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Title:
A STERILISATION CONTAINER, METHOD OF STERILISATION AND STERILISATION APPARATUS
Document Type and Number:
WIPO Patent Application WO/2016/039647
Kind Code:
A4
Abstract:
A steam steriliser, a single use/disposable container for use in the steriliser and a sterilisation method. The container is a rigid or semi-rigid container having a sealable elongate conduit through which steam sterilant may be introduced into the container and steam sterilant and condensate may be removed from the container. Once one or more items to be sterilised are placed in the container a cover is sealed over the mouth of the container. The steam steriliser has a sterilisation chamber adapted to receive the container and provide sterilant within and around the container. Sterilant is provided to the container via the conduit which is sealed at the end of the sterilisation process.

Inventors:
KEMP TERRY DEAN (AU)
DOWMAN ALAN REG (NZ)
Application Number:
PCT/NZ2015/050142
Publication Date:
June 02, 2016
Filing Date:
September 11, 2015
Export Citation:
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Assignee:
MERCER TECHNOLOGIES LTD (NZ)
International Classes:
A61L2/07; A61B50/30; A61L2/26; B65B31/06; B65B55/18
Attorney, Agent or Firm:
ELLIS TERRY et al. (The TerraceWellington, 6143, NZ)
Download PDF:
Claims:
AMENDED CLAIMS

received by the International Bureau on 16 May 2016 (16.05.2016)

WHAT WE CLAIM IS:

1. A single-use rigid or semi-rigid single use/disposable container having:

a. a base and side walls defining a cavity for containing an item during steam sterilisation and isolating it from its surroundings after sterilisation;

b. a rim extending outwardly from the walls; and

c. a sealable conduit that is elongate in cross section and configured and

arranged to allow, in use, steam sterilant to be introduced into the container and steam sterilant and condensate to be removed from the container via the conduit.

2. A container as claimed in claim 1 wherein the elongate conduit is provided at, near or in the base to facilitate draining of the container.

3. A container as claimed in claim 1 or claim 2 wherein the aspect ratio of the cross-section of the elongate conduit is greater than 2:1.

4. A container as claimed in any one of the preceding claims wherein the elongate conduit includes two opposing side walls of greater than 50mm in length that may be sealed together to seal the elongate conduit.

5. A container as claimed in claim 4 wherein the spacing between the side walls of the elongate conduit is between 5mm and 25mm.

6. A container as claimed in claim 4 or claim 5 wherein the elongate conduit side walls extend outwardly from the body of the container more than 5mm.

7 A container as claimed in any one of the preceding claims wherein the elongate conduit extends along more than half the length of a side wall of the container. 29

8. A container as claimed in any one of the preceding claims formed of a material capable of withstanding internal steam sterilisation process temperatures of at least 1 15 degrees Celsius for at least 40 minutes.

9. A container as claimed in any one of the preceding claims formed of a material selected from polypropylene (PP), linear low-density polyethylene LDPE), high density polyethylene (HDPE), Biax Nylon (BOPA) PET-AIOx/PP (Aluminium Oxide coated PET such as Barrialox) or EVOH.

10. A container as claimed in any one of the preceding claims including a cover fused to the rim of the container formed of a thermoformable material or a non- stretch plastics material.

11. A method of steam sterilisation comprising:

a. providing a rigid or semi-rigid container having an opening for receiving an item to be sterilised and a sealable conduit that is elongate in cross section and located at or near the base of the container extending away from the container;

b. placing an item to be sterilised within the cavity;

c. applying a cover over the opening;

d. removing fluid from the container;

e. introducing steam sterilant into the container through the elongate conduit and around the container to provide the required sterilisation;

f. extracting fluid in the container via the elongate conduit; and

g. sealing the elongate conduit.

12. A method as claimed in claim 1 1 wherein the elongate conduit is sealed by heat sealing walls of the elongate conduit together or by adhesive bonding of the walls of the elongate conduit together. 30

13. A method as claimed in claim 11 or claim 12 wherein the cover is secured to the container by heat sealing, ultrasonic welding, microwave welding or laser welding.

1 . A method as claimed in any one of claims 11 to 13 wherein steam stenlant of a temperature of at least 115° C is supplied to the interior of the container for at least 40 minutes.

15. A steam steriliser comprising:

a. a sterilisation chamber having a cavity dimensioned to receive one or more rimmed containers to be sterilised;

b. one or more top plate adapted to clamp against each rim during sterilisation; c. one or more ports providing a fluid path from within the chamber to the

exterior of the chamber;

d. a vacuum for extracting fluid from the chamber via the one or more port; e. a steam source for supplying steam sterilant to a conduit of a container via the one or more port; and

f. a sealing device for sealing the conduit of the container.

16. A steam steriliser as claimed in claim 15 wherein the one or more ports include an elongate port adapted to couple with an elongate conduit of a container as claimed in any one of claims 1 to 10 during sterilisation.

17. A steam steriliser as claimed in claim 16 wherein the sterilisation chamber has top, bottom and side walls forming a generally tubular chamber with doors at either end allowing the entry and removal of containers.

18. A steam steriliser as claimed in claim 17 including lower anvils along each side wall to support rims of containers within the chamber. 31

19. A steam steriliser as claimed in claim 16 or claim 17 including a sealing unit located above the anvils and one or more spacers to seal a cover to rims of a container. 20. A steam steriliser as claimed in claim 19 wherein the sealing unit is a heat sealing unit, ultrasonic welder, or clamping mechanism.