The EL-WiFi-21CFR-ULT is an Ultra Low Temperature 21CFR compliant WIFI data logger, with a built-in display, designed for monitoring vaccines in ultra low temperature dry ice storage. The measurement range is -100 to +100°C (-148 to +212°F) using the probe supplied with the logger. The logger automatically records data and uploads it to the EasyLog 21CFR Cloud using your standard wireless network. The device will store data internally if it loses WiFi connection and automatically uploads it to the Cloud once reconnected.
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.
A 21CFR Cloud subscription delivers all of the flexibility of remote monitoring and can be installed as part of a 21CFR compliant system. Features include permission-based use, authority level sign-off and full system audit to ensure data monitored and collected is regulated to 21CFR Part 11 standard. This device requires a subscription to our EasyLog 21CFR Cloud service.
Ultra-Low Temperature Monitoring Solutions:
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.
Used in conjunction with our 21CFR Part 11 software, our 21CFR data loggers enjoy all of the core offerings of the original 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 USB variants log data which can be downloaded via USB to PC or Laptop. Meanwhile, the Wi-Fi variants record data automatically to the 21CFR Cloud; an online data storage and device management system (subscription required).
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 the ULT 21CFR WIFI 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, N or T-type thermocouple probes
- Accuracy: ±2.5°C / ±4.5°F
- User-selectable logging rate between 10 seconds and 12 hours
- Battery: rechargeable battery (typical 6 months battery life) / mains powered option
- Wirelessly stream and view data on the 21CFR Cloud
- Easy device setup using free PC Software
- View and analyse multiple devices in one account
- Configurable high and low alarms that trigger an email notification
- LCD screen displaying live data with push button to easily record physical checks/audits to the 21CFR Cloud
- Can be supplied with an optional UKAS Calibration Certificate (additional cost incurred)