Blackbox for sensitive freight.testo184 Data logger:Temperaturemonitoringandqualitydatadocumentationinthe transport of foods and pharmaceutical goods.

2

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

3

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.

4

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

5

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.

6

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

7

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ü

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üü

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

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2013

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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