WO2025085367A1 - Unité d'emballage et procédé d'extension de la durée de conservation d'un produit emballé - Google Patents

Unité d'emballage et procédé d'extension de la durée de conservation d'un produit emballé Download PDF

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Publication number
WO2025085367A1
WO2025085367A1 PCT/US2024/051237 US2024051237W WO2025085367A1 WO 2025085367 A1 WO2025085367 A1 WO 2025085367A1 US 2024051237 W US2024051237 W US 2024051237W WO 2025085367 A1 WO2025085367 A1 WO 2025085367A1
Authority
WO
WIPO (PCT)
Prior art keywords
flexible bag
outer flexible
packaged products
sterilized
package unit
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2024/051237
Other languages
English (en)
Inventor
James R. Lamb
Florian Chapalain
Geoffroy Gruson
Nikolai LOMASOV
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Amcor Flexibles North America Inc
Original Assignee
Amcor Flexibles North America Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Amcor Flexibles North America Inc filed Critical Amcor Flexibles North America Inc
Publication of WO2025085367A1 publication Critical patent/WO2025085367A1/fr
Anticipated expiration legal-status Critical
Pending legal-status Critical Current

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D77/00—Packages formed by enclosing articles or materials in preformed containers, e.g. boxes, cartons, sacks or bags
    • B65D77/04—Articles or materials enclosed in two or more containers disposed one within another
    • B65D77/0406—Rigid containers in preformed flexible containers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D77/00—Packages formed by enclosing articles or materials in preformed containers, e.g. boxes, cartons, sacks or bags
    • B65D77/04—Articles or materials enclosed in two or more containers disposed one within another

