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Last modified: 2018-01-18 
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Features PyroButton-SQL PyroButton-Standard PyroButton-Basic
21 CFR Part 11
21 CFR 11 Compliance
 
Data-logger operations
Automatic adapter detection
PyroButton data-acquisition set up/upload
Reading/download measurement results
Wizard for configuration Set-up of Measurement
Stop Measurement
Set PyroButton into "Sleep" mode
Measurement templates for quick set-up - -
High throughput batch set-up/upload of the data-acquisition of PyroButton - -
High throughput batch reading/download of measurements - -
 
Data management
Secured storage of Critical Control Parameters in PyroButton memory
Measured data are saved into file -
Out-of-limit data relative to 2-levels of lower-upper limits
Measured data are saved into SQL database - -
Backup and Restore capabilities for MSSQL database - -
Properties of closed environment: dimensions, set specification(s) of temperature and/or humidity, limit specifications of temperature and/or humidity, pressure as required, bioburden as required, ISO classification as required - -
Properties of open environment: GPS specification - -
Application modules: Clean room, Equipment, Facility, Process, Stability Chamber, Sterilization, Open Space monitoring, and Transportation - -
Container/Closure Systems management - -
SOP management - -
Searchable measurement database containing all measurement data - -
Measurement Selector Wizard - -
 
Integrated SQC/SPC module
Moisture Permeability Evaluation
Hygroscopicity evaluation - -
Performance Qualification of steam sterilization - -
Performance Qualification of ETO sterilization relative temperature & humidity - -
Load qualification of steam & ETO sterilizations - -
Temporal Map - -
Sensor-positional map - -
Temperature and/or humidity mapping, qualification, & validation of incubators, refrigerators, freezers, stability chambers, warehouses, processing facilities, & transportation containers - -
Load qualification & load validation of incubators, refrigerators, freezers, stability chambers, warehouses, processing facilities, & transportation containers - -
Temperature/humidity evaluation relative to GPS positions of the sensors - -
List of Data-loggers near to expiry date - -
List of measurements, which had been stopped - -
Compartment log - -
 
Data-loggers
Serial, Parallel and USB port handling
Handling of PyroButton-G
Handling of PyroButton-L
Handling of PyroButton-T
Handling of PyroButton-TH
Encryption of the data-loggers (software and/or hardware)
Measurement alarms
Histogram
Attrition and life-time estimation
Data-logger position, 3D coordinates, mounting, container/closure management - -
User defined custom properties - -
 
Calibrations
Warning if calibration is required
(customizable)

(within 60 days)

(within 60 days)
Calibration attributes (calibrator, company/person, SOP identifier, certificate identifier, date of next scheduled calibration)
Temperature calibration
Rel. humidity calibration
Measurement uncertainty -
Calibration history, display of calibration table and curve - -
Performance Qualification of the data-logger relative to calibration data - -
 
Measurement data
Measurement graph (temperature and/or humidity trend(s)) with excursion analysis
(enhanced)
Simultaneous display of two or more measurements
(arbitrary)

(parallel measurements only)

(parallel measurements only)
Printable measurement summary
(enhanced)
Exporting data to Excel
Exporting data to XML
Smoothing RH data
Uncertainty of measurement calculations
Customizable smoothing parameters -
Average, minimum, maximum, standard deviation calculation for partial curves - -
 
Miscellaneous
Celsius, Fahrenheit and Kelvin temperature units can be selected
Local time/date or UTC (standardized) time/date zone can be selected



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