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Drug Clinical Trials Direct to Patients (DTP)
End-to-end temperature monitoring solutions

Temperature monitoring throughout the supply chain of clinical trial drugs

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  • From labeling to the last kilometer: matched monitoring of the entire cold chain

With the increase in direct-to-patient (DTP) delivery of medications, the scope of GMPs and GCPs has shifted somewhat to focus on temperature monitoring capabilities for large couriers and patients. As a result, any device that provides patients with a clear indication that a medication is ”okay to take” or ”not okay to take” supports compliance and helps ensure patient safety.

 

Advanced automation equipment, such as Dividella's packaging machines NeoTOP and NeoTRAY, can apply and activate intelligent electronic temperature indicators on the cartridges to measure stability estimates and monitor the cartridges throughout the supply chain.

Electronic Intelligent Temperature Indicators / Comparison of Electronic Temperature Labels and Chemical Indicators

Temperature monitoring at the kit level during clinical trials is not a new concept. Chemical indicators applied at the cartridge level have existed for decades.


However, these metrics are often not precise enough for IMPs and are difficult to validate and therefore do not meet the GxP standard.

 

Electronic ”smart” cartridge-grade indicators offer significant advantages over chemical indicators. The following options should be considered when evaluating various electronic indicators. Ideally, your selection should include the following criteria:

  • Developed and produced according to GAMP®5 guidelines with unique ID number for traceability
  • Low cost. (Can tens of thousands of reagent kits be equipped at a low enough price?)
  • Must be thin enough (<3 mm) and small enough to be used at the reagent cartridge level (e.g., less than the size of a credit card)
  • Self-adhesive directly to reagent cartridges or in thousands on an automated packaging line.
  • Battery capacity sufficient to cover the entire life of a typical reagent cartridge (up to 4 years)
  • Calibrated, accurate temperature sensor (with NIST-traceable calibration certificate)
  • Continuous temperature monitoring and tracking of residual stability budgets
  • Read status at any time without additional equipment (is it available?)
  • Record and archive status in a compliant manner (no manipulation possible); easily provide feedback (alerts) to sponsors when stability budgets are exceeded
  • Tracking statistics (e.g. time, maximum and minimum values for each temperature zone) and alarm dates/times for further analysis by sponsors
  • Pre-qualified by the World Health Organization (WHO) PQS Status

Intelligent Temperature Indicators / Electronic Temperature Labels for Various Applications
DTP Temperature Monitoring Solution for the Entire Supply Chain

The HONGKE LIBERO ITS Temperature Logger provides accurate temperature monitoring data for your pharmaceutical shipments.

Helps you understand the temperature status of pharmaceuticals during DTP transportation, ensuring that products are shipped at the proper temperature conditions and are compliant.

The LIBERO ITS is a configurable device that is pre-configured for your convenience. We offer a variety of standard configurations in boxes of 10 or 400 units.

For 3200 units or more, we can also custom configure multi-level temperature alarms (up to 6 limits) and allowable offset times to meet your specific requirements.

COOL Refrigerated

Clinical Trial
Internet Pharmacy
Direct patient orientation

  • +2 °C to +8 °C (severe curve)
  • 12 months retention period
    Up to 5 years of battery life
  • 100% (NIST Traceable) Calibration
  • 10 per box or 400 per box
  • Unstable budget
Program Details

ROOM Indoor room

Compact
TATS Materials
High-value food
End-to-End Pharmaceuticals

  • +15 °C to +25 °C (strict)
  • 12 months retention period
  • Up to 5 years of battery life
  • 100% (NIST Traceable) Calibration
  • 10 per box or 400 per box
  • Unstable budget
Program Details

NO-FREEZE low temperature & non-refrigerated

Internet Pharmacy
High-value food

  • Above 0 °C
  • 12 months retention period
  • Up to 5 years of battery life
  • 100% (NIST Traceable) Calibration
  • 10 per box or 400 per box
  • Unstable budget
Program Details

We dream of a world where medicines are safe, and HONGKE helps you make patient-centered clinical trials easier, helping to ensure the safety of patients' medicines and improve the quality of life.

Rainbow Technology will provide you with any support you need!

The professional Hongke team will be the first to respond and provide you with the best service to solve all your problems.

Acquisition of equipment

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GxP Services, Consultation and Calibration

Provides GxP support across the entire supply chain

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