testo 184 testo 184 D t Data Loggers for Transport L f T t - PowerPoint PPT Presentation

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

testo 184: The new transport data logger family testo 184: The new transport data logger family pharma transport cold chain testo USB USB no software no software 184 food NFC cold chain

The six different models The six different models testo 184 T3 testo 184 T1 testo 184 T2 • multi-use logger • single-use logger single use logger • single-use logger single use logger • measures °C • measures °C • measures °C • 1.5 years battery • 90 days lifetime • 150 days lifetime life • • no display no display • • with display with display • with display testo 184 T4 testo 184 H1 testo 184 G1 • multi-use logger • multi-use logger • multi-use logger • measures °C • measures °C, %RH • measures °C, %RH and g (m/s 2 ) and g (m/s 2 ) • for dry ice appli- • 1 year battery life cations (-80 °C) • for shock-sensible • with display goods • no display • • with display with display

Requirements in transport applications Requirements 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: (is geographically somewhere totally different than) + + (2 nd interface) ( ) + + (2 nd cable) + (2 nd software) (2 software) Basic requirement: No interface no cable no software! Basic requirement: No interface, no cable, no software!

Further requirements in transport applications Further 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 g be fulfilled.

Key features of testo 184 Key features of testo 184 Flat device NFC Flat device: Easily fits y NFC: NFC: Logger can be read out by Logger can be read out by inside or on top of packages an NFC compatible smartphone, which allows on site analysis of data Clear alarm indication Clear alarm indication: Through the display and through green/ and through green/ Bar code Bar code B Bar code: Unique serial d U i i l red LED number displayed as bar code to include logger in logistic processes easily logistic processes easily Start button Start button: Press short for starting the short for starting the logger or press long for setting time marks USB device USB device: Logger can be connected Stop button Stop button: Press it after the to the computer via USB. No interface transport is over to get only required. The USB protection cap is transport-relevant data t t l t d t fixed to the housing and can‘t be lost.

Key features of testo 184 Key features of testo 184 The logger creates an automated pdf summary report, when you No software for read out No software for read out plug it into a computer. The logger can be configured with the help of a PDF applet No software for configuration No software for configuration that can be found inside the logger. No download, no th t b f d i id th l N d l d installation, no costs. The pdf report comes in the PDF/A standard which means that the file is The pdf report comes in the PDF/A standard, which means that the file is PDF report optimized for longtime preservation. A copy of the last report is saved inside the logger until it is reconfigured. All loggers come with a common standard preconfiguration (+2…+8 °C) Preconfiguration that fits to many customer requirements. If the customer is fine with these settings he just has to press the START button settings, he just has to press the START button – no further configuration! 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 is channels For example: Only give me an alarm if the temperature is Cumulative alarms Cumulative alarms 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 MKT (mean kinetic temperature) values are calculated and shown in the display of the MKT MKT logger. There is also the possibility to set MKT alarms.

Relevant norms in the pharmaceutical industry Relevant norms in the pharmaceutical industry • The control of product quality throughout the whole GxP production storage and distribution process is stated in production, 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 to But 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 x th 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 industry Relevant 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 and electronic signatures. d l t i i t • With the help of the specifically developed ComSoft CFR software all these rules can be fulfilled. The CFR software can be used with all t184 data loggers. ISO 9001:2008 • 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 y right frame conditions in a company. • The quality management of many pharmaceutical companies is certified according to this norm or at least follows its main requirements according to this norm or at least follows its main requirements. • For those companies it is important to know that also their suppliers (in this case 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 industry Relevant norms in the food industry EN 12830 EN 12830 • The EN 12830 is a European standard regarding temperature recorders p g g p for 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 12830 for 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 competitors in this industry. tit i thi i d t