Method of packaging oxygen reference solution using flexile package with inside valve

• US 5,780,302 A
• Filed: 10/29/1996
• Issued: 07/14/1998
• Est. Priority Date: 11/02/1995
• Status: Expired due to Term

• Current Assignee: Siemens Healthcare Diagnostics Incorporated (Siemens AG)
• Original Assignee: Chiron Diagnostics Corp (Bayer AG)
• Inventors: Conlon, Dennis R., Sullivan, Kevin J., Green, Robert B.
• Primary Examiner(s): WALLENHORST, MAUREEN
• Application Number:
  US08/740,410
• Time in Patent Office: 623 Days
• Field of Search: 436/8, 436/9, 436/11, 436/16, 436/68, 422/99, 422/100, 422/102, 422/103
• US Class Current: 436/8
• CPC Class Codes: B01L 2200/025 Align devices or objects to ensure defined positions relative to each other
• CPC Class Codes: B01L 2200/026 Fluid interfacing between devices or objects, e.g. connectors, inlet details
• CPC Class Codes: B01L 2300/10 Means to control humidity and/or other gases
• CPC Class Codes: B01L 3/505 flexible containers not provided for above
• CPC Class Codes: B32B 15/08 of synthetic resin
• CPC Class Codes: B32B 15/085 comprising polyolefins
• CPC Class Codes: B32B 15/09 comprising polyesters
• CPC Class Codes: B32B 2307/10 having particular acoustical properties
• CPC Class Codes: B32B 2307/31 Heat sealable
• CPC Class Codes: B32B 2367/00 Polyesters, e.g. PET, i.e. polyethylene terephthalate
• CPC Class Codes: B65D 75/58 Opening or contents-removing devices added or incorporated during package manufacture B65D75/36, B65D85/1027 take precedence
• CPC Class Codes: B65D 75/5861 Spouts B65D75/5811, B65D75/5822 take precedence
• CPC Class Codes: B65D 75/5877 connected to a planar surface of the package wall
• CPC Class Codes: G01N 2001/2893 Preparing calibration standards
• CPC Class Codes: G01N 2496/70 Blood gas control solutios containing dissolved oxygen, bicarbonate and the like
• CPC Class Codes: G01N 2496/80 Multi-analyte reference solutions containing cholesterol, glucose and the like
• CPC Class Codes: G01N 33/4925 measuring blood gas content, e.g. O2, CO2 , HCO3
• CPC Class Codes: G01N 33/96 involving blood or serum control standard
• CPC Class Codes: Y10T 436/10 Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing
• CPC Class Codes: Y10T 436/100833 Simulative of a gaseous composition
• CPC Class Codes: Y10T 436/102499 : Blood gas standard or control

Abstract

A novel flexible package for an oxygen reference solution has been developed. This package is made from a laminated film including preferably polypropylene as the inner layer, aluminum foil as the middle layer, and polyester as the outer layer. The seams are heat sealed, while an optional access device for allowing access to the solution after the storage period, is attached to the inside wall of the bag without breeching the middle barrier layer.

Claims

1. A method of maintaining the stability of an oxygen reference solution comprising the step of:

packaging an oxygen reference solution in a package comprising;

multiple laminated layers, said laminated layers comprising;

an inner layer of a heat-sealable polymer film;

a middle layer of aluminum; and

an outer layer selected from the group consisting of polyester nylon and a lacquer coating; and

an access device disposed completely within said package in contact with said oxygen reference solution wherein said access device does not breach said multiple laminated layers and wherein said access device allows access to the oxygen reference solution in the package while maintaining the integrity of the solution during storage and preventing exposure of the solution to the outside environment when the access device is punctured by a probe.

2. A method of claim 1 in which said heat-sealable polymer film is selected from the group consisting of polypropylene and polyester.

3. A method of claim 1 in which said inner layer has a thickness approximately between 1.5 mil and 5 mil, said middle layer has a thickness approximately between 0.3 mil and 1 mil, and said outer layer has a thickness of approximately 0.2 mil to 2 mil.

4. A method of claim 1 in which said inner layer has a thickness of about 2-5 mil, said middle layer has a thickness of about 0.5-0.7 mil, and said outer layer has a thickness of about 0.5 mil.

5. A method of claim 1 in which said inner layer has a thickness of about 4 mil, said middle layer has a thickness of about 0.5 mil, and said outer layer has a thickness of about 0.5 mil.

6. A method of claim 1 in which said oxygen reference solution comprises a known, stable level of oxygen.

7. A method of claim 6 in which the oxygen reference solution contains a known, stable level of glucose.

8. A method of claim 6 in which said oxygen reference solution also comprises other metabolites.

9. A method of claim 8 in which said metabolites are selected from the group consisting of lactate and urea.

10. A method of claim 1 in which said access device is connected to one or more walls of said package.

11. A method of claim 10 in which said package is formed into a 3-side, center-sealed pouch.

12. A method of claim 1 in which said access device is made of polypropylene.

13. A method of claim 1 in which said access device is not connected to a surface of the package.