It’s Simple. - Test Equipment Depot: Test & Measurement · PDF file ·...
Transcript of It’s Simple. - Test Equipment Depot: Test & Measurement · PDF file ·...
NEWtesto184datalogger:Temperaturemonitoringandqualitydatadocumentationduringthetransportoffoodsandpharmaceuticalgoods.
It’s Simple.Protecttheintegrityofyourproductsandyourbrandduringcold chain transportation.
99 Washington Street Melrose, MA 02176 Phone 781-665-1400Toll Free 1-800-517-8431
Visit us at www.TestEquipmentDepot.com
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testo 184
Optimum temperatures for sensitive goods.Shippingtemperatureandenvironmentally-sensitiveproductsrequireareliablelogger
thatprovidesaccuratedataeachandeverytime.Monitorthetransportofcoldchainproducts
with thetesto184dataloggers.
DeliveryTransportStorageProduction
Withthetesto184dataloggers,youcanmonitoreverystepofthe
coldchain.Theloggerstravelduringfreightandinloadingrooms,
monitoringtemperaturesthroughoutthetransportationofsensitive
goodsontherail,intheair,orontheroad.
Attheirdestination,youcanquicklyconfirmthattheproperstor-
ageconditionshavenotbeenexceeded.Toobtaindetailed
information,simplyconnecttheloggertoaPC,andaPDFreport
isimmediatelygeneratedwithallrelevantdata.
Forevenmoreefficiencyandconvenience,allrequiredfilesand
informationarestoreddirectlyandsecurely,including:
configurationfile,calibrationcertificate,instructionmanualand
PDFreportofyourrecordeddata.
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Temperature monitoring for
pharmaceutical logistics
AvisitfromaGMP(GoodManufacturingPractice)inspectorcan
beaseriousissueforyourcompanyifyoudon’thavethecorrect
equipment.Neitherinsufficientrefrigeration
duringthetransportofthelastdelivery,northeincomplete
documentationofthetemperaturevaluesinyourpaperworkwill
passinspection.Intheworstcase,thereisathreatofproduct
recall,hugefinancialdeficitsandthelossofyourgoodreputation
inthepharmaceuticalindustry.
Or,avisitfromaGMPinspectorcanbeabreeze.Withthetesto
184dataloggers,all(bio-)pharmaceuticalscanbeprotectedfrom
unnoticedgapsinthecoldchain.Theentiredistributionprocess
ismonitoredanddocumentedsimply,securelyandcompliantly
withallcommonstandards,guidelinesandregulations:
• ThetemperaturedataloggersT1,T2,T3andT4aredelivered
withacalibrationcertificatetraceableaccordingtoISO17025,
whichisstoredasaPDFdirectlyinthelogger.
• ThankstotheuseofthevalidatableComSoftCFRsoftware,21
CFRPart11-compliantapplicationswithalltesto184data
loggersispossible.
• Forthepurposesoftheanalysisofstabilitydata,thelogger
supportsyouwithanautomaticMKT-valuecalculation,andthe
optionofsettingMKTalarms.
• Thecomprehensivealarmmanagementallowsthesettingof
multiplealarmlimits.Itisalsopossibletosetcumulativealarms,
e.g.whenthetemperaturemaynotexceedthelimitvalueof
30°Cforlongerthan30minutes.
• Theextremelyintuitiveoperationandtheeasyidentificationof
alarmsleadtoalowtrainingrequirementforyourstaff.
Temperature monitoring for
food logistics
Theadherencetopre-definedtemperaturevaluesisofparamount
significanceinthetransportationoffood.Thisistheonlyway
legalhygienestandardscanbefulfilledandthequality,safetyand
preservationoffoodgoodsguaranteed.Theprecisemonitoringof
thecomplexprocessesandproceduresisdefinedintheHACCP
guidelines(HazardAnalysisCriticalControlPoints),whose
purposeisthepreventionofhealthrisksinthefoodsector.
Thetesto184dataloggersarecertifiedbyHACCPInternational,
andcriticalforthemonitoringoffoodproductstorageintransport
fromthefarmerallthewaytothesupermarketcustomer.The
documentationofthequalitydataisextremelyeasythankstothe
convenientreadoutfunctionbyanautomaticallygeneratedPDF
report.Temperature-sensitivefoodsarrivesafelyandyourbrand
staysprotected.
