The EL-21CFR-ULT is a Ultra-Low-Temperature 21CFR compliant, USB temperature data logger, supplied with T-type thermocouple probe capable of measuring ultra-low temperatures down to -100°C.
As a number of coronavirus vaccines come to fruition, we are likely to see vaccine distribution on a scale never witnessed before. Reliable temperature monitoring throughout the cold chain is imperative to ensure that vaccine potency is maintained and that those organisations involved in the storage of vaccines have robust records that prove their due diligence in the process.
FilesThruTheAir offer a wide range of specialist data loggers, designed to record temperature and alert users to any temperature issues that arise. We have product options available for both chilled and ultra-low temperature vaccines, as well as 21CFR compliant applications.
Our USB data loggers automatically record temperature data, which can be downloaded to PC or laptop via USB at any time convenient to the user. Never miss a critical temperature check and have easy access to robust temperature records that prove your due diligence in maintaining vaccines at the correct temperature.
Features of Ultra-Low-Temperature 21CFR USB Data Logger:
- Perfect for monitoring ultra-low-temperature storage environments for certain vaccines and cryogenics
- Measurement range with provided T-type probe: -100 to +100°C (-148 to +212°F)
- Compatible with J, K or T-type thermocouple probes
- Accuracy: ±2.5°C / ±4.5°F (data logger only, thermocouple error not included)
- User-selectable logging rate between 1 second and 12 hours
- Two years’ typical battery life
- Easy device set-up using free PC Software
- Configurable high and low alarms that trigger an on-board LED
- Can be supplied with an optional UKAS Calibration Certificate (additional cost incurred).
This 21CFR Part 11 compliant ultra-low temperature data logger is designed for monitoring vaccines in cryogenic dry ice storage. The measurement range is -100 to +100°C (-148 to +212°F) using the probe supplied with the logger. The device can record over 32,000 readings and is simple to set up using the 21CFR Part 11 software, which allows users to set their own high and low alarm thresholds, with alarm hold and delayed start features as well. Flashing lights alert users to any temperature excursions. Just plug the logger into your PC’s USB port to download data which can then be graphed, printed and exported to other applications for detailed analysis.
Why buy a 21CFR logger?
The 21 CFR Part 11 regulations issued by the US Food and Drug Administration (FDA) give the criteria under which electronic records can be considered by the FDA as equivalent to signed paper records. If you need to meet these regulations or have enhanced data security requirements then you should choose one of our 21CFR loggers, otherwise, our standard loggers will suffice.
Used in conjunction with EasyLog USB 21CFR Part 11 software, the logger enjoys all of the core features of the standard EasyLog software, but with additional 21CFR characteristics including user permissions, encrypted data which cannot be edited, full audit trail and electronic signatures for all activity
The device can be supplied with a UKAS calibration certificate for an additional cost.
