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Ultra Rapid Microbial Testing Solutions

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Page 1: CONTROL WITH CONFIDENCE - biomerieux-usa.com€¦ · • SPECIFICITY of living microorganisms detection ... - safer, automatic control of reagents volumes with visual alarm - easier

RELEASE YOUR PRODUCTS FASTER WITHUltra Rapid Microbial Testing Solution

BEVERAGES

Ultra Rapid Microbial Testing SolutionschromID™ B CEPACIAEnhanced Detection for Effective Prevention

Chromogenic Medium that detects the presence of Burkholderia cepacia organisms from total aerobic microbial counts

CONTROL WITH CONFIDENCE

Page 2: CONTROL WITH CONFIDENCE - biomerieux-usa.com€¦ · • SPECIFICITY of living microorganisms detection ... - safer, automatic control of reagents volumes with visual alarm - easier

DIRECT COUNT

bioMérieux, Inc.100 Rodolphe StreetDurham, NC 27712U.S.A.Tel: (800) 682-2666 Fax: (800) 968-9494 www.biomerieux-usa.com

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• Detect Bacteria, Yeasts, Molds• Down to 1 cell per gram of

product• 25 or 50 tests per batch• IQ, OQ, PQ validation package

• Powders,• Detergents• Dual phase• Wipes…

D0537 UNIVERSAL PROTOCOL (BACTERIA AND YEASTS DETECTION)

Sample volume 1g

Sensitivity 1 organism/g of product

Batch time D-Count® 50

D-Count® 25

Up to 300 tests/batch - 50 tests in 75 minutes (48 samples + 1 negative control + 1 positive control) or 25 tests in 45 minutes (23 samples + 1 negative control + 1 positive control)

Up to 150 tests/batch - 25 tests in 45 minutes (23 samples + 1 negative control + 1 positive control)

Product release Down to 1 day

D0560 FUNGI DETECTION

Sample volume 0.1g

Sensitivity Down to 10 organism/g of product

Batch time D-Count® 50

D-Count® 25

Up to 150 tests/batch - 25 tests in 47 minutes (23 samples + 1 negative control + 1 positive control)

Up to 150 tests/batch - 25 tests in 60 minutes (23 samples + 1 negative control + 1 positive control)

Product release Down to 2 days

D0511 DIRECT COUNT IN PROCESS WATER – FOR BACTERIA AND YEASTS

Sample volume 1 to 250ml

Sensitivity Down to 50 organism/ml

Range Linear up to 106 organisms/ml

Batch time D-Count® 50

D-Count® 25

Up to 300 tests/batch - 50 tests in 75 minutes (48 samples + 1 negative control + 1 positive control) or 25 tests in 45 minutes (23 samples + 1 negative control + 1 positive control)

Up to 150 tests/batch - 25 tests in 45 minutes (23 samples + 1 negative control + 1 positive control)

Product release 20 minutes

PRESENCE/ABSENCE

Recommended for Personal Care, Cosmetic, Home care and Non-Sterile Pharmaceutical products. Validation study results prove:• SPECIFICITY of living microorganisms detection• LIMIT OF DETECTION (<1CFU/g) between CHEMUNEX® and traditional plate ISO detection methods• 100% RESULTS CORRELATION between CHEMUNEX® and traditional plate ISO methods

Products containing vegetal ingredients, and vegetal raw materials, are analyzed with the same sensitivity than other products (no background), thanks to the CHEMUNEX® technology based on direct microorganisms detection

END PRODUCTS EXAMPLES

• Skin care• Hair care• Oral care• Color cosmetics

IN-PROCESS

• Raw materials• Process water• Bulks testing

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bioMérieux, Inc.100 Rodolphe StreetDurham, NC 27712U.S.A.Tel: (800) 682-2666Fax: (800) 968-9494www.biomerieux-usa.com

PRESENCE/ABSENCE

YEAST IN FRUIT CONCENTRATES

BACTERIA IN FRUIT CONCENTRATES

• Detect Bacteria, Yeasts, Molds• Sensitivity down to 1 Microorganism• Save up to 5-7 days• 25 or 50 samples per batch

IN-PROCESS

• Raw materials• Process water• In-Process testing• Thermal treatment check

Final Products (not limited)

• Filterable or pulp-containing juices• Soft drinks• Iced teas• Energy drinks• Fruit concentrates

COMMERCIAL STERILITY TEST OF BEVERAGES

Sample volume 1ml

Sensitivity of the method 1 organism/bottle for bacteria and yeasts

Batch time Down to 90 minutes for 48 samples + 1 negative and 1 positive controls

Products Non carbonated beverages, soft drinks,…

Product release 24 hours after bottling

YEASTS AND MOLDS IN BEVERAGES & FRUIT JUICES

Sample volume 100 ml

Sensitivity of the method 1 organism/bottle

Batch time Down to 70 minutes for 48 samples + 1 negative and 1 positive controls

Products beverages & soft drinks,…

Product release 72 hours after bottling

YEASTS & MOLDS IN FILTERABLE BEVERAGES

Sample volume up to the whole bottle

Sensitivity of the method 1 cell/filtered volume

Batch time Down to 70 minutes for 48 samples + 1 negative and 1 positive controls

Products Filterable beverages

Product release 50 hours after bottling

CHEMUNEX® RECOGNIZED EXPERTISE IN MICROBIAL TESTING FOR FRUIT JUICES & SOFT DRINKS

Product releases based on effectiveness, safety and speed are becoming an in-creasingly important factor for all beverages manufacturers worldwide. As traditional microbiology is limited by the growth rate of microorganisms on culture media, rapid microbiology systems have become more and more interesting to quality assurance managers during the last few years, also driven by trend of preservative-free beverages and change from traditional glass bottle to modern PET bottle requiring highest de-mands for aseptic filling.

OTHER SPECIFIC APPLICATIONS AVAILABLE UPON REQUEST

DIRECT COUNT IN PROCESS WATER

Sample volume 1 ml

Sensitivity of the method 50 organisms/ml

Batch time Down to 80 minutes for 48 samples + 1 negative and 1 positive controls

Product release 20 minutes

DIRECT COUNT

• Quantitative results within minutes• Ready-to-use reagents• Capacity 25 or 50 tests per batch

THE 3RD D-COUNT® GENERATION IS EVEN:

Automated Cell Labeling

BASED ON A PROVEN TECHNOLOGY

Samples are treated with reagents that only label viable microorganisms. These labels are based on a non-fluorescent substrate which is enzymatically cleaved within the cell to liberate fluorochrome, which then accumulates. No cell growth or multiplication is required for direct count applications. The sample labeling is fully automated.

The labeled sample is automatically injected into the flow of the analyzer, forming a narrow analysis stream that ensures microorganisms to pass the laser excitation beam one by one. The fluorescent signals from each cell are collected by sensitive detectors and analyzed by digital data processing.

CHEMUNEX® ULTRA RAPID MICROBIAL ANALYZERS

Proprietary digital signal processing software ensures that only viable microorganisms are counted by the system. Results are displayed as direct counts and stored for full traceability. No interpretation is needed, results can be directly compared to a plate count for validation. Results can be printed in a range of formats including routine laboratory log sheets, LIMS-connection (Excel export files…)

Laser Excitation

Digital Data Processing

Flow cell Detector

Laser Detector

Enzyme

Microorganism

Free fluorochrome

Viabilitysusbtrate

- faster, up to 20% time saved per batch compared to the previous generation

- better adapted to your needs, easy upgrade from D-Count® 25 to D-Count® 50

- more compact, integrated control unit (25% shorter)

- safer, automatic control of reagents volumes with visual alarm

- easier to use, touch screen, intuitive software in 6 languages- more powerful, full traceability, trends analysis, designed for LIMS connection and

online customer support and proactive maintenance

• Up to 50 samples per hour• Rapid enumeration and presence/absence results• Direct correlation with plate count

• Quantitative results within minutes• Ready-to-use reagents• Capacity 25 or 50 tests per batch

THE 3RD D-COUNT® GENERATION IS EVEN:

Automated Cell Labeling

BASED ON A PROVEN TECHNOLOGY

Samples are treated with reagents that only label viable microorganisms. These labels are based on a non-fluorescent substrate which is enzymatically cleaved within the cell to liberate fluorochrome, which then accumulates. No cell growth or multiplication is required for direct count applications. The sample labeling is fully automated.

The labeled sample is automatically injected into the flow of the analyzer, forming a narrow analysis stream that ensures microorganisms to pass the laser excitation beam one by one. The fluorescent signals from each cell are collected by sensitive detectors and analyzed by digital data processing.

CHEMUNEX® ULTRA RAPID MICROBIAL ANALYZERS

Proprietary digital signal processing software ensures that only viable microorganisms are counted by the system. Results are displayed as direct counts and stored for full traceability. No interpretation is needed, results can be directly compared to a plate count for validation. Results can be printed in a range of formats including routine laboratory log sheets, LIMS-connection (Excel export files…)

Laser Excitation

Digital Data Processing

Flow cell Detector

Laser Detector

Enzyme

Microorganism

Free fluorochrome

Viabilitysusbtrate

- faster, up to 20% time saved per batch compared to the previous generation

- better adapted to your needs, easy upgrade from D-Count® 25 to D-Count® 50

- more compact, integrated control unit (25% shorter)

- safer, automatic control of reagents volumes with visual alarm

- easier to use, touch screen, intuitive software in 6 languages- more powerful, full traceability, trends analysis, designed for LIMS connection and

online customer support and proactive maintenance

• Up to 50 samples per hour• Rapid enumeration and presence/absence results• Direct correlation with plate count

• Quantitative results within minutes• Ready-to-use reagents• Capacity 25 or 50 tests per batch

THE 3RD D-COUNT® GENERATION IS EVEN:

Automated Cell Labeling

BASED ON A PROVEN TECHNOLOGY

Samples are treated with reagents that only label viable microorganisms. These labels are based on a non-fluorescent substrate which is enzymatically cleaved within the cell to liberate fluorochrome, which then accumulates. No cell growth or multiplication is required for direct count applications. The sample labeling is fully automated.

The labeled sample is automatically injected into the flow of the analyzer, forming a narrow analysis stream that ensures microorganisms to pass the laser excitation beam one by one. The fluorescent signals from each cell are collected by sensitive detectors and analyzed by digital data processing.

CHEMUNEX® ULTRA RAPID MICROBIAL ANALYZERS

Proprietary digital signal processing software ensures that only viable microorganisms are counted by the system. Results are displayed as direct counts and stored for full traceability. No interpretation is needed, results can be directly compared to a plate count for validation. Results can be printed in a range of formats including routine laboratory log sheets, LIMS-connection (Excel export files…)

Laser Excitation

Digital Data Processing

Flow cell Detector

Laser Detector

Enzyme

Microorganism

Free fluorochrome

Viabilitysusbtrate

- faster, up to 20% time saved per batch compared to the previous generation

- better adapted to your needs, easy upgrade from D-Count® 25 to D-Count® 50

- more compact, integrated control unit (25% shorter)

- safer, automatic control of reagents volumes with visual alarm

- easier to use, touch screen, intuitive software in 6 languages- more powerful, full traceability, trends analysis, designed for LIMS connection and

online customer support and proactive maintenance

• Up to 50 samples per hour• Rapid enumeration and presence/absence results• Direct correlation with plate count