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Last Updated: March 28, 2024

Claims for Patent: 8,183,052


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Summary for Patent: 8,183,052
Title:Methods and apparatus for sterility testing
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.
Inventor(s): Reed; Michael W. (Lake Forest Park, WA), Barker; Lynn M. (Edmonds, WA), Klip; Evert Jan (Dalen, NL)
Assignee: Blood Cell Storage, Inc. (Seattle, WA)
Application Number:12/480,574
Patent Claims: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, 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.

2. The method of claim 1, wherein the filter comprises a membrane having a pore size of about 0.45 .mu.m.

3. The method of claim 1, wherein the probe is physically isolated from the fluorescent species immobilized on the substrate by a window transparent to the excitation light and the fluorescent emission.

4. The method of claim 1, wherein the probe comprises one or more optical fibers.

5. The method of claim 1, wherein the fluorescent species is selected from the group consisting of 5'(and 6')-carboxy -3,10-dihydroxy-spiro[7H-benzo[c]xanthene-7,1'(3'H)-isobenzofuran]-3'- one and 2-(2-chloro-3-hydroxy-9-carboxyethyl-10-oxo-10H-benzo[c]xanthen-7- -yl)benzoic acid.

6. The method of claim 1, wherein the sample comprises blood or a blood product.

7. 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 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.

8. The method of claim 7, wherein the 2-halo seminaphthofluorescein is a 2-chloro seminaphthofluorescein.

9. The method of claim 7, wherein the 2-halo seminaphthofluorescein is 2-(2-chloro-3-hydroxy-9-carboxyethyl-10-oxo-10H-benzo[c]xanthen-7-yl)benz- oic acid.

10. The method of Claim 7, wherein the albumin is a human serum albumin.

11. The method of Claim 7, wherein the conjugate is a 2-(2-chloro-3-hydroxy-9-carboxyethyl-10-oxo-10H-benzo[c]xanthen-7-yl) benzoic acid/human serum albumin conjugate.

12. The method of claim 7, wherein the sample comprises blood or a blood product.

Details for Patent 8,183,052

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Grifols Therapeutics Llc ALBUKED, PLASBUMIN-20, PLASBUMIN-25, PLASBUMIN-5 albumin (human) For Injection 101138 10/21/1942 ⤷  Try a Trial 2024-08-19
Baxalta Us Inc. BUMINATE, FLEXBUMIN albumin (human) Injection 101452 03/03/1954 ⤷  Try a Trial 2024-08-19
Csl Behring Ag ALBURX albumin (human) Injection 102366 07/23/1976 ⤷  Try a Trial 2024-08-19
Grifols Biologicals Llc ALBUTEIN albumin (human) Injection 102478 08/15/1978 ⤷  Try a Trial 2024-08-19
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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