Validation Dataloggers: Trends, considerations, along with the various dataloggers that are used for different purposes. Staying on top of emerging trends is key to being in compliance in order to pass an FDA audit.. Jason Daoust is the Business Development Manager for Masy Systems, Inc. He has been with Masy for over 8 years and has an in-depth knowledge of industry trends and technology. Jason has worked with multiple data logger manufacturers and is heavily involved in testing the functional capabilities to determine form and fit for validation use in cGMP environments. He works closely with hundreds of validation and calibration service companies and departments listening to their needs and providing the right products for them to be successful in completing their work. Jason regularly performs training on the use of validation data loggers in cGxP environments to some of the largest and smallest companies in North America. Prior to Masy, Jason worked as an independent business consultant working with product evaluations and release.

1. Validation Dataloggers
Jason Daoust
Masy Systems, Inc.
August 20th, 2014

2. Environmental mapping equipment
•Evolving over the years

3. Industry Acceptance: Validation Dataloggers
•Increasing significantly
•Most major and minor companies are realizing benefits
•No perfect validation dataloggerin the industry at this time
•Each system has trade-offs
•Loggers for specific applications vary significantly
•Temp ranges
•Probe types

4. 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

5. What is a Validation Datalogger?
•Defining Characteristics:
•Self contained
•Store data locally
•Individually calibrated
•Operate independently

6. 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

7. Changes to adopt VDLs
•Protocol updates
•“Validation Datalogger”
•Acceptable failure rate
•Pre/Post verification considerations
•Handling battery life/replacement
•Handling calibrations
•Internally vs. Externally

8. 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?

9. Use Considerations:
•Batteries: Temp range and cost
•A limiting factor for using VDLs
•Specified batteries typically freezeat -110C
•Not really effective below -85C
•Specified batteries typically boilat 100C
•Almost all explodeabove 150C
•Thermal barriers for higher temp applications will buy you some time
•Adds thermal mass to study

10. 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?

11. Probe Types and applications
•Penetrating a container/product or shelf temperature
•Autoclaves, SIPs
•Lyophilizers, warehouses

12. 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

13. 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

14. 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

15. Verifications/Calibrations: Equipment Required
•Humidity
•Thunder Scientific chamber
•Chilled mirrors
•Smaller chambers available
•Kaymont2000
•Kaye Humilab
•RotronicHygroGen2

16. 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

17. Questions?
Jason Daoust
Masy Systems, Inc.
10 Lomar Park
Pepperell, MA 01463
978-433-6279
Jason.Daoust@Masy.com