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US 12,746,301 B2Granted
Methods and systems for sterilization
AssigneeRegeneron Pharmaceuticals, Inc.
InventorsPhilip Shodder, Dustin Blodgett, Dakota Bolt
Life of this patent
Estimating the term…
Abstract
Embodiments of the present disclosure relate to systems and methods for the application of vaporized chemicals in sterilization procedures, and systems and methods for controlling (e.g., distributing, moving, or exhausting) such chemicals. For example, embodiments of the present disclosure may relate to systems and methods for effecting terminal sterilization of medical products using vaporized hydrogen peroxide (VHP), and/or for the distribution of VHP to, or removal of VHP from, a sterilization system or parts thereof.
Claims23
A sterilization method comprising:
- pre-conditioning a sterilization apparatus including a sterilization chamber comprising a sterilization load, wherein pre-conditioning the sterilization apparatus includes increasing a temperature of a portion of the sterilization apparatus to a temperature greater than a maximum temperature of the sterilization load, wherein the portion of the sterilization apparatus includes an inlet and a conduit connecting a vaporized hydrogen peroxide (VHP) injector to the inlet;
- executing a sterilization phase, wherein the sterilization phase includes a plurality of sterilization pulses, wherein each sterilization pulse includes introducing vaporized hydrogen peroxide into the sterilization chamber via the inlet, and a temperature of the sterilization chamber is less than or equal to the maximum temperature of the sterilization load throughout the sterilization phase;
- and
- executing an aeration phase, wherein the aeration phase includes a plurality of aeration pulses, wherein the plurality of aeration pulses includes:
- a primary aeration pulse comprising:
- achieving a first vacuum pressure within the sterilization chamber, wherein the first vacuum pressure is 500 to 800 millibar;
- and
- after a first vacuum hold, increasing the pressure of the sterilization chamber to a pressure greater than 700 millibar;
- and
- a secondary aeration pulse comprising:
- achieving a second vacuum pressure within the sterilization chamber, wherein the second vacuum pressure is less than 650 millibar;
- and
- after a second vacuum hold, adding air to the sterilization chamber while exhausting the sterilization apparatus.
10 more elements
A sterilization method comprising:
- pre-conditioning a sterilization apparatus including a sterilization chamber comprising a sterilization load, wherein pre-conditioning the sterilization apparatus includes increasing a temperature of a portion of the sterilization apparatus to a temperature greater than a maximum temperature of the sterilization load, wherein the portion of the sterilization apparatus includes an inlet and a conduit connecting a vaporized hydrogen peroxide (VHP) injector to the inlet;
- and
- executing a sterilization phase, wherein a temperature of the sterilization chamber is less than or equal to the maximum temperature of the sterilization load throughout the sterilization phase, the sterilization phase includes first, second, and third sterilization pulses, and wherein each sterilization pulse includes:
- achieving a sterilization pressure within the sterilization chamber;
- and
- when the sterilization chamber is at the sterilization pressure, adding an amount of vaporized hydrogen peroxide to the sterilization chamber via the inlet;
- and
- executing an aeration phase comprising:
- achieving a vacuum pressure within the sterilization chamber, wherein the vacuum pressure is less than 650 millibar;
- and
- after a vacuum hold, adding air to the sterilization chamber while exhausting the sterilization apparatus;
- wherein the amount of vaporized hydrogen peroxide added to the sterilization chamber during the first sterilization pulse is sufficient to establish a lethal concentration of hydrogen peroxide in the chamber;
- the amount of vaporized hydrogen peroxide added to the sterilization chamber during the second sterilization pulse is less than the amount of vaporized hydrogen peroxide added to the sterilization chamber during the first sterilization pulse;
- and
- the amount of vaporized hydrogen peroxide added to the sterilization chamber during the second sterilization pulse is less than the amount of vaporized hydrogen peroxide added to the sterilization chamber during the third sterilization pulse.
12 more elements
A sterilization method comprising:
- pre-conditioning a sterilization apparatus including a sterilization chamber comprising a sterilization load, wherein pre-conditioning the sterilization apparatus includes increasing a temperature of a portion of the sterilization apparatus to a temperature greater than a maximum temperature of the sterilization load, wherein the portion of the sterilization apparatus includes an inlet and a conduit connecting a vaporized hydrogen peroxide (VHP) injector to the inlet;
- and
- a first sterilization pulse including adding a first amount of vaporized hydrogen peroxide to the sterilization chamber via the inlet, wherein the first amount is sufficient to establish a lethal concentration of hydrogen peroxide in the sterilization chamber;
- a plurality of second sterilization pulses, wherein each second sterilization pulse includes adding a second amount of vaporized hydrogen peroxide to the sterilization chamber via the inlet, wherein the second amount is less than the first amount;
- and
- a plurality of third sterilization pulses, wherein each third sterilization pulse includes adding a third amount of vaporized hydrogen peroxide to the sterilization chamber via the inlet, wherein the third amount is less than the second amount;
- wherein, throughout the sterilization method, a temperature of the sterilization chamber is less than or equal to the maximum temperature of the sterilization load throughout the sterilization phase.
4 more elements
Dependencies are inferred from the claim text.