Non-porous material as sterilization barrier

• US 8,557,179 B2
• Filed: 10/31/2008
• Issued: 10/15/2013
• Est. Priority Date: 10/31/2007
• Status: Expired due to Fees

• Current Assignee: Novo Nordisk A/S
• Original Assignee: Novo Nordisk A/S
• Inventors: Larsen, Bjrn Gullak, Jensen, Brian, Christensen, Ulla Holm
• Primary Examiner(s): Joyner, Kevin
• Application Number:
  US12/740,765
• Publication Number:
  US 20110008206A1
• Time in Patent Office: 1,810 Days
• Field of Search: 422/26, 422/33
• US Class Current: 422/26
• CPC Class Codes: A61L 2/07 Steam
• CPC Class Codes: A61L 2/20 Gaseous substances, e.g. vapours
• CPC Class Codes: A61L 2/26 Accessories or devices or components used for biocidal treatment
• CPC Class Codes: A61L 2202/121 Sealings, e.g. doors, covers, valves, sluices
• CPC Class Codes: A61L 2202/15 Biocide distribution means, e.g. nozzles, pumps, manifolds, fans, baffles, sprayers
• CPC Class Codes: F04B 43/02 having plate-like flexible members, e.g. diaphragms F04B43/14 takes precedence

Abstract

The invention provides a device comprising a sealed interior portion with at least one opening covered by a sterilization barrier formed from a non-porous material allowing a sterilization gas to penetrate but prevents germs from penetrating. The size and configuration of the at least one sterilization barrier formed from a non-porous material are adapted to allow at least 50% of the sterilization gas, that would pass between a sterilization gas-containing exterior and the sealed interior portion when a pressure difference is created there between, to pass through the non-porous material.

Claims

1. A method comprising the steps of:

providing a device comprising;

a sealed interior portion with at least one opening to the exterior covered by a sterilization barrier formed from a non-porous material allowing a sterilization gas to penetrate but prevents germs from penetrating, wherein;

the device is in the form of a pump with a flow path arranged between an inlet and an outlet, the pump comprising at least one valve member arranged in the flow path, and

the size and configuration of the at least one sterilization barrier formed from a non-porous material comprising liquid silicone rubber allowing at least 50% of the sterilization gas, that would pass between a sterilization gas-containing exterior and the sealed interior portion when a pressure difference is created there between, to pass through the non-porous material,

placing the device in a sterilization enclosure,

creating a relative vacuum in the sealed interior portion by controlling the pressure in the sterilization enclosure,

introducing sterilization gas in the sterilization enclosure thereby raising the pressure therein above the relative vacuum created in the sealed interior portion, and

allowing the sterilization gas to penetrate into the sealed interior portion, whereby at least 50% of the sterilization gas passes between the sterilization enclosure and the sealed interior portion through the at least one sterilization barrier formed from a non-porous material.

2. A method as in claim 1, wherein at least one sterilization barrier formed from non-porous material is moulded in a non-planar configuration.

3. A method as in claim 1, wherein the sterilization gas is steam.