21CFR-Compliant WiFi Cryogenic Vaccine Data Logger with Display
The EL-WiFi-21CFR-ULT is a 21CFR Part 11-compliant Cloud-enabled wireless ultra-low temperature 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.
21CFR-Compliant WiFi Cryogenic Vaccine Data Logger with Display
The EL-WiFi-21CFR-ULT is a 21CFR Part 11-compliant Cloud-enabled wireless ultra-low temperature 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.
Specifications
Measurement Range: -100 to +100°C (-148 to +212°F)
Accuracy: ±2.5°C (±4.5°F) typical
Logging Rate: User selectable between 1 second and 12 hours
Storage Capacity: Unlimited
Dimensions (logger): 82 x 70 x 23mm (3.22 x 2.75 x 0.91”)
Dimensions (probe): 300 x Ø1.5mm x 1m cable (11.8 x Ø0.06″ x 39.4″ cable)
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:
