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freezemarker

FREEZEmarker® is a single-use indicator that irreversibly changes colour from green to white to signal that a freeze event has occurred when transporting pharmaceutical goods.

A FREEZEmarker can be affixed to an individual unit to monitor the product from manufacture to point-of-care (POC), or later in the cold chain to monitor the product for a portion of its distribution. FREEZEmarker indicators are available with response temperatures of 0°C, -1°C, and -6°C.

Many medical products can be damaged and lose effectiveness if they are frozen. This is particularly true of products that require refrigerated storage. If there is a freeze event followed by a thaw, the user would have no way of knowing the freeze event occurred. Therefore, the FREEZEmarker helps identify and prevent the administration of products that have experienced a freeze event.

Key features of FREEZEmarker are:

  • Irreversible
  • Single use
  • Easy-to-understand
  • Easy-to-read
  • Device activation not required
  • Superior monitoring reliability
  • Nontoxic materials used in product

Benefits

  • Avoid administration of freeze exposed medications to patients
  • Extend quality control (QC) and risk management from production to patient
  • Strengthen conformance to International Code on Harmonization (ICH) Q9 and Q10
  • Reduce unnecessary waste and limit the destruction of products incorrectly suspected of freeze abuse
  • Support call center efforts provide definitive information about potentially freeze-damaged products to healthcare professionals and patients
  • Environmentally friendly

FREEZEmarker performance and use

  • Response temperatures: 0°C (±1ºC) -1°C (±1ºC) -6°C (±2ºC)
  • Response time: Within 30 minutes
  • Storage temperature: Refrigerated temperature (2°C to 8°C)
  • Shelf-life: One and a half years to four years, determined by category
  • Usage: Single use
  • Temperature monitoring: Continual
  • Device Size: 20mm x 29mm
  • Additional features: Adhesive backing available

Quality management system

  • Temptime’s quality management system is consistent with Food and Drug Administration (FDA) quality system requirement (QSR) 21 CFR 820 good manufacturing practices (GMP) for medical devices
  • ISO 9001:2008
  • ISO 13485:2003