System and method for freeze-drying and packaging

• US 9,561,893 B2
• Filed: 11/25/2014
• Issued: 02/07/2017
• Est. Priority Date: 12/05/2013
• Status: Active Grant

• Current Assignee: Teleflex Life Sciences LLC (Teleflex Incorporated)
• Original Assignee: Vascular Solutions Incorporated
• Inventors: Root, Howard, Penegor, Stephen Anthony, Murto, James Arnold
• Primary Examiner(s): GRAVINI, STEPHEN MICHAEL
• Application Number:
  US14/553,722
• Publication Number:
  US 20150158652A1
• Time in Patent Office: 805 Days
• Field of Search: 342/84, 342/87, 34/90, 206/210, 206/524.8, 604/403, 604/410
• US Class Current: 1/1
• 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 system, comprising:

a gas-impermeable flexible container including at least a front surface and a back surface, the front and back surfaces defined in a first direction by a first dimension and defined in a second direction, which is perpendicular to the first direction, by a second dimension,

the first direction having an intermediate location separating the flexible container into a first portion and a second portion;

a gas-permeable membrane located within the first portion and integrated into the front or back surface, the membrane configured to transmit air or solvent vapor out of, and resist liquid or contaminant passage into, the flexible container; and

a plurality of ports to allow for the introduction or withdrawal of a material into or out of the flexible container.

2. The system of claim 1, further comprising a membrane frame coupled to both the membrane around its perimeter and the front or back surface of the flexible container.

3. The system of claim 1, wherein the front and back surfaces of the flexible container are sealed to one another along an outer perimeter, and wherein a cross-section of the flexible container at the intermediate location defines an ellipsoid shape.

4. The system of claim 1, wherein the membrane includes a material selected from a porous polymer, a woven polymeric fabric, a non-woven polymeric fabric, glass fiber or cellulose.

5. The system of claim 4, wherein the membrane includes a porous polymer material in the form of polytetrafluoroethylene.

6. The system of claim 1, wherein the plurality of ports includes a material entry port coupled to the flexible container within the first portion.

7. The system of claim 1, wherein the plurality of ports includes a reconstitution port and an application port, each of which is coupled to an outer perimeter of the second portion of the flexible container and in fluid communication with an interior of the flexible container.

8. The system of claim 1, further comprising a quantity of the material in the form of biological material within the flexible container.

9. The system of claim 2, further comprising at least one column member engaged with the membrane frame, the at least one column member configured to support the membrane and the membrane frame a spaced distance from any material received within the flexible container.

10. The system of claim 9, wherein the at least one column member includes a plurality of column members configured to change shape or position, relative to the membrane frame, upon application of a downward force to the membrane frame.

11. The system of claim 10, wherein each of the plurality of column members include at least one end engaged with the membrane frame and at least one end in contact with a surface of the flexible container.

12. The system of claim 11, wherein each of the plurality of column members defines a U-shape, with the curvature of the U-shape engaged with the membrane frame.

13. The system of claim 1, further comprising a removable cover protecting an upward surface of the membrane.

14. The system of claim 2, further comprising one or more magnetic or hook members coupled to or integrated with the flexible container, the membrane, or the membrane frame and configured to interact with an external magnetic member or an external support to maintain the membrane a spaced distance from any material received within the flexible container.

15. The system of claim 9, wherein the at least one column member is integral with the membrane frame.

16. A system for freeze-drying and packaging biological material, comprising:

a gas-impermeable flexible container including at least a front surface and aback surface, the front and back surfaces defined in a first direction by a first dimension and defined in a second direction by a second dimension, which is larger than the first dimension;

a gas-permeable membrane separate from and integrated into the front or back surface, the membrane configured to transmit air or solvent vapor out of, and resist liquid or contaminant passage into, the flexible container, and

at least one port to allow for the introduction or withdrawal of a material into or out of the flexible container.

17. The system of claim 16, further comprising means to support the membrane a spaced distance from any material received within the flexible container.