Testing For Sterility Condition Patents (Class 435/31)
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Publication number: 20040259188Abstract: Method and system for decontaminating letters and packages deposited with, collected by and forwarded by, e.g. the US Postal Service. Letters and packages are collected in a substantially microorganism impermeable but gas permeable receptacle which can be sealed and placed in a sterilizing gas atmosphere consisting of chlorine dioxide a diluent, and optionally water vapor.Type: ApplicationFiled: August 10, 2004Publication date: December 23, 2004Inventors: Aaron A. Rosenblatt, Thomas E. McWhorter
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Publication number: 20040248235Abstract: A sterilization indicator for testing the effectiveness of a sterilization procedure comprises a source of an enzyme, a sterilant-resistant chemical associated with the enzyme, and a substrate that reacts with the enzyme to form a detectable enzyme-modified product that provides an indication of the failure of the sterilization procedure. The sterilant-resistant chemical may be a polyglycerol alkyl ester, polyglycerol alkyl ether, an ethoxylated polyhydric alcohol ester, or a polyhydric alcohol ether. The indicator may be used to test the effectiveness of a hydrogen peroxide plasma sterilization procedure and may be provided with a non-challenge test pack or a lumen-challenge test pack.Type: ApplicationFiled: June 25, 2004Publication date: December 9, 2004Applicant: 3M Innovative Properties CompanyInventors: William E. Foltz, Robert A. Asmus, Ronald G. Lulich
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Publication number: 20040224379Abstract: Toxic substances in a sample can be detected by combining the sample with a living culture of Tetramitus rostratus (10), and monitoring (12) the morphological state and/or swimming behavior of the living culture of Tetramitus rostratus in the presence of the sample. Loss of coordination of swimming behavior of the Tetramitus rostratus is indicative of the presence of a toxic substance in the sample. The sample tested may be a solid or liquid sample, or it may be a gaseous sample (for example an air sample (5) which may contain an airborne toxin).Type: ApplicationFiled: October 22, 2002Publication date: November 11, 2004Inventor: Robert L Jaffe
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Patent number: 6773898Abstract: 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.Type: GrantFiled: September 9, 2002Date of Patent: August 10, 2004Assignee: Raven Biological Laboratories, Inc.Inventors: Russell Nyberg, Daniel J. Dwyer, Robert V. Dwyer, Jr.
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Patent number: 6767732Abstract: A method and apparatus is provided for detection of volatile products from a sample using a transducer which changes voltage as a function of contact of the volatile products with the transducer to produce a gas signature of the volatile products and a spectrophotometer to analyze the volatile products to produce a spectral footprint of the volatile products. The apparatus and method are used to detect spoilage of a biological material, such as a food. The apparatus is also used to detect microorganisms and by comparing the gas signature and spectral footprint to a library of gas signatures and spectral footprints, the apparatus enables identification of the microorganisms and in particular identification of pathogenic microorganisms.Type: GrantFiled: July 2, 2001Date of Patent: July 27, 2004Assignee: Board of Trustees of Michigan State UniversityInventors: Evangelyn C. Alocilja, Steve A. Marquie, Cynthia Meeusen, Spring M. Younts, Daniel L. Grooms
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Publication number: 20040121021Abstract: A substrate impregnated with an indicator that bleaches at an approximately linear rate in relation to the concentration of ozone in an aqueous solution. The color-impregnated substrate provides a visual determination that sufficient ozonation disinfection of a surface has occurred by using a direct measurement of the Ct value rather than just the measurement of an instantaneous concentration of ozone. The substrate may be used in a system for disinfecting a surface comprising means for contacting a surface to be disinfected with ozone, wherein one or more indicator-impregnated substrates are proximate to the surface; and means for comparing the second color to known colors of the indicator that correspond to different ozone Ct values. When the second color matches the known color for a target Ct value, a predetermined level of disinfection has been accomplished.Type: ApplicationFiled: December 19, 2002Publication date: June 24, 2004Inventors: Zoran Minevski, Jason Maxey
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Publication number: 20040106167Abstract: A novel biological indicator system to detect the effectiveness of a sterilization treatment and methods for assessing the viability of and/or changes in bacterial spore exposed to a sterilization or disinfection method by multiangle light scattering thereby detecting a change in the spores as indicators of spore viability and the efficacy of the sterilization or disinfection method.Type: ApplicationFiled: November 24, 2003Publication date: June 3, 2004Applicant: ICF Technologies, Inc.Inventors: Ira C. Felkner, Joseph P. Laico
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Patent number: 6689577Abstract: A reagent for microscopy-based detection of pathogens, especially spirochetes, from body fluids characterized by that containing the following ingredients: tetracain (125-200 mg/l), mannit (1500-2000 mg/l), EGTA (etilene bis[oxyetiline-nitrilo]-tetraacetate), 0.76-0.114 mg/l magnesium-chloride (preferably in amount of 0.10 mg/l), caffeine-sodium-benzoate (2000-4000 mg/l), glucose (1800-2200 mg/l), glycerol (75-105 mg/l), optimally tri-sodium-citrate (preferable in an amount of 10000 mg/l), Hoechst 33342 dye (1.11 mg/l), if required 20 to 40 ml of distilled water and RPMI 1640 culture media to make 100 ml. Also, a method for detecting pathogens.Type: GrantFiled: January 2, 2002Date of Patent: February 10, 2004Inventors: Bela Pal Bozsik, Janos Albert, Ilona Dufla
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Patent number: 6660489Abstract: A method for extracting ATP from a biological sample is disclosed. The method involves introducing a cationic extractant and an anionic substance and then extracting ATP. The method may be used to assay for the presence of ATP in a biological sample or to determine the amount of ATP extracted from a biological sample. The method is particularly useful in detecting contamination on surfaces and in food products. A reagent, a test device and a test kit that involve the use of the method to detect contamination are also disclosed.Type: GrantFiled: August 21, 2001Date of Patent: December 9, 2003Assignee: Becton, Dickinson and CompanyInventors: Leanne M. Schrecengost, Jon C. Wannlund, Robert W. Rosenstein
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Patent number: 6653096Abstract: A process challenge device tailored to mimic the resistance of a particular product-package combination to a particular biological inactivation, disinfection, or sterilization process. The device is used to challenge the process, thus providing a means to validate the efficacy of the process. In one embodiment, the process indicator includes a biological indicator organism stored on a carrier enclosed within a chamber formed by a barrier film material. The specific indicator organism and carrier substrate are chosen for their appropriateness for a given process. The materials comprising the barrier film material of the process challenge device are chosen for the materials' specific resistance to the given process. The process challenge device may also comprise a separate second chamber filled with an appropriate culture medium or enzyme substrate that is separated from the chamber containing the process indicator by a separation means, such as a valve, a clip, or a frangible separation.Type: GrantFiled: August 24, 1999Date of Patent: November 25, 2003Assignee: Process Challenge DevicesInventors: Dennis Christensen, R. Daniel Webster, Harvey A. Markinson
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Patent number: 6632661Abstract: A device for culturing microorganisms and its use are described. The claimed device comprises a substrate having a top side, a pedestal mounted on the top side of the substrate and comprising a non-absorbent culture surface, a flexible cover sheet attached to the substrate and comprising a bottom surface, the cover sheet being configured to cover the culture surface, and a culture medium deposited on one or more surfaces selected from: the culture surface, and the cover sheet bottom surface. An aqueous sample is spread and contained by the claimed device without additional equipment or manipulation by the end user.Type: GrantFiled: December 7, 2000Date of Patent: October 14, 2003Assignee: 3M Innovative Properties CompanyInventor: Peter D. Wickert
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Patent number: 6632632Abstract: A rapid method for detecting spoilage of a food sample, particularly a fish sample, by detecting and enumerating sulfide-producing bacteria (SPB). A growth medium containing iron and sulfur is combined with the food sample forming an incubation mixture which is incubated for a period of time. A plurality of fluorescence measurements are taken during an incubation period of about 4 hours to 17 hours at 30° C. SPB are determined to be present in the sample if the fluorescence measurement initially increases and then decreases to form a fluorescence maximum (peak). The time to detection of the fluorescence peak can be used with a correlation schedule to enumerate the SPB in the food sample. A visual test can also be used to identify color changes in the incubation mixture to provide a semi-quantitative enumeration of SPB effective in about 4 hours to 17 hours at 30° C.Type: GrantFiled: December 14, 2001Date of Patent: October 14, 2003Assignee: Colifast ASInventors: Grete Lorentzen, Olaug Taran Skjerdal, James D. Berg
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Patent number: 6627413Abstract: The present invention discloses a process for quantitative and/or qualitative determination of the microbial contamination of suspensions, emulsions or dispersions containing minerals and/or pigments and/or fillers and/or fiber materials wherein following the addition of one or more substances which can be degraded by microorganisms, mixing and optionally subsequent incubation a sample of the suspensions, emulsions or dispersions is centrifuged to separate the microorganisms from the minerals and/or fillers and/or pigments and/or fiber materials and the number and/or size and/or type of the microorganisms is determined in the aqueous supernatant phase after one or more incubations.Type: GrantFiled: October 3, 2001Date of Patent: September 30, 2003Assignee: Omya AGInventors: Matthias Buri, Patrick Schwarzentruber
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Patent number: 6623955Abstract: A rapid method of determining the efficacy of a sterilization cycle, and an indicator adapted to perform such method, comprising subjecting to the sterilization cycle a source of active enzyme having activity which correlates with the viability of a microorganism commonly used to monitor sterilization, and incubating the enzyme source, following the completion of the sterilization cycle, with an effective amount of a substrate system capable of reacting with any residual active enzyme to produce a detectable enzyme-modified product.Type: GrantFiled: May 18, 1995Date of Patent: September 23, 2003Assignee: 3M Innovative Properties CompanyInventors: Richard R. Matner, William E. Foltz, Lewis P. Woodson
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Publication number: 20030170901Abstract: A electronic system for tracking and monitoring articles to be subjected to a sterilization cycle is disclosed. The method uses a sterilization indicator and electronically links sterilization information with the articles subjected to the sterilization process. The indicator allows a sterilization cycle to be monitored without the need for a user to subjectively distinguish between color, quality or intensity of display patterns.Type: ApplicationFiled: November 25, 2002Publication date: September 11, 2003Applicant: 3M Innovative Properties CompanyInventors: Roland C. Kippenhan, Steven S. Kirckof, Philip A. Bolea, Richard M. Rumble, Rodney K. Hehenberger, Ramon T. Ignacio
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Patent number: 6613505Abstract: A method and composition for destruction of infectious prion proteins in tissue, by thermal/enzymatic treatment of the tissue with a prion-destructive protease. The method and composition are applicable to treatment of tissue containing or contaminated with prion protein strains associated with transmissible spongiform encephalopathy (TSE) and/or other prion protein-mediated diseases.Type: GrantFiled: April 12, 2001Date of Patent: September 2, 2003Assignee: BioResource International, Inc.Inventor: Jason C. H. Shih
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Publication number: 20030162243Abstract: A sterilization indicator for testing the effectiveness of a sterilization procedure comprises a source of an enzyme, a sterilant-resistant chemical associated with the enzyme, and a substrate that reacts with the enzyme to form a detectable enzyme-modified product that provides an indication of the failure of the sterilization procedure. The sterilant-resistant chemical may be a polyglycerol alkyl ester, polyglycerol alkyl ether, an ethoxylated polyhydric alcohol ester, or a polyhydric alcohol ether. The indicator may be used to test the effectiveness of a hydrogen peroxide plasma sterilization procedure and may be provided with a non-challenge test pack or a lumen-challenge test pack.Type: ApplicationFiled: December 11, 2001Publication date: August 28, 2003Applicant: 3M Innovative Properties CompanyInventors: William E. Foltz, Robert A. Asmus, Ronald G. Lulich
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Publication number: 20030157588Abstract: A rapid method of determining the efficacy of a sterilization cycle, and an indicator adapted to perform such method, comprising subjecting to the sterilization cycle a source of active enzyme having activity which correlates with the viability of a microorganism commonly used to monitor sterilization, and incubating the enzyme source, following the completion of the sterilization cycle, with an effective amount of a substrate system capable of reacting with any residual active enzyme to produce a detectable enzyme-modified product.Type: ApplicationFiled: May 18, 1995Publication date: August 21, 2003Inventors: RICHARD R. MATNER, WILLIAM E. FOLTZ, LEWIS P. WOODSON
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Publication number: 20030148526Abstract: A chemical actinometer for determining the absolute level of exposure to ultraviolet light of a fluid to be treated for disinfection purposes. The actinometer includes a translucent sample cell through which the chemical actinometric fluid flows. The area of exposure of the actinometric fluid is controlled by allowing the ultraviolet light to pass through only a portion of the sample cell. A suitable actinometric fluid is a combination of iodide and iodate in a solution. The sample cell is positioned within an ultraviolet disinfection reactor at a position to receive ultraviolet light from the ultraviolet light source.Type: ApplicationFiled: January 8, 2001Publication date: August 7, 2003Inventor: Christopher R. Schulz
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Publication number: 20030138873Abstract: A culture system and method for determining the effect of a test agent on the development, homeostasis or degradation of engineered cartilage tissue. The engineered cartilage tissue is obtained by isolating chondrogenic cells and culturing them to obtain chondrocytes in a cell-associated matrix. The chondrocytes and cell associated matrix are then cultured on a semipermeable membrane to provide the engineered cartilage tissue. The engineered tissue, or one of its precursors, can be contacted with the test agent to determine what effect, if any, the test agent has on engineered cartilage.Type: ApplicationFiled: January 22, 2002Publication date: July 24, 2003Inventors: Koichi Masuda, Eugene J-M.A. Thonar, Brian Pfister, Michael Hejna
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Patent number: 6589479Abstract: The invention relates to a method of monitoring a sterilization process having an oxidation-type sterilant, said process comprising the steps of: providing an indicator compound capable of exhibiting a color change upon exposure to the sterilant, the indicator compound being free of heterocyclic nitrogen, diazo nitrogen and amino nitrogen, and selected from the group consisting of anthraquinone dyes, triarylmethane dyes and xanthene dyes; exposing the indicator compound to the sterilization process; and observing the compound for a change of colour. The invention also relates to an indicator for an ozone sterilization process. A preferred indicator compound is rosolic acid.Type: GrantFiled: June 13, 2001Date of Patent: July 8, 2003Assignee: Technologies of Sterilization with Ozone TSO3, Inc.Inventors: Sylvie Dufresne, Robert Boulay
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Patent number: 6566508Abstract: Disclosed are novel coumarin based fluorogenic compounds useful in assaying for biological activity. Specifically, these fluorogenic compounds exhibit fluorescence at particular wavelengths when cleaved by target enzymes. Preferred compounds include sugar and peptide derivatives of umbelliferone derivatives bearing a heterocyclic five membered ring at the 3-position. These compounds can be used for rapidly detecting food pathogens and for determining sterilization effectiveness. The compounds may also be used in a form bounded to a polymeric support or to a biomolecule or macromolecule.Type: GrantFiled: March 11, 2002Date of Patent: May 20, 2003Assignee: 3M Innovative Properties CompanyInventors: James Gregory Bentsen, Christopher Allen Mickelson, Orlin Bruce Knudson, Kevin Michael Lewandowski
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Patent number: 6566090Abstract: A sterilization indicator is useful for testing the effectiveness of sterilization procedures that disinfect objects by contacting them with a liquid sterilization procedure. The indicator includes an outer container having an open end and a cover material associated with the open end that is impermeable to liquids and bacteria. An enzyme-gel matrix is coated on a surface within the outer container that comprises a biologically inert polymeric gel and a source of an active enzyme dispersed within the gel. The enzyme has an activity that is correlated with the survival of at least one test microorganism that is commonly used to monitor the effectiveness of a sterilization procedure. A breakable ampoule within the outer container contains a substrate that is capable of reacting with any active enzyme remaining after the indicator has been subjected to a sterilization procedure to provide a detectable indication that the sterilization procedure was ineffective.Type: GrantFiled: December 6, 2001Date of Patent: May 20, 2003Assignee: 3M Innovative Properties CompanyInventors: Kelvin J. Witcher, Lewis P. Woodson
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Patent number: 6562582Abstract: Methods for clearing Chlamydia from biological materials, e.g., cells and animals, infected therewith are described. Methods for maintaining Chlamydia-free cells and animals are also described.Type: GrantFiled: February 18, 1998Date of Patent: May 13, 2003Assignee: Vanderbilt UniversityInventors: William M. Mitchell, Charles W. Stratton
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Patent number: 6555379Abstract: A device for monitoring a processing liquid comprising at least one sensor for generating at least one monitoring signal, and a device for processing the monitoring signal and for generating a control signal for directly or indirectly influencing the composition or condition of the processing liquid. A device is also provided for detecting, storing, and maintaining the reliability of performance of the sensor. In addition, actuators are provided for converting given criteria or specified values.Type: GrantFiled: September 8, 2000Date of Patent: April 29, 2003Assignee: Filterwerk Mann & Hummel GmbHInventors: Karl-Guenter Bremer, Thomas Hoefler, Peter Holzhauer, Thomas Netsch, Eckehard Walitza
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Publication number: 20030077688Abstract: A rapid method of determining the efficacy of a sterilization cycle, and an indicator adapted to perform such method, comprising subjecting to the sterilization cycle a source of active enzyme having activity which correlates with the viability of a microorganism commonly used to monitor sterilization, and incubating the enzyme source, following the completion of the sterilization cycle, with an effective amount of a substrate system capable of reacting with any residual active enzyme to produce a detectable enzyme-modified product.Type: ApplicationFiled: July 12, 2002Publication date: April 24, 2003Applicant: Minnesota Mining and Manufacturing Company to 3M Innovative Properties CompanyInventors: Richard R. Matner, William E. Foltz, Lewis P. Woodson
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Patent number: 6548248Abstract: A method of determining the effectiveness of a sterilization cycle in a sterilization chamber by the use of an indicator containing DNA and a dye which can be bound thereto. The indicator containing DNA is placed in the sterilization chamber prior to the beginning of the sterilization cycle. When the DNA is subjected to heat and steam, the molecule is fragmented so that it is no longer capable of binding the dye. The DNA is withdrawn from the indicator after the sterilization cycle, contacted by a solution of the dye and, thereafter, dipped into wash water. If sufficient fragmentation has taken place, a substantial percentage of the dye will be washed off during the second dip. This is easily recognized by the operator and the efficacy of the cycle can be determined. On the other hand, if insufficient heat and steam has been applied, the remaining DNA will retain the dye and little or no change in color will be observed.Type: GrantFiled: November 10, 1999Date of Patent: April 15, 2003Assignee: Propper Manufacturing Co., Inc.Inventor: Dennis Kinney
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Publication number: 20030064427Abstract: The invention relates to methods and kits and methods for assessing the effectiveness of a sterilization process by determining the release of dipicolinic acid (DPA) from bacterial or other spores that contain DPA. A biological indicator containing a spore may be included together with articles being sterilized, and an assay of DPA released from the spore can be performed moments after the sterilization process is completed, or during the process. The kits and methods thus provide a rapid and reliable method of assessing the effectiveness of a sterilization process and, consequently, assure the sterility of article subjected to the same process.Type: ApplicationFiled: September 16, 2002Publication date: April 3, 2003Applicant: ICF Technologies, Inc.Inventors: Ira C. Felkner, Joseph P. Laico
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Patent number: 6528277Abstract: This invention relates to a container and method for detecting a specific environmental parameter or combination of parameters, or for determining the effectiveness of a sterilization procedure. The invention relates to test indicators containing controlled volumes of compressed, gas-permeable materials, and modified caps comprising one or more apertures, sterilant permeable inserts, protruding members, or a combination thereof, and to methods for using test indicators for determining the efficacy of different types of sterilization processes. If proper sterilization conditions are not met, the interactive enzyme system remains active, and a color product forms upon the addition of the remaining components of the enzyme system. If the proper sterilization conditions are met, the sterilant destroys the interactive enzymes and no color product is formed. Inactivation of the enzyme system parallels the inactivation of bacterial spores subjected to the sterilization process.Type: GrantFiled: October 27, 2000Date of Patent: March 4, 2003Assignee: 3M Innovative Properties CompanyInventors: Judy K. Hendricks, Shaundrea L. Rechsteiner, Joel R. Gorski, Adam Lee, Roger Fiske
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Publication number: 20030027242Abstract: A novel biological indicator system to detect the effectiveness of a sterilization treatment and methods for assessing the viability of and/or changes in bacterial spores exposed to a sterilization or disinfection method by multiangle light scattering thereby detecting a change in the spores as indicators of spore viability and the efficacy of the sterilization or disinfection method.Type: ApplicationFiled: March 4, 2002Publication date: February 6, 2003Applicant: ICF Technologies, Inc.Inventors: Ira C. Felkner, Joseph P. Laico
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Patent number: 6514721Abstract: An air sampler device and method for collecting airborne pathogens and psychrometric data for room or remote air samples wherein the sample volume is electronically controlled. Particulates in the air are caused to impact the surface of the growth/inhibitor media contained in the pathogen dish thereby depositing pathogenic microorganisms in the media. The growth/inhibitor media may be a solid, liquid, gel, or mixture thereof. After the pathogen dish is incubated, colony forming units are counted for determination of air quality parameters. A chip-based sensor measures psychrometric properties of the air sample.Type: GrantFiled: July 3, 2001Date of Patent: February 4, 2003Assignee: Biochem Technologies, Inc.Inventor: Leon Bryan Spurrell
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Patent number: 6511819Abstract: A rapid method for detecting the presence or absence of coliform bacteria in a liquid or liquified dairy sample, for example, skimmed milk, lowfat milk, or whole milk. A growth medium containing a fluorogenic substrate is combined with the dairy sample and is incubated for a brief period of time, for example for about 4 hours, after which a first fluorescence value of 4-methylumbelliferone is measured. The dairy sample is incubated again for about 2-8 hours after which a second fluorescence value of 4-methylumbelliferone is measured. Total, fecal, or thermotolerant coliform bacteria are determined to be present in the sample if the second fluorescent value exceeds the first fluorescent value by a predetermined 4-methylumbelliferone concentration threshold.Type: GrantFiled: March 29, 2001Date of Patent: January 28, 2003Assignee: Nye Colifast ASInventors: Ingun Tryland, James D. Berg, Kari Skjanes
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Publication number: 20020192731Abstract: A method and composition for sterilizing articles that are contaminated with infectious prion protein, such as surgical instruments, kitchen utensils, laboratory tools, etc., comprising the steps of: (a) heating the articles to be treated at a moderate temperature well below the incineration temperature of said infectious prion protein, wherein said moderate temperature is sufficient to enhance the proteolytic susceptibility of infective prion protein associated with said articles; and (b) exposing the heated articles to a proteolytic enzyme that is effective for at least partial reduction of the infective protein prion associated with said articles under said moderate temperature.Type: ApplicationFiled: October 26, 2001Publication date: December 19, 2002Inventor: Jason C. H. Shih
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Patent number: 6495341Abstract: The present invention is a method and apparatus for monitoring, preferably in real time, the physical or chemical conversion of a grain material. The method employs multivariate analysis of a collected sample. In a preferred embodiment a steeping conversion is monitored by multicomponent chemical analysis of the steepwater.Type: GrantFiled: December 28, 2000Date of Patent: December 17, 2002Assignee: Alpha MOSInventor: Frederic Zenhausern
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Publication number: 20020160440Abstract: A BIER vessel evaluates biological indicators for sterilization processes. By flowing gaseous sterilant, such as vaporized hydrogen peroxide, through a chamber (12) before, during, and after introducing the indicators, the indicators are instantaneously exposed to preselected steady state conditions, allowing accurate and reproducible evaluation of the indicator response. A door (32) to an opening (30) in the chamber opens for introducing the indicators to the chamber without appreciably disturbing the steady state conditions therein. After a preselected time, the biological indicators are removed and evaluated for remaining biological activity.Type: ApplicationFiled: April 17, 2002Publication date: October 31, 2002Inventors: Gerald E. McDonnell, Iain F. McVey, Michael Geanous
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Publication number: 20020150962Abstract: A method and an apparatus for preventing reversion of the color of an indicator dye in a biological indicator is disclosed. The indicator dye changes color if viable microorganisms are present after sterilization, because acidic byproducts are formed when the microorganisms metabolize the growth medium. It has been found that the dye can change color back to the original color after the completion of the sterilization due to leaching or diffusion of basic impurities into the growth medium. The method and the apparatus employ a dual buffer system with one buffer which operates at high pH to moderate pH fluctuations at the start of the sterilization and a second buffer which operates at low pH to minimize pH fluctuations after the sterilization is complete. Less high pH buffer than low pH buffer is used in order to maximize the speed and sensitivity of the biological indicator.Type: ApplicationFiled: February 27, 2002Publication date: October 17, 2002Applicant: Ethicon, Inc.Inventors: Henry K. Hui, Leslie A. Feldman, Richard A. Gorham
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Patent number: 6458554Abstract: A method and an apparatus for preventing reversion of the color of an indicator dye in a biological indicator is disclosed. The indicator dye changes color if viable microorganisms are present after sterilization, because acidic byproducts are formed when the microorganisms metabolize the growth medium. It has been found that the dye can change color back to the original color after the completion of the sterilization due to leaching or diffusion of basic impurities into the growth medium. The method and the apparatus employ a dual buffer system with one buffer which operates at high pH to moderate pH fluctuations at the start of the sterilization and a second buffer which operates at low pH to minimize pH fluctuations after the sterilization is complete. Less high pH buffer than low pH buffer is used in order to maximize the speed and sensitivity of the biological indicator.Type: GrantFiled: February 27, 2002Date of Patent: October 1, 2002Assignee: Ethicon, Inc.Inventors: Henry K. Hui, Leslie A. Feldman, Richard A. Gorham
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Publication number: 20020137123Abstract: A method and an apparatus for preventing reversion of the color of an indicator dye in a biological indicator is disclosed. The indicator dye changes color if viable microorganisms are present after sterilization, because acidic byproducts are formed when the microorganisms metabolize the growth medium. It has been found that the dye can change color back to the original color after the completion of the sterilization due to leaching or diffusion of basic impurities into the growth medium. The method and the apparatus employ a dual buffer system with one buffer which operates at high pH to moderate pH fluctuations at the start of the sterilization and a second buffer which operates at low pH to minimize pH fluctuations after the sterilization is complete. Less high pH buffer than low pH buffer is used in order to maximize the speed and sensitivity of the biological indicator.Type: ApplicationFiled: February 27, 2002Publication date: September 26, 2002Applicant: Ethicon, Inc.Inventors: Henry K. Hui, Leslie A. Feldman, Richard A. Gorham
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Patent number: 6455272Abstract: Multiple early-load-release evaluations of sterilizing effectiveness for both “dry” and “wet” sterilizer loads, are made available by selective spectroscopic quantitative measurements of peak absorption of electromagnetic radiation, in selected UV and visible-light wavelength spectra developed for evaluating thermally-responsive change, in a fluid-state indicator material, which is correlated with the sterilizing effect of a selected cycle on bacterial spores of a sterilizer load. Biological evaluation of sterilizing effectiveness is made available with the same test devices, free of the risk of contamination, by measuring peak absorption of electromagentic radiation at developed wavelength spectra which evaluate pH change, if any, due to spore-growth, or the absence thereof, following a predetermined spore incubation period subsequent to completion of the thermal sterilizing cycle.Type: GrantFiled: August 13, 2001Date of Patent: September 24, 2002Inventor: John R. Gillis
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Publication number: 20020123089Abstract: A novel biological indicator system to detect the effectiveness of a sterilization treatment and methods for assessing the viability of and/or changes in bacterial spores exposed to a sterilization or disinfection method by multiangle light scattering thereby detecting a change in the spores as indicators of spore viability and the efficacy of the sterilization or disinfection method.Type: ApplicationFiled: October 31, 2001Publication date: September 5, 2002Applicant: ICF Technologies, Inc.Inventors: Ira C. Felkner, Joseph P. Laico
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Publication number: 20020115131Abstract: A sterilization indicator is useful for testing the effectiveness of sterilization procedures that disinfect objects by contacting them with a liquid sterilization procedure. The indicator includes an outer container having an open end and a cover material associated with the open end that is impermeable to liquids and bacteria. An enzyme-gel matrix is coated on a surface within the outer container that comprises a biologically inert polymeric gel and a source of an active enzyme dispersed within the gel. The enzyme has an activity that is correlated with the survival of at least one test microorganism that is commonly used to monitor the effectiveness of a sterilization procedure. A breakable ampoule within the outer container contains a substrate that is capable of reacting with any active enzyme remaining after the indicator has been subjected to a sterilization procedure to provide a detectable indication that the sterilization procedure was ineffective.Type: ApplicationFiled: December 6, 2001Publication date: August 22, 2002Applicant: 3M Innovative Properties CompanyInventors: Kelvin J. Witcher, Lewis P. Woodson
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Patent number: 6436659Abstract: A method and an apparatus for preventing reversion of the color of an indicator dye in a biological indicator is disclosed. The indicator dye changes color if viable microorganisms are present after sterilization, because acidic byproducts are formed when the microorganisms metabolize the growth medium. It has been found that the dye can change color back to the original color after the completion of the sterilization due to leaching or diffusion of basic impurities into the growth medium. The method and the apparatus employ a dual buffer system with one buffer which operates at high pH to moderate pH fluctuations at the start of the sterilization and a second buffer which operates at low pH to minimize pH fluctuations after the sterilization is complete. Less high pH buffer than low pH buffer is used in order to maximize the speed and sensitivity of the biological indicator.Type: GrantFiled: October 27, 2000Date of Patent: August 20, 2002Assignee: Ethicon, Inc.Inventors: Henry K. Hui, Leslie A. Feldman, Richard A. Gorham
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Patent number: 6428746Abstract: A method determines an efficacy of a decontamination procedure. The method includes providing a test object and a control object. The test object is contaminated with a first known amount of inoculum comprising microorganisms. The control object is contaminated with a second known amount of the inoculum. The first known amount of inoculum and the second known amount of inoculum are substantially the same. The decontamination procedure is performed on the contaminated test object but not on the contaminated control object. The microorganisms from the decontaminated test object and the contaminated control object are recovered. A number of microorganisms recovered from the decontaminated test object is compared with a number of microorganisms recovered from the contaminated control object.Type: GrantFiled: February 4, 2000Date of Patent: August 6, 2002Assignees: Custom Ultrasonics Inc.Inventors: Lawrence F. Muscarella, Frank E. J. Weber
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Patent number: 6406879Abstract: A test device and a method for assessing the biocidal efficacy of a liquid are disclosed.Type: GrantFiled: March 31, 1998Date of Patent: June 18, 2002Assignee: Albert Browne LimitedInventors: Phillip Richard James, Richard Mark Bancroft
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Patent number: 6391578Abstract: A method for partitioning an aqueous biological liquid sample into discrete microvolumes for detection and enumeration of microorganisms is described. The method involves distributing microvolumes of a sample to a plurality of hydrophilic liquid-retaining zones of a culture device, where each liquid-retaining zone is surrounded by a portion of a hydrophobic “land” area. Also disclosed are devices for carrying out these methods.Type: GrantFiled: April 2, 2001Date of Patent: May 21, 2002Assignee: 3M Innovative Properties CompanyInventors: Michael G. Williams, Kurt J. Halverson, Gary E. Krejcarek, Ai-Ping Wei, James G. Berg, Peter D. Wickert, Clyde D. Calhoun, Mark K. Debe, Jean Qiu
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Publication number: 20020058296Abstract: This invention is directed to sterilization indicator systems for determining the effectiveness of sterilization processes. Test indicator devices comprise a container that is open on one end and has liquid impermeable and substantially gas non-absorptive walls which surround the biological or chemical material to be used as the indicator system, the opening contains a barrier that allows fluid such as gas to flow from the outside, through the plug and into the interior chamber containing the indicator system providing the detection. The entire indicator is further contained within a sealed pouch that is liquid impermeable and gas permeable under the conditions of a gas over steam sterilization system. The flexible pouch allows the test indicator to properly function while protecting the indicator from the environment while maintaining reliability of the test results.Type: ApplicationFiled: September 13, 2001Publication date: May 16, 2002Inventors: Michael J. Miller, Judy K. Hendricks
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Patent number: 6376211Abstract: Novel methods of identifying antimicrobial and anti-proliferative agents and therapeutic uses are provided.Type: GrantFiled: April 6, 2000Date of Patent: April 23, 2002Assignee: XOMA Technology Ltd.Inventors: Roger G. Little, II, Susan Abrahamson
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Publication number: 20020042078Abstract: In a method for examining the sterility of in particular liquid media, such as pharmaceutical and/or medical preparations, the microorganisms which may be contained in the media are mechanically concentrated thereby forming a concentrate, and the free nucleic acids which may be in the concentrate are dissociated through the addition of at least one desoxyribonuclease (DNAse). The desoxyribonucleic acid (DNA) and the ribonucleic acid (RNA) of the microorganisms which may be contained in the concentrate are then extracted, thereby simultaneously destroying the cell walls of the microorganisms and of the added DNAse. The DNA and preferably also the RNA are chromatographically isolated and the RNA is transcribed to cDNA through the addition of reverse transcriptase (revertase). The DNA is then concentrated using a polymerase chain reaction (PCR) incorporating primers derived from highly-conserved regions and/or random primers and/or arbitrary primers, and the concentrated DNA is qualitatively evaluated.Type: ApplicationFiled: October 3, 2001Publication date: April 11, 2002Applicant: BioChem Labor fur biologische und chemische Analytik GmbHInventors: Herbert Hermann, Wolfgang Leis
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Publication number: 20020037546Abstract: This invention relates to novel apparatus and methods for inserting and positioning a compressible material into a container and for using the container for detecting a specific environmental parameter or combination of parameters, or for determining the effectiveness of a sterilization procedure. Precise positioning of a plug of compressible material in a container has been discovered to provide flexibility necessary for production of indicator systems that vary in their response to sterilizing conditions to reflect the efficacy of sterilizers based on different modes of sterilization and reproduceability necessary for accurate monitoring of each mode. The invention also relates to test indicators containing controlled volumes of compressed, gas-permeable materials and to methods for using test indicators for determining the efficacy of different types of sterilization processes. The test indicator consists of a plurality of interactive enzymes in a container with at least one opening.Type: ApplicationFiled: September 19, 2001Publication date: March 28, 2002Inventors: Judy K. Hendricks, Shaundrea L. Rechsteiner, Joel R. Gorski
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Patent number: 6361962Abstract: Methods, materials, and systems for detecting toxins are provided. In one aspect, a toxin contamination detector includes a substrate on which a bar code is printed. The bar code has a first color (e.g., black) that is effective to reflect light from a bar code scanning device to produce a bar code result. A toxin indicator is also included. The toxin indicator has a second color in the absence of toxin, which second color does not substantially affect or alter the bar code result. However, the toxin indicator presents a third color in the presence of toxin which substantially changes the bar code result; thereby indicating the presence of toxin.Type: GrantFiled: October 6, 1999Date of Patent: March 26, 2002Assignee: Verseau GroupInventors: David P. Lentini, Vincent S. Camacho