System and method for freeze-drying and packaging

• US 10,377,520 B2
• Filed: 01/05/2017
• Issued: 08/13/2019
• Est. Priority Date: 12/05/2013
• Status: Active Grant

• Current Assignee: Teleflex Life Sciences LLC (Teleflex Incorporated)
• Original Assignee: Teleflex Innovations S.a.r.l. (Teleflex Incorporated)
• Inventors: Root, Howard, Penegor, Stephen Anthony, Murto, James Arnold
• Primary Examiner(s): Gravini, Stephen M
• Application Number:
  US15/399,643
• Publication Number:
  US 20170113824A1
• Time in Patent Office: 950 Days
• Field of Search: 34287
• CPC Class Codes: A61J 1/10 Bag-type containers
• CPC Class Codes: A61J 1/1475 Inlet or outlet ports
• CPC Class Codes: A61J 1/2093 Containers having several compartments for products to be mixed
• CPC Class Codes: A61M 2202/0415 Plasma
• CPC Class Codes: A61M 5/14 Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
• CPC Class Codes: B65B 3/003 Filling medical containers such as ampoules, vials, syringes or the like
• CPC Class Codes: B65B 51/225 by ultrasonic welding
• CPC Class Codes: B65B 63/08 for heating or cooling articles or materials to facilitate packaging
• CPC Class Codes: B65B 7/02 Closing containers or receptacles deformed by, or taking-up shape, of, contents, e.g. bags, sacks
• CPC Class Codes: B65C 1/02 Affixing labels to one flat surface of articles, e.g. of packages, of flat bands
• CPC Class Codes: B65D 81/245 Internal membrane, floating cover or the like isolating the contents from the ambient atmosphere loosely-attached linings B65D25/16; dispensing pistons B65D83/0005; flexible bags for expelling the contents B65D83/0055

Abstract

A system and method for protecting biological or other material from contamination through the steps of filling, freeze-drying, packaging, storing and use are disclosed. A system can include a flexible container, a membrane configured to transmit air or solvent vapor out of the flexible container, and a membrane frame supporting the membrane and engaged with at least one column member. The at least one column member can be configured to maintain the membrane and the membrane frame a spaced distance from one or more contents received within the flexible container. Upon application of a downward force, the at least one column member can assume a collapsed configuration. A method can include inserting a biological material, for example, into a flexible container, freeze-drying the biological material, moving the freeze-dried biological material to a portion of the flexible container that includes at least one port, and sealing the biological material within the portion.

Claims

1. A method, comprising:

inserting a biological material into freeze-drying container in which a first container side includes a gas-permeable membrane;

freeze-drying the biological material in the freeze-drying container, including allowing air or solvent vapor to escape the container through the membrane; and

sealing the biological material within a portion of the freeze-drying container spaced from the membrane.

2. The method of claim 1, further comprising preventing the membrane from contacting the biological material.

3. The method of claim 2, wherein preventing the membrane from contacting the biological material includes supporting the membrane at a spaced distance from a second container side using a membrane frame and at least one column member.

4. The method of claim 3, further comprising, prior to sealing the biological material within the portion of the freeze-drying container spaced from the membrane, applying a force to the membrane frame in a direction of the second container side.

5. The method of claim 4, wherein applying the force to the membrane frame in the direction of the second container side includes causing the at least one column member to collapse relative to the membrane frame.

6. The method of claim 1 wherein inserting the biological material into the container includes introducing the biological material through a material entry port in fluid communication with a portion of the freeze-drying container including the membrane.

7. The method of claim 1, wherein freeze-drying the biological material in the freeze-drying container includes freeze-drying blood plasma from a single donor or a pool of donors.

8. The method of claim 1 wherein sealing the biological material within the portion of the freeze-drying container spaced from the membrane includes establishing fluid communication between a reconstitution port and the biological material.

9. The method of claim 1 wherein sealing the biological material within the portion of the freeze-drying container spaced from the membrane includes establishing fluid communication between an application port and the biological material.

10. The method of claim 1, wherein sealing the biological material within the portion of the freeze-drying container spaced from the membrane includes sealing across the freeze-drying container at a location in which the portion of the freeze-drying container has capacity to receive at least 200 mL of a reconstitution liquid.

11. The method of claim 10, further comprising cutting through, or adjacent to, a formed seal and discarding a portion of the freeze-drying container including the membrane.

12. The method of claim 1, further comprising labeling the portion of the freeze-drying container in which the biological material is sealed.

13. The method of claim 12, further comprising aseptically storing the biological material in the sealed and labeled portion of the freeze-drying container until it is used.

14. The method of claim 1, further comprising, prior to freeze-drying the biological material in the freeze-drying container, removing a cover protecting an outer surface of the membrane.

15. A method, comprising:

freeze-drying a biological material in a freeze-drying container, including allowing air or solvent vapor to escape the freeze-drying container through a gas-permeable membrane;

confirming the freeze-dried biological material is moved to a portion of the freeze-drying container spaced from the membrane; and

sealing the biological material within the portion of the freeze-drying container spaced from the membrane.

16. The method of claim 15, wherein sealing the biological material within the portion of the freeze-drying container spaced from the membrane includes heat sealing, RF;

welding or ultrasonic welding across the freeze-drying container at a location in which the portion of the freeze-drying container has capacity to receive at least 200 mL of a reconstitution liquid.

17. The method of claim 15, further comprising reconstituting the biological material in the portion of the freeze-drying container spaced from the membrane, including adding a reconstitution liquid to the biological material via a reconstitution port and subsequently mixing the reconstitution liquid and the biological material.

18. The method of claim 17, further comprising administering the reconstituted biological material to a patient via an application port.

19. The method of claim 15, further comprising cutting through, or adjacent to, a formed seal and discarding a portion of the freeze-drying container including the membrane.

20. The method of claim 15, further comprising labeling the portion of the freeze-drying container in which the biological material is sealed.