Definitions

  • This disclosure is related to sterilized packaged products and a system and method for extending the shelf life of those packaged goods.
  • flexible packaging materials have been utilized for sterilized products to improve flexibility, reduce bulkiness and increase sustainability efforts.
  • the techniques described herein relate to a package unit including: an outer flexible bag and one or more sterilized packaged products hermetically sealed inside the outer flexible bag.
  • the techniques described herein relate to a package unit wherein the outer flexible bag includes an oxygen transmission rate (OTR) of less than 2 cc/m 2 /day according to ASTM Fl 927 using conditions of 1 atmosphere, 23 °C and 50% RH).
  • OTR oxygen transmission rate
  • the techniques described herein relate to a package unit wherein the outer flexible bag includes a moisture vapor transmission rate (MVTR) of less than 2 g/m 2 /day according to ASTM F 1249 at 38°C/90%RH. [0008] In some aspects, the techniques described herein relate to a package unit further including an inert headspace within the outer flexible bag.
  • MVTR moisture vapor transmission rate
  • the techniques described herein relate to a package unit wherein the inert headspace includes inert gas and an oxygen level less than 5% by volume.
  • the techniques described herein relate to a package unit further including an air headspace within the outer flexible bag.
  • the techniques described herein relate to a package unit wherein the sterilized packaged products are vacuum packaged inside the outer flexible bag.
  • the techniques described herein relate to a package unit wherein the sterilized packaged products have been sterilized in an environment including elevated temperature and moisture.
  • the techniques described herein relate to a package unit wherein the environment further included inert gas.
  • the techniques described herein relate to a system for storing sterilized packaged products including: an outer flexible bag and one or more sterilized packaged products hermetically sealed inside the outer flexible bag.
  • the techniques described herein relate to a system further including an inert headspace inside the outer flexible bag.
  • the techniques described herein relate to a system further including an air headspace inside the outer flexible bag.
  • the techniques described herein relate to a method for extending shelf-life of sterilized packaged products including: hermetically sealing a product in a package including one or more primary package components to result in packaged products; sterilizing the packaged products in a sterilizing cycle including elevated temperature and moisture to result in sterilized packaged products; and sealing one or more sterilized packaged products in an outer flexible bag.
  • the techniques described herein relate to a method wherein sealing the sterilized packaged products in an outer flexible bag further includes an inert headspace inside the outer flexible bag.
  • the techniques described herein relate to a method wherein sealing the sterilized packaged products in an outer flexible bag further includes an air headspace inside the outer flexible bag. [0020] In some aspects, the techniques described herein relate to a method wherein sealing the sterilized packaged products in an outer flexible bag further includes removal of most of the headspace prior to the final sealing.
  • package unit refers to one or more products packaged in a primary package, all within a secondary package of an outer flexible bag.
  • primary package components refers to the package that is in contact with the packaged product.
  • sterilizized packaged products refers to hermetically sealed primary packages that contain a product and have gone through a sterilization process such as retort. The sterilization process rids the product of harmful microbial activity, rendering the product stable even at room temperature.
  • hermetic refers to a seal or sealed package that is completely closed and essentially airtight.
  • Hermetically sealed packages generally have a need for storage and package integrity over a period that is greater than a few days.
  • Package integrity includes a consistent appearance, maintenance of barrier properties, maintenance of lamination bonds, and maintenance of seals.
  • hermetic package or “hermetically sealed” refers to a package that is closed in some manner such that the inside of the package and the product therein are isolated from the environment outside of the package.
  • sealed hermetic packages are significantly airtight and moisture proof. For medical products, hermetic packages are often maintaining a sterile environment inside, preventing ingress of bacteria or other living microorganisms.
  • the headspace within a hermetically sealed package is the gas filled space between the packaged product and the packaging material.
  • air headspace refers to the gas within a package as consisting of a composition generally the same as air (i.e., 80% nitrogen, 20% oxygen).
  • inert headspace refers to the gas with a package as consisting of a composition that includes a significant proportion of an inert gas.
  • the package is sealed after flushing the package to at least 50%, at least 80% or at least 90% inert gas.
  • the inert headspace may include less than 5% oxygen or less than 2% oxygen.
  • inert gas refers to non-reactive gasses such as nitrogen or carbon dioxide.
  • the package barrier may reduce the influx of moisture or water through the barrier film during the shelf-life of a packaged product (i.e., while the package is hermetically sealed).
  • the moisture vapor transmission rate (MVTR or WVTR) of the barrier film is an indication of the barrier provided and can be measured according to ASTM Fl 249 using conditions of 1 atmosphere, 23 °C and 90% RH.
  • the package barrier may reduce the influx of oxygen or escape of headspace gas through the barrier film during the shelf-life of a packaged product (i.e. while the package is hermetically sealed).
  • the oxygen transmission rate (OTR) of the barrier film is an indication of the barrier provided and can be measured according to ASTM Fl 927 using conditions of 1 atmosphere, 23 °C and 50% RH.
  • Described in this application are package units that are designed to the extend the shelf life of sterilized packaged products.
  • These sterilized packaged products may have package components (i.e., primary package components) that are designed for increased sustainability such as, but not limited to, recyclability.