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testo 184
Plug and Play.Alltheadvantagesofthetesto184dataloggersataglance.
Clear indication of alarmsAglanceatthedisplayortheLEDsisenoughtoknowwhetherlimitvalueshavebeenexceededduringtransport.
Convenient readout APDFreportwiththetransportdataiscreatedimmediatelyuponconnectionofthetesto184dataloggertotheUSBportofacomputer.Thisissuitableforlong-termarchivingaccordingtoPDF/Astandard.
Easy operationtesto184isintuitivelyoperated,andcanbeusedwithoutspecialtrainingorpreviousknowledge:The"Start"buttonbeginsdatarecording."Stop"endsit.
Mobile readout/printout on siteAlltesto184dataloggerscanbereadouton-sitewithanNFC-capableAndroid smartphone.DatatransferfromthedataloggertoacompatibleTestoprinteralsofunctionswirelesslyviaNFC.
Simple configuration - no software requiredAsimple,easytofollow,configurationfileis onboardevery184sothatnosoftwareis neededfordownloadsorset-up.Evendifferentlanguagescanbeselectedforshipperand receiver.
IT-safeThetesto184dataloggersworksecurelywithoutsoftwareinstallationordownload,sothatITproblemsaretriggeredneitherbythefirewallnoravirusscanner.
Actualsize
CFR readyISO9001:2008
CERTIFIED
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ISO, GxP, CFR, HACCP and EN 12830.Themostimportantstandardsforthetransportofpharmaceuticalsandfoods.
GxP-guidelinesInaGxP-regulatedenvironment,especiallyhighdemandsareplacedonqualitymanagement.NotonlyGMPorGLP,butalsoGDP(GoodDistributionPractice)guidelinesplayanincreasinglyimportantpart.Sincethedistributionofpharmaceuticaland medicinalproductsisnothingmorethanmobilestorage,thesamerulesapplyhereasinproduction,withregardtomonitoringandqualityassurance.Withthehelpofthetesto184datalogger,GxP-compliantworkisnoproblemforyou.
ISO 9001:2008ISO9001:2008isthemostsignificantinternationalnormforqualitymanagementsystems,andguaranteestheframeworkconditionsforahighlevelofquality-capabilityforproductsandprocesses.However,inconnectionwiththis,itisalso indispensabletobefullyinformedoftheprofessionalquality assuranceofthethesuppliersinvolvedintheprocess.TestoAG,asanISO9001:2008-certifiedcompany,fullycomplieswiththeserequirements,andensurestheadherencetothenormsthroughinternalauditsaswellasaccreditedexternalaudits.
FDA 21 CFR Part 11TheFDAregulation21CFRPart11,onwhich,amongothers,Appendix11oftheEU-GMPisbased,makesstipulationsonelectronicallystoreddocumentsinwhichelectronicsignaturesaremade.Theuseofthetesto184dataloggers(incombinationwiththevalidatableComSoftCFRsoftware)provides:Limitationof accesstoauthorizedpersons,AuditTrailswithtimestamp,aswellaselectronicsignatures,allowinga21CFRPart11- compliantuseofthedataloggers.
HACCP International certificationHACCPInternationalisaleadingorganizationinthefieldoffoodsafety,andtestsproductsfortheirsuitabilityforfood environmentprocessesaccordingtotheInternationalHACCPguidelines.Thetesto184dataloggersarecertifiedas“food-safe”byHACCPInternational,andthuscanberecommendedwithoutrestrictionforuseintheHACCPenvironment.
EN 12830ThestandardEN12830establishesthetechnicalandfunctionalpropertiesoftemperatureregistrationinstrumentsfortransport,storageanddistributionplantsforchilled,frozenordeep-frozenfoodsandice-cream.Thetransportloggerstesto184T1,T2,T3andT4fulfiltheserequirements,andhavebeencorrespondinglycertifiedbyTÜV.
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testo 184
Safe monitoring of temperature, humidity and shock.
Overviewofthetesto 184dataloggers.
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Order No. 0572 1841
Measurementparameters Temperature
–
–
Exchangeablebattery
Operatingtime
Batterylife
Measuringrange
Resolution
Measurementrate
Storagetemperature
Memory
Accuracy
Temperature
Protectionclass
Alarmidentification
ReadoutviaNFC
AutomaticPDFgeneration
EN12830-certified
HACCP-certified
CompatiblewithtestoComSoftCFR21Part11
TemperaturecalibrationcertificatetraceableaccordingtoISO17025
Order No. 0572 1842 Order No. 0572 1843
Temperature
–
–
90days
-31°to158°F(-35°to70°C)
0.18°F(0.1°C)
Unlimited150days
500days(at+77°Fand15min.meas.cycle)
-31°to158°F(-35°to70°C)-31°to158°F(-35°to70°C)
0.18°F(0.1°C) 0.18°F(0.1°C)
±0.9°F(±0.5°C)±0.9°F(±0.5°C)±0.9°F(±0.5°C)
1 min to 24 h
-67°to158°F(-55°to70°C)
1 min to 24 h
-67°to158°F(-55°to70°C)
1 min to 24 h
-67°to158°F(-55°to70°C)
16,000readings
IP67
byLEDs
40,000readings
IP67
byLEDsanddisplay
40,000readings
IP67
byLEDsanddisplay
testo 184 T1 testo 184 T2 testo 184 T3
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Temperature Temperature/humidity Temperature/humidity/shock
Order No. 0572 1844 Order No. 0572 1845 Order No. 0572 1846
Unlimited Unlimited Unlimited
100days(at-112°F(-80°C)and15min.meas.cycle)
500days(at77°F(25°C)and15min.meas.cycle)
120days(at+77°F(25°C)and15min.meas.cycle)
-112°to158°F(-80°to70°C) -4°to+158°F(-20°to70°C)/0to100%RH -4°to+158°F(-20°to70°C)/0to100%RH/0to10g
0.18°F(0.1°C) 0.18°F(0.1°C)/0.1%RH 0.18°F(0.1°C)/0.1%RH/0.1g
±1.4°F(±0.8°C)(-112°to-31.2°F)(-80°to-35.1°C)
±0.9°F(±0.5°C)(-31°to158°F)(-35°to70°C)
±0.9°F(±0.5°C)(32to+158°F)(0°to70°C)±1.4°F(±0.8°C)(-4to32°F)(-20°to0°C)±1.8%RH+3%ofm.v.at77°F(25°C)
(5to80%RH)±0.03%RH/K(0to140°F)(0°to60°C)
±0.9°F(±0.5°C)(32to158°F)(0°to70°C)±1.4°F(±0.8°C)(-4to32°F)(-20°to0°C)±1.8%RH+3%ofm.v.at77°F(25°C)
(5to80%RH)±0.03%RH/K(0to140°F)(0°to60°C)
±0.1g+5%ofm.v.
1 min to 24 h
-112°to158°F(-80°to70°C)
1 min to 24 h
-67°to158°F(-55°to70°C)
1 min to 24 h
-67°to158°F(-55°to70°C)
40,000readings
IP67
byLEDs
64,000readings
IP30
byLEDsanddisplay
–
64,000readings(temperatureandhumidity) +1,000readings(shock)
IP30
byLEDsanddisplay
–
– –
testo 184 T4 testo 184 H1 testo 184 G1
testo 184
0981
398
4/m
sp/I
/11.
2013
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testo 184 T3• Measurementparameter:Temperature• Operatingtime:unlimited• Availableinpacksof:1,10and50
testo 184 T4• Measurementparameter:Temperature• Operatingtime:unlimited• Availableinpacksof:1and10
testo 184 T1• Measurementparameter:Temperature• Operatingtime:90days• Availableinpacksof:1,10and50
testo 184 T2• Measurementparameter:Temperature• Operatingtime:150days• Availableinpacksof:1,10and50
testo 184 G1• Measurementparameters:Temperature,
humidityandshock• Operatingtime:unlimited• Availableinpacksof:1
testo 184 H1• Measurementparameters:Temperature
andhumidity• Operatingtime:unlimited• Availableinpacksof:1,10and50
Ordering information testo 184 data logger.
WallholderPartno.01921963
Partno.05721845
Wallholderincluded
Partno.05721846
WallholderPartno.01921963
WallholderPartno.01921963
Partno.05721843 Partno.05721844
WallholderPartno.01921963
Partno.05721842Partno.05721841
Test Equipment Depot - 800.517.8431 - 99 Washington Street Melrose, MA 02176
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