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. Learn more about 21 CFR Part 11.
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.
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 customized calibration at whatever measurement points you need. Please contact our sales team for details.
Calibration options available for the EL-21CFR-ULT:
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.
Whether you’re optimizing processes, safeguarding stock, or storing and transporting valuable assets, reliable data is critical to success.
Pharmaceutical Cold Chain
Using precise temperature loggers in pharmaceutical cold chains to ensure drug efficacy, quality, and health standard compliance.
21CFR Compliant Data Loggers
Offering 21CFR compliant data loggers ensuring secure, reliable data management and regulatory compliance.
The US FDA (Food & Drugs Administration) Code of Federal Regulations 21 Part 11, is an extension to the existing regulations that defines which electronic records and signatures that are to be considered accurate to replace paper records for the Pharmaceutical and Medical industry. Our system has been designed to assist companies comply with these regulations.
If left unused for extended periods of time lithium metal batteries, including those used in the EasyLog range of data loggers, naturally form a non-conductive internal layer – a Passivation layer – preventing them from self-discharge and effectively increasing their shelf life. When first installed in the data logger, this may cause a momentary drop in the battery voltage (the Transient Minimum Voltage) as the internal layer is broken down, resulting in the data logger resetting. Inserting the batteries in the data logger and leaving it connected to a PC for about 30 seconds will remove this layer. After this, remove and re-install the batteries to reset the data logger. Overall battery life will not be affected.