2013 E-Catalog - BioPharma & Cosmetics - Isla Lab Products

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print bioMérieuxPage 1 of 1072013 e-Catalog - BioPharma &CosmeticsRapid Microbiology / Rapid Alternative MicroBiology / BacT/ALERT 3D Dual-T Automated Sterility SystemBacT/ALERT 3D Dual-T - Automated Dual Temperature Sterility TestingSystemBacT/ALERT Dual-T is an automated microbial detection system that performs sterility testing at twotemperatures: 32.5 C and 22.5 C. Ease of use, objective results, reproducibility and traceability are hallmarksof BacT/ALERT’s modular design.Time-Tested and TrustedPharmaceutical and cell therapy companies worldwide trust the proven performance of BacT/ALERT toconfidently release their products faster than traditional methods. Decreased time todetection yields shortened production cycles and quicker product release; shortening time to market andaffording lean manufacturing though production agility.Real-time, in-process monitoring yields valuable, actionable information for faster informed decisions and aquick recovery when a contamination event occurs.BacT/ALERT’s patented colorimetric technology and industrially-optimized range of culture media deliverdetection of a wide range of organisms within 24-72 hours.*Sterility SimplifiedThe Dual-T system consists of one controller module, one standard 32.5 C incubator module and one 22.5 C lowtemperature (LT) incubator module. Each incubator module will simultaneously incubate and detectcontamination within 240 individual samples.The intuitive touchscreen interface, standardized sample preparation methods and objective colorimetrictechnology make the BacT/ALERT not only appealing to operators of various skill levels but also allow them todeliver consistent, accurate and objective results.Optional OBSERVA data management software offers full traceability and further data management optionsthrough customizable storage, queries and reports. LIMS integration is also possible.Operation is easy as 1-2-3Select appropriate BacT/ALERT culture medium bottleInoculate bottle with sampleLoad bottle into BacT/ALERT systemBacT/ALERT Dual-T SystemBarcode scanning reduces risk of human error.What's happening inside?Each BacT/ALERT bottle contains sterile culture medium and is imbedded with a colorimetric sensor that changesfrom gray to yellow in the presence of CO2 produced by growing microorganisms.Continuous MonitoringOnce bottles are loaded, the colorimetric sensors are scanned every ten minutes. Once growth is detected, thesystem alarms both audibly and visually and the sample data is recorded.Patented Colorimetric TechnologyValue for the QC Lab, Production and FinanceFrom increased productivity in the lab to reducing product quarantine time, BacT/ALERT has value to many parts ofthe pharmaceutical manufacturing organization.BacT/ALERT Culture MediaAutomation of the USP, EP 2.6.1 and JP 54 chapters for sterility testingSimple, standardized workflowReduced hands-on time and labor costsReduced inventory holding costsObjective results for even viscous/cloudy samplesRobust detection bacteria, yeasts and moldsNon-destructive sterility test methodTwo temperature incubation (32.5 C and 22.5 C) available with BacT/ALERT Dual TNew Adsorbent Polymeric Beads (APB) Media available for neutralization of antibiotics and other antimicrobialsIsolator compatible mediaProven compatibility with biological samples that cannot be arma/fo/print all.php12/10/2013

