more containers positioned inside each of the one or more bags, wherein each of the one or more containers includes a porous portion configured to allow a sterilizing gas to penetrate therein; and one or more sterilizable items positioned inside each of the one or more containers.

[0005] In some non-limiting embodiments or aspects, the gas-impervious material of the outer bag may include at least one of low density polyethylene (LDPE), linear low density polyethylene (LLDPE), metallocene polyethylene, biaxially-oriented polyethylene terephthalate (BoPET), or ethylene-vinyl acetate / polyethylene (EVA / PE).

[0006] In some non-limiting embodiments or aspects, the gas-impervious portion of the one or more bags may include at least one of low density polyethylene (LDPE), linear low density polyethylene (LLDPE), metallocene polyethylene, biaxially-oriented polyethylene terephthalate (BoPET), or ethylene-vinyl acetate / polyethylene (EVA / PE).

[0007] In some non-limiting embodiments or aspects, the porous portion of the one or more bags may be constructed at least in part from high-density polyethylene (HDPE) fibers, coated cellulose fibers, or uncoated cellulose fibers.

[0008] In some non-limiting embodiments or aspects, the porous portion of the one or more containers may be constructed at least in part from high-density polyethylene (HDPE) fibers, coated cellulose fibers, or uncoated cellulose fibers.

[0009] In some non-limiting embodiments or aspects, the outer bag may comprise a resealable opening sized to permit the one or more bags to be placed therein.

[0010] In some non-limiting embodiments or aspects, each of the one or more bags may comprise a resealable opening sized to permit the one or more containers to be placed therein.

[0011] In some non-limiting embodiments or aspects, the packaging system may include an outer container, wherein the outer bag may be at least partially positioned within the outer container.

[0012] In some non-limiting embodiments or aspects, the outer container may be constructed from cardboard or polypropylene.

[0013] In some non-limiting embodiments or aspects, the one or more bags may comprise a plurality of bags.

[0014] In some non-limiting embodiments or aspects, the one or more containers may comprise a plurality of containers positioned inside each of the plurality of bags.

[0015] In some non-limiting embodiments or aspects, the one or more sterilizable items may comprise a plurality of sterilizable items positioned inside each of the plurality of containers.

[0016] In some non-limiting embodiments or aspects, a process for packaging a medical device is disclosed, comprising: placing a sterilizable item into a container, the container including a porous portion configured to allow a sterilizing gas to penetrate therein; placing the container into a bag, the bag comprising: a gas-impervious portion; and a porous portion configured to allow a sterilizing gas to penetrate into the bag; placing the bag into an outer bag, wherein the outer bag is constructed from a gas-impervious material; introducing a sterilizing agent into the outer bag such that sterilizing agent passes through the porous portions of the bag and the container; and creating a vacuum within the outer bag by evacuating gas out of the outer bag.

[0017] In some non-limiting embodiments or aspects, the outer bag may include a valve, the sterilizing agent may be introduced through the valve, and gas may be evacuated out of the valve to create a vacuum within the outer bag.

[0018] In some non-limiting embodiments or aspects, the process may comprise placing the outer bag in an outer container.

[0019] In some non-limiting embodiments or aspects, placing the outer bag in an outer container may occur before introducing the sterilization agent into the outer bag.

[0020] In some non-limiting embodiments or aspects, the outer bag may include a valve accessible through an opening in the outer container, and the sterilizing agent may be introduced through the valve while the outer bag is in the outer container.

[0021] In some non-limiting embodiments or aspects, the bag may comprise a resealable opening, and placing the container in the bag may include passing the container through the resealable opening.

[0022] In some non-limiting embodiments or aspects, the outer bag may comprise a resealable opening, and placing the bag in the outer bag may include passing the bag through the resealable opening.

[0023] Further examples of the present disclosure will now be described in the following numbered clauses.

[0024] Clause 1: A packaging system, comprising: an outer bag constructed from a gas-impervious material, the outer bag including a valve in fluid communication with an interior cavity of the outer bag; one or more bags positioned in the interior cavity of the outer bag, wherein each of the one or more bags includes a gas-impervious portion and a porous portion configured to allow a sterilizing gas to penetrate therein; one or more containers positioned inside each of the one or more bags, wherein each of the one or more containers includes a porous portion configured to allow a sterilizing gas to penetrate therein; and one or more sterilizable items positioned inside each of the one or more containers.

[0025] Clause 2: The system of clause 1, wherein the gas-impervious material of the outer bag includes at least one of low density polyethylene (LDPE), linear low density polyethylene (LLDPE), metallocene polyethylene, biaxially-oriented polyethylene terephthalate (BoPET), or ethylene-vinyl acetate / polyethylene (EVA / PE).

[0026] Clause 3: The system of clause 1 or clause 2, wherein the gas-impervious portion of the one or more bags includes at least one of low density polyethylene (LDPE), linear low density polyethylene (LLDPE), metallocene polyethylene, biaxially-oriented polyethylene terephthalate (BoPET), or ethylene-vinyl acetate / polyethylene (EVA / PE).

[0027] Clause 4: The system of any of clauses 1-3, wherein the porous portion of the one or more bags is constructed at least in part from high-density polyethylene (HDPE) fibers, coated cellulose fibers, or uncoated cellulose fibers.

[0028] Clause 5: The system of any of clauses 1-4, wherein the porous portion of the one or more containers is constructed at least in part from high-density polyethylene (HDPE) fibers, coated cellulose fibers, or uncoated cellulose fibers.

[0029] Clause 6: The system of any of clauses 1-5, wherein the outer bag comprises a resealable opening sized to permit the one or more bags to be placed therein.

[0030] Clause 7: The system of any of clauses 1-6, wherein each of the one or more bags comprises a resealable opening sized to permit the one or more containers to be placed therein.

[0031] Clause 8: The system of any of clauses 1-7, further comprising an outer container, wherein the outer bag is at least partially positioned within the outer container.

[0032] Clause 9: The system of clause 8, wherein the outer container is constructed from cardboard or polypropylene.

[0033] Clause 10: The system of any of clauses 1-9, wherein the one or more bags comprises a plurality of bags.

[0034] Clause 11: The system of clause 10, wherein the one or more containers comprises a plurality of containers positioned inside each of the plurality of bags.

[0035] Clause 12: The system of clause 11, wherein the one or more sterilizable items comprises a plurality of sterilizable items positioned inside each of the plurality of containers.

[0036] Clause 13: A process for packaging a medical device comprising: placing a sterilizable item into a container, the container including a porous portion configured to allow a sterilizing gas to penetrate therein; placing the container into a bag, the bag comprising a gas-impervious portion; and a porous portion configured to allow a sterilizing gas to penetrate into the bag; placing the bag into an outer bag, wherein the outer bag is constructed from a gas-impervious material; introducing a sterilizing agent into the outer bag such that sterilizing agent passes through the porous portions of the bag and the container; and creating a vacuum within the outer bag by evacuating gas out of the outer bag.

[0037] Clause 14: The process of clause 13, wherein the outer bag includes a valve, the sterilizing agent is introduced through the valve, and gas is evacuated out of the valve to create a vacuum within the outer bag.

[0038] Clause 15: The process of clause 13 or clause 14, further comprising placing the outer bag in an outer container.

[0039] Clause 16: The process of clause 15, wherein placing the outer bag in an outer container occurs before introducing the sterilization agent into the outer bag.

[0040] Clause 17: The process of clause 16, wherein the outer bag includes a valve accessible through an opening in the outer container, and wherein the sterilizing agent is introduced through the valve while the outer bag is in the outer container.

[0041] Clause 18: The process of any of clauses 13-17, wherein the bag further comprises a resealable opening, and wherein placing the container in the bag includes passing the container through the resealable opening.

[0042] Clause 19: The process of any of clauses 13-18, wherein the outer bag further comprises a resealable opening, and wherein placing the bag in the outer bag includes passing the bag through the resealable opening.BRIEF DESCRIPTION OF THE DRAWINGS

[0043] The above-mentioned and other features and advantages of this disclosure, and the manner of attaining them, will become more apparent and the disclosure itself will be better understood by reference to the following descriptions of embodiments of the disclosure taken in conjunction with the accompanying drawings, wherein: Fig. 1 is a perspective view of an example of a container of a packaging system constructed in accordance with the principles of the present invention. Fig. 2 is a side view of an example of a bag of a packaging system constructed in accordance with the principles of the present invention. Fig. 3 is a perspective view of an example of an outer bag and outer container of a packaging system constructed in accordance with the principles of the present invention. DESCRIPTION OF THE INVENTION

[0044] The following description is provided to enable those skilled in the art to make and use the described embodiments contemplated for carrying out the invention. Various modifications, equivalents, variations, and alternatives, however, will remain readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the present invention.