  • the primary package components may include fewer types or lower quantities of high performance materials that offer excellent protection through the sterilization process and throughout shelf life.
  • the package units described assist in extending the shelf-life of the sterilized packaged products.
  • the package units include one or more sterilized packaged products.
  • the sterilized packaged products are food or medical products that require or benefit from the sterilization process (i.e., retort or autoclave), rendering them shelf stable or otherwise safe.
  • the sterilized packaged products are hermetically sealed in packaging that is designed to survive the abusive sterilization process and provide necessary barrier after the sterilization process, among other functions.
  • the packaging may be more susceptible to environmental conditions, lowering performance of the primary packaging primary package components.
  • the sterilized packaged products may be in the form of a pouch, a bag, a tray/lid or any other configuration of polymer based packaging.
  • the primary package components may be clear or opaque and may be printed.
  • the primary packaging components of the sterilized packaged products provide an oxygen transmission rate (OTR) of less than 2 cm 3 /m 2 /day, less than 1 cm 3 /m 2 /day, less than 0.5 cm 3 /m 2 /day, or less than 0.1 cm 3 /m 2 /day (measured according to ASTM Fl 927 using conditions of 1 atmosphere, 23 °C and 50% RH). This ensures that following the sterilization process, the product remains sufficiently protected.
  • OTR oxygen transmission rate
  • certain primary package components are highly affected by the sterilization process and/or by the environment after sterilization.
  • the primary package components may experience decreased OTR upon exposure to high humidity levels, such as RH greater than 70%.
  • Another example includes primary package components that suffer an extended retort shock, having a lower than normal oxygen barrier level (high OTR) for a temporary period of time.
  • high OTR normal oxygen barrier level
  • the sterilized packaged products are sealed inside an outer flexible bag or other similar secondary package.
  • the sterilized packaged products may be stacked tightly inside the outer flexible bag or there may be a tray or strap keeping the sterilized packaged products neatly organized.
  • the outer flexible bag will provide either or both of oxygen barrier and water vapor barrier as will be discussed in the embodiments and depending on the specific application needs.
  • the outer flexible bag may be clear or opaque and may be printed.
  • the hermetic seal of the outer flexible bag may be achieved by any means, such as heat sealing.
  • the outer flexible bag may be vacuum packaged around the sterilized packaged products, wherein most or nearly all of the headspace in the package is removed before sealing.
  • Certain embodiments of the package unit may include sterilized packaged products hermetically sealed inside of an outer flexible bag and having an air headspace.
  • An air headspace may have a composition essentially identical to the normal earth atmosphere.
  • An air headspace may also have a bit of inert gas flushing, but not enough to lower the oxygen level in the headspace below 5%, by volume. In other words, in this situation, if the primary package components loses oxygen barrier properties, there is oxygen available to travel through to the product.
  • an air headspace may be appropriate is when 1) the primary package components have high oxygen barrier properties which are susceptible to moisture and 2) the outer flexible bag provides excellent moisture barrier properties (i.e., low moisture vapor transmission rate (MVTR)).
  • MVTR moisture vapor transmission rate
  • the outer flexible bag may be applied to the sterilized packaged products after the sterilization process is completed and may be kept in place through distribution, being removed prior to stocking for retail sale or other storage. Alternatively, the outer flexible bag may remain hermetically sealed until the point of use of the product.
  • examples of primary package components include but are not limited to OPP / OPP-SiO x / PP or OPP I OPP- AlOx / PP wherein OPP is oriented polypropylene film and PP is a polypropylene based sealing layer that may be a cast or blown film.
  • the 7’ represents a connection of layers or films which may be made by adhesive layers.
  • Examples of primary package components include but are not limited to OPP I PP-EVOH-PP or OPP with EVOH / PP wherein PP-EVOH-PP is a coextruded nonoriented film containing polypropylene and EVOH and OPP with EVOH is a coextruded oriented film containing polypropylene and EVOH.
  • the sterilized packaged products may have a primary package component having an oxygen barrier of less than 2 cm 3 /m 2 /day, less than 1 cm 3 /m 2 /day, less than 0.5 cm 3 /m 2 /day, or less than 0.1 cm 3 /m 2 /day (measured according to ASTM F1927 using conditions of 1 atmosphere, 23 °C and 50% RH), before the sterilization process takes place.
  • This oxygen barrier level may be temporarily (hours, days or weeks) lowered due to the sterilization process.
  • the oxygen barrier level may be lowered upon exposure to a high humidity environment, such as humidity greater than 70%, 75%, 80%, 85% or 90%.
  • the package unit includes an outer flexible bag having a low moisture vapor transmission rate such as lower than 2 g/m 2 / day or lower than 1 g/m 2 / day.
  • the outer flexible bag protects the primary package components of the sterilized packaged products from environmental moisture, thus maintaining the oxygen barrier at the desired high level during distribution and storage and maintaining the integrity of the product therein.
  • the outer flexible bag structure may include a metalized OPP layer.
  • Examples of the outer flexible bag include, but are not limited to, OPP/metOPP, OPP/OPP-SiO x , thick (circa 200 micron) CPP or HDPE monoweb, aluminum/heat seal coating or OPET/aluminum/PE, wherein metOPP is vacuum metalized oriented polypropylene film, CPP is cast polypropylene, HDPE is high-density polyethylene, OPET is an oriented polyester film, aluminum is a thin sheet of aluminum alloy and PE is polyethylene.
  • Certain embodiments of the package unit may include sterilized packaged products hermetically sealed inside of an outer flexible bag and having an inert headspace.
