testo 184testo 184D t L f T tData Loggers for Transport

June 2014

testo 184: The new transport data logger familytesto 184: The new transport data logger family

transportpharma

cold chain

USB no softwaretesto USB no software184

NFCfood

cold chain

The six different modelsThe six different models

testo 184 T1

• single-use logger

testo 184 T2

• single-use logger

testo 184 T3

• multi-use loggersingle use logger

• measures °C

• 90 days lifetime

• no display

single use logger

• measures °C

• 150 days lifetime

• with display

• measures °C

• 1.5 years battery life

• no display • with display• with display

testo 184 T4 testo 184 H1 testo 184 G1

• multi-use logger

• measures °C

• multi-use logger

• measures °C, %RH

• multi-use logger

• measures °C, %RH and g (m/s2)• for dry ice appli-

cations (-80 °C)

• no display

• 1 year battery life

• with display

and g (m/s2)

• for shock-sensible goods

• with display• with display

Requirements in transport applicationsRequirements in transport applications

The sender of a package (configuring the logger) ≠ The receiver of a package (reading out the logger)

Therefor you would need:Therefor you would need:

+ (2nd interface)+(is geographically somewhere

totally different than)

( )

+ (2nd cable)+

+ (2nd software)

Basic requirement: No interface no cable no software!

(2 software)

Basic requirement: No interface, no cable, no software!

Further requirements in transport applicationsFurther requirements in transport applications

• The limited space inside packages and boxes requires a flat device, which easily fits on top.

• The device must be very easy to use since• The device must be very easy to use, since logistic employees are no measurement experts.

• It is important that the logger only records transport-relevant data and stops afterwards.

• Due to the change in responsibilities during transport, it is important to distinguish seperate sections of the transport.

• Alarms must be recognized very easily• Alarms must be recognized very easily.

• Industry-relevant norms and regulations must y gbe fulfilled.

Key features of testo 184Key features of testo 184

Flat device: Easily fits NFC: Logger can be read out byNFCFlat device yinside or on top of packages

NFC: Logger can be read out by an NFC compatible smartphone, which allows on site analysis of data

Clear alarm indication:Through the displayand through green/ B d U i i l

Clear alarm indication

Bar codeand through green/red LED

Bar code: Unique serial number displayed as bar code to include logger in logistic processes easily

Bar code

logistic processes easily

Start button: Press short for starting theStart button

short for starting the logger or press long for setting time marks

Stop button: Press it after the transport is over to get only

t t l t d t

USB device: Logger can be connected to the computer via USB. No interface required. The USB protection cap is

Stop buttonUSB device

transport-relevant data fixed to the housing and can‘t be lost.

Key features of testo 184Key features of testo 184

The logger creates an automated pdf summary report, when you No software for read out plug it into a computer.

The logger can be configured with the help of a PDF applet th t b f d i id th l N d l d

No software for read out

No software for configuration that can be found inside the logger. No download, no installation, no costs.

The pdf report comes in the PDF/A standard which means that the file is

No software for configuration

The pdf report comes in the PDF/A standard, which means that the file is optimized for longtime preservation. A copy of the last report is saved inside the logger until it is reconfigured.

PDF report

All loggers come with a common standard preconfiguration (+2…+8 °C) that fits to many customer requirements. If the customer is fine with these settings he just has to press the START button no further configuration!

Preconfigurationsettings, he just has to press the START button – no further configuration!

Cumulative alarms: There is the possibility to set cumulative alarms for all temperature channels For example: Only give me an alarm if the temperature isCumulative alarms channels. For example: „Only give me an alarm, if the temperature is over 8°C for a total of 30 minutes (not consecutively).“

MKT (mean kinetic temperature) values are calculated and shown in the display of the

Cumulative alarms

MKT MKT (mean kinetic temperature) values are calculated and shown in the display of the logger. There is also the possibility to set MKT alarms.MKT

Relevant norms in the pharmaceutical industryRelevant norms in the pharmaceutical industry

GxP • The control of product quality throughout the whole production storage and distribution process is stated inproduction, storage and distribution process is stated in different guidelines like GMP, GLP or GDP.For the testo 184, especially GDP (Good Distribution Practice) is very important!Practice) is very important!

• Testo data loggers can provide a GxP-compliant documentation and evaluation and support pharmaceutical companies in their validation process as well as in the constant control of their products.

