Testo 184 - Data Loggers
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Transcript of Testo 184 - Data Loggers
Blackbox for sensitive freight.testo184 Data logger:Temperaturemonitoringandqualitydatadocumentationinthe transport of foods and pharmaceutical goods.
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testo 184
Whetheryouworkinfoodorpharma:Bothgroups have
certain refrigeration requirements in transport,andthe
process of the coldchainbetweenthemanufacturerand
customer,mayundernocircumstancesbeinterrupted.
Qualitydeficits,financiallossesorevenseriousdamage to
the health of the consumer or patient can be the
consequence.
Withthetesto 184 dataloggers,youcanmonitoreverystep
ofthecoldchain.Theloggerstravelonyourbehalfin
freightandloadingrooms,monitoringtemperaturesduring
thetransportofsensitivegoodsonrail,intheairoronthe
road.
Attheirdestination,yourseeataglancewhetherthe
configured limit values have been adhered to. In order to
obtain detailedinformation,you may connecttheloggerto
aPCtoproduce aPDFreportimmediately.
Inorderforyoutobeabletoworkmoreefficientlywiththe
dataloggers,allrequiredfilesandinformationarestored
directlyandsecurelyinthe testo184:Configurationfile,
calibrationcertificate(testo184T1toT4only),instruction
manualandPDFreportofyourrecordedmeasurement
data.
Optimum temperatures for sensitive goods.MonitoringTemperature, Humidity and Shock within thecoldchain
sectorwiththe testo 184 data loggers.
DeliveryTransportStorageProduction
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Temperature monitoring in
pharmaceutical logistics
AvisitfromaGMPinspectorcanbe difficult or easy.If
data for refrigerationduringthetransportofthelastAPI
delivery is incorrect,orthedocumentationofthe
temperaturevaluesis incomplete, you have an issue.In
theworstcase,thereisathreatofproductrecall,huge
financialdeficitsandthelossofyourgoodreputationin
thepharmaceuticalindustry.
Equally,avisitfromaGMPinspectorcanbe routinefor
you, withthetesto184datalogger,all
(bio-)pharamceuticalscanbeprotectedfromunnoticed
gapsinthecoldchain,andtheentiredistributionpath
mon-itoredanddocumentedsimply,securelyand
compliantlywithallcommonstandards,guidelinesand
regulations:
• ThetemperaturedataloggersT1,T2,T3andT4are
delivered with a calibration certificate traceable according
to ISO17025,whichisstoredasaPDFdirectlyinthe
logger.
• Thankstotheuseof theComSoftCFRsoftware,21CFR
Part11-compliantapplicationswithalltesto 184 data
loggers are possible.
• Forthepurposesof analysis stability within thedata,the
loggersofferyouautomaticMKT-valuecalculations,and
theoptionofsettingMKTalarms.
• The comprehensive alarm management allows the setting
of multiple alarm limits. It is also possible to set
cumulativealarms.
• The extremely intuitive operation and the easy
identification of alarms, will lead to a low training
requirementforyour staff.
Temperature monitoring in
food logistics
The adherence to pre-defined temperature values is of
paramountsignificanceinthetransportoffood.Thisisthe
onlywaylegalhygienestandardscanbefulfilledandthe
quality,safetyandpreservationoffoodstuffsguaranteed.
Theprecisemonitoringofthecomplexprocessesand
proceduresisdefinedinHACCPguidelines(Hazard
AnalysisCriticalControlPoints),whosepurposeisthe
preventionofhealthrisksinthefoodsector.
Thetesto 184 dataloggersarecertifiedbyHACCP
International,andare createdforthemonitoringoffood
productstorageintransport,fromthefarmertothe
supermarketcustomer.Thedocumentationofdatais
extremelyeasythankstotheconvenientreadoutfunction
byautomaticallygeneratedPDFreports.Ensuring
temperature sensitivefoods,arrivesafely.
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testo 184
Plug and Play.All advantages of the data loggers testo 184 at a glance.
Clear indication of alarmsAglanceatthedisplayortheLEDsisenoughtoknowwhetherlimitvalueshavebeentriggered during transport.
Convenient readout A PDF report is created within the loggers, highlighting the transport data for analysis.This is suitable for long-term archiving according to PDF/A standard.
Easiest operationtesto184isintuitivelyoperated,andcanbe used without special training or previous knowledge:The"Start"buttonbeginsdatarecording."Stop"endsit.
Mobile readout/printout on siteAll testo 184 data loggers can be read out on sitewithanNFC-capableAndroidphone.Data transfer from the data logger to a compatibleTestoprinteralsofunctionswirelesslyviaNFC.
Easiest configuration Ineachtesto184,aconfigurationfileisstored. Which means nosoftware download,noinstallation,nouserinterfaceandnoadditionalcosts.
IT-safeThetesto184dataloggersworksecurelywithoutsoftwareinstallationordownload,soITproblemsshould be a thing of the past.
Originalsize
CFR readyISO9001:2008
CERTIFIED
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GxP-guidelines
InaGxP-regulatedenvironment,especiallyhighdemands
areplacedonqualitymanagement.NotonlyGMPorGLP,
butalsoGDP(GoodDistributionPractice)guidelinesplay
anincreasinglyimportantpart.Sincethedistributionof
pharmaceutical products is nothing more thanmobile
storage,thesamerulesapplyhereasinproduction,with
regardstomonitoringandqualityassurance.Withthe
helpofthetesto 184 datalogger,GxP-compliantworkis
noproblemforyou.