  • An inert headspace may have a composition including one or more inert gases including, but not limited to, nitrogen (N2) or carbon dioxide (CO2).
  • An inert headspace has an oxygen level below 5%, by volume. In other words, in this situation, if the primary package components loses oxygen barrier properties, there is no oxygen available to travel through to the product.
  • an inert headspace may be appropriate is when 1) the primary package components have high oxygen barrier properties which are susceptible to moisture and 2) the outer flexible bag provides inert gas barrier properties. In this way, the product can be sterilized within the primary package components, benefitting from the normally good oxygen barrier. Additionally, in the case that the primary package components lapse in oxygen barrier, such as due to retort shock, there is no oxygen in immediate proximity to the sterilized packaged products to permeate.
  • the outer flexible bag may be applied to the sterilized packaged products after the sterilization process is completed and may be kept in place through distribution, being removed prior to stocking for retail sale or other storage. Alternatively, the outer flexible bag may remain hermetically sealed until the point of use of the product.
  • examples of primary package components include but are not limited to OPP / OPP-SiO x I PP or OPP / OPP- A1O X / PP.
  • Examples of primary package components include but are not limited to OPP / PP-EVOH-PP or OPP with EVOH / PP.
  • the sterilized packaged products may have a primary package component having an oxygen barrier of less than 2 cm 3 /m 2 /day, less than 1 cm 3 /m 2 /day, less than 0.5 cm 3 /m 2 /day, or less than 0.1 cm 3 /m 2 /day (measured according to ASTM F1927 using conditions of 1 atmosphere, 23 °C and 50% RH) before the sterilization process takes place.
  • This oxygen barrier level may be temporarily (hours, days or weeks) lowered due to the sterilization process.
  • the oxygen barrier level may be lowered upon exposure to a high humidity environment, such as humidity greater than 70%, 75%, 80%, 85% or 90%.
  • the package unit includes an outer flexible bag having a low inert gas transmission rate.
  • a low inert gas transmission rate is most easily selected by using a low oxygen transmission rate structure such as lower than 1 cm 3 /m 2 /day or lower than 0.5 cm 3 /m 2 /day.
  • the outer flexible bag maintains the inert gas within the headspace and preventing oxygen ingress through the primary package components during distribution and storage and maintaining the integrity of the product therein.
  • the outer flexible bag structure may include a metalized OPP layer.
  • Examples of the outer flexible bag include, but are not limited to, OPP/metOPP, OPP/OPP-SiO x , aluminum/heat seal coating or OPET/aluminum/PE.
  • Certain embodiments of the package unit may include sterilized packaged products hermetically sealed and vacuum packaged inside of an outer flexible bag. In other words, in this situation, most if not nearly all of the headspace in the outer flexible bag is removed before the final seal is made and there is very little oxygen available to travel through to the product.
  • the outer flexible bag may provide low moisture vapor transmission rate and/or low oxygen transmission rate, as necessary for the application.
  • the product can be sterilized within the primary package components, benefitting from the normally good oxygen barrier, and then vacuum packaged in the outer flexible bag for additional protection. Tn the case that the primary package components temporarily lapse in oxygen barrier, such as due to retort shock, there is no oxygen in immediate proximity to the sterilized packaged products to permeate. In the case that the primary package components lapse in oxygen barrier due to exposure to moisture, an outer flexible bag with high moisture barrier will prevent this from occurring.
  • the outer flexible bag may be applied to the sterilized packaged products after the sterilization process is completed and may be kept in place through distribution, being removed prior to stocking for retail sale or other storage. Alternatively, the outer flexible bag may remain hermetically sealed until the point of use of the product.
  • a package unit comprising: an outer flexible bag and one or more sterilized packaged products hermetically sealed inside the outer flexible bag.
  • Clause 3 The package unit of clause 1 or 2 wherein the outer flexible bag comprises a moisture vapor transmission rate (MVTR) of less than 2 g/m 2 /day according to ASTM F 1249 at 38°C/90%RH.
  • MVTR moisture vapor transmission rate
  • Clause 4 The package unit of any one of clauses 1 to 3 further comprising an inert headspace within the outer flexible bag.
  • Clause 6 The package unit of clause 1 or 3 further comprising an air headspace within the outer flexible bag.
  • Clause 7 The package unit of any one of clauses 1 to 3 wherein the sterilized packaged products are vacuum packaged inside the outer flexible bag.
  • Clause 8 The package unit of any one of clauses 1-4 or 6-7 wherein the sterilized packaged products have been sterilized in an environment including elevated temperature and moisture.
  • Clause 9 The package unit of clause 8 wherein the environment further included inert gas.
  • Clause 10 A system for storing sterilized packaged products comprising: an outer flexible bag and one or more sterilized packaged products hermetically sealed inside the outer flexible bag.
  • Clause 11 The system of clause 10 further comprising an inert headspace inside the outer flexible bag.
  • Clause 12 The system of clause 10 further comprising an air headspace inside the outer flexible bag.
  • a method for extending shelf-life of sterilized packaged products comprising: hermetically sealing a product in a package comprising one or more primary package components to result in packaged products; sterilizing the packaged products in a sterilizing cycle including elevated temperature and moisture to result in sterilized packaged products; and sealing one or more sterilized packaged products in an outer flexible bag.
  • Clause 14 The method of clause 13 wherein sealing the sterilized packaged products in an outer flexible bag further comprises an inert headspace inside the outer flexible bag.
  • Clause 16 The method of clause 13 wherein sealing the sterilized packaged products in an outer flexible bag further comprises removal of most of the headspace prior to the final sealing.

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  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Packages (AREA)

Abstract

La présente invention concerne une unité d'emballage comprenant un sachet souple externe renfermant un ou plusieurs produits conditionnés stérilisés et scellés hermétiquement à l'intérieur du sachet. Le sachet souple externe fournit une barrière de protection pour les produits conditionnés stérilisés, assurant leur intégrité et leur propreté. Le scellement hermétique des produits conditionnés à l'intérieur du sachet souple externe maintient l'intégrité de l'emballage primaire. Cette unité d'emballage offre une manière commode et sûre de stocker et de transporter des produits stérilisés, appropriés pour diverses applications où le maintien de la stérilité du produit est essentiel.
PCT/US2024/051237 2023-10-16 2024-10-14 Unité d'emballage et procédé d'extension de la durée de conservation d'un produit emballé Pending WO2025085367A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202363544362P 2023-10-16 2023-10-16
US63/544,362 2023-10-16

Publications (1)

Publication Number Publication Date
WO2025085367A1 true WO2025085367A1 (fr) 2025-04-24

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2024/051237 Pending WO2025085367A1 (fr) 2023-10-16 2024-10-14 Unité d'emballage et procédé d'extension de la durée de conservation d'un produit emballé

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3057471A (en) * 1957-03-22 1962-10-09 Ethicon Inc Anti-contamination package assembly for surgical supplies
US4295566A (en) * 1980-05-07 1981-10-20 Becton, Dickinson And Company Air-evacuated package with vacuum integrity indicator means
EP1637467B1 (fr) * 2004-09-15 2007-04-25 Wild Fungi, S.A. Système de conditionnement de champignons en atmosphère contrôlée
US20210316919A1 (en) * 2020-04-13 2021-10-14 The Procter & Gamble Company Recyclable sachets
WO2021251945A1 (fr) * 2020-06-08 2021-12-16 Bemis Company, Inc. Emballage stérilisable en autoclave prêt à recycler résistant à la chaleur
US20230136856A1 (en) * 2020-03-25 2023-05-04 Nissan Chemical Corporation Irradiated resin molding

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3057471A (en) * 1957-03-22 1962-10-09 Ethicon Inc Anti-contamination package assembly for surgical supplies
US4295566A (en) * 1980-05-07 1981-10-20 Becton, Dickinson And Company Air-evacuated package with vacuum integrity indicator means
EP1637467B1 (fr) * 2004-09-15 2007-04-25 Wild Fungi, S.A. Système de conditionnement de champignons en atmosphère contrôlée
US20230136856A1 (en) * 2020-03-25 2023-05-04 Nissan Chemical Corporation Irradiated resin molding
US20210316919A1 (en) * 2020-04-13 2021-10-14 The Procter & Gamble Company Recyclable sachets
WO2021251945A1 (fr) * 2020-06-08 2021-12-16 Bemis Company, Inc. Emballage stérilisable en autoclave prêt à recycler résistant à la chaleur

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