validation dataloggers_jason daoust_masy systems
DESCRIPTION
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.TRANSCRIPT
Validation
Dataloggers
Jason Daoust
Masy Systems, Inc.
August 20th, 2014
Environmental mapping equipment
• Evolving over the years
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
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
What is a Validation Datalogger?
• Defining Characteristics:
• Self contained
• Store data locally
• Individually calibrated
• Operate independently
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
Changes to adopt VDLs
• Protocol updates
• “Validation Datalogger”
• Acceptable failure rate
• Pre/Post verification considerations
• Handling battery life/replacement
• Handling calibrations
• Internally vs. Externally
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?
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
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?
Probe Types and applications
• Penetrating a container/product
or shelf temperature
• Autoclaves, SIPs
• Lyophilizers, warehouses
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
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
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
Verifications/Calibrations:
Equipment Required
• Humidity
• Thunder Scientific chamber
• Chilled mirrors
• Smaller chambers available
• Kaymont 2000
• Kaye Humilab
• Rotronic HygroGen2
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
Questions?
Jason DaoustMasy Systems, Inc.10 Lomar ParkPepperell, MA [email protected]