• GDP is not very specific about the design and amount of the required quality management during transportation. But most interpretations ask pharma companies toBut most interpretations ask pharma companies to(a) validate their transportation processes, since a transport is nothing else than a mobile storage(b) regularly control their transportation processes by(b) regularly control their transportation processes by monitoring the temperature inside a sufficient amount of packages [e.g. every xth package, at least x packages per truck, …](c) make sure that the used data loggers still provide the(c) make sure that the used data loggers still provide the needed quality by calibrating them regularly [e.g. once a year]

Relevant norms in the pharmaceutical industryRelevant norms in the pharmaceutical industry

21 CFR Part 11

• 21 CFR Part 11 as well as the Annex 11 of the EU-GMP make very strict rules regarding the character of electronic records

d l t i i tand electronic signatures.

• With the help of the specifically developed ComSoft CFR software all these rules can be fulfilled. The CFR software can

ISO 9001:2008

be used with all t184 data loggers.

• The ISO 9001:2008 is probably the most important norm in quality management. It guarantees that the quality of products and processes are supported by the g q y p p pp yright frame conditions in a company.

• The quality management of many pharmaceutical companies is certified according to this norm or at least follows its main requirementsaccording to this norm or at least follows its main requirements.

• For those companies it is important to know that also their suppliers (in thiscase Testo) secure their product quality by a sufficient quality management system as well. Therefor it’s a benefit that Testo is ISO 9001:2008 certified and secures its norm compliance by internal as well as accredited external audits.

Relevant norms in the food industryRelevant norms in the food industry

EN 12830EN 12830

• The EN 12830 is a European standard regarding temperature recorders p g g pfor the transport, storage and distribution of chilled and frozen food.

• All temperature data loggers T1, T2, T3 and T4 are certified by the TÜV for complying to DIN EN 12830for complying to DIN EN 12830.

• This includes EMC tests, a certain IP protection value, etc.

HACCP

• To be in compliance with food safety requirements and regulations as well as following HACCP standards and procedures is a big topic for our food target group.

• Testo 184 data loggers are tested and evaluated by HACCP International.

• To have certified “food save” products can be an advantage against other tit i thi i d tcompetitors in this industry.

Frequently Asked QuestionsFrequently Asked Questions

The testo 184 T1 (90 days) and 184 T2 (150 days) are single-use loggers.Single-use loggers

What does single-use mean?The loggers can only be used for 90 or 150 days. The time starts, when the logger is activated for the first time There is no possibility to change the battery After the definedactivated for the first time. There is no possibility to change the battery. After the defined usage time the logger doesn‘t measure any more.

Why do we need single-use loggers?Thanks to globalization cold chain products are shipped throughout the whole world today. Very often the costs of sending back the logger to the origin are very high and hindered by custom regulations.I th di t ib ti f ld h i d t l ft th bl th t thIn the distribution of cold chain products we also very often see the problem, that they are transported to external partners, who have on interest at all in sending the data logger back to the sender.Therefor man c stomers req ire to se single se loggers especiall if the ship a lotTherefor many customers require to use single-use loggers, especially if they ship a lot internationally.

But are testo 184 loggers not way too expensive for a „throw away product“?No, the testo 184 loggers are very reasonably priced in comparison to the benchmark products like Elpro Libero or Sensitech TempTale 4, who have huge success on the market. You also should compare their price to the value of the goods they protect, especially in the pharmaceutical industry. A truck load can be worth millions of € or $. And then think about how much the customer would lose, if his data logger didn‘t work right.

Frequently Asked QuestionsFrequently Asked Questions

The testo 184 T4 was especially developed for dry ice applications.Dry ice logger

Where is dry ice used for transports?Especially in the pharmaceutical industry, for example when transporting blood plasma, organs, virus, scientific material, etc.g , , ,

Why are the conditions in dry ice so hard?Dry ice sublimates at -78,48 °C. Our 184 T4 logger housings are made out of a special ABS polymer that can survive in such temperaturespolymer that can survive in such temperatures.The extremely cold conditions are also very hard for the batteries. Nevertheless our 184 T4 batteries can hold for 100 days at -80 °C.

The testo 184 G1 can measure acceleration or shocks.

How does this fit to the transport of cold chain products?It d ‘t Th 184 G1 ‘t b ld l t i th h /f d i d t B t i ll l i ti

Shock logger

It doesn‘t. The 184 G1 won‘t be sold a lot in the pharma/food industry. But especially logistic companies very often have products that react sensible to shocks and have to be controlled for it.

What are typical applications for the testo 184 G1?The testo 184 G1 is perfect for controlling the transport of valuable art, sensible machines or electronics. The 3-axes-acceleration sensor determines, how much acceleration the products were facing and in which direction. A wall holder should be used and is included in the delivery of testo 184 G1.

Frequently Asked QuestionsFrequently Asked Questions

The testo 184 G1 can measure acceleration or shocks.Shock logger

What is controlled for by measuring shock?It can be controlled, if the transported product was facing a temporary high acceleration that could have led to damaging the good For doing this the max limit of shock thethat could have led to damaging the good. For doing this, the max. limit of shock the product can face has to be known (for example: 2.5 g).

Can the testo 184 G1 logger measure the acceleration constantly?N Th d t l ’t ib ti ti h k t lNo. The data logger can’t measure vibrations or continuous shock events over a longer time. Instead it controls the acceleration values compared to the set up limit (trigger value) with a frequency of 1600 Hz. As soon as the trigger value is exceeded, it starts recording until the acceleration falls below the trigger value again If you don’t set the trigger valueuntil the acceleration falls below the trigger value again. If you don t set the trigger value high enough, a lot of values are written into the memory in a short time – but the limited storage of the logger won’t be able to do this very long. Therefor the trigger value should not be set too low If the trigger value represents a realistic amount of acceleration that cannot be set too low. If the trigger value represents a realistic amount of acceleration that can damage the good, in principle it doesn’t matter anymore, if this value was exceeded three times or three thousand times.

f ?What results can I see in the PDF report and in the software?Because of the fixed time scale, in the PDF report it is only possible to see a dot indicating the max. value of every shock event exceeding the limit. This is shown as vector sum of th 3 If t t d t il d f th i l / / dthe 3 axes. If you want to see a detailed curve or one of the single x-/y-/z- axes, you need to use ComSoft Prof or CFR.

Frequently Asked QuestionsFrequently Asked Questions

Here is an example:Shock logger

m/s2

Logger starts recording as soon as trigger value is reached

trigger value(shock limit, at which transported good will

)

Shock event is indicated by a dot in the PDF report

be damaged)Logger is scanning for shocks with frequency of 1600 Hz Logger goes back to

scanning mode

t

Big road hole

Frequently Asked QuestionsFrequently Asked Questions

One of the testo 184’s USPs is to function without any softwareComSoft

Is ComSoft supported anyway?Yes, ComSoft 4 Prof as well as ComSoft 4 CFR 21 Part 11 will be supported by the testo 184 If t t t k d t il d l i f hi d d t hi h ’t b184. If a customer wants to make a detailed analysis of his measured data, which can’t be covered by the PDF report, he can use one of those software versions. The ComSoft 21 CFR Part 11 gives the customer the known benefits of user-management, audit trails, hash codes etc and enables him to set up a 21 CFR Part 11 conform system (in combinationcodes, etc and enables him to set up a 21 CFR Part 11 conform system (in combination with the right SOPs).

Why is ComSoft Basic 5 not supported?With the automatic PDF report we already provide the customer a free, basic read out solution for his data loggers. Since the configuration can be done without any software as well, there is no need of providing an updated version of ComSoft Basic 5.

How do PDF configuration and the rules of 21 CFR Part 11 fit together?They don’t. 21 CFR Part 11 requires for example to control changes in configuration and to log them with the help of the user management in place. This means that if you use your og e e e p o e use a age e p ace s ea s a you use youdata logger together with our ComSoft CFR software, the PDF configuration function as well as the possibility to drag & drop configuration data will have to be de-activated.

Frequently Asked QuestionsFrequently Asked Questions

testo 184 is the first Testo product that uses Near Field Communication (NFC)NFC

What is NFC?NFC is a short distance radio communication standard, which is a sub-category of RFID. It i i l i t t bil t t th t bl tIts original purpose is to set up a mobile payment system that enables you to use your smartphone to pay for example at the supermarket check-out or at the subway station. We use the NFC standard to transfer data to compatible smartphones that have the Testo NFC app installedapp installed.

How can the information be transferred?To transfer information from the data logger to the smartphone you have to put the smartphone on top of the logger. Then the applet will be reading out the most relevant (but not all) data. We want to keep the transfer time as short as possible and NFC is not the fastest wireless technology.

Which smartphones are supported and where do I get the app?So far most of the new Android smartphones on the market have an NFC chip inside. That’s why we developed an Android applet only. Apple iOS is not supported, which is a s y e de e oped a d o d app e o y pp e OS s o suppo ed, c sbased on the fact that the iPhone still doesn’t work with NFC.Currently it is not 100% clear, where the customer will be able to download the applet.This information will follow with one of the next MLC milestones.

Technical dataTechnical data

Thank youFor more details log on to www testo in/184For more details log on to www.testo.in/184

Or write to us at info@testoindia comOr write to us at info@testoindia.com

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