[0045] For purposes of the description hereinafter, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal", and derivatives thereof shall relate to the concept as it is oriented in the drawing figures. However, it is to be understood that the concept may assume various alternative variations, except where expressly specified to the contrary. It is also to be understood that the specific devices illustrated in the attached drawings, and described in the following specification, are simply exemplary embodiments of the concept. Hence, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered as limiting.

[0046] The word "comprising" and "comprises", and the like, does not exclude the presence of elements or steps other than those listed in any claim or the specification as a whole. In the present specification, "comprises" means "includes" and "comprising" means "including."

[0047] As used herein, "at least one of' is synonymous with "one or more of." For example, the phrase "at least one of A, B, or C" means any one of A, B, or C, or any combination of any two or more of A, B, or C. For example, "at least one of A, B, and C" includes A alone; or B alone; or C alone; or A and B; or A and C; or B and C; or all of A, B, and C.

[0048] The term "at least" is synonymous with "greater than or equal to." The terms "first", "second", and the like are not intended to refer to any particular order or chronology, but refer to different conditions, properties, or elements. As used herein, the singular form of "a", "an", and "the" include plural referents unless the context clearly dictates otherwise.

[0049] All numbers used in the specification and claims are to be understood as being modified in all instances by the term "about". By "about" is meant within plus or minus twenty-five percent of the stated value. However, this should not be considered as limiting to any analysis of the values under the doctrine of equivalents.

[0050] Unless otherwise indicated, all ranges or ratios disclosed herein are to be understood to encompass the beginning and ending values and any and all subranges or subratios subsumed therein. For example, a stated range or ratio of "1 to 10" should be considered to include any and all subranges or subratios between (and inclusive of) the minimum value of 1 and the maximum value of 10; that is, all subranges or subratios beginning with a minimum value of 1 or more and ending with a maximum value of 10 or less. The ranges and / or ratios disclosed herein represent the average values over the specified range and / or ratio.

[0051] The present disclosure provides systems, devices, and methods of use thereof for sterile storage, transport, and visible indication of a compromised environment within one or more containers having multiple individual sterilization bags therein that comprise a packaging assembly or system, generally indicated as 10.

[0052] Referring now to FIG. 1, the system 10 may include a container 12 according to the present disclosure generally includes or defines a plurality of walls 14 assembled or joined to define an interior cavity 16 therein sized and shaped to contain one or more devices, components, instruments, or other items (collectively referred to as '18') to be sterilized and / or maintained in a sterile condition. Items 18 may include, for example, one or more syringes, needle guards, collection tubes, or any other manner of sterilizable item, which may be intended for use in a healthcare setting or otherwise. The container 12 may include or define one or more trays, shelfs, organizers, or other structure 20 sized and shaped to stabilize, support, organize, or otherwise receive one or more of the items 18 therein. The container 12 may include a lid 22 sized and shaped to seal the interior cavity 16 of the container 12 and the contents therein. The lid 22 may include a hinge and / or a clasp configured to permanently or reversibly attach the lid 22 to the container. In one example or aspect, the lid 22 may include or comprise one or more layers of film, sheeting, or other pliable material that is sealed to the container 12 to enclose the items 18 therein. The lid 22 may be sealed or otherwise coupled to the container 12 through heat sealing, adhesive, or any other suitable process to ensure the sterility of the environment within the container 12.

[0053] One or more portions of the container 12 may be constructed from or otherwise include a sufficiently porous material that is breathable and permeable to gases for sterilization but is impermeable to microorganisms. Such material may include, for example, Tyvek ®< films or other materials providing the properties and features described herein.