ISO 9001:2008
ISO9001:2008isthemostsignificantinternationalnorm
forqualitymanagementsystems,andguaranteesthe
frameworkconditionsforahighlevelofquality-capability
forproductsandprocesses.Inconnectionwiththis,itis
importanttobefullyinformedoftheprofessionalquality
assuranceofthethesuppliersinvolvedintheprocess.
TestoAG,asanISO9001:2008 certifiedcompany,fully
complieswiththeserequirements,andensuresthe
adherence to the norms through internal audits as well as
accreditedexternalaudits.
FDA 21 CFR Part 11
TheFDAregulation21CFRPart11,onwhich,among
others,Appendix11oftheEU-GMPisbased,makes
stipulationsonelectronicallystoreddocumentsinwhich
electronicsignatures are made.
The use of the testo 184 data loggers in combination with
theComSoftCFRsoftwareprovides,amongotherthings:
Limitationofaccesstoauthorisedpersons,AuditTrailswith
timestamp,aswellaselectronicsignatures,allowing21
CFRPart11-compliantuseofthedataloggers.
HACCP International certification
HACCPInternationalisaleadingorganisationinthefield
offoodsafety,andtestsproductsfortheirsuitabilityfor
processes in a food environment, according to the
international HACCP guidelines. The testo 184 data
loggers are certified as"food-safe"byHACCP
International,andthuscanberecommended without
restriction for use in the HACCP environment.
EN 12830
ThestandardEN12830establishesthetechnicaland
functional properties of temperature registration
instruments for transport,storageanddistributionplants
forchilled,frozenordeep frozenfoodsandice-cream.The
testo 184 T1, T2, T3 and T4transportloggers,fulfilthese
requirements,andhavebeencorrespondinglycertifiedby
TÜV.
GxP, CFR, HACCP and EN 12830.The most important standards for the transport of pharmaceuticals goods
and foods at a glance.
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testo 184
Safe monitoring of temperature, humidity and shock.Overviewofthetesto 184 data loggers.
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testo 184 T1
Measurementparameters Temperature
–
–
Exchangeablebattery
Operatingtime
Batterylife
Measuringrange
Resolution
Measurementrate
Storage temperature
Memory
Accuracy
Temperature
Protection class
Alarm identification
ReadoutviaNFC
Automatic PDF generation
EN12830-certified
HACCP-certified
Compatible with testo ComSoft CFR 21 Part 11
Temperature calibration certificate traceableaccordingtoISO17025
testo 184 T2 testo 184 T3
Temperature
–
–
90days
-35to+70°C
0.1 °C
Unlimited150days
500days(at+25°Cand15min.meas.cycle)
-35to+70°C-35to+70°C
0.1 °C 0.1 °C
±0.5°C±0.5°C±0.5°C
1 min to 24 h
-55to+70°C
1 min to 24 h
-55to+70°C
1 min to 24 h
-55to+70°C
16000 readings
IP67
byLEDs
40000 readings
IP67
byLEDsanddisplay
40000 readings
IP67
byLEDsanddisplay
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ü ü ü
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Temperature Temperature/humidity Temperature/humidity/shock
testo 184 T4 testo 184 H1 testo 184 G1
Unlimited Unlimited Unlimited
100days(at-80°Cand15min.meas.cycle)
500days(at+25°Cand15min.meas.cycle)
120days(at+25°Cand15min.meas.cycle)
-80to+70°C -20to+70°C/0to100%RH -20to+70°C/0to100%RH/0to10g
0.1 °C 0.1°C/0.1%RH 0.1°C/0.1%RH/0.1g
±0.8°C(-80to-35.1°C)±0.5°C(-35to+70°C)
±0.5°C(0to+70°C)±0.8°C(-20to0°C)
±1.8%RH+3%ofm.v.at+25°C(5to80%RH)
±0.03%RH/K(0to+60°C)
±0.5°C(0to+70°C)±0.8°C(-20to0°C)
±1.8%RH+3%ofm.v.at+25°C(5to80%RH)
±0.03%RH/K(0to+60°C)±0.1g+5%ofm.v.
1 min to 24 h
-80to+70°C
1 min to 24 h
-55to+70°C
1 min to 24 h
-55to+70°C
40000 readings
IP67
byLEDs
64000 readings
IP30
byLEDsanddisplay
–
64000readings(temperatureandhumidity) +1000readings(shock)
IP30
byLEDsanddisplay
–
– –
testo 184
0981
398
4/m
sp/I
/11.
2013
Sub
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All
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www.testolimited.com
testo 184 T3• Measurementparameter:Temperature• Operatingtime:unlimited• Availableinpacksof:1,10and50off
testo 184 T4• Measurementparameter:Temperature• Operatingtime:unlimited• Availableinpacksof:1and10off
testo 184 T1• Measurementparameter:Temperature• Operatingtime:90days• Availableinpacksof:1,10and50off
testo 184 T2• Measurementparameter:Temperature• Operatingtime:150days• Availableinpacksof:1,10and50off
testo 184 G1• Measurementparameters:Temperature,
humidityandshock• Operatingtime:unlimited• Availableinpacksof:1
testo 184 H1• Measurementparameters:Temperature
andhumidity• Operatingtime:unlimited• Availableinpacksof:1,10and50off
Ordering information testo 184 Data loggers.
Wall holder Part no. 0192 1963
Partno.05721845
Wall holder included
Partno.05721846
Wall holder Part no. 0192 1963
Wall holder Part no. 0192 1963
Partno.05721843 Partno.05721844
Wall holder Part no. 0192 1963
Partno.05721842Partno.05721841
Testo Limited
Newman LaneAlton, HampshireGU34 2UR
Tel: 01420 544433Fax: 01420 544434