Temperature has a direct impact on the usability of vaccines. The vaccine used against Tuberculosis, BCG, will completely degrade if it’s stored in an environment at room-temperature for more than 2 days. For adults, this single vaccine costs around £80, so it adds up as a big loss for a medical practice if the vaccine deteriorates. But it goes beyond that. If life-saving vaccines are being transported to third-world countries and they’ve deteriorated during shipping, this could cause a loss of life.
The absence of vaccine monitoring is detrimental. Pharmaceutical regularly compliance demands that temperature monitoring solutions are in place.
Vaccines being transported must have a temperature monitoring means in place for the entire journey. Pharmaceutical validation must be executed, as if the temperatures of the environment rises or drops out of the set range, the vaccine could be ineffective. In the worst cases, this deficient vaccine could cost lives.
Below are the requirements of the Centers for Disease Control and Prevention (CDC) for medical companies who want to provide vaccines for the Vaccines for Children (VFC) initiative.
Medical providers must:
- Have continuous temperature monitoring solutions in place
- The data must be backed up
- The data logger device must have a readable screen on the cold storage box it’s shipped in
- Clinics must check and review the data every morning to monitor the condition
Additional recommendations of the CDC for data loggers are as follows:
- Alarm for when the temperature goes out of range
- Detachable probe
- Low-battery indicator
- Current, minimum, and maximum temperature display
- Accurate to +/-0.5° C (+/-1° F)
- Takes readings every 30 minutes (minimum)
The TRED30-16R temperature data logger with probe meets the requirements set out by the CDC and is compliant to the World Health Organisation (WHO) PQS specification E006/TR06.3. Supplied with a thermal dampener, a clean and adaptable alternative to Glycol, it buffers temperature readings to stop temperature spikes caused by opening and closing doors. There’s a visual display, an audible alarm and this data logger stores up to 15,900 temperature readings.
Wessex Power can help you to meet the requirements set out by the CDC and FDA, as well as ensuring you are 21 CFR Part 11 compliant. To find out more about how we can provide pharmaceutical validation solutions for your business, contact our team today on 01929 459459 or use our online form. We have nearly 40 years of experience and provide lifetime aftercare and support.