Process for the sterile packaging of a polyethylene prosthetic implant

1. A process for the sterile packaging of a prosthetic implant made of polyethylene comprising:

successively placing the implant in a flexible, gas-impermeable sachet having an opening adapted to be sealed, creating a vacuum in the sachet and then sealing its opening;

placing the sachet containing the implant in a gas-impermeable envelope including an opening adapted to be sealed;

establishing an inert gaseous atmosphere in the envelope by injecting an inert gas inside the envelope until the pressure inside the envelope reaches a predetermined pressure less than atmospheric pressure;

closing the envelope hermetically by sealing its opening; and

sterilizing the implant within the sachet and the envelope by irradiation, wherein a pressure of the inert gas in the envelope is greater than or equal to a pressure in the sachet.

2. The process of claim 1 , wherein sealing the opening of the sachet and sealing the opening of the envelope comprise heat-sealing their respective openings.

3. The process of claim 1 , wherein the inert gaseous atmosphere formed in the envelope is constituted by argon, nitrogen or a mixture of these gaseous elements.

4. The process of claim 1 , wherein the sachet includes a layer of aluminum.

5. The process of claim 1 , wherein the envelope includes a layer of a polyamide and a layer of a polyethylene.

6. The process of claim 1 , wherein establishing the inert gaseous atmosphere in the envelope comprises:

creating a vacuum around and inside the envelope; and

subjecting the envelope to atmospheric pressure after hermetically closing the envelope so that the inert gaseous atmosphere in the envelope has a pressure greater than the pressure in the sachet.

7. The process of claim 1 , wherein the inert gas is injected into the envelope until a pressure of the inert gaseous atmosphere in the envelope reaches a predetermined value between about 0.3 and about 0.7 bar.

8. The process of claim 1 , wherein, before or after irradiation of the implant, an assembly formed by the implant, the sachet and the envelope is placed in a rigid packing whose internal volume is substantially equal to a volume occupied by the assembly.

9. The process of claim 8 , wherein, before placing the assembly formed by the implant, the sachet and the envelope in the rigid packing, the envelope is folded on itself.

10. The process of claim 8 , wherein the rigid packing and the envelope cooperate by being of complementary shapes in order to immobilize the sachet containing the implant.

11. A process for the sterile packaging of a prosthetic implant that includes polyethylene, the process comprising:

sealing the prosthetic implant in a flexible, gas-impermeable sachet at a first pressure;

locating the sachet containing the prosthetic implant in a gas-impermeable envelope, the envelope including an opening adapted to be sealed;

establishing an inert gaseous atmosphere in the envelope;

hermetically sealing the opening so that the inert gaseous atmosphere in the envelope comprises a second pressure less than atmosphere pressure and greater than or equal to the first pressure in the sachet; and

sterilizing the implant within the sachet and the envelope by irradiation.

12. The process of claim 11 , wherein the sachet includes a layer of aluminum.

13. The process of claim 11 , wherein the sachet is opaque to visible light.

14. The process of claim 11 , wherein sealing the implant in the sachet comprises:

reducing a pressure in and around the sachet containing the prosthetic implant to about the first pressure; and

sealing the sachet.

15. The process of claim 11 , wherein sealing the implant in the sachet comprises:

evacuating the envelope containing the sachet and the prosthetic implant;

introducing an inert gas into the envelope at about the second pressure; and

sealing the envelope.

16. The process of claim 11 , wherein the inert gaseous atmosphere comprises argon, nitrogen, or a mixture thereof.

17. The process of claim 11 , wherein the envelope comprises a layer of a polyamide and a layer of a polyethylene.

18. The process of claim 11 , wherein the envelope comprises a rigid or semi-rigid material.

19. The process of claim 11 , wherein establishing the inert gaseous atmosphere in the envelope comprises injecting an inert gas inside the envelope until a pressure inside the envelope reaches about the second pressure.

20. The process of claim 11 , wherein the second pressure comprises a pressure of about 0.3 to about 0.7 bar.

21. The process of claim 11 , and further comprising locating an assembly comprising the envelope containing the sachet and the prosthetic implant in a rigid container comprising an internal volume substantially equal to a volume occupied by the assembly.

22. The process of claim 11 , and further comprising locating an assembly comprising the envelope containing the sachet and the prosthetic implant in a rigid container comprising an internal shape complementary to a shape of the assembly.

23. A process for the sterile packaging of a prosthetic implant that includes polyethylene, the process comprising:

locating the prosthetic implant in a flexible, gas-impermeable sachet;

locating the sachet containing the prosthetic implant in a gas-impermeable envelope;

reducing a pressure in and around the sachet containing the prosthetic implant to about a first pressure;

sealing the sachet;

evacuating the envelope containing the sachet and the prosthetic implant;

introducing an inert gas into the envelope;

sealing the envelope so that the inert gaseous atmosphere in the envelope comprises a second pressure less than atmospheric pressure and greater than or equal to the first pressure in the sachet; and

sterilizing the envelope containing the implant within the sachet by irradiation.

24. The process of claim 23 , wherein the envelope comprises a rigid or semi-rigid material.

25. The process of claim 23 , wherein the second pressure comprises about 0.3 and about 0.7 bar.

26. A process for the sterile packaging of a prosthetic implant that includes polyethylene, wherein the prosthetic implant is sealed at a first pressure in a flexible, gas-impermeable sachet, the process comprising:

locating the sachet containing the prosthetic implant in a gas-impermeable envelope, the envelope including an opening adapted to be sealed;

establishing an inert gaseous atmosphere in the envelope;

hermetically sealing the opening so that the inert gaseous atmosphere in the envelope comprises a second pressure less than atmospheric pressure and greater than or equal to the first pressure in the sachet; and

sterilizing the implant within the sachet and the envelope by irradiation.

27. The process of claim 26 , wherein the envelope comprises a rigid or semi-rigid material.

28. The process of claim 26 , wherein establishing the inert gaseous atmosphere in the envelope comprises injecting an inert gas inside the envelope until a pressure inside the envelope reaches about the second pressure.

29. The process of claim 26 , wherein the second pressure comprises a pressure of about 0.3 to about 0.7 bar.

30. The process of claim 26 , and further comprising locating an assembly comprising the envelope containing the sachet and the prosthetic implant in a rigid container comprising an internal volume substantially equal to a volume occupied by the assembly.

31. The process of claim 26 , and further comprising locating an assembly comprising the envelope containing the sachet and the prosthetic implant in a rigid container comprising an internal shape complementary to a shape of the assembly.