print bioMérieuxPage 2 of 107BacT/ALERT 3D for Bacterial Detection in Blood ProductsAnalytical sensitivity and clinical specificity of the system enables the detection of a wide variety of microorganisms in blood products atvery low levels. BacT/ALERT is used by blood banks, cord blood banks and other institutes that bank cellular products to detectmicroorganisms.BacT/ALERT BPA culture bottles and BacT/ALERT BPN culture bottles are specifically developed for the blood collection industry with aspecific intended use and regulatory requirements.Media and test samples should be validated for each application. Industry "i" bottles have performance characteristics and quality control performed with relevant USP,EP and JP microorganisms.*Kielpinski, G. et al. Roadmap to approval: use of an automated sterility test method as a lot release test for Carticel, autologous cultured - chondrocytes. Cytotherapy2005;7(6):531-541BACT/ALERT 3D SYSTEMSREF.PackagingBacT/ALERT 3D 120 Combination Module (Right 247013 / Left 247014)247014 /247013120 cellsBacT/ALERT 3D 240 System Includes Controller Module, 240 cell Incubator ModuleLeft(210159) Right (210161)4700002240 cellsBacT/ALERT 3D Controller Module Including touch-screen, keyboard and barcodescanner210148OneBacT/ALERT 3D Incubator Module Incubates up to 240 bottles in 4 drawers of 60 cells(Left 210159 / Right 210161)210159 /210161240 cellsBACT/ALERT 3D DUAL-T SYSTEMSREF.BacT/ALERT 3D Dual-T System Includes Controller Module, 240 cell Incubator Module,4700493240 cell Low Temperature (LT) Incubator ModuleLow Temperature (LT) Module containing one incubator (240 capacity)BACT/ALERT COMPUTER SYSTEMS411062REF.Packaging2x240 cells240 cellsPackagingBacT/ALERT 3D Select Link213706OneOBSERVA Non-interface Data System Management for Blood Bank412762240 cellsOBSERVA Data Management System for BacT/ALERT 3D consolidates data andresults into a single workstation. Capable of integrating with labs that have Vitek 2.4700013OneBACT/ALERT IMPLEMENTATION GUIDESREF.PackagingBacT/ALERT System410176OneDual T System Implementation Guide410935OneBACT/ALERT BOTTLES FOR INDUSTRIAL om/us/pharma/fo/print all.phpPackaging12/10/2013

print bioMérieuxPage 3 of 107BacT/ALERT BPA Culture bottles279018100 Bottles279019100 Bottles259786100 Bottles251062100 Bottles251063100 Bottles259785100 Bottles251061100 BottlesAerobic Culture Medium for Blood ProductsBacT/ALERT BPN Culture bottlesAnaerobic Culture Medium for Blood ProductsBacT/ALERT iAST Culture bottlesStandard Aerobic Culture MediumBacT/ALERT iFA Aerobic Culture bottlesAerobic Culture Medium with Charcoal NeutralizerBacT/ALERT iFN Anaerobic Culture bottlesAnaerobic Culture Medium with Charcoal NeutralizerBacT/ALERT iNST Culture bottlesStandard Anaerobic Culture MediumBacT/ALERT iPF Culture bottlesAerobic Pediatric Culture Medium with Charcoal NeutralizersBACT/ALERT ACCESSORIES & BacT/ALERT Adapter Inserts27901360/boxBacT/ALERT Bottle Barcode Labels2596621,000/boxBacT/ALERT Cell Plugs2598565/boxBacT/ALERT i Bottle Re-seal259787100/boxBacT/ALERT Incubator Thermometer89048-6001/boxBacT/VIEW Operator Manual for BacT/ALERT 3D456131871/boxBottle Carrying Rack940-0046011/boxCalibration Kit456065431/boxAdapter CapsBacT/ALERT 3D Industrial Operator ManualBACT/ALERT INSTRUMENT STANDSREF.PackagingBacT/ALERT 3D Benchtop Cart2134181/boxBacT/ALERT 3D Control Module om/us/pharma/fo/print all.php12/10/2013

print bioMérieuxPage 4 of 107BacT/ALERT 3D Control Module Stand and Stacking Rack for 1-2 incubators2135881/boxBacT/ALERT 3D Stacking Rack for 1-22135891/boxRapid Microbiology / Rapid Alternative MicroBiology /DELETE!!CHEMUNEX Rapid Microbiology AnalyzersRapid Testing Benefits the Lab and ProductionCosmetics and personal care companies worldwide have relied on CHEMUNEX technology to deliver safe, highquality products to their customers for more than 20 years. These companies also enjoy the financial benefits of rapidmicrobiology - gaining efficiencies on both the production floor and in the laboratory.Quick turnaround time from QC shortens production cycles by reducing final product quarantine times. Fast QC alsoempowers production with knowledge from in-process testing so products found to be out of specification can berejected prior to final filling. If deviations are found, CHEMUNEX helps pinpoint root cause so swift correctiveaction can be taken to recover from adverse events gracefully.The collective time savings allows cosmetics manufacturers to run leaner through safety stock optimizationand production agility.Unique, Proven TechnologyDetects viable bacteria, yeasts and moldsEffective for organisms that are environmentally stressed, nutrient-depleted or in presence of preservativesObjective Yes/No results in 24 hours (50 hours for molds)Full validation support availableSolutions for Finished and In-process Products, Raw Materials and Process WaterCosmetics / Personal CareTotal Viable Count (TVC) - Bacteria and YeastSensitivity:1 organism/gram of productProduct release time: 24-hoursApplications: Syrups, ointments, tablets, powdersYeasts and MoldsSensitivity:10 organisms/gram of productProduct release time: 50-hoursApplications: Syrups, ointments, tablets, powdersDirect Count (Enumeration)Sensitivity: 5 organisms/mLProduct release time: 20 minutesApplications: Process waterThree Levels of Automation to Fit Your NeedsAutomated high-throughput analysisD-Count print all.php50 tests / hour12/10/2013

