# US 12,553,075 B2 · Bioburden analyzer with ultraviolet enhancement

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- Number: US 12,553,075 B2
- Document ID: US12553075B2
- Status: Granted
- Kind: B2
- Application number: 18/203,947
- Filed: 2023-05-31
- Published: 2024-12-05
- Granted: 2026-02-17
- Earliest claimed: 2023-05-31
- Assignees: Mettler-Toledo Thornton, Inc.
- Applicants: Mettler-Toledo Thornton, Inc.
- Inventors: Robert J McLean; Anthony C. Bevilacqua, Jr.; Kim Perkins; Anjan Reijnders
- Web page: https://patentgrep.com/patent/US12553075B2

## CPC

- C12Q 1/02: involving viable microorganisms
- G01N 21/6486: {Measuring fluorescence of biological material, e.g. DNA, RNA, cells (G01N21/6428 takes precedence)}
- B01L 3/502715: {characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces}
- C12M 41/36: {of biomass, e.g. colony counters or by turbidity measurements (electrooptical investigation of individual particles G01N15/14, flow cytometers G01N15/1404)}
- G01N 21/85: Investigating moving fluids or granular solids
- B01L 2300/0654: Lenses; Optical fibres
- B01L 2300/088: Channel loops
- B01L 2300/168: Specific optical properties, e.g. reflective coatings
- G01N 21/94: Investigating contamination, e.g. dust (G01N21/85 takes precedence)
- G01N 33/1826: {Organic contamination in water}
- G01N 2021/8557: {Special shaping of flow, e.g. using a by-pass line, jet flow, curtain flow}
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)
- B01L: CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- C12M: APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; {APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS}

## Abstract

Bioburden analysis devices and related systems and methods are disclosed which utilize ultraviolet (UV) irradiation to enhance accuracy of results. A light source producing UV light is positioned along a passageway for a fluid flow upstream of a laser subsystem. The laser subsystem includes a laser which excites particulate within the fluid and a photo detector which measures fluorescence of the particulate within the fluid. By exposing the particulate to UV light prior to laser excitement, signal to noise ratio is increased, providing more accurate results.

## Claims

### Claim 1

A bioburden analysis system comprising:
a passageway for a flow of a fluid, wherein at least a first portion of the passageway at least primarily comprises a UV transparent or translucent material;
an ultraviolet (UV) light source positioned along the first portion of the passageway for irradiating particulate within the fluid with UV light when activated, wherein the UV light source emits UV light when activated; and
a laser subsystem positioned along a second portion of the passageway downstream of the first portion of the passageway, said laser subsystem comprising:
at least one laser for exciting the particulate within the fluid; and
at least one photo detector for measuring fluorescence of the particulate within the fluid;
wherein:
the first portion of the passageway comprises multiple windings helically arranged about the UV light source; or
the UV light source comprises multiple lighting elements, each configured to produce UV light, the first portion of the passageway extends in a linear fashion adjacent to each of the multiple lighting elements, and the multiple lighting elements are arranged in a helical fashion about the first portion of the passageway.

### Claim 2 (depends on 1)

The bioburden analysis system of claim 1 wherein:
the first portion of the passageway is located less than 10 mm from the UV light source.

### Claim 3 (depends on 2)

The bioburden analysis system of claim 2 wherein:
the first portion of the passageway comprises an internal diameter on a same order of magnitude as a depth of the UV penetration from the UV light source when activated.

### Claim 4 (depends on 2)

The bioburden analysis system of claim 2 wherein:
the UV transparent or translucent material comprises fused silica or quartz.

### Claim 5 (depends on 2)

The bioburden analysis system of claim 2 wherein:
the first portion of the passageway is configured to provide a flow rate of the fluid from about 0.01 μL/min to about 500 mL/min.

### Claim 6 (depends on 2)

The bioburden analysis system of claim 2 wherein:
the first portion of the passageway is configured to maintain the fluid within irradiation distance of the UV light source for a time period from about 5 to 90 seconds.

### Claim 7 (depends on 2)

The bioburden analysis system of claim 2 wherein:
the UV light source is part of an enhancement subsystem and is controlled to provide discontinuous light.

### Claim 8 (depends on 1)

The bioburden analysis system of claim 1 wherein:
the passageway comprises a sample line extending from a main fluid passageway forming part of a larger system; and
the system is configured to accommodate a continuous flow of the fluid through the sample line.

### Claim 9 (depends on 8)

The bioburden analysis system of claim 8 further comprising:
a controller configured to receive fluorescence data from the laser subsystem and record bioburden levels in a continuous manner in substantially real-time for the continuous flow of the fluid through the sample line using a pre-programmed signal threshold for bioburden detection based on laser excitation by the laser subsystem following exposure to the UV light from the UV light source which is different from a signal threshold for detecting a same type or types of bioburden using the bioburden analysis system and exposing the same type or types of bioburden to laser excitation by the laser subsystem without prior exposure to the UV light from the UV light source.

