# US 10,945,959 B2 · System and method for freeze-drying and packaging

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- Number: US 10,945,959 B2
- Document ID: US10945959B2
- Status: Granted
- Kind: B2
- Application number: 16/295,165
- Filed: 2019-03-07
- Published: 2020-09-10
- Granted: 2021-03-16
- Earliest claimed: 2019-03-07
- Assignees: Teleflex Life Sciences Limited
- Applicants: Teleflex Life Sciences Limited
- Inventors: James A. Murto; Stephen Anthony Penegor
- Web page: https://patentgrep.com/patent/US10945959B2

## CPC

- A61K 9/19: lyophilised {, i.e. freeze-dried, solutions or dispersions (lyophilised products with subsequent particle size reduction A61K9/14; granules or pellets made by lyphilisation A61K9/1682; solid oral dosage forms made by lyophilisation A61K9/2095; lyophilisation additives A61K47/00)}
- A61B 5/150755: {Blood sample preparation for further analysis, e.g. by separating blood components or by mixing}
- A61J 1/1406: {Septums, pierceable membranes}
- A61J 1/1412: {Containers with closing means, e.g. caps}
- A61K 9/0026: {Blood substitute; Oxygen transporting formulations; Plasma extender}
- A61K 35/16: Blood plasma; Blood serum (umbilical cord blood A61K35/51)
- F26B 5/06: the process involving freezing
- F26B 25/14: Chambers, containers, receptacles of simple construction
- A61K 2236/51: Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61J: CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- F26B: DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM (drying devices for combines A01D41/133; racks for drying fruit or vegetables A01F25/12; drying foodstuffs A23; drying hair A45D20/00; body-drying implements A47K10/00; drying household articles A47L; drying gases or vapours B01D; chemical or physical processes for dewatering or like separating liquids from solids B01D43/00; centrifugal apparatus B04; drying ceramics C04B33/30; drying yarns or fabrics in association with some other form of treatment D06C; drying frames for laundry without heating or positive air circulation, domestic laundry-or spin-driers, wringing or hot pressing laundry D06F; furnaces, kilns, ovens F27)

## Abstract

A system and method for freeze-drying a heat-sensitive substance. In some embodiments, the system and method include freeze-drying the heat-sensitive substance in an upright container with a membrane for transmitting air or vapor solvent out of the container.

## Claims

### Claim 1

A system comprising:
an upright container comprising a body defined by an upper portion, with an opening formed therein, and a lower portion;
a removable cap sealably attached to the upper portion of the body and configured to cover the opening; and
a permeable membrane configured to transmit air or solvent vapor out of the upright container while resisting liquid or contaminant passage into the upright container, the membrane disposed above a fill line of the upright container.

### Claim 2 (depends on 1)

The system of claim 1, further comprising a membrane frame coupled to the perimeter of the membrane.

### Claim 3 (depends on 2)

The system of claim 2, wherein the membrane frame attaches to the upper portion of the body such that the membrane covers the opening of the upright container.

### Claim 4 (depends on 3)

The system of claim 3, wherein the membrane frame attaches to the top of the body via a lip and groove mechanism or threads.

### Claim 5 (depends on 2)

The system of claim 2, wherein the membrane frame is inserted into and attached to the upper portion of the body and transmits air or solvent vapor out of the upright container while resisting liquid or contaminant passage into the upright container when the cap is removed from the upper body.

### Claim 6 (depends on 5)

The system of claim 5, wherein the membrane frame is inserted into and attached to the upper portion of the body via friction fit, a lip and groove mechanism, or threads.

### Claim 7 (depends on 2)

The system of claim 2, wherein the membrane frame is inserted into and attached to the cap of the upright container and transmits air or solvent vapor out of the upright container while resisting liquid or contaminant passage into the upright container when the cap is attached to the upper body.

### Claim 8 (depends on 7)

The system of claim 7, wherein the membrane frame is inserted into and attached to the cap via friction fit, a lip and groove mechanism, or threads.

### Claim 9 (depends on 1)

The system of claim 1, wherein the upright container is a glass lyophilization vial.

### Claim 10 (depends on 1)

The system of claim 1, wherein the upright container is a conical centrifuge tube.

### Claim 11 (depends on 1)

The system of claim 1, wherein the upright container is a microcentrifuge tube.

### Claim 12 (depends on 1)

The system of claim 1, wherein the cap is a snap cap closure.

### Claim 13 (depends on 1)

The system of claim 1, wherein the cap is a plug or stopper.

### Claim 14 (depends on 1)

The system of claim 1, further comprising a heat-sensitive substance.

### Claim 15 (depends on 14)

The system of claim 14, wherein the heat-sensitive substance is a biological material.

### Claim 16 (depends on 14)

The system of claim 14, wherein the heat-sensitive substance is a pharmaceutical formulation.

### Claim 17 (depends on 14)

The system of claim 14, wherein the heat-sensitive substance is a therapeutic product.

### Claim 18 (depends on 1)

The system of claim 1, wherein the upright container is a blood collection tube.

### Claim 19 (depends on 1)

The system of claim 1, wherein the cap is a screw cap.
