Packaging method to enable re-sterilization of medical device

Patent metadata

Field	Value
Publication number	US-10293965-B2
Application number	US-201615164269-A
Country	US
Kind code	B2
Filing date	May 25, 2016
Priority date	May 27, 2015
Publication date	May 21, 2019
Grant date	May 21, 2019

Abstract

A method of packaging pre-filled medical devices is disclosed. The method comprises producing a packaging having a front panel and a back panel defining a compartment capable of holding one or more medical devices wherein at least one of the front panel or top panel has a portion containing a gas permeable material while the remaining portion of the pouch is gas impermeable. This gas permeable material allows gas to pass through the material and contact the one or more articles contained within the compartment or allows gas to pass through the gas permeable material from the inside of the compartment to the outside of the container. Upon completion of sterilization, the pouch is sealed and the gas permeable portion is cut away leaving the sterilized medical device enclosed in a completely gas impermeable pouch.

First claim

What is claimed is:

1. A method of packaging and sterilizing a chemically sensitive medical device, comprising:
providing a pre-filled medical device;
providing a pouch having a non-permeable chamber and a gas-permeable header;
placing the medical device in the pouch;
sealing the pouch along the gas-permeable header, such that the non-permeable chamber remains accessible through the gas-permeable header;
sterilizing the medical device with a first sterilizing agent provided through the gas-permeable header to the non-permeable chamber, the first sterilizing agent being free of ethylene oxide;
sealing the medical device in the non-permeable chamber within the pouch;
removing the gas permeable header resulting in a medical device packaged within the non-permeable chamber; and
sterilizing the medical device in the non-permeable chamber with a second sterilizing agent.

2. The method of claim 1 , wherein the first sterilizing agent is steam, heat, nitrous dioxide, or a combination thereof.

3. The method of claim 1 , wherein the gas impermeable chamber of the pouch is made of a laminate of one or more plastic layers and aluminum foil.

4. The method of claim 1 , wherein the gas permeable header of the pouch is made of air permeable plastic film, paper or nonwoven.

5. The method of claim 1 , wherein the medical device comprises a plastic ampoule, drug vial with rubber stopper, IV solution bag, IV solution pouch or pre-filled syringe.

6. The method of claim 5 , wherein the medical device is filled with aqueous solution, a therapeutic agent or a combination thereof.

7. The method of claim 6 , wherein the aqueous solution is saline.

8. The method of claim 1 , wherein the step of providing a pouch having a non-permeable chamber and a gas-permeable header is by flow wrapping.

9. The method of claim 1 , wherein the step of providing a pouch having a non-permeable chamber and a gas-permeable header is by blister packing.

10. The method of claim 1 , wherein the step of providing a pouch having a non-permeable chamber and a gas-permeable header is by 3-sided or 4-sided pouch.

11. The method of claim 1 , wherein the second sterilizing agent is ethylene oxide, steam, gas plasma, ozone, hydrogen peroxide, heat, nitrous dioxide sterilization, or a combination thereof.

12. A method of packaging and sterilizing a chemically sensitive medical device, comprising:
providing a front panel comprising a first heat-sealable film having a gas permeable section attached to a separate gas-impermeable section, the front panel having a top edge, a bottom edge, and two side edges;
providing a back panel comprising a second heat-sealable film having a gas permeable section attached to a separate gas-impermeable section, the back panel having a top edge, a bottom edge, and two side edges;
aligning the gas permeable section of the front panel with the gas permeable section of the back panel;
sealing the top edge, the bottom edge, and two side edges of the front panel to the bottom edge, and two side edges of the back panel to form an exterior pouch, the exterior pouch having a gas permeable section and a gas impermeable header section;
placing one or more pre-filled medical devices in the gas-impermeable section of the pouch;
sealing the film of the front panel to the film of the back panel in between the one or more medical device to create one or more interior three-sided individual chambers around the pre-filled medical device, each of the one or more three-sided individual chambers having an opening at the bottom of the gas permeable header section of the exterior pouch, the gas permeable header section being oriented on top of the openings and oriented parallel to two or more openings;
performing sterilization with a sterilizing agent being free of ethylene oxide;
sealing along the opening of each of the one or more three-sided individual chambers located at the bottom of the gas permeable header section to form a second fully enclosed pouch around the pre-filled medical device, the second fully enclosed pouch having only gas-impermeable film; and
cutting the gas permeable section along a separation line to separate a second gas impermeable pouch.

13. The method of claim 12 , wherein the step of performing sterilization is steam sterilization, heat sterilization, nitrous dioxide sterilization, or a combination thereof.

14. The method of claim 12 , wherein the gas impermeable section of the pouch is made of a laminate of one or more plastic layers and aluminum foil.

15. The method of claim 12 , wherein the gas permeable section of the pouch is made of air permeable plastic film, paper or nonwoven.

16. The method of claim 12 , wherein the medical device comprises a plastic ampoule, drug vial with rubber stopper, IV solution bag, IV solution pouch or pre-filled syringe.

17. The method of claim 16 , wherein the pre-filled medical device is filled with aqueous solution, a therapeutic agent or a combination thereof.

18. A method of packaging and sterilizing a chemically sensitive medical device, comprising:
providing a front panel comprising a first heat-sealable film having a gas permeable section attached to a separate gas-impermeable section, the front panel having a top edge, a bottom edge, and two side edges;
providing a back panel comprising a second heat-sealable film having a gas permeable section attached to a separate gas-impermeable section, the back panel having a top edge, a bottom edge, and two side edges;
aligning the gas permeable section of the front panel with the gas permeable section of the back panel;
sealing the top edge, the bottom edge, and two side edges of the front panel to the bottom edge, and two side edges of the back panel to form an exterior pouch, the exterior pouch having a gas permeable section and a gas impermeable header section;
placing one or more pre-filled medical devices in the gas-impermeable section of the pouch;
sealing the film of the front panel to the film of the back panel in between the one or more medical device to create one or more interior three-sided individual chambers around the pre-filled medical device, each of the one or more three-sided individual chambers having an opening at the bottom of the gas permeable header section of the exterior pouch, the gas permeable header section being oriented on only one side of the openings;
performing sterilization with a sterilizing agent being free of ethylene oxide;
sealing along the opening of each of the one or more three-sided individual chambers located at the bottom of the gas permeable header section to form a second fully enclosed pouch around the pre-filled medical device, the second fully enclosed pouch having only gas-impermeable film; and
cutting the gas permeable section along a separation line to separate a second gas impermeable pouch.

19. The method of claim 18 , wherein the medical device comprises a plastic ampoule, drug vial with rubber stopper, IV solution bag, IV solution pouch or pre-filled syringe.

20. A method of packaging and sterilizing a chemically sensitive medical device, comprising:
providing a front panel comprising a first heat-sealable film having a gas permeable section attached to a separate gas-impermeable section, the front panel having a top edge, a bottom edge, and two side edges;
providing a back panel comprising a second heat-sealable film having a gas permeable section attached to a separate gas-impermeable section, the back panel having a top edge, a bottom edge, and two side edges;
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Assignees

• Becton Dickinson Co

Inventors

• Lu Di
• Zerda Adam

Classifications

• A61L2103/15

  Laboratory, medical or dentistry appliances, e.g. catheters or sharps · CPC title

• A61L2103/05

  Living organisms or biological materials · CPC title

• A61B50/30

  Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments (for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40) · CPC title

• B65B55/18

  by liquids or gases (B65B55/14 takes precedence) · CPC title

• B65B55/14 Primary

  by heat · CPC title