### Claim 10 (depends on 1)

The bioburden analysis system of claim 1 wherein:
the passageway comprises, or is connected to, at an input end thereof, a storage tank for the fluid; or
the passageway is connected, at an input end and an output end thereof, to an ambient environment with the fluid.

### Claim 11 (depends on 1)

The bioburden analysis system of claim 1 further comprising:
an enclosure provided about the UV light source and the first portion of the passageway, wherein the enclosure comprises one or more UV reflective materials.

### Claim 12 (depends on 1)

The bioburden analysis system of claim 1 further comprising:
an enclosure provided about the UV light source, which provides the first portion of the passageway, wherein the enclosure provides a liquid-tight seal for a bath of the fluid and the UV light source extends within at least a portion of the enclosure.

### Claim 13

A method for detecting biological contamination in a fluid comprising:
providing a sample flow of a fluid within a sample line;
irradiating the sample flow of the fluid with ultraviolet (UV) light from a light source comprising one or more lighting elements positioned along the sample line;
exciting particulate within the sample flow of the fluid by way of a laser positioned downstream of the light source to cause or increase fluorescence of at least microbiological portions of the particulate within the sample flow of the fluid; and
measuring the fluorescence of the particulate within the sample flow of the fluid by way of a photo detector; and
electronically recording detected bioburden levels based, at least in part on the detected levels of the fluorescence of the sample flow of the fluid using a pre-programmed signal threshold for bioburden detection based on laser excitation by the laser subsystem following exposure to the UV light from the UV light source which is different from a signal threshold for detecting a same type or types of bioburden using the bioburden analysis system and exposing the same type or types of bioburden to laser excitation by the laser subsystem without prior exposure to the UV light from the UV light source.

### Claim 14 (depends on 13)

The method of claim 13 wherein:
the detected bioburden levels of the sample flow of the fluid are electronically recorded in substantially real time.

### Claim 15 (depends on 13)

The method of claim 13 wherein:
the first portion of the sample line is coiled about the light source in a spiral in multiple windings;
a distance between the light source and the sample line is less than 10 mm;
the first portion of the sample feed line coiled about the light source primarily comprises fused silica; and
the sample flow of the fluid is continuous for at least a period of time.

### Claim 16

A bioburden analysis system comprising:
a passageway for a flow of a fluid, wherein at least a first portion of the passageway at least primarily comprises a UV transparent or translucent material;
an ultraviolet (UV) light source positioned along the first portion of the passageway for irradiating particulate within the fluid with UV light when activated, wherein the UV light source emits UV light when activated;
a laser subsystem positioned along a second portion of the passageway downstream of the first portion of the passageway, said laser subsystem comprising:
at least one laser for exciting the particulate within the fluid; and
at least one photo detector for measuring fluorescence of the particulate within the fluid;
a controller configured to receive fluorescence data from the laser subsystem and record bioburden levels in a continuous manner for the continuous flow of the fluid through the sample line using a pre-programmed signal threshold for bioburden detection based on laser excitation by the laser subsystem following exposure to the UV light from the UV light source which is different from a signal threshold for detecting a same type or types of bioburden using the bioburden analysis system and exposing the same type or types of bioburden to laser excitation by the laser subsystem without prior exposure to the UV light from the UV light source.

### Claim 17 (depends on 16)

The bioburden analysis system of claim 16 wherein:
the controller is configured to receive the fluorescence data and record the bioburden levels in substantially real-time.

### Claim 18 (depends on 16)

The bioburden analysis system of claim 16 wherein:
the first portion of the passageway comprises multiple windings helically arranged about the UV light source; or
the UV light source comprises multiple lighting elements, each configured to produce UV light, the first portion of the passageway extends in a linear fashion adjacent to each of the multiple lighting elements, and the multiple lighting elements are arranged in a helical fashion about the first portion of the passageway.

### Claim 19 (depends on 18)

The bioburden analysis system of claim 18 wherein:
the first portion of the passageway is located less than 10 mm from the UV light source; and
the first portion of the passageway comprises an internal diameter on a same order of magnitude as a depth of the UV penetration from the UV light source when activated.

### Claim 20 (depends on 19)

The bioburden analysis system of claim 19 wherein:
the first portion of the passageway is configured to provide a flow rate of the fluid from about 0.01 μL/min to about 500 mL/min; and
the first portion of the passageway is configured to maintain the fluid within irradiation distance of the UV light source for a time period from about 5 to 90 seconds.