[0054] Now referring to FIG. 2, the system 10 may generally include a bag 24 configured or adapted to receive and contain one or more of the containers 12 therein. The bag 24 may be sized and shaped to define an inner volume with the capacity to contain a desired quantity of container 12, and any intermediate packaging or otherwise, facilitating packing, transport, and or storage of the items 18. The bag 24 may generally include an outer wall or surface 26 constructed from one or more layers of a film or other material providing the characteristics and features described herein, such that the outer wall 26 encloses or defines an interior cavity 28 to accommodate the one or more containers 12 stored therein. The bag 24 may include one or more openings 30 therein to permit insertion or removal of contents into and out of the bag 24. Such openings 30 may have a resealable closure to permit the bag 24 to be re-used, or alternatively, may have one or more openings 30 permanently sealed or fused after contents are deposited within the bag 24.

[0055] The bag 24 may define or include a substantially non-porous, gas-impervious portion 32 and a gas permeable, porous portion 34. "Gas-impervious" refers to a portion with a low permeability to gases. The permeability of the gas-impervious portion 32 may depend on the desired shelf life of the packaging, of the considered gas(es) and of the thickness of the porous portion 34. In one non-limiting example, a low permeability to oxygen is a permeability less than 1,000cm 3< / 25µm / 24h. In one aspect or example, the non-porous portion 32 may include one or more layers of polymeric materials, including but not limited to polyethylene, in particular low density polyethylene (LDPE) or linear low density polyethylene (LLDPE), metallocene polyethylene, biaxially-oriented polyethylene terephthalate (BoPET), ethylene-vinyl acetate / polyethylene (EVA / PE), polyethylene / polyamide mixtures (PE / PA / PE), and mixtures thereof.

[0056] The porous portion 34 may be adapted or configured to facilitate gas sterilization of the contents of the bag 24 and the container(s) 12 therein, while remaining impermeable to contaminants including microorganisms, bacteria, etc. Such gas sterilization may include, for example, transmission or exposure to ethylene oxide (EtO), steam, or other agent through the porous portion 34. By porous, it is meant that the material, thickness, and permeability to gas of the portion 34 are configured to allow a sufficient flow of sterilizing gas to pass through the wall. In one example, the porous portion 34 may be constructed from a nonwoven material made of high-density polyethylene (HDPE) fibers, such as Tyvek ®< , which is frequently used to fulfill the function of the porous wall in a sterilizable bag. In other examples, the nonwoven material may at least partially include coated cellulose fibers and / or uncoated cellulose fibers.

[0057] In one example, the non-porous portion 32 has a greater surface area of the outer wall 26 of the bag 24 than the porous portion 34. The surface area of the porous portion 34 may generally be sufficient to allow an efficient decontamination of the contents of the bag 24, while being limited in order to reduce the porosity of the bag 34 after a sterilization process. As one example, for EtO sterilization, the surface area of the porous portion 34 may be configured so as to allow sufficient EtO desorption, As another example, for steam sterilization, the surface area of the porous portion 34 may be configured so as to prevent excess water accumulation.

[0058] Now referring to FIG. 3, the system 10 may include an outer bag 36 configured to receive and contain one or more of the bags 24 therein. The outer bag 36 may be sized and shaped to define an inner volume with the capacity to contain a desired quantity of the bags 24 (with one or more containers 12 in each bag 24), and any intermediate packaging or otherwise, facilitating packing, transport, and or storage of the bags 24, containers 12, and items 18. The outer bag 36 may generally include an outer wall or surface 38 constructed from one or more layers of a film or other material providing the characteristics and features described herein, such that the outer wall 38 encloses or defines an interior cavity 40 to accommodate the one or more bags 24 stored therein. The outer bag 36 may include one or more openings 42 therein to permit insertion or removal of contents into and out of the outer bag 36. Such openings 42 may have a resealable closure to permit the outer bag 36 to be re-used, or alternatively, may have one or more openings 36 permanently sealed or fused after contents are deposited within the outer bag 36.

[0059] The outer bag 36 may be constructed from one or more substantially non-porous, gas-impervious materials, include one or more layers of polymeric materials. In one example or aspect, such materials may include, but not be limited to, polyethylene, in particular low density polyethylene (LDPE) or linear low density polyethylene (LLDPE), metallocene polyethylene, biaxially-oriented polyethylene terephthalate (BoPET), ethylene-vinyl acetate / polyethylene (EVA / PE), polyethylene / polyamide mixtures (PE / PA / PE), and mixtures thereof.