print bioMérieuxPage 5 of 107Automated analysisBactiFlow ALS25 tests / hourSemi-automated analysisBactiFlow 15 tests / hourThe D-Count and BactiFlow ALS systems combine fully-automated fluorescent viable cell labeling and digital flow cytometry into powerful systems that detect andcount individual cells without the need for cell growth.Release your products fasterReduce quarantine timeOptimize safety stock levelsReduce warehousing expenseRespond quickly to changes in demandVirtually eliminate product loss due to raw material contaminationScreen incoming raw materials in minutesReact quickly to adverse eventsRapid confirmation of corrective action effectivenessMinimized production disruptionProtect the integrity of your product's good nameObjective, robust methodology ensures certainty of resultsRapid Microbiology / Rapid Alternative MicroBiology / DELETE!ScanRDI - Rapid Microbial Detection and EnumerationSterility Results in 3 Hours!ScanRDI revolutionized rapid microbial detection when it was first introduced and its combination of speed and sensitivity remains unrivaled to this day.The unique technology not only delivers actionable sterility results in 3 hours but is sensitive enough to detect a single bacterium, yeast or mold. Even spores, stressedand fastidious organisms are detected in minutes; offering an extraordinarily rapid alternative to traditional 14-day sterility testing.Traceability, 21 CFR part 11 compliance and full validation support (IQ, OQ and PQ) offer peace of mind.ApplicationsFinished product releaseIn-process / bioburden testingWater analysisRaw material inspectionEnvironmental monitoringDetect All Types of Contamination 21 CFR Part 11 ComplianceBacteriaYeastsMoldsSporesAudit traile-SignatureReview / review and approveArchive and /us/pharma/fo/print all.php12/10/2013

print bioMérieuxPage 6 of 107Detection PrincipleViable cells are labeledLabeled cells produce fluorescenceFluorescence is detected by ScanRDIFilter, Label, ScanFiltration captures microorganisms on a special membrane. Metabolically active cells on the membrane are labeledwith a reagent inducing enzymatic cleavage of a non-fluorescent substrate to liberate free fluorochrome into the cell'scytoplasm. Non-viable cells are not labeled.Laser scanning of the membrane is fully overlapping to ensure detection of any living cell present on the filter emittinglight produced by the fluorochrome. It takes less than 3 minutes to scan the entire membrane and display the accuratenumber of viable cells. Powerful discrimination ensure only labeled microorganisms are detected.Results are immediately displayed as direct viable cell counts requiring no operator interpretation. Additionally, a scanmap displays the precise location of each detected microorganism at the surface of the membrane. This enables fastvisual result confirmation using an optional microscope attachment. Data output is in the form of a tabulated datasheet, which includes daily control results and a complete file.INSTRUMENTSREF.Legionella GVPC Agar43031*20Letheen AgarM111210LT 100 Agar4328120m-HPC AgarM1213*10MacConkey Agar (MAC)M101710MacConkey Sorbitol AgarM1186*10Mannitol Salt AgarM101810m’Endo Agar, LesM107010Nutrient AgarM102310Oxford Agar, Modified (MOX)M109110M1229*10Plate Count Agar a/fo/print all.php12/10/2013

print bioMérieuxPage 7 of 107Potato Dextrose Agar Acidified—3.5 pH—Deep Fill (PDA)M106110Potato Dextrose Agar—Deep Fill (PDA)M103810GENERAL PURPOSE BROTHS & DILUENTSREF.Pseudomonas Isolation AgarM1093TOTAL VIABLE COUNT (TVC)REF.Tryptic soy agar (TSA)Tryptic soy broth (TSB)YEAST & MOLD ENUMERATIONSabouraud dextrose agar (SDA)ESCHERICHIA COLI10PackagingM1040100mm plateT807620ml pour tubeP230090ml wide mouthREF.PackagingM1025100mm plateT800820ml pour tubeREF.PackagingMacConkey agar (MAC)M1017100ml plateMacConkey broth (MAC)P3155*100ml wide mouthP127090ml Boston roundP230090ml wide mouthTryptic soy broth (TSB)CANDIDA ALBICANSSabouraud dextrose agar (SDA)SALMONELLARappaport vassiliadis broth (RV)Tryptic soy broth (TSB)Xylose Lysine Deoxycholate agar (XLD)PSEUDOMONAS AERUGINOSACetrimide agarREF.PackagingM1025100mm plateT800820ml pour tubeREF.Packaging4211010ml tubesP127090ml Boston roundP230090ml wide mouthM1031100mm /us/pharma/fo/print all.phpPackaging100mm plate12/10/2013

print bioMérieuxTryptic soy broth (TSB)STAPHYLOCOCCUS AUREUSMannitol salt agarTryptic soy broth (TSB)CLOSTRIDIAPage 8 of 107P127090ml Boston roundP230090ml wide mouthREF.PackagingM1018100mm plateP127090ml Boston roundP230090ml wide mouthREF.PackagingColumbia agarM1261*100mm plateReinforced medium for ClostridiaP3150*100ml wide mouthBILE-TOLERANT GRAM-NEGATIVE BACTERIAEnterobacteria enrichment broth MosselViolet red bile glucose agar (VRBG)GENERALBuffered sodium chloride-peptone solution pH 7.0Phosphate buffer solution pH 7.2NON-STERILE PRODUCT TESTING MEDIAREF.Packaging42621100ml pour bottleM1260*100mm plateREF.Packaging42609100ml pour bottleP121090ml Boston roundP2340*100ml wide mouthT80359ml tubesT8181-C*10ml tubesREF.PackagingBlood Agar Slant—16 ml—20x150 mmT8221*20Buffered Peptone Water—9 ml42111100Buffered Sodium Chloride—Peptone Solution—9 mlT8218-C*100Butterfields Phosphate Buffered Water—9 mlCapitalVialsCV1100-C100Butterfields Phosphate Buffered Water—9 ml-20x150 mmT8204-C*100Clear Thio - 9ml4201820DE Neutralizing Broth—9 mlT8163*20Eugon LT 100 Broth - pharma/fo/print all.php12/10/2013

print bioMérieuxPage 9 of 107Fraser Broth—10 ml4207220Lauryl Sulfate Tryptose Broth w/Durham Tube—10 mlT809620CV102025CV1020-C100Letheen Broth—5 mlCV1080-C*100Letheen Broth—9 mlCV1180-C*100T808020Phosphate Buffer, Sterile—10 ml—pH 7.2T8181-C*100Phosphate Buffer, Sterile—9 ml—pH 7.2T803520Letheen Broth—10 mlM Broth—10 mlT8190*20T8190-C*100Rappaport Vassiliadis Broth (RV)—10 ml4207320Rappaport Vassiliadis Soy Broth (RVS)—10 ml4211020R2A Agar—20 ml-20x150 mm—Pour TubeT800820T8008-C*100Sabouraud Dextrose Agar Slant (SDA)T707720Sabouraud Dextrose Agar w/Chloramphenicol —20 ml-20x150 mm—Pour TubeT8198*20CV1200-C*100T707920Sabouraud Dextrose Agar (SDA)—20 ml-20x150 mm—Pour TubeSaline, Sterile 0.85%—9.9 mlSelenite Cystine Broth—10 mlT803420T8034-C100Thioglycollate with Indicator (FTM)—10 mlT706520Thioglycollate with Indicator (FTM)—15 ml-20x150 mmT8231*20Triple Sugar Iron Agar Slant (TSI)T708720Tetrathionate Broth Base—10 mlTryptic Soy Agar (TSA)—20 ml-20x150 mm—Pour TubeTryptic Soy Agar Slant (TSA)Tryptic Soy Agar w/L & P80 (TSALP80)—20 ml-20x150 mm—Pour TubeTryptic Soy Broth (TSB)—10 mlTryptic Soy Broth (TSB)—15 ml-20x150 mmTryptic Soy Broth (TSB)—20 ml-20x150 -biomerieux.com/us/pharma/fo/print all.php12/10/2013

