ATP-ThermoProfile™:
The Excellency Solution to ensure Cold Chain Compliance

An Optimal Solution for to control the Cold Chain during Shipments:

The ATP-ThermoProfile™ solution proves to be optimal for controlling and confirming the cold chain during and along the shipments of perishable or sensitive products, and includes all necessary functionalities for inventory management of temperature data loggers and their logging missions follow-up.

ATP-ThermoProfile™ fully complies with the CFR21 part 11 requirements. It is a software tool that enables to trace and monitor the cold chain and temperature conditions all along the development, manufacturing, commercialization and distribution, and during warehousing and transportation of Life Science and Healthcare products.

• Monitor the temperature of shipments (pallets, containers, boxes…) and reduce the quarantine applied to products.
• Perform Mapping of Warehouses, Refrigerators/Freezers.
• Measure Environmental Temperatures.
• Execute Qualification Protocol.

Advantages provided with ATP-ThermoProfile™:

• Available as a Stand-Alone (SA) system or a Database (DB) system.
• Compliant to US-FDA CFR21 part 11 (electronic records and signatures).
• Easy and rapid programming of the temperature monitoring missions.
• Friendly user software, oriented to all type of users (beginners or experts).
• Software that includes all necessary functionalities for inventory management and missions monitoring such as, scheduled calibration reminder, list of current missions, search tools, preformatted reports and graphics.
• Integrated multilingual support allowing instant translation of user interfaces as well as the created reports in the language of your choice.
• Full logistic support such as scheduled reminder for calibration, exchange program, calibration, design of customized binding devices, documentary support, training and validation.

ATP-ThermoProfile™ enables an easy configuration of Missions

ATP-ThermoProfile™ makes possible to set up temperature logging missions in a secured and regulated environment, preventing any illegal modifications of generated data. The solution gives you a complete control and monitoring of the cold chain and temperature conditions that relate to your products, from the manufacturing site up to the final administration to thepatients.

The ATP-ThermoProfile™ solution gives you different access and discrimination levels that will change with your cold chain and supply chain management needs: Complete functionalities: the main site accesses the complete solution functionalities, including programming, downloading and data analysis/storage. Satellite functionalities: the satellite sites access only to some of the functionalities. The use of satellite sites and functionalities, along with a secured Web communications, enables to speed up the produced data analysis as well as the release of quarantine on received products.

Technical Specifications for ATP-ThermoProfile™ Data Loggers:

• Re-usable Data Loggers, Unwired self-powered data loggers
• 3 data logger types:
  
  
  M05P26
  Extended temperature range: -5ºC to 26ºC;
  Resolution: 0,125ºC; Accuracy: 0,250ºC
  
  P15P26
  Extended temperature range: 15ºC to 26ºC;
  Resolution: 0,125ºC; Accuracy: 0,250ºC
  
  M40P85
  Extended temperature range: -40ºC to 85ºC;
  Resolution: 0,50ºC; Accuracy: 0,50ºC
  
  Additional data loggers are available for the DataBaseconfiguration: Xi3 & ThermAssureRF (RFID)
  
  
• Reduced size: 5,9 x 17,4 mm
• Mission sampling capability: 2048 temperatures
• Delay for starting a mission: 1 to 45 days
• High and low alarm levels
• Inviolable mission counter; IP68 casing (shockproof)
• Re-usable; Lifetime 5 years (non-exchangeable battery)
• Re-calibrate (1 year certificate of calibration)
• Data loggers are equiped with individual and personalized plastic labels