Method of decontaminating a chamber that has movable shelves
First Claim
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1. A method for decontaminating a chamber system to a predetermined level, that comprises the steps of:
- a) providing a chamber system having at least a lower and an upper shelf, at least one of which is vertically movable while maintaining its horizontal position, a condenser, and piping that are fluidly connected to each other and to a vacuum system;
b) placing at least one container containing a predetermined amount of liquid sterilant into the chamber on at least one shelf;
c) placing a loose fitting cap on said at least one container;
d) moving one of the shelves until the adjacent shelf presses against the at least one container cap thereby sealing the container;
e) evacuating the chamber, condenser and piping to a vacuum of predetermined subatmospheric absolute pressure, wherein the chamber system is isolated from the vacuum system;
f) moving another of said movable shelves until the cap on the at least one container is no longer sealed on the container;
g) vaporizing at least a portion of said liquid sterilant by exposing said liquid sterilant to the evacuated chamber environment; and
h) maintaining the vacuum and exposing the interior of said chamber to sterilant vapor for a predetermined time until a predetermined level of decontamination is achieved.
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Abstract
A method of decontaminating or sterilizing chamber systems including freeze dryers at low temperature and pressure levels by utilizing vaporized sterilant, preferably hydrogen peroxide, peracetic acid and mixtures thereof is disclosed.
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Citations
22 Claims
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1. A method for decontaminating a chamber system to a predetermined level, that comprises the steps of:
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a) providing a chamber system having at least a lower and an upper shelf, at least one of which is vertically movable while maintaining its horizontal position, a condenser, and piping that are fluidly connected to each other and to a vacuum system; b) placing at least one container containing a predetermined amount of liquid sterilant into the chamber on at least one shelf; c) placing a loose fitting cap on said at least one container; d) moving one of the shelves until the adjacent shelf presses against the at least one container cap thereby sealing the container; e) evacuating the chamber, condenser and piping to a vacuum of predetermined subatmospheric absolute pressure, wherein the chamber system is isolated from the vacuum system; f) moving another of said movable shelves until the cap on the at least one container is no longer sealed on the container; g) vaporizing at least a portion of said liquid sterilant by exposing said liquid sterilant to the evacuated chamber environment; and h) maintaining the vacuum and exposing the interior of said chamber to sterilant vapor for a predetermined time until a predetermined level of decontamination is achieved. - View Dependent Claims (2, 3, 4, 5, 6, 7)
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8. A method for decontaminating a chamber system that comprises the steps of
a) providing a chamber system having a bottom, at least one middle and a top shelf, wherein at least two of the shelves are vertically movable while maintaining a horizontal position and which can be stopped in any position, a condenser, and piping that are fluidly connected to each other and to a vacuum system; -
b) placing multiple containers containing a predetermined amount of liquid sterilant into the chamber on at least two of the shelves each of which is directly below and adjacent to one of the other shelves; c) placing a loose fitting cap on each container; d) selectively moving each movable shelf to press the caps and seal the containers on an adjacent shelf; e) evacuating the chamber, condenser and piping to a vacuum of a first predetermined subatmospheric absolute pressure, wherein the chamber system is isolated from the vacuum system; f) moving at least one of the movable shelves until the cap on each container on a respective adjacent shelf is released and the container is no longer sealed; g) vaporizing the liquid sterilant in each non-sealed container by exposing the liquid to the evacuated chamber; h) maintaining the vacuum and exposing the interior of the chamber to sterilant vapor for a first predetermined time; i) venting air into the chamber, thereby raising the pressure within the chamber to a second predetermined subatmospheric absolute pressure; j) evacuating the chamber, condenser and piping to a vacuum of a third predetermined subatmospheric absolute pressure, wherein the chamber system is isolated from the vacuum system; k) moving at least a second one of the movable shelves until the cap on each container on a respective adjacent shelf is released and the container is no longer sealed; i) vaporizing the liquid sterilant in each non-sealed container by exposing the liquid to the evacuated chamber environment; and m) maintaining the vacuum and exposing the interior of said chamber to sterilant vapor for a second predetermined time until a predetermined level of decontamination is achieved. - View Dependent Claims (9, 10, 11, 12, 13)
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14. A method of decontaminating a chamber system, which comprises the steps of:
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a) providing a chamber system having a plurality of shelves, at least one of which is vertically movable while maintaining its horizontal position, a condenser, and piping that are fluidly connected to each other and to a vacuum system; b) placing n sets of containers, each set consisting of at least one container, into the chamber on at least one of the shelves, each container containing a predetermined amount of liquid sterilant, and wherein each container further comprises a cap assembly, a compression spring, a plunger, a sealing device, and a bottom assembly such that each set has a cap assembly of a different length; c) placing the cap assembly loosely on each container; d) moving the movable shelves until the cap assembly on each container is pressed by one of the respective adjacent shelves and seals substantially all of the containers; e) evacuating the chamber, condenser and piping to a vacuum of a predetermined subatmospheric absolute pressure, wherein the chamber system is isolated from the vacuum system; f) moving at least one of the movable shelves to a first predetermined level until the cap assembly is released and the seal on at least one of the containers is broken; g) vaporizing the liquid sterilant by exposing said liquid to the evacuated chamber environment; h) maintaining the vacuum and exposing the interior of the chamber system to sterilant vapor for a first predetermined time; i) injecting air into the chamber; j) re-evacuating the chamber, condenser and piping; k) moving at least another movable shelf to another predetermined level until the cap assembly is released and the seal of at least one additional container is broken; l) vaporizing the liquid sterilant by exposing said liquid to the evacuated chamber environment; m) maintaining the vacuum and exposing the interior of the chamber system to sterilant vapor for another predetermined time; and n) maintaining the vacuum and exposing the interior of the chamber system to sterilant vapor until a predetermined level of decontamination is achieved. - View Dependent Claims (15, 16, 17, 18, 19, 20, 21, 22)
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Specification