Temperature calibration and calibration verification of PyroButton data-loggers

Case Study 101PB

Case Study 101PB

Proj.ID/DIMS: TCV-20050119/D21299

Objective:

The objective of the study is to demonstrate the temperature calibration and calibration verification process of PyroButton data-loggers. Main components of the demonstration include:

• Evaluation of a non-calibrated PyroButton relative to temperature accuracy
• Evaluation of a calibrated PyroButton relative to temperature accuracy
• Comparison of raw (i.e., pre-calibrated data) and calibrated data
• Calculation the correction factor
• Verification of the temperature calibration
• Performance Qualification of the calibrations as applicable

Abbreviation:

BLF - PyroButton License File
CoC - Certificate of Calibration

Definitions:

Calibration of PyroButton is the process of temperature measurements at the required intervals against a recognized reference standard (e.g., NIST) for the determination of the adjustment factors needed to ensure that the results of temperature measurements by the calibrated PyroButton are within the required accuracy.

Calibration verification of PyroButton is the process of temperature measurements at the required intervals against a recognized reference standard (e.g., NIST) to verify that the temperature output of the calibrated PyroButton remain within specification.

Certificate of Calibration is a documentary evidence of the calibration, which is issued by Opulus. CoC shall contain the following information:

• Unique ID of the CoC
• Type of PyroButton being calibrated
• Unique ID of the calibrated PyroButton
• Calibration SOP(s)
• ID of the equipment used for the calibration
• ID of the references used for the calibration
• Reference values, calibrated values, and the deviations
• Results relative to the specification requirements
• Calibration factors for the PyroButton
• Calibration curve
• QC & QA approvals of the Certificate of Calibration.

BLF is the license file generated by Opulus for each PyroButton as part of the PyroButton registration requirement. BLF contains Critical Control Parameters (CCP) to ensure the reliable and 21 CFR Part 11 compliant operation of each PyroButton data-logger. The integrity of BLF files is protected from unapproved access. CCP data stored in BLF include:

• type of PyroButton,
• name of the manufacturer,
• date of calibration,
• date of next scheduled calibration, and
• the correction factors.

Benefits of using calibrated PyroButton data-loggers:

• 21 CFR Part 11 compliance is ensured
• Integrity audit test is performed on each data-logger prior to calibration
• Each PyroButton data-logger is calibrated at least 5 different temperatures & the calibration is verified prior to shipment
• Improved temperature accuracy
• Corrections based on the calibration factors are automatically performed for each temperature measurement
• Certificate of Calibration is provided for each data-logger
• Regulatory compliance is ensured
• Extended warranty period
• High Return-On-Investment

PyroButton Calibration Process

Materials & equipment:

• PBC-Temp temperature calibrator having the following specification:
  • Temperature range -20 to +85°C
  • Temperature resolution ±0.002°C
  • Temperature accuracy ±0.05°C
  • Thermal stability ±0.02°C
  • Calibrated against NIST reference relative to the temperature range used
    
    
• PyroButton-TH combined temperature/humidity data-logger having the following characteristics:
  • Temperature range -20 to +85°C,
  • Temperature resolution ±0.0625°C,
  • Temperature accuracy ±0.1°C, if calibrated against reference relative to the temperature range used
    
    
• PyroButton-SQL software
• PB-Adapter-S8 - PyