METHODS AND DEVICES FOR STERILIZING AND HOLDING BUFFERING SOLUTION CARTRIDGES

• US 20110165017A1
• Filed: 07/09/2010
• Published: 07/07/2011
• Est. Priority Date: 07/09/2009
• Status: Active Grant

• Current Assignee: Onpharma Inc. (Bausch Health Cos., Inc.)
• Original Assignee: Onpharma Inc. (Bausch Health Cos., Inc.)
• Inventors: Stepovich, Matthew J., Nguyen, Harry, Christian, Jeffrey J.
• Granted Patent: US 8,585,963 B2
• Time in Patent Office: Days
• US Class Current: 422/1
• CPC Class Codes: A61L 2/04 Heat A61L2/08 takes precedence
• CPC Class Codes: A61L 2202/21 Pharmaceuticals, e.g. medicaments, artificial body parts
• CPC Class Codes: Y10T 436/2575 Volumetric liquid transfer

Abstract

Trays comprising a base have a plurality of axial slots adapted to receive buffer or other medical solution containers within the slots. A spring or other compression element at the bottom of the slot is configured to engage a plunger at the bottom of the solution container when present in the slot so that pressure is applied to the contents of the container in order to stabilize the contents while the containers are sterilized at an elevated temperature.

Claims

1. A method for sterilizing a container filled with a medical solution which evolves vapor when heated, said method comprising:

providing a sealed container filled with the medical solution;

applying pressure above atmospheric to the medical solution within the sealed container; and

exposing the container to an elevated temperature sufficient to sterilize the medical solution within the container, wherein said temperature would be sufficient to evolve vapor at atmospheric pressure; and

wherein the applied pressure is sufficient to inhibit the evolution of vapor within the container without precipitating the buffer.

2. A method as in claim 1, wherein the applied pressure allows for thermal expansion of the solution during sterilization, such that the solution does not achieve a pressure sufficient to cause the transformation of components of the solution to solid form.

3. A method as in claim 1, wherein the buffer is sodium bicarbonate, the sterilization temperature is in the range from 100°

C. to 150°

C., and the pressure applied to the buffer before during and after autoclaving is at least 0.7 kPa (14.7 psig) but not more than 8.3 kPa (175 psig).

4. A method as in claim 3, wherein the container is exposed to the elevated temperature and applied pressure for a time in the range from 3 minutes to 60 minutes.

5. A method as in claim 1, wherein the container has an open interior filled with the medical solution, a needle-penetrable septum, and a plunger, wherein the pressure is applied by engaging a compression member against the plunger.

6. A method as in claim 5, wherein a plurality of containers are held in a tray having a plurality of springs arranged to engage the plungers to apply said pressure.

8. A tray as in claim 6, further comprising a plurality of containers, with each container positioned in a slot.

10. A tray as in claim 8, wherein the buffer is a sodium bicarbonate buffer.

12. A tray as in claim 10, wherein the pressure is in the range from 0.7 kPa (14.7 psig) to 8.3 kPa (175 psig).

13. A tray as in claim 12, wherein the plunger has an area of about 20 mm² and compression members are coil springs with a spring constant in the range from 1.1 Nm (10 lb/in) to 11 Nm (100 lb/in) and wherein the retainer positions the container to compress the spring by a distance in the range from 0.5 mm to 5 mm.

7. A tray for holding a plurality of medical solution cartridges for sterilization and storage, said tray comprising:

a base having a plurality of aligned slots, each slot being arranged to receive a single container;

a compression member disposed at a bottom of each slot, said compression member oriented to engage a plunger on a bottom of the container when the container is in the slot; and

a retainer disposed at the top of each slot, said retainer is positioned to engage a top of the container to position the container axially within the slot so that the plunger on said container is held against the compression member at the bottom of the slot with a force sufficient to raise the pressure of the medical solution within the container sufficiently to inhibit the evolution of vapor within the solution when the container is exposed to an elevated temperature sufficient to sterilize the solution.

9. A tray as in claim 7, wherein the medical solution comprises a buffer.

11. A tray as in claim 9, wherein the compression member raises the pressure to at least 0.7 kPa.