ITS - Senze-Instruments Benelux

Senze-Instruments BENELUX
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Process & Quality Control

ITS

Temperature > Cold Chain Monitoring
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ELPRO's LIBERO ITS won this year's IQPC award in the category
Best Global Temperature Control.

This is the "Oscar of the cold chain industry"
LIBERO ITS
Inexpensive multi-level indicator with wireless read-out functionality per Smartphone App.
Perfect for temperature and stability monitoring of pharmaceutical products or clinical studies along the entire supply chain !
For up to five years.
Your Advantages :
- Thin and small, durable, smart and cost effective
- Quick implementation, also by 3rd parties
- Compatible with liberoMANAGER cold chain database
- 100 % calibrated, conform to regulatory guide lines
- Stability monitoring along the entire supply chain –  last-mile intelligence
Characteristics:
Logger/module type: PDF-Indicator
Measurement parameters:  Temperature
Usage:  Single Use
Certificates:  Validation certificate
LIBERO ITS
Innovative multi-level indicator with disruptive wireless  read-out technology

LIBERO ITS is a device for continuous temperature monitoring and calculating remaining stability budget of pharmaceutical products or clinical studies along the entire supply chain.
It is thin and small enough to go on clinical kits and sales units of pharmaceuticals and durable enough to stay on the product during its entire shelf life for up to 4 years.
LIBERO ITS manages deviations for up to 6 alarm levels.
The alarm status is always visible and can be extracted wirelessly per Smartphone app.
Follow all your shipments in the same database: LIBERO ITS is compatible with liberoMANAGER, ELPRO’s cold chain database.
Technical Specifications LIBERO ITS
Typ                                                            PDF Indicator with multiple alarm levels  
Application area                               Cold Chain Monitoring without need for temperature graph or tabular data  
                                                                                    - Last mile, direct-to-patient
                                                                                    - life-time monitoring on box level
Recording options and mode    Single use    
                                                                    Start/Stop mode (start by breaking off tab / option «never stop» or «stop
                                                                    statistics by button»)
Operating range                                -30 °C..+70 °C
Measurement accuracy                ±0.5 °C in the core range of -10 °C to +50 °C   
                                                                    Typical accuracy (95 % of all indicators) ±0.4 °C in the core range of -10 °C
                                                                   to +50 °C
                                                                     Accuracy outside core temperature range:   
                                                                    ±1.0 °C from -30.0 °C to -10.1 °C as well as +50.1 °C to +70.0 °C   
Resolution                                             0.1 °
Measurement interval                  1 minute
Expiry date and                                 - Auto expiry date management: Expired indicator cannot be started anymore
battery life                                            - Started indicator runs for maximum 4 years* (or optional: until stopped)    
                                                                      *Option «always blink» and use in frozen applications can limit the battery
Battery type                                        Button cell contained in equipment, UN3091, exempt from DGR declaration
Certificates                                          Ilac / NIST / ISO 17025 traceable production calibration certificate
Programmable alarms                      6 temperature alarm levels with alarm delay options (single or cumulative)  
Start-up delay                                        0 minutes to 45 days configurable  
Display                                                       Alarm status shown by LED (no display)
Status visibility                                      - Status: Ready, Operating, Stopped, EOL
                                                                        - OK, ALARM  
                                                                        - Configuration profile identification Report  PDF file generation
                                                                          via Smartphone app automatically establishes
                                                                           an evaluation report with embedded  changing protected data.
                                                                          Complies with the ISO standard 19005-1:2005 Document Management
                                                                          for the long-term preservation of electronic documents (PDF/A).
                                                                       - Statistics (min/max, alarm) and detailed indicator information
                                                                         (ID, configuration, etc.)
                                                                       - For customer-specific configurations, customizable report title and text area
                                                                         for additional information   (e.g. shipment information, destination, etc.)
Traceability  Device                             ID number as data matrix (traceable to component level)
Case | dimension | weight              Metal housing | 26 × 28 × 2.8 mm  / | 4.5 g
Certifications  CE |                              EN12830 | WEEE | RoHS | RTCA DO-160 (EMC) | UN 38.3 |
                                                                       Safe Transport of Chemical Goods
Indicator configuration and          Indicators with ELPRO defined standard configuration and label.
additional analysis software        Customer-specific configuration and hardware options for larger quantities.
                                                                      Wireless read-out of statistics possible with Smartphone app.  
                                                                       liberoMANAGER database  as cloud service to store
                                                                      shipment reports and results, analyze shipments,  manage release status and
                                                                      trigger customer specific workflows in cold chain processes.
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