Validation

Dataloggers

Jason Daoust

Masy Systems, Inc.

August 20th, 2014

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

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 01463978-433-6279Jason.Daoust@Masy.com