21CFR-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.
21CFR-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.
Specifications
Measurement Range: -100 to +100°C (-148 to +212°F)
Accuracy: ±2.5°C (±4.5°F) typical
Readings: 32,510
Logging Rate: User selectable between 1 second and 12 hours
Operating Temperature (logger only): -10 to +40°C (+14 to +104°F)
Dimensions (logger): 118 x 27 x 27mm (4.6 x 1.1 x 1.1”)
Dimensions (probe): 300 x Ø1.5mm x 1m cable (11.8 x Ø0.06″ x 39.4″ cable)
Battery Life: 2 years
Resources
Links
FAQ’s
Q: Could you explain what 21CFR Part 11 is?
A: 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.
Q: Why aren’t my batteries working?
A: 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.
Calibration
For data logger calibration requests, please visit this page:
Applications
To read more about data logger applications, please click one of the following links:
