Packaging for sterile objects or objects to be sterilized

• US 7,303,073 B2
• Filed: 04/18/2003
• Issued: 12/04/2007
• Est. Priority Date: 04/22/2002
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Grimard, Jean-Pierre, Raynal-Olive, Claire
• Primary Examiner(s): GEHMAN, BRYON P
• Application Number:
  US10/511,579
• Publication Number:
  US 20050226763A1
• Time in Patent Office: 1,691 Days
• Field of Search: 206438-439, 206363-370, 206570-572, 34284-301, 422 26- 28, 422292-300, 533/96, 534/25
• US Class Current: 206/439
• CPC Class Codes: A61L 2/208 Hydrogen peroxide
• CPC Class Codes: A61L 2/26 Accessories or devices or components used for biocidal treatment
• CPC Class Codes: A61L 2202/182 Rigid packaging means
• CPC Class Codes: A61M 5/001 Apparatus specially adapted for cleaning or sterilising syringes or needles
• CPC Class Codes: A61M 5/002 Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics needle protection, e.g. caps, A61M5/3202; for sharps A61B50/3001

Abstract

A package for transporting objects which are sterile or which are to be sterilized. The package has a box for accommodating objects, and a covering sheet made of a leak tight material which is fastened to the box so as to seal the box in a leak tight manner. The package has a layer of a material forming a screen which is at least partial with respect to a decontamination gas and/or able to absorb a decontamination gas. The layer is sized to be placed in the box along the covering sheet such that the layer lies above the objects. A plate or grill is provided with projections and is shaped, depending on the position of the package, to allow unrestricted diffusion of the sterilization gas over the objects, and to restrict or prevent diffusion of the decontamination gas over these same objects.

Claims

1. A package intended to be used to transport objects which are sterile or to be sterilized, comprising:

a box intended to accommodate the objects;

a covering sheet made of a selectively leaktight material which is fastened onto the box so as to seal the box in a leaktight manner;

a layer of a material forming a screen which is capable of at least one of passing a decontamination gas and being able to absorb the decontamination gas;

the layer having a shape and dimensions such that the layer can be placed in the box along the covering sheet above objects contained in the package, one of said layer and the objects being mobile between a diffusion position wherein unrestricted diffusion of a sterilization gas in the package is allowed, and a nondiffusion position wherein diffusion of at least a portion of the decontamination gas is prevented from entering the package;

the package further comprising a plate provided with projections, the plate being shaped in order, in said diffusion position, to allow unrestricted diffusion of the sterilization gas in the package, and, in said nondiffusion position, to prevent at least a portion of the decontamination gas from diffusing in the package.

2. The package as claimed in claim 1, wherein said layer is attached to the covering sheet, and the layer is dimensioned so as to define, on the covering sheet, a peripheral region for fastening the covering sheet to the box.

3. The package as claimed in claim 1, wherein said layer is arranged on the objects placed inside the box, prior to sealing the covering sheet.

4. The package as claimed in claim 1, wherein said layer of material comprises a pair of layers of material and wherein one of said layers is attached to the covering sheet and the other of said layers is arranged inside the box.

5. The package as claimed in claim 1, wherein said layer of material comprises a plurality of layers of material in order to form said screen.

6. The package as claimed in claim 5, wherein the layers of material forming said screen are identical from one layer to the other.

7. The package as claimed in claim 5, wherein the layers of material forming said screen are different from one layer to the other.

8. The package as claimed in claim 7, wherein the layers are shaped to define, when the layers are in place in the box, at least one of a lateral opening, a peripheral opening, and an interstice between the edges of the layers and walls of the box.

9. The package as claimed in claim 8, wherein said layers have smaller dimensions than those of the box, such that said layers define at least one interstice between edges of said layers and the walls of the box.

10. The package as claimed in claim 9, wherein said layers comprise, at their edges, one of notches and cutouts such that the notches and cutouts form openings between edges of said layers and the walls of the box.

11. The package as claimed in claim 1, wherein said one of the layer and the objects go from the diffusion position to the nondiffusion position by gravity depending on whether the package is placed in a first position corresponding to the diffusion position, or whether the package is placed in a second position, reversed with respect to said first position, corresponding to the nondiffusion position.

12. The package as claimed in claim 1, wherein the covering sheet is formed of high-density polyethylene.

13. A process of fabricating the package of claim 1 comprising the steps of:

forming a screen from at least one material which is capable of at least one of passing a decontamination gas, and being able to absorb a decontamination gas;

making a layer of the material having a shape and dimension such that the layer can be placed in the box along the covering sheet above the objects contained in the package;

making a plate provided with projections shaped in order, in a diffusion position, to allow unrestricted diffusion of the sterilization gas in the package and, in a nondiffusion position, to prevent at least a portion of the decontamination gas from diffusing in the package.

14. The process as claimed in claim 13, further comprising the steps of:

dimensioning said layer such that, when the layer is attached to the covering sheet the layer defines on this covering sheet a peripheral region for fastening the covering sheet to the box; and

attaching said layer to the covering sheet.

15. The process as claimed in claim 13 further comprising the step of arranging said layer on the objects placed inside the box, prior to sealing the covering sheet.

16. The process as claimed in claim 13, wherein the layer comprises a plurality of layers, said process further comprising the steps of:

dimensioning at least one of said layers such that, when the at least one layer is attached to the covering sheet the at least one layer defines on the covering sheet a peripheral region for fastening the covering sheet to the box;

attaching the at least one layer to the covering sheet, and arranging at least one other layer of said plurality of layers on the objects placed inside the box, prior to sealing the covering sheet.

17. A sterilizing and decontamination process using the package as claimed in claim 1, which comprises the steps of:

placing the package in the diffusion position during the sterilization process; and

placing the package in the nondiffusion position during the decontamination process.

18. A sterilization and decontamination process using the package as claimed in claim 11, comprising the steps of:

placing the package in a first position during the sterilization process, in which said layer and the objects are in the diffusion position, such that said layer restricts the diffusion of the sterilization gas in the package; and

placing the package in a second position during the decontamination process, in which said layer and the objects are in the nondiffusion position, such that said layer restricts the diffusion of the decontamination gas in the package.