print bioMérieuxTryptic Soy Broth (TSB)—9 mlDILUTION VIALSPage 10 of 1074210020T8179-C*100REF.Packaging0.1% Peptone Water - 90 ml46996640.1% Peptone Water - 99 ml46997*64Butterfields Phosphate Buffered Water—90 ml4699864Butterfields Phosphate Buffered Water—99 ml4699964Phosphate Buffer w/Magnesium Chloride - 90ml4699564Phosphate Buffer w/Magnesium Chloride - 99ml4699364POUR BOTTLES, SCREW CAP ? 90 ML FILLPhosphate Buffer—pH 7.2POUR BOTTLES, SCREW CAP — 100 ML FILLREF.P1210REF.Packaging25PackagingSabouraud Dextrose Agar w/L & P 80 (SDALP80)P2220*25Tryptic Soy Agar (TSA)P111025Tryptic Soy Agar w/L & P 80 (TSALP80)P2230*25POUR BOTTLES, SCREW CAP — 200 - 500 ML FILLREF.PackagingPhosphate Buffer30221512Plate Count Agar—500 mlP2850*10R2A Medium—400 mlP1640*10Sabouraud Dextrose Agar (SDA)—200 mlP2160*10Sabouraud Dextrose Agar (SDA)—500 mlP207010Sabouraud Dextrose Agar w/Chloramphenicol—500 mlP2900*10Sabouraud Dextrose Agar w/L & P 80 (SDALP80)P2820*10Saline, Sterile 0.85%—500 pharma/fo/print all.php12/10/2013

print bioMérieuxPage 11 of 107Standard Methods Agar—500 mlP1071*10Tryptic Soy Agar (TSA)—220 mlP112010Tryptic Soy Agar (TSA)—500 mlP205010WIDE MOUTH BOTTLES, WITH SCREW CAPS 90 ML FILLREF.PackagingLactose BrothP228025MacConkey Broth (MAC)P2980*25Sabouraud Dextrose Broth (SDB)P2320*25TAT BrothP235025Tryptic Soy Broth w/0.5% L & 4% P 20P2540*25WIDE MOUTH BOTTLES, WITH SCREW CAPS 100 ML FILLREF.PackagingLactose Broth w/0.5% L & 4% P 20P2860*25Letheen Broth30220212MacConkey Broth (MAC)P315525Phosphate Buffer, pH 7.2P2340*25Reinforced Medium for ClostridiumP3150*25Tryptic Soy Broth w/0.5% L & 4% P 20P2870*25POUR BOTTLE, WITH SCREW CAPS 50-225 MLREF.PackagingBuffered Peptone Solution, pH 7.0 - 90 ml426096Buffered Peptone Water—225 ml420436Buffered Peptone Water—90 ml420426Cefixime Tellurite Supplement (4 ml)426066Eugon LT 100 Broth - 50 ml426136Fraser Broth—225 ml420466420486426154Half Fraser Broth—225 o/print all.php12/10/2013

print bioMérieuxPage 12 of 107Mossel Broth - 100 ml426216Rapid Microbiology / Rapid Alternative MicroBiology /DELETE!!ScanRDI - Rapid Microbial Detection and EnumerationSterility Results in 3 HoursScanRDI revolutionized rapid microbial detection when it was first introduced and its combination of speed andsensitivity remains unrivaled to this day.The unique technology not only delivers actionable sterility results in 3 hours but is sensitive enough to detect asingle bacterium, yeast or mold. Even spores, stressed and fastidious organisms are detected in minutes;offering an extraordinarily rapid alternative to traditional 14-day sterility testing.Traceability, 21 CFR part 11 compliance and validation support offer peace of mind.ApplicationsFinished product releaseIn-process / biobruden testingWFI analysisRaw material screeningEnvironmental MonitoringDetect All Types of Microbial ContaminationDetection PrincipleBacteriaYeastsMoldsSporesViable cells are labeledLabeled cells produce fluorescenceFluorescence is detected by ScanRDISpecific Cell LabelingThe "viability substrate" component of the labeling solution enters the microorganism through the cell membrane. Living cells cleave the nonfluorescent viability substrate by an enzymatic reaction, releasing fluorescent particles (free fluorochrome) within the cell. The cell's membraneholds the light-emitting fluorochrome within the cell and allows it to be detected by the ScanRDI's laser. Nonliving cells are not metabolically actiand not labeled.Filter, Label, ScanFiltration captures microorganisms on a special membrane.A solution is added to the membrane to "label" only living cells by making them fluoresce.The ScanRDI's laser scans the entire membrane in less than three minutes and immediately displays the total number of living cells fixed to the membrane.The scan map and microscope attachment allow for quick visual confirmation of results.Data output is in the form of a tabulated data sheet, which includes daily control results and a complete a/fo/print all.php12/10/2013

print bioMérieuxPage 13 of 107REF.INSTRUMENTSBactiFlow D-Count BactiFlow 302-A0001Semi-automated flow cytometer (15 tests/h)D-count 301-A0001Fully-automated flow cytometer (50 tests/h)BactiFlow ALS400-A0001Fully-automated flow cytometer (25 tests/h)Rapid Microbiology / Rapid Alternative MicroBiology / ScanRDI Three-Hour Sterility ResultsScanRDI - Rapid Microbial Detection and EnumerationSterility Results in 3 HoursScanRDI revolutionized rapid microbial detection when it was first introduced and itscombination of speed and sensitivity remains unrivaled to this day.The unique technology not only delivers actionable sterility results in 3 hours but is sensitiveenough to detect a single bacterium, yeast or mold. Even spores, stressed and fastidiousorganisms are detected in minutes; offering an extraordinarily rapid alternative to traditional14-day sterility testing.Traceability, 21 CFR part 11 compliance and validation support offer peace of mind.ApplicationsFinished product releaseIn-process / biobruden testingWFI analysisRaw material screeningEnvironmental MonitoringDetect All Types of ContaminationDetection PrincipleViable cells are rma/fo/print all.php12/10/2013

print bioMérieuxPage 14 of 107BacteriaYeastsMoldsSporesLabeled cells produce fluorescenceFluorescence is detected by ScanRDISpecific Cell LabelingThe "viability substrate" component of the labeling solution enters the microorganism through the cell membrane. Livingcells cleave the non-fluorescent viability substrate by an enzymatic reaction, releasing fluorescent particles (freefluorochrome) within the cell. The cell's membrane holds the light-emitting fluorochrome within the cell and allows it to bedetected by the ScanRDI's laser. Nonliving cells are not metabolically active and not labeled.Filter, Label, ScanFiltration captures microorganisms on a special membrane.A solution is added to the membrane to "label" only living cells by making them fluoresce.The ScanRDI's laser scans the entire membrane in less than three minutes and immediately displays the total number of living cells fixed to the membrane.The scan map and microscope attachment allow for quick visual confirmation of results.Data output is in the form of a tabulated data sheet, which includes daily control results and a complete file.INSTRUMENTSSCANRDI ANALYZERREF.415443FIFU & CB04 CompatibleACCESSORIESCAMERAREF.200-B2003-01Digital NikonCB04 FILTRATION SUPPORT KIT415447FIFU FILTRATION SUPPORT KIT415448FILTRATION ACCESSORIES KIT415449FILTRATION RAMP 3 PORTS200-B0131-01FILTRATION RAMP 6 PORTS200-B0136-01MICROSCOPE KIT SCANRDI415446415212POWER SUPPLY /fo/print all.php12/10/2013

print bioMérieuxPage 15 of 107US ConfigurationPRINTER SCANRDI416009SOFTSCAN SOFTWARE CD415445UPS 1500VA - 110 V413646110 VUSER MANUAL SCANRDI415473English VersionVACUUM PUMP415474115VRapid Microbiology / Rapid Alternative MicroBiology / CHEMUNEX Rapid Detection for Cosmetics & Personal CareCHEMUNEX Rapid Microbiology AnalyzersRapid Testing Benefits the Lab and ProductionCosmetics and personal care companies worldwide have relied on CHEMUNEX technology todeliver safe, high-quality products to their customers for more than 20 years. Thesecompanies know they are not only releasing a safe product but also enjoying the financialbenefits of ultra-rapid microbial testing - gaining efficiencies on both the production floor and inthe laboratory.Quick turnaround time from QC shortens production cycles by reducing final productquarantine times. Fast QC also empowers production with knowledge from in-process testingso products found to be out of specification can be rejected prior to final filling. If deviationsare found, CHEMUNEX helps pinpoint root cause so swift corrective action can be taken torecover from contamination events. The collective time savings allows manufacturers to runleaner through stock optimization and production agility.Proven VersatilityCompatible with challenging plant-based / organic matricesDetects viable bacteria, yeasts and moldsEffective for organisms that are environmentally stressed, nutrient-depleted or in presence of preservativesObjective Yes/No results in 24 hours (50 hours for molds)Full validation support availableTest Process Water, In-process and Finished Products on the Same arma/fo/print all.php12/10/2013

print bioMérieuxPage 16 of 107Total Viable Count (TVC) - Bacteria and YeastSensitivity: 1 organism/gram of productProduct release time: 24-hoursApplications: Syrups, lotions,ointments, tablets, powdersYeasts and MoldsSensitivity: 10 organisms/gram of productProduct release time: 50-hoursApplications: Syrups, lotions, ointments, tablets, powdersDirect Count (Enumeration)Sensitivity: 50 organisms/mL (5/ML with filtration)Product release time: 20 minutesApplications: Process waterThree Levels of Automation to Fit Your NeedsAutomated high-throughput analysisD-Count 50 tests / hourAutomated analysisBactiFlow ALS25 tests / hourSemi-automated analysisBactiFlow 15 tests / hourThe D-Count and BactiFlow ALS systems combine fully-automated fluorescent viable cell labeling and digital flow cytometry into powerful systems that detect andcount individual cells without the need for cell growth.Release your products fasterReduce quarantine timeOptimize safety stock levelsReduce warehousing expenseRespond quickly to changes in demandVirtually eliminate product loss due to raw material contaminationScreen incoming raw materials in minutesReact quickly to adverse eventsRapid confirmation of corrective action effectivenessMinimized production disruptionProtect the integrity of your product's nameObjective, robust methodology ensures certainty of rma/fo/print all.php12/10/2013

print bioMérieuxPage 17 of 107REF.INSTRUMENTSBactiFlow ALS 400-A0001Fully-automated flow cytometer (25 tests/h)BactiFlow 302-A0001Semi-automated flow cytometer (15 tests/h)D-Count 301-A0001Fully-automated flow cytometer (50 tests/h)IDENTIFICATION AND MICROBIAL GENOTYPING / IDENTIFICATION AND MICROBIAL GENOTYPING / LyfoCults Plus QC SetsLyfoCults Plus QC SetsLyfoCults Plus is a storage, hydration and inoculation systemThe all-In-One Design is simple and easy to use.Built in inoculation wand that eliminates the need for additional tools and reduces contamination.The delivery system is glass free to improve safety. Other systems use glass in the device.Hydrate immediately saving time. Other systems take up to 45 minutes to rehydrate.Convenient QC sets for all identification products (VITEK 2 Compact, API /ID32).Available in 2 packs.The most technologically advanced microorganism system on the marketAll customers are required to sign an ATCC end-user agreement prior to puchasing LyfoCults Plus products.The ATCC Licensed Derivative Emblem, the ATCC Licensed Derivative word mark, and the ATCC catalog marks aretrademarks of ATCC . BioMérieux, Inc. is licensed to use these trademarks and to sell products derived from ATCC cultures.STREAMLINED SETS (FOR SOFTWARE VERSION 5.01 AND HIGHER)REF.PackagingVITEK 2 ANC Streamlined QC SetBacteroides ovatus ATCC BAA-1296 Clostridium septicum ATCC 12464 4106042VITEK 2 BCL Streamlined QC SetBrevibacillus agri ATCCÂ 51663â„ 3007842VITEK 2 CBC Streamlined QC SetCorynebacterium urealyticum ATCC 43044 Microbacterium testaceum ATCC 15829 4106022VITEK 2 GN Streamlined QC SetEnterobacter cloacae ATCC 700323 Stenotrophomonas maltophilia ATCC 17666 4105862VITEK 2 GP Streamlined QC SetEnterococcus casseliflavus ATCC 700327 Streptococcus thermophilus ATCC 19258 4106162VITEK 2 NH Streamlined QC SetEikenella corrodens ATCCÂ BAA-1152â„ 3010642VITEK 2 YST Streamlined QC SetCandida albicans ATCCÂ 14053â„ 3009272COMPREHENSIVE SETS (FOR SOFTWARE VERSION 5.01 AND /pharma/fo/print all.phpPackaging12/10/2013

print bioMérieuxVITEK 2 ANC Comprehensive QC SetBacteroides ovatus ATCC BAA-1296 Bacteroides vulgatus ATCC 8482 Clostridium perfringens ATCC 13124 Clostridium septicum ATCC 12464 Clostridium sordellii ATCC 9714 Corynebacterium striatum ATCC BAA-1293 Parabacteroides distasonis ATCC BAA-1295 VITEK 2 AST -GN QC SetEscherichia coli ATCC 25922 Escherichia coli ATCC 35218 Klebsiella pneumoniae ATCC 700603 Pseudomonas aeruginosa ATCC 27853 VITEK 2 AST -GP QC SetEnterococcus faecalis ATCC 29212 Enterococcus faecalis ATCC 51299 Escherichia coli ATCC 35218 Staphylococcus aureus ATCC 29213 Staphylococcus aureus ATCC BAA-976 Staphylococcus aureus ATCC BAA-977 Staphylococcus aureus ATCC BAA-1026 Streptococcus pneumoniae ATCC 49619 VITEK 2 AST -YS QC SetCandida krusei ATCC 6258Candida parapsilosis ATCC 22019VITEK 2 BCL Comprehensive QC SetAneurinibacillus aneurinilyticus ATCC 11376 Bacillis badius ATCC 14574 Bacillus circulans ATCC 61 Bacillis megaterium ATCC 14581 Bacillis pumilus ATCC BAA-1434 Brevibacillus agri ATCC 51663 Brevibacillus laterosporus ATCC 64 Enterobacter aerogenes ATCC 13048 Paenibacillus macerans ATCC 8509 Paenibacillus polymyxa ATCC 7070 Paenibacillus validus ATCC 29948 Staphylococcus epidermidis ATCC 12228 VITEK 2 GN Comprehensive QC SetAcinetobacter baumannii ATCC BAA-747 Enterobacter cloacae ATCC 700323 Elizabethkingia meningoseptica ATTC 13253 Klebsiella oxytoca ATCC 700324 Ochrobactrum anthropi ATCC BAA-749 Proteus vulgaris ATCC 6380 Pseudomonas aeruginosa ATCC 9721 Pseudomonas aeruginosa ATCC BAA-1744 Shigella sonnei ATCC 25931 Stenotrophomonas maltophilia ATCC 17666 VITEK 2 GP Comprehensive QC SetEnterococcus casseliflavus ATCC 700327 Enterococcus sacchar

BacT/ALERT Bottle Barcode Labels 259662 1,000/box BacT/ALERT Cell Plugs 259856 5/box BacT/ALERT i Bottle Re-seal 259787 100/box BacT/ALERT Incubator Thermometer 89048-600 1/box BacT/VIEW Operator Manual for BacT/ALERT 3D 45613187 1/box Bottle Carrying Rack 940-0046-01 1/box Calibration Kit 45606543 1/box Packaging BACT/ALERT INSTRUMENT STANDS .

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The Rutgers Mini-MBA : BioPharma Entrepreneurship is designed to help individuals and organizations navigate through the entire venture creation process, from idea generation to building viable BioPharma businesses. Participants will also enjoy access to the Rutgers Entrepreneurship community, including the Rutgers IP transfer process.

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