EasyLog | EL-21CFR-ULT21CFR-Compliant Ultra Low Temperature Cryogenic Vaccine Data Logger
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 Lascar's 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 product is supplied with a ½ AA battery, the probe (300mm probe on a 1m long cable), and a mounting bracket.
This product complies with BS EN 12830:2018 (Temperature recorders for the transport, storage, and distribution of temperature-sensitive goods).
PLEASE NOTE: You can add up to TWO SPARE BATTERIES for every data logger ordered. If you wish to order more than this quantity, please contact your local sales office for special shipping information.
FAQ'sCould you explain what 21CFR Part 11 is?
Why aren't my batteries working?
Calibration testing carried out on our products provides assurance of the ongoing accuracy of your EasyLog data logger. This is relevant for all users, but is especially important for medical, food and scientific applications, and where audit compliance needs to be demonstrated. We provide a number of standard calibration options suitable for common applications such as monitoring fridges, chilled goods and freezers, but can also provide customised calibration at whatever measurement points you need. Please contact our sales team for details.
Calibration options available for the EL-21CFR-ULT:
- EL-CAL-T ULT - Temp Points: -70°C and 0°C
Calibration certificates are available to purchase separately traceable to appropriate international standards, depending on your location.
The EL-21CFR-ULT ultra low temperature data logger is designed for monitoring vaccines in cryogenic dry ice storage and transit, in accordance with 21CFR Part 11 compliant data security procedures.
For application stories on our data loggers, visit our Case Studies section.
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