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1. WO2020112651 - BIOLOGICAL STERILIZATION INDICATOR

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[ EN ]

CLAIMS

What is claimed is:

1. A biological sterilization indicator for determining the effectiveness of a sterilization process, the sterilization indicator comprising:

a container configured to contain a concentration of microorganisms and/or an enzyme;

a cap comprising a chamber configured to contain a culture medium and/or a substrate reactive with the enzyme; and

a breakable barrier attached to the cap enclosing the culture medium and/or a substrate reactive with enzyme within the chamber, wherein the breakable barrier is formed from a multilayer structure comprising an aluminum layer and a sealing layer, wherein the sealing layer has a thickness of about 0.5 mil to about 3.0 mil.

2. The biological sterilization indicator of claim 1, wherein the cap is formed from at least one thermoplastic polymer.

3. The biological sterilization indicator of claim 2, wherein the cap is formed from polypropylene.

4. The biological sterilization indicator of claim 1, wherein the sealing layer is formed from a heat sealable material, and wherein the sealing layer of the breakable barrier is heat sealed to the cap.

5. The biological sterilization indicator of claim 4, wherein the sealing layer comprises polypropylene.

6. The biological sterilization indicator of claim 1, wherein the multilayer structure has a thickness of about 0.7 mil to about 4.0 mil, wherein the aluminum layer has a thickness of about 0.3 mil to about 1.2 mil, and the sealing layer has a thickness of about 0.5 mil to about 3.0 mil.

7. The biological sterilization indicator of claim 1, wherein the cap is formed from polypropylene, and the breakable barrier is formed from the multilayer structure comprising the aluminum layer having a thickness of about 20 pm (0.79 mil) and the sealing layer formed from a homopolymer polypropylene film having a thickness of about 1 mil to 2 mil.

8. The biological sterilization indicator of claim 1, wherein the aluminum layer and the sealing layer are laminated with an adhesive layer therebetween.

9. The biological sterilization indicator of claim 1, wherein the cap is formed from polypropylene, and the breakable barrier is formed from the multilayer structure having an outer layer/aluminum layer/tie layer/sealing layer configuration or an outer layer/aluminum layer/tie layer/adhesive layer/sealing layer configuration.

10. The biological sterilization indicator of claim 9, wherein the multilayer structure configuration includes the outer layer formed from a nitrocellulose based lacquer coating in weight of about 1.0 g/m2, the aluminum layer formed from an aluminum foil having a thickness of about 20 pm (0.79 mil), the tie layer formed from a polypropylene based lacquer coating in weight of about 3.5 g/m2, and the sealing layer formed from polypropylene.

11. The biological sterilization indicator of claim 10, wherein the sealing layer is formed from a homopolymer polypropylene film having a thickness of about 1 mil.

12. The biological sterilization indicator of claim 10, wherein the sealing layer is formed from a homopolymer polypropylene film having a thickness of about 2 mil.

13. The biological sterilization indicator of claim 1, wherein the cap includes an outer wall, an upper, closed end, a lower end, an opening adjacent the lower end of the cap, and an inner wall defining the chamber having an opening adjacent the lower end of the cap, wherein the breakable barrier is heat sealed to the inner wall such that the breakable barrier covers the opening of the chamber.

14. The biological sterilization indicator of claim 1, wherein the container comprises at least one puncture member configured to puncture the breakable barrier.

15. The biological sterilization indicator of claim 14, wherein the at least one puncture member is defined by at least one projection arranged within the container.

16. The biological sterilization indicator of claim 1, wherein the cap and the container are configure to engage with each other in a first position wherein the breakable barrier is arranged a distance apart from the at least one puncture member, and wherein the cap and the container are configured such that the cap is moveable to a second position wherein the at least one puncture member comes in contact with the breakable barrier and breaks the breakable barrier to release the culture medium and/or the substrate reactive with the enzyme into the container.

17. The biological sterilization indicator of claim 16, wherein the cap and container are configured to engage each other in a snap-fit relationship.

18. The biological sterilization indicator of claim 16, wherein the cap and container are configured to engage each other in a screw-thread relationship.

19. The biological sterilization indicator of claim 1, wherein at least one of the cap and/or the container comprises at least one aperture through which a sterilant enters the container.