VVM Support

Storage and Application

The HEATmarker® VVM Vaccine Vial Monitors should be stored at any temperature below -24ºC prior to use. The color-changing properties of the VVMs are also sensitive to UV light and should therefore be stored in the dark.

The VVM is applied by the manufacturer to the vaccine vial during the manufacturing process. The polymerization of the active surface of the VVM is continuous and faster at higher temperatures. Avoid prolonged exposure of the VVM to elevated temperatures prior to and during application. The VVM monitors the temperature history of the vaccine from the time of manufacturing until the time the product is used.

Since the VVM is sensitive to UV light, the vial to which the VVM has been applied should be protected from sunlight and other sources of UV light.

How to Read the VVM

  1. When the center square is lighter than the reference ring, the vaccine is OK to be used (as long as it is within the manufacturer’s expiration date).
  2. When the center square has the same color as the reference ring, endpoint has been reached; the vaccine should not be used.
  3. When the center square is darker than the reference ring, the endpoint has been exceeded; the vaccine should not be used.

Precautions

  • HEATmarker® Vaccine Vial Monitors are sensitive to UV light.
  • Store unused VVMs in a dark area or in a light-protecting container or pouch at or below -24ºC.
  • After application, the vial to which the VVM has been applied should be protected from exposure to sunlight or other UV light.
  • The VVM is not a replacement for the manufacturer’s expiration date. Do not use a vaccine that has exceeded its original expiration date even if the VVM has not reached endpoint.
  • Adhesion of the VVM may be affected by affixing it to a wet and/or frozen surface. For best results, affix the VVM to a dry substrate at a temperature above 0ºC.

Resources

  1. Quality of the Cold Chain: WHO-UNICEF Policy Statement WHO/ V&B /99.18
  2. WHO-UNICEF Policy Statement on the Implementation of Vaccine Vial Monitors WHO/ IVB /07.04
  3. VVM Specifications are described in PQS Performance Specifications WHO/PQS/E06/IN05.2 (English) (July 2011)
  4. Allegra, J. R., Brennan, J., Lanier, V., Lavery, R. and Mackenzie, B. “Storage Temperatures of Out-of-Hospital Medications”, Academic Emergency Medicine, November 1999, pp.1098-1103.
  5. Allegra, J. R., Brennan, J., Fields, L., Grabiner, F., Kiss, G., Lavery, R., and Prusik, T. “Monitoring the Storage Temperature of Ambulance Medications with Time-Temperature Indicators”. Hospital Pharmacy. Volume 35, March 2000. pp. 246-250.
  6. United States Pharmacopeia, General Chapter Monitoring Devices – Time, Temperature and Humidity.
  7. United States Pharmacopeia, Proposed General Chapter Emergency Medical Services Vehicles and Ambulances – Storage of Medications.
  8. United States Pharmacopeia, Proposed General Chapter Environmentally Sensitive Preparations.