TransTracker Indicators

Product Features & Benefits

  • Irreversible
  • Instantaneous heat or freeze excursion identification
  • Single use
  • Easy to read and understand
  • Device activation not required
  • Superior monitoring reliability
  • Non toxic materials used in product
  • Cost effective versus other electronic and chemical indicators
  • Easy to integrate into the existing packing process
  • Environmentally friendly (no battery or hazardous waste disposal)
  • Reduce unnecessary waste - limit the destruction of products incorrectly suspected of heat or freeze damage
  • Strengthen conformance to International Code on Harmonization (ICH) 09 and Q10
  • Enhance quality risk management and support continual quality improvement

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TransTrackerC

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TransTrackerD

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TransTrackerF

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TransTrackerCF

TransTrackerC signals that a freeze event has occurred

TempTime's time-temperature monitoring devices are engineered to consistently meet the challenges of cold chain monitoring for shipping and storing temperature sensitive pharmaceuticals, biologics, and devices.

TransTrackers accurately measure cumulative time and temperature exposure, heat excursions outside the refrigerated zone, or controlled room temperature and freezing.

Many medical products can be damaged and lose potency if they are exposed to temperatures above or below a certain threshold for a period of time. Such excursions can go unnoticed during shipping of the medical products. Leading medical product manufacturers and distributors use TransTrackers to ensure compliance with regulatory guidelines, extend their qualify systems into the distribution system, and communicate their commitment to cold chain best practices.

TempTime's qualify management system is consistent with FDA Quality System Requirement (QSR)21 CFR 820 (GMP for medical devices).

The TransTracker C is a single-use indicator that irreversibly changes from green to white to signal that a freeze event has occurred during shipping. TransTracker C devices are placed inside multiple unit secondary packages or shipping boxes to monitor freeze events during transportation.

The TransTracker D is a single-use, instantaneous threshold indicator that irreversibly changes color from light grey to dark grey/black, to signal that a heat excursion at a harmful temperature has occurred for some seconds. TransTracker D devices are placed inside multiple unit secondary packages or shipping boxes to monitor heat excursions during transportation.

The TransTracker F is a single-use threshold indicator that changes color from white to red to signal that a heat excursion has occurred for a short period of time. TransTracker F devices are placed in multiple unit secondary packages or shipping boxes and signal if a temperature defined by the end user has been reached during transportation.

The TransTracker CF is a single use device that has two indicators: one that irreversibly changes color from white to red to signal that a heat threshold excursion has occurred with some time delay, and another that irreversibly changes from green to white to signal that a freeze event has occurred. These devices monitor heat and freeze sensitive products during short-term shipping. The TransTracker CF device is placed inside or can be affixed to the exterior of multiple unit secondary packages or shipping boxes.

TransTracker Indicator Performance and Use
  TransTracker C TransTracker D TransTracker F TransTracker CF
Response Temperatures 0°C, -1°C, -6°C 40°C and above
in 5°C increments
9°C, 25°C 0°C, -1°C, -6°C with threshold
heat response temps of
25°C (±1°C)
Accuracy 0°C and -1°C ±1°C
-6°C ±2°C
±1°C ±1°C ±1°C, except -6°C ±1°C
Response Time within 30 minutes within seconds within 2 hours heat within 2 hours,
freeze within 30 minutes
Storage Temperature Refrigerated
2°C to 8°C
Refrigerated
2°C to 8°C
Frozen
≤ -6°C
Refrigerated
2°C to 8°C
Shelf Life 1-1/2 to 4 years
determined by category
2 years 4 years 1-1/2 years
Usage Single Use Single Use Single Use Single Use
Temperature Monitoring Continual Continual Continual Continual
Device Size 54mm x 84mm 54mm x 84mm 54mm x 84mm 564mm x 108mm
Adhesive Backing Availablity yes yes yes yes
Card Design Customization Availablity yes yes yes yes

TransTracker C Product Information
Part No. Description Response Temperature
TT10101-1 C Card with FM-C -6°C
TT1223-1 C Card with FM-B -1°C
TT10103-1 C Card with FM-L 0°C

TransTracker D Product Information
Part No. Description Response Temperature
TT10328-1 D Card with DEGmarker 40 40°C
TT10329-1 D Card with DEGmarker 45 45°C

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TransTracker F Product Information
Part No. Description Response Temperature
TT1213-1 F Card with TH-F A 9°C
TT10122-1 F Card with TH-F M 25°C

TransTracker CF Product Information
Part No. Description Response Temperature
TT10153-1 CF Card with TH-F M & FM-B 25°C and -1°C
TT10157-1 CF Card with TH-F M & FM-L 25°C and 0°C
TT10158-1 CF Card with TH-F M & FM-C 25°C and -6°C

Please contact us for pricing information.