WO1994017836B1 - A method of decontaminating a chamber that has movable shelves - Google Patents

A method of decontaminating a chamber that has movable shelves

Info

Publication number
WO1994017836B1
WO1994017836B1 PCT/US1994/000564 US9400564W WO9417836B1 WO 1994017836 B1 WO1994017836 B1 WO 1994017836B1 US 9400564 W US9400564 W US 9400564W WO 9417836 B1 WO9417836 B1 WO 9417836B1
Authority
WO
WIPO (PCT)
Prior art keywords
chamber
container
vacuum
liquid
sterilant
Prior art date
Application number
PCT/US1994/000564
Other languages
French (fr)
Other versions
WO1994017836A1 (en
Filing date
Publication date
Priority claimed from US08/013,429 external-priority patent/US5286448A/en
Application filed filed Critical
Priority to JP6518046A priority Critical patent/JPH08509391A/en
Priority to EP94906654A priority patent/EP0682532B1/en
Priority to DE69412068T priority patent/DE69412068T2/en
Publication of WO1994017836A1 publication Critical patent/WO1994017836A1/en
Publication of WO1994017836B1 publication Critical patent/WO1994017836B1/en

Links

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.

Claims

AMENDED CLAIMS
[received by the International Bureau on 29 July 1994 (29.07.94); original claim 21 cancelled; original claims 1-20 replaced by amended claims 22-42; new claim 43 added (7 pages)]
22. 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.
23. The method of claim 22, wherein the liquid sterilant in said container is selected from the group consisting essentially of hydrogen peroxide and peracetic acid and mixtures thereof. 24. The method of claim 22, wherein the liquid sterilant in said container is from between about 30% to about 35% by weight concentration of aqueous hydrogen peroxide solution.
25. The method of claim 22, wherein the mass of liquid sterilant is small compared to the mass of the container to prevent freezing.
26. The method of claim 22, wherein the predetermined level of decontamination is sterilization.
27. The method of claim 22, wherein the chamber system is a freeze dryer system.
28. The method of claim 22, wherein the method further comprises repeating steps d) through h) for each additional shelf until a predetermined level of decontamination is achieved.
29. 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; - 26 - 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; ) 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 - 27 - vapor for a second pre-determined time until a predetermined level of decontamination is achieved.
30. The method of claim 29, wherein the liquid sterilant is selected from the group consisting essentially of hydrogen peroxide and peracetic acid and mixtures thereof.
31. The method of claim 29, wherein the liquid sterilant is from between about 30% to about
35% by weight concentration of aqueous hydrogen peroxide solution.
32. The method of claim 29, wherein the predetermined amount of liquid hydrogen peroxide is distributed among the containers placed on the chamber shelves.
33. The method of claim 29, wherein the predetermined level of decontamination is sterilization.
34. The method of claim 29, wherein the chamber system is a freeze dryer system.
35. A method of decontaminating a chamber system, which comprises the steps of: 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 pre-determined amount of - 28 - 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;
1) vaporizing the liquid sterilant by exposing said liquid to the evacuated chamber environment; - 29 - 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.
36. The method of claim 35, wherein the bottom assembly of said containers has raised dimples permitting the area on the shelf below the containers to be sterilized.
37. The method of claim 35, wherein the liquid sterilant is selected from the group consisting of hydrogen peroxide and peracetic acid and mixtures thereof.
38. The method of claim 35, wherein the liquid hydrogen peroxide is from between about 30% to about 35% by weight concentration of aqueous hydrogen peroxide solution.
39. The method of claim 35, wherein the predetermined level of decontamination is sterilization.
40. The method of claim 35, wherein the chamber system is a freeze dryer system.
41. The method of claim 35, wherein the liquid sterilant in each container is about 1 and about 2 grams of liquid hydrogen peroxide.
42. The method of claim 35, wherein the number of sets of containers, n, is any number - 30 - between 2 and 20 and in which steps (e) through (g) are repeated once for each set of containers.
43. The method of claim 35, wherein the method further comprising repeating steps k) through m) until a predetermined level of decontamination is achieved.
PCT/US1994/000564 1993-02-04 1994-01-12 A method of decontaminating a chamber that has movable shelves WO1994017836A1 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
JP6518046A JPH08509391A (en) 1993-02-04 1994-01-12 Disinfection method for chambers with movable shelves
EP94906654A EP0682532B1 (en) 1993-02-04 1994-01-12 A method of decontaminating a chamber that has movable shelves
DE69412068T DE69412068T2 (en) 1993-02-04 1994-01-12 METHOD FOR DECONTAMINATING A CHAMBER THAT HAS MOVING SHELVES

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US08/013,429 US5286448A (en) 1993-02-04 1993-02-04 Method of decontaminating a chamber that has movable shelves
US013,429 1993-02-04

Publications (2)

Publication Number Publication Date
WO1994017836A1 WO1994017836A1 (en) 1994-08-18
WO1994017836B1 true WO1994017836B1 (en) 1994-09-29

Family

ID=21759925

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1994/000564 WO1994017836A1 (en) 1993-02-04 1994-01-12 A method of decontaminating a chamber that has movable shelves

Country Status (6)

Country Link
US (2) US5286448A (en)
EP (1) EP0682532B1 (en)
JP (1) JPH08509391A (en)
CA (1) CA2155336A1 (en)
DE (1) DE69412068T2 (en)
WO (1) WO1994017836A1 (en)

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