[0060] The outer bag 36 may include a valve 44 attached on or about a portion of the outer wall 38. The valve 44 may be adapted or configured to facilitate and / or regulate selective fluid flow in and out of the interior cavity 40 of the outer bag 36. In one example or aspect, the valve 44 may be used to introduce a sterilizing agent into the interior cavity 40 of the outer bag 36, while subsequently being used to evacuate any gaseous contents in the interior cavity 40 and thus create a vacuum within the interior cavity 40, as described herein. In some embodiments, the valve 44 may include a cap thereon (e.g., polypropylene cap) that seals the valve 44 after vacuum.

[0061] Continuing to refer to FIG. 3, the system 10 may include an outer container 46 adapted or configured to receive the outer bag 36 at least partially therein. The outer container 46 may include an upper portion 48, a lower portion 50, one or more sidewalls 52 extending between the upper and lower portions, and a cavity 54 defined therein. The upper portion 48 and / or lower portion 50 may define or include one or more substantially planar surfaces to enable a plurality of similarly configured containers to be stacked upon one another. The outer container 46 may include or define an opening 56 in one or more of the sidewalls 52 adapted or configured to provide access to the valve 44 or other portion of the outer bag 36.

[0062] The outer container 46 may be constructed from one or more of cardboard and / or akylux (polypropylene). The outer container 46 may provide sufficient rigidity and / or strength to resist impact, sterilization process conditions (e.g., heat and humidity resistance), or other potentially damaging forces experienced by the outer bag(s) 36, bag(s) 24, container(s) 12, items 18, and / or other components of the system 10 during transport or storage, and may have sufficient rigidity or strength to support multiple containers in a stacked configuration.

[0063] In an example of use of the system 10, a plurality of items 18 may be inserted or positioned into a plurality of the containers 12. The plurality of the containers 12 may be inserted or otherwise positioned in a plurality of the bags 24. A plurality of the bags 24 may be inserted or otherwise positioned in a single outer bag 36. The contents of the outer bag 36 may then be sterilized. Such sterilization may be achieved, for example, by introducing a sterilizing gas through the valve 44 of the outer bag 36 in sufficient quantities and for sufficient duration to permeate the porous portions 34 of each bag 24 in the outer bag 36, and subsequently into each containers 12 inside each bag 24. Once the sterilization process is complete, and the items 18 are sterilized, a vacuum pump or other fluid extraction device (not shown) may be attached to the valve 44 and actuated to evacuate air, sterilization gas, or other fluid from the containers 12, bags 24, and the outer bag 36 so as to create a vacuum for tamper evidence. The outer bag 36 may, for example, be evacuated until the outer bag 36 is substantially collapsed around the interior contents of the outer bag 36, indicating that all or most gas / fluid has been removed from the outer bag 36. Once excess gas or fluid has been sufficiently evacuated from the outer bag 36, the outer bag 36 may be transported and / or stored for future use.

[0064] Upon reaching a destination or otherwise being ready for use, the outer bag 36 can be visually inspected to ascertain whether the evacuated condition is still present, which is a direct indication of whether the interior sterilized environment of the outer bag 36 - including the environments in each and every container 12 and bag 24 inside the outer bag 26 - has been compromised. For example, even a small hole or breach of the outer bag 36 will remove the vacuum state therein, causing the outer bag 36 to 'relax' or otherwise expand from the evacuated, collapsed state, and will be readily visible without requiring close-up inspection of the entire surface of the outer bag 36 or individual inspection of every bag 24 therein.

[0065] It will be appreciated by persons skilled in the art that the present disclosure is not limited to what has been particularly shown and described herein above. In addition, unless mention was made above to the contrary, it should be noted that all of the accompanying drawings are not to scale. Of note, the system components have been represented where appropriate by conventional symbols in the drawings, showing only those specific details that are pertinent to understanding the embodiments of the present disclosure so as not to obscure the disclosure with details that will be readily apparent to those of ordinary skill in the art having the benefit of the description herein. Moreover, while certain embodiments or figures described herein may illustrate features not expressly indicated on other figures or embodiments, it is understood that the features and components of the examples disclosed herein are not necessarily exclusive of each other and may be included in a variety of different combinations or configurations without departing from the scope and spirit of the disclosure. A variety of modifications and variations are possible in light of the above teachings without departing from the scope and spirit of the disclosure, which is limited only by the following claims.

Claims

1. A packaging system, comprising: an outer bag constructed from a gas-impervious material, the outer bag including a valve in fluid communication with an interior cavity of the outer bag; one or more bags positioned in the interior cavity of the outer bag, wherein each of the one or more bags includes a gas-impervious portion and a porous portion configured to allow a sterilizing gas to penetrate therein; one or more containers positioned inside each of the one or more bags, wherein each of the one or more containers includes a porous portion configured to allow a sterilizing gas to penetrate therein; and one or more sterilizable items positioned inside each of the one or more containers.

2. The packaging system of claim 1, wherein the gas-impervious material of the outer bag includes at least one of low density polyethylene (LDPE), linear low density polyethylene (LLDPE), metallocene polyethylene, biaxially-oriented polyethylene terephthalate (BoPET), or ethylene-vinyl acetate / polyethylene (EVA / PE).

3. The packaging system of claim 1, wherein the gas-impervious portion of the one or more bags includes at least one of low density polyethylene (LDPE), linear low density polyethylene (LLDPE), metallocene polyethylene, biaxially-oriented polyethylene terephthalate (BoPET), or ethylene-vinyl acetate / polyethylene (EVA / PE).

4. The packaging system of claim 1, wherein the porous portion of the one or more bags is constructed at least in part from high-density polyethylene (HDPE) fibers, coated cellulose fibers, or uncoated cellulose fibers.

5. The packaging system of claim 1, wherein the porous portion of the one or more containers is constructed at least in part from high-density polyethylene (HDPE) fibers, coated cellulose fibers, or uncoated cellulose fibers.

6. The packaging system of claim 1, wherein the outer bag comprises a resealable opening sized to permit the one or more bags to be placed therein.

7. The packaging system of claim 1, wherein each of the one or more bags comprises a resealable opening sized to permit the one or more containers to be placed therein.

8. The packaging system of claim 1, further comprising an outer container, wherein the outer bag is at least partially positioned within the outer container.

9. The packaging system of claim 8, wherein the outer container is constructed from cardboard or polypropylene.

10. The packaging system of claim 1, wherein the one or more bags comprises a plurality of bags.

11. The packaging system of claim 10, wherein the one or more containers comprises a plurality of containers positioned inside each of the plurality of bags.

12. The packaging system of claim 11, wherein the one or more sterilizable items comprises a plurality of sterilizable items positioned inside each of the plurality of containers.

13. A process for packaging a medical device comprising: placing a sterilizable item into a container, the container including a porous portion configured to allow a sterilizing gas to penetrate therein; placing the container into a bag, the bag comprising: a gas-impervious portion; and a porous portion configured to allow a sterilizing gas to penetrate into the bag; placing the bag into an outer bag, wherein the outer bag is constructed from a gas-impervious material; introducing a sterilizing agent into the outer bag such that sterilizing agent passes through the porous portions of the bag and the container; and creating a vacuum within the outer bag by evacuating gas out of the outer bag.

14. The process of claim 13, wherein the outer bag includes a valve, the sterilizing agent is introduced through the valve, and gas is evacuated out of the valve to create a vacuum within the outer bag.

15. The process of claim 13, further comprising placing the outer bag in an outer container.

16. The process of claim 15, wherein placing the outer bag in an outer container occurs before introducing the sterilization agent into the outer bag.

17. The process of claim 16, wherein the outer bag includes a valve accessible through an opening in the outer container, and wherein the sterilizing agent is introduced through the valve while the outer bag is in the outer container.

18. The process of claim 13, wherein the bag further comprises a resealable opening, and wherein placing the container in the bag includes passing the container through the resealable opening.

19. The process of claim 13, wherein the outer bag further comprises a resealable opening, and wherein placing the bag in the outer bag includes passing the bag through the resealable opening.

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