Methods and apparatus for sterility testing
First Claim
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1. A method for testing the sterility of a sample comprising:
- (a) providing a filter device having a chamber and a filter configured to collect culturable organisms within the chamber;
(b) filtering a sample through the filter such that any collected culturable organisms are retained on the filter within the chamber;
(c) adding a culture medium to the chamber such that at least a portion of the collected culturable organisms are resuspended in the culture medium;
(d) after a pre-determined period of time, irradiating a fluorescent species immobilized on a substrate with excitation light emanating from a probe physically isolated from the fluorescent species immobilized on the substrate,wherein the fluorescent species comprises a seminaphthofluorescein/human serum albumin conjugate,wherein the fluorescent species immobilized on the substrate is in liquid communication with the culture medium,wherein the excitation light has a wavelength sufficient to effect fluorescent emission from the fluorescent species, andwherein the fluorescent species exhibits a first emission intensity at a first emission wavelength and a second emission intensity at a second emission wavelength, the ratio of the first and second emission intensities being dependent on pH;
(e) measuring the first and second emission intensities to determine the pH of the culture medium; and
(f) inferring from the determined pH of the culture medium the sterility of the sample.
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Abstract
Methods and apparatus for testing the sterility of a product to be administered to a patient. The sterility of the product is tested by monitoring the pH change of a culture medium in contact with any culturable organisms (e.g., bacteria) that are collected by filtration of the product to be tested.
94 Citations
12 Claims
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1. A method for testing the sterility of a sample comprising:
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(a) providing a filter device having a chamber and a filter configured to collect culturable organisms within the chamber; (b) filtering a sample through the filter such that any collected culturable organisms are retained on the filter within the chamber; (c) adding a culture medium to the chamber such that at least a portion of the collected culturable organisms are resuspended in the culture medium; (d) after a pre-determined period of time, irradiating a fluorescent species immobilized on a substrate with excitation light emanating from a probe physically isolated from the fluorescent species immobilized on the substrate, wherein the fluorescent species comprises a seminaphthofluorescein/human serum albumin conjugate, wherein the fluorescent species immobilized on the substrate is in liquid communication with the culture medium, wherein the excitation light has a wavelength sufficient to effect fluorescent emission from the fluorescent species, and wherein the fluorescent species exhibits a first emission intensity at a first emission wavelength and a second emission intensity at a second emission wavelength, the ratio of the first and second emission intensities being dependent on pH; (e) measuring the first and second emission intensities to determine the pH of the culture medium; and (f) inferring from the determined pH of the culture medium the sterility of the sample. - View Dependent Claims (2, 3, 4, 5, 6)
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7. A method for testing the sterility of a sample, comprising:
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(a) providing a filter device having a chamber and a filter configured to collect culturable organisms within the chamber; (b) filtering a sample through the filter such that any collected culturable organisms are retained on the filter within the chamber; (c) adding a culture medium to the chamber such that at least a portion of the collected culturable organisms are resuspended in the culture medium; (d) after a pre-determined period of time, irradiating a fluorescent species immobilized on a substrate in communication with the culture medium with excitation light having a wavelength sufficient to effect fluorescent emission from the fluorescent species, wherein the fluorescent species exhibits a first emission intensity at a first emission wavelength and a second emission intensity at a second emission wavelength, the ratio of the first and second emission intensities being dependent on pH, and wherein the fluorescent species comprises a 2-halo seminaphthofluorescein/albumin conjugate; (e) measuring the first and second emission intensities to determine the pH of the culture medium; and (f) inferring from the determined pH of the culture medium the sterility of the sample. - View Dependent Claims (8, 9, 10, 11, 12)
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Specification