Patent EP0152298A2 successfully refreshed from Google Patents.
EP0152298A2
Expired / Lapsed
EP
⏱️ 0.0 years remaining
Apparatus and method for dertermining the effectiveness of sterilization
Assignee: Baxter International Inc
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Filing: 1985-02-08
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Granted: —
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Expires: 2005-02-08
Abstract
Abstract A test container comprises a vial (11) within which is disposed a sealed media-containing ampoule (12) and a test strip (14) having a predetermined form of micro-organism thereon. A closure member (15) is threadedly engageable with the vial for movement between a first position, which permits entry of sterilizing atmosphere into the vial and into contact with micro-organisms on the test strip, and a second position (not shown) which simultaneously causes fracturing the ampoule (12) and seals (at 36) the interior of the vial (11) so that gas generated by viable micro-organisms in contact with the media during incubation are contained in the-vial. By analyzing the gas generated by the surviving micro- organisms a rapid, quantitative indication is given of the effectiveness of the sterilizing procedure.
Inventors
- 👤 John W. Bornhoeft
- 👤 Scott Leal
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-11-01 15:53
CPC Classifications
C; C12; C12Q; C12Q1/00; C12Q1/02; C12Q1/22
Claims Analysis
Total Claims: 24
Claim 1
Independent Claim
175 words
A test container for use in determining the effectiveness of sterilization comprising: a vial (11); and characterised by means (12;90) for supporting within said vial (11) a test strip (14), having a predetermined form of micro-organism thereon, and an aqueous growth medium (16), such that said test strip (14) is normally maintained out of contact with said medium (16), a closure member (15) mountable in a first position on said vial (11) which permits entry of a sterilizing atmosphere into said vial (11) and into contact with the micro-organisms on said test strip (14) during a sterilization cycle, and means for permitting said test strip (14) to be brought into contact with said aqueous medium (16) in said vial (11) at a selected time after the sterilizing cycle; said closure member (15) being movable to a second position on said vial (11) which seals the interior of said vial (11) so that gases generated by viable micro-organisms in contact with said medium during incubation thereof are contained in said vial (11) to permit their analysis.
Claim 2
Dependent Claim
175 words
A test container for use in determining the effectiveness of sterilization comprising: a vial (11); and characterised by means (12;90) for supporting within said vial (11) a test strip (14), having a predetermined form of micro-organism thereon, and an aqueous growth medium (16), such that said test strip (14) is normally maintained out of contact with said medium (16), a closure member (15) mountable in a first position on said vial (11) which permits entry of a sterilizing atmosphere into said vial (11) and into contact with the micro-organisms on said test strip (14) during a sterilization cycle, and means for permitting said test strip (14) to be brought into contact with said aqueous medium (16) in said vial (11) at a selected time after the sterilizing cycle; said closure member (15) being movable to a second position on said vial (11) which seals the interior of said vial (11) so that gases generated by viable micro-organisms in contact with said medium during incubation thereof are contained in said vial (11) to permit their analysis.
Claim 3
Dependent Claim
67 words
A test container according to claim 1, in which the said supporting means comprises a sealed ampoule (12) containing said aqueous medium (16) and made of frangible material, the means for permitting contact of the test strip (14) with the medium (16) comprises means (30) for fracturing said ampoule (12) in response to movement of said closure member (15) from said first position to said second position.
Claim 4
Dependent Claim
46 words
A test container according to claim 2, in which said closure member (15) is threadably engageable with the end of said vial (11) for threaded advancement between said first and second positions in response to rotation of said closure member (15) relative to the vial (11).
Claim 5
Dependent Claim
41 words
A test container according to claim 2 or 3, including first locking means (41,42) for positively locking said closure member (15) in said first position, and second locking means (44) for positively locking said closure member in said second, sealing position.
Claim 6
Dependent Claim
59 words
A test container according to any of claims 2 to 4, in which the said ampoule (12) contains an aqueous growth medium which includes a radio-active isotope component such that when brought in contact with viable micro-organisms on said test strip (14) and incubated for a determined period will result in the evolution of detectable radio-active carbon dioxide gas.
Claim 7
Dependent Claim
31 words
A test container according to any of claims 2 to 5, including means responsive to threaded advancement of said closure member (15) onto said vial (11) for breaking said ampoule (12).
Claim 8
Dependent Claim
54 words
A test container according to claim 6, including ram means (30) disposed within said vial (11) for relative longitudinal movement, said closure member (15) being engageable with said ram means (30) upon threaded advancement onto said vial (11) for longitudinally moving said ram means to a position that causes breakage of said ampoule (12).
Claim 9
Dependent Claim
62 words
A test container according to claim 7, in which said vial (11) is formed with downwardly and inwardly tapered ramps (31) which support said ram means (30) when said closure member (15) is in said first position and which cam said ram means into ampoule-breaking position upon threaded advancement of said closure member (15) on said vial (11) to said second position.
Claim 10
Dependent Claim
44 words
A test container according to claim 8, in which said ram means (30) includes a collar (30a) disposed in concentric relation about the ampoule (12) and a pair of flexible pincher legs (30b) depending from said collar in adjacent relation to said ampoule (12).
Claim 11
Dependent Claim
45 words
A test container according to claim 3, or to any claim dependent on claim 3, in which the threads of said closure member (15) and vial (11),define a gas passageway between said closure member and vial when said closure member is in said first position.
Claim 12
Dependent Claim
51 words
A test container according to claim 3 or to any claim dependent on claim 3, in which some of the threads of said vial (11) and closure member (15) are recessed to permit passage of gas between said closure member and vial when said closure member is in said first position.
Claim 13
Dependent Claim
79 words
A test container according to claim 7, including pincher means (75) located in the bottom of said vial (11) and having a pair of upstanding pincher arms (76) disposed adjacent said ampoule (12), said ram means (30) including a pair of depending legs (30bw), and said ram means being movable in said vial in response to threaded advancement of said closure member (15) onto said -vial so that said ram legs wedgedly force said pincher arms into ampoule-breaking engagement.
Claim 14
Dependent Claim
40 words
A test container according to claim 3, in which said closure member (15) includes bearing means (85) which, in response to threaded advancement of said closure member (15) onto said vial, axially compresses said ampoule (12) to effect breakage thereof.
Claim 15
Dependent Claim
34 words
A test container according to claim 2 or 3, in which said vial (11) is made of flexible plastic material which can be manually manipulated to effect selected breakage of the ampoule (12,Fig.15) therein.
Claim 16
Dependent Claim
37 words
A test container according to claim 1, in which said vial (ll) is formed with an upstanding relatively narrow upper neck portion (88), and said test strip (14y) is annular shaped and disposed on said neck portion.
Claim 17
Dependent Claim
41 words
A test container according to any preceding claim, in which said closure member (15) includes an upper end (52) closed by a rubber septum (51) which permits passage of gas-removing needles into the container (10) without entry of the outside environment.
Claim 18
Dependent Claim
47 words
A test container according to any preceding claim, in which said closure member (15) is formed with a flexible sealing lip (36) on the underside thereof that is engageable by the upper end of said vial (11) when said closure member (15) is in said second position.
Claim 19
Dependent Claim
73 words
A test container according to claim 1, in which said vial (11) is shaped to contain said aqueous medium within a section (86) of said vial that is sealed from said test strip by a dislodgable stopper (90), the means for permitting contact of the test strip (14) with the medium (16) comprising means (35y) for dislodging said stopper (90) in response to movement of said closure member (15) to said second position.
Claim 20
Independent Claim
168 words
A method of testing the effectiveness of sterilization comprising the steps of: placing with items to be sterilized a vial (11) containing a test strip (14) with a predetermined form of micro-organisms thereon and an aqueous growth medium (16) such that when brought in contact with viable micro-organisms on said test strip and incubated for a predetermined period will result in the evolution of detectable gas, maintaining the test strip (14) in said vial (11) out of contact with the said medium therein while exposing the test strip to the sterilizing atmosphere during a sterilization cycle along with the items to be sterilized, contacting the test strip with the medium in said vial following the sterilization cycle, sealing the medium and test strip in the vial, incubating the vial and its sealed contents for a predetermined period to cause any viable micro-organisms remaining following the sterilization cycle to evolve a gas, and analyzing the gas evolved in said sealed vial to determine the effectiveness of the sterilization cycle.
Claim 21
Independent Claim
168 words
A method of testing the effectiveness of sterilization comprising the steps of: placing with items to be sterilized a vial (11) containing a test strip (14) with a predetermined form of micro-organisms thereon and an aqueous growth medium (16) such that when brought in contact with viable micro-organisms on said test strip and incubated for a predetermined period will result in the evolution of detectable gas, maintaining the test strip (14) in said vial (11) out of contact with the said medium therein while exposing the test strip to the sterilizing atmosphere during a sterilization cycle along with the items to be sterilized, contacting the test strip with the medium in said vial following the sterilization cycle, sealing the medium and test strip in the vial, incubating the vial and its sealed contents for a predetermined period to cause any viable micro-organisms remaining following the sterilization cycle to evolve a gas, and analyzing the gas evolved in said sealed vial to determine the effectiveness of the sterilization cycle.
Claim 22
Dependent Claim
48 words
A method according to claim 19, wherein the said medium (16) includes a radio-active isotope component such that the gas evolved during incubation is radio- active, and including analyzing the radio-activity of said gas evolved in said sealed vial (11) to determine quantitatively the degree of sterilization effected.
Claim 23
Dependent Claim
18 words
A method according to claim 19 or 20, including fracturing said ampoule and sealing said vial substantially simultaneously.
Claim 24
Dependent Claim
66 words
A method according to claim 19, 20 or 21, including maintaining said test st::ip (14) out of contact with said aqueous medium (16) during a sterlizing cycle by containing said medium in a sealed frangible ampoule (12) disposed within said vial (11), and fracturing said ampoule (12) to contact said test strip with said medium (16) following exposure of said test strip to a sterilizing cycle.
References Cited (Backward Citations)
No citation records indexed.
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