2. Introduction and background
• Worked in industry for almost 10 years
• Validation Services
• Autoclaves, Refrigerators, Freezers, Incubators,
Warehouses
• Calibration Services
• Super Thermometers, SPRTs, PRTs, Validator 2000s,
IRTDs, Validation Data Loggers
• Equipment Rentals and Sales
• Facility Monitoring
• BioStorage
4. Industry Acceptance:
Validation Dataloggers
• Increasing significantly
• Most major and minor companies are
realizing benefits
• No perfect validation datalogger in the
industry at this time
• Each system has trade-offs
• Loggers for specific applications vary
significantly
• Temp ranges
• Probe types
5. Standalone Validation Dataloggers
• Temperature ranges
• Anywhere from -200ºC to 400ºC+
• Body w/battery: -80ºC to 140ºC
• Humidity ranges
• Typically anywhere from 0% to 95% (non
condensing
• Pressure
• Typically 0 to 72.5 psia (0 to 5 BAR)
• Time
6. What is a Validation Datalogger?
• Defining Characteristics:
• Self contained
• Store data locally
• Individually calibrated
• Operate independently
7. Standard Benefits
• No more wires
• Saves a lot of time and effort
• Quicker setup time
• Program and go
• Great for large and small spaces
• Reducing/eliminating verification needs
•Some are intrinsically safe
•Excellent for potentially explosive
environments
• Most can be submerged
9. Validation Considerations
• Validation of the software
• Accept the manufacturer’s executed software
validation or write your own?
• GAMP 5 guidelines
• Validation of the system
• What if you add 1 more logger?
10. Use Considerations:
• Batteries: Temp range and cost
• A limiting factor for using VDLs
• Specified batteries typically freeze at -110C
• Not really effective below -85C
• Specified batteries typically boil at 100C
• Almost all explode above 150C
• Thermal barriers for higher temp applications will
buy you some time
• Adds thermal mass to study
11. Considerations:
• Do you really need live data?
• Most loggers on the market are blind and you
only receive information once the study is
complete and information is downloaded
• There are transmitting loggers available
• Will they handle the environment you want to
map?
12. Probe Types and applications
• Penetrating a container/product
or shelf temperature
• Autoclaves, SIPs
• Lyophilizers, warehouses
13. Verifications: Wired vs. Wireless
System Comparisons
• Wired systems
• Almost always calibrate wired sensors
(thermocouples) prior to and after each study
• Almost never verify temp standard pre/post
• Data Loggers
• Each is a calibrated instrument
• Some systems allow pre/post
• Fewer allow adjustments
• It all comes down to your Risk Analysis
14. Verifications/Calibrations
• Calibrations
• Typically performed by manufacturer or approved
lab
• Type of calibration performed varies
• Number of points, tolerance, repeatability, interval
• Verifications
• Wide variety of practices in industry
• Some systems you can interface with existing
equipment, some require proprietary software +
equipment
• Some allow adjustments, some do not
15. Verifications/Calibrations:
Equipment Required
• Temperature
• Liquid baths for stability/accuracy
• Fluke 7381/7341 deep wells
• Need some type of basket to hold loggers
• Dry baths for quick verifications
• Must accept wider tolerances
• Fluke metrology wells, Kaye LTR/HTR
• Must have probe long enough to hit bottom of
insert
17. In Review
• Embrace this growing technology
• Saves time and effort
• Consider your application
• Significant variations in available loggers
• Adjust protocol appropriately
• Decide how you handle calibrations and
verifications
