Process challenge device
First Claim
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1. A device for testing the effectiveness of a sterilization procedure and a sterilant, the device comprising:
- a housing having an open first end portion, an open second end portion, and an open pathway extending between said first and second end portions through which sterilant travels; and
a Biological Indicator comprising a sample of biological organisms having known resistance characteristics;
said open pathway being adapted to receive the Biological Indicator so that the Biological Indicator is exposed to the sterilant during the sterilization procedure.
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Abstract
A process challenge device and method of using the same is presented for testing the efficiency of various sterilization procedures on objects to be sterilized. The device is assembled from two tapered end portions having opposite open ends and an open pathway extending therethrough. A central chamber in the open pathway receives a Biological Indicator for testing the efficiency of the sterilization process. The device is ideal for testing a sterilization process on elongated objects such as tubing, at any point along their length. The coupling structures on the end portions provide the device with single-use security.
19 Citations
23 Claims
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1. A device for testing the effectiveness of a sterilization procedure and a sterilant, the device comprising:
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a housing having an open first end portion, an open second end portion, and an open pathway extending between said first and second end portions through which sterilant travels; and
a Biological Indicator comprising a sample of biological organisms having known resistance characteristics;
said open pathway being adapted to receive the Biological Indicator so that the Biological Indicator is exposed to the sterilant during the sterilization procedure. - View Dependent Claims (2, 3)
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4. An in-line process challenge device for testing the effectiveness of a sterilization procedure and a sterilant used during the sterilization procedure, the process challenge device comprising:
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a first housing portion having a first opening and a first coupling surface;
a second housing portion having a second opening and a second coupling surface;
said first and second coupling surfaces being adapted to be operatively connected to one another so that said first opening and said second opening are placed in open communication with one another and allow sterilant to pass through the device;
means for securing said first and second coupling surfaces to one another;
means for substantially preventing the sterilant from penetrating between the first housing portion and the second housing portion during the sterilization procedure; and
a Biological Indicator positioned intermediate said first and second openings. - View Dependent Claims (5, 6, 7)
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8. A method for testing the effectiveness of a sterilization procedure, comprising the steps of:
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(a) providing a process challenge device, comprising;
(i) a housing having an open first end portion, an open second end portion, and an open pathway extending between said open first and second end portions through which sterilant travels; and
(ii) a Biological Indicator disposed in said open pathway intermediate said open first and second end portions;
(b) operatively connecting the process challenge device to an object to be sterilized;
(c) subjecting the process challenge device and the object to a sterilization procedure; and
(d) examining the Biological Indicator. - View Dependent Claims (9, 10, 11, 12, 13, 14, 15, 16, 17)
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18. A device for testing the effectiveness of a sterilization procedure and a sterilant, the device comprising:
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a housing having an open first end portion, an open second end portion, and an open pathway extending between said first and second end portions through which sterilant travels; and
a Biological Indicator;
said open pathway being adapted to receive the Biological Indicator so that the Biological Indicator is exposed to the sterilant during the sterilization procedure;
said housing being comprised of material that is substantially liquid impermeable and substantially gas non-absorptive.
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19. A device for testing the effectiveness of a sterilization procedure and a sterilant, the device comprising:
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a housing having an open first end portion, an open second end portion, and an open pathway extending between said first and second end portions through which sterilant travels; and
a Biological Indicator;
said open pathway being adapted to receive the Biological Indicator so that the Biological Indicator is exposed to the sterilant during the sterilization procedure;
said first end portion and said second end portion being separate structures;
said first end portion being provided with a first coupling surface and said second end portion being provided with a second coupling surface;
said first and second coupling surfaces being adapted to be operatively secured to one another.- View Dependent Claims (20, 21, 22)
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23. A device for testing the effectiveness of a sterilization procedure and a sterilant, the device comprising:
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a housing having an open first end portion, an open second end portion, and an open pathway extending between said first and second end portions; and
a Biological Indicator;
said open pathway being adapted to receive the Biological Indicator so that the Biological Indicator is exposed to the sterilant during the sterilization procedure;
said first end portion being shaped to generally taper toward the opening in said first end portion;
said second end portion being shaped to generally taper toward the opening in said second end portion.
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Specification