STERILIZED OR DEPYROGENED PACKAGING

• US 20120006717A1
• Filed: 03/19/2010
• Published: 01/12/2012
• Est. Priority Date: 03/20/2009
• Status: Active Grant

• Current Assignee: Pall Life Sciences Belgium BVBA (Danaher Corporation)
• Original Assignee: Disposable-Lab
• Inventors: ZAMBAUX, Jean-Pascal
• Granted Patent: US 8,950,579 B2
• Time in Patent Office: Days
• US Class Current: 206/524.6
• CPC Class Codes: A61L 2/04 Heat A61L2/08 takes precedence
• CPC Class Codes: A61L 2/26 Accessories or devices or components used for biocidal treatment
• CPC Class Codes: B65B 31/04 Evacuating, pressurising or gasifying filled containers or wrappers by means of nozzles through which air or other gas, e.g. an inert gas, is withdrawn or supplied
• CPC Class Codes: B65B 55/02 Sterilising, e.g. of complete packages

Abstract

The invention relates mainly to a packaging which may be sterilized and/or depyroged. The invention relates in particular to a packaging for the sterilization or pyrogen free packaging for one or more packaged devices, said packaging comprising a valve or outlet tube.

Claims

1. A packaging made of one or more materials which do not degrade at a sterilization or depyrogenation temperature, said packaging comprising a packaging outlet and an outlet tube connected to said packaging outlet, said outlet tube comprising a proximal end and a distal end, said outlet tube comprising between the proximal end and the distal end a closing means made partly or completely of a shape memory material.

2. The packaging of claim 1, wherein said closing means is in a closed position when the temperature is below a reference temperature (closing temperature) for closing the outlet tube so that a gas may not penetrate into the packaging through said packaging outlet or in an open position when the temperature is above said reference temperature (closing temperature) for allowing a gas passing through the packaging outlet.

3. The packaging of claim 1, wherein said shape memory material is a shape memory alloy.

4. The packaging of claim 1, wherein said packaging is made of a material selected from the group consisting of a polymer selected from the group of a polyaryletherketone, a PEEK (Poly(ether ether ketone), in particular poly(oxy-1,4-phenylene-oxy-1,4-phenylene-carbonyl-1,4-phenylene);

polytetrafluoroethylene (PTFE);

a perfluoroalkoxy (PFA) polymer;

poly(tetrafluoroethylene-co-perfluoromethyl vinyl ether) (MFA);

polyperfluoro(ethylene-co-propylene) (FEP);

poly(ethylene-alt-chlorotrifluoroethylene) (ECTFE);

poly(ethylene-co-tetrafluoroethylene) (ETFE);

poly(vinylidene fluoride) (PDVF);

tetrafluoroethylene-co-hexafluoropropylene-co-vinylidene fluoride terpolymer (THV);

poly(bisphenol A-co-4-nitrophthalic anhydride-co-1,3-phenylenediamine) (PEI);

poly(4-methyl-1-pentene) (PMP); and

suitable mixtures thereof.

5. The packaging of claim 1, wherein said sterilization or depyrogenation temperature is of at least 253°

C.

6. The packaging of claim 1, wherein said packaging comprises a support area for locating and supporting one or more packaged devices, said support area is provided with or without separate compartments, wherein each one or more packaged device may be located in a separate compartment.

7. The packaging of claim 1, wherein said packaging is a tray for one or more packaged devices, said tray comprising side walls, a bottom wall and a completely or partly open top surface defining an inside packaging area and an outside packaging area, wherein at least one wall or top surface comprises an outlet to which is connected an outlet tube to let a gas pass through said outlet, wherein said outlet tube comprises a proximal end and a distal end, said outlet tube comprising between the proximal end and the distal end a closing means made partly or completely of a shape memory material, said closing means closing the outlet tube, said packaging is provided with or without a removable sheet or film placed on the tray top surface to isolate the inside packaging area from the outside packaging area.

8. The packaging of claim 1, wherein said closing means is placed around the outlet tube between said proximal and distal end to close the outlet tube by compression or squeezing when said closing means is in closed position and when said closing means is in an open position the outlet tube is not compressed or squeezed to let a gas pass through the outlet tube from the proximal end to the distal end.

9. The packaging of claim 1, wherein said closing means in an open position presents a ring, a oval, or a U-shape, or presents a tubular shape surrounding the outlet tube so that the outlet tube is opened, and said closing means, in a closed position, compresses or squeezes the outlet tube to close the outlet tube.

10. The packaging of claim 1, wherein said closing means is a plate or cylinder located inside said outlet tube, wherein said plate or cylinder is straight in the open position so that the outlet tube is opened, said plate or cylinder presenting one or more angles in a closed position to close the outlet tube.

11. The packaging of claim 1, wherein said closing means is a spring fixed at two different locations on the outlet tube, wherein said closing means is in a closed position when said spring is in a compressed position to close the outlet tube by pinching or squeezing.

16. The packaging of claim 1, comprising one, two or more packaging areas to package separately one or more packaged devices.

17. The packaging of claim 16, wherein said packaging comprises at least two or more packaging areas comprising an outlet, wherein said outlets are connected together and forming a main outlet, wherein said main outlet comprises a valve made partly or completely of a shape memory material which changes its shape at a closing temperature Tc higher than room temperature (25°

C.), said valve closing the main outlet at room temperature and opening a passage for a gas through said main outlet when the temperature is above Tc, said packaging being under a partial vacuum when the valve is closed.

18. The packaging of claim 2, wherein said shape memory material is a shape memory alloy.

19. The packaging of claim 2, wherein said sterilization or depyrogenation temperature is of at least 253°

C.

20. The packaging of claim 3, wherein said sterilization or depyrogenation temperature is of at least 253°

C.

21. The packaging of claim 2, wherein said packaging comprises a support area for locating and supporting one or more packaged devices, said support area is provided with or without separate compartments, wherein each one or more packaged device may be located in a separate compartment.

22. The packaging of claim 3, wherein said packaging comprises a support area for locating and supporting one or more packaged devices, said support area is provided with or without separate compartments, wherein each one or more packaged device may be located in a separate compartment.

23. The packaging of claim 5, wherein said packaging comprises a support area for locating and supporting one or more packaged devices, said support area is provided with or without separate compartments, wherein each one or more packaged device may be located in a separate compartment.

24. The packaging of claim 2, wherein said packaging is a tray for one or more packaged devices, said tray comprising side walls, a bottom wall and a completely or partly open top surface defining an inside packaging area and an outside packaging area, wherein at least one wall or top surface comprises an outlet to which is connected an outlet tube to let a gas pass through said outlet, wherein said outlet tube comprises a proximal end and a distal end, said outlet tube comprising between the proximal end and the distal end a closing means made partly or completely of a shape memory material, said closing means closing the outlet tube, said packaging is provided with or without a removable sheet or film placed on the tray top surface to isolate the inside packaging area from the outside packaging area.

12. A method for sterilization or depyrogenation of one or more packaged devices placed in a packaging, wherein said method comprises placing into a sterilization or depyrogenation apparatus a packaging made of one or more materials which do not degrade at a sterilization or depyrogenation temperature, said packaging comprising one or more packaged devices, said packaging comprising a packaging outlet and an outlet tube connected to said packaging outlet, said outlet tube comprising a proximal end and a distal end, said tube comprising between the proximal end and the distal end a closing means made partly or completely of a shape memory material.

13. The method of claim 12, wherein said method comprises increasing the temperature in the oven from a first temperature T1, wherein said closing means is in a closed position closing the outlet tube, to a second temperature T2 wherein said closing means is in an open position to open the outlet tube, maintaining this second temperature T2 for a sufficient period of time to ensure vials or containers sterilization or depyrogenation, decreasing the temperature from the second temperature T2 to a third temperature T3 lower than the closing temperature of said closing means to close the outlet tube with or without obtaining a partial vacuum in the packaging.

14. A packaging obtainable by a method of claim 12.

25. A packaging obtainable by a method of claim 13.

15. A packaging made of one or more materials which do not degrade at a sterilization or depyrogenation temperature, wherein said packaging comprising one or more packaged devices, wherein said packaging comprising an outlet and a valve made partly or completely of a shape memory material which changes its shape at a closing temperature Tc higher than room temperature (25°

C.), said valve closing the outlet at room temperature and opening a passage for a gas through said outlet when the temperature is above Tc, said packaging being under a partial vacuum when the valve is closed.

26. The packaging of claim 15, comprising one, two or more packaging areas to package separately one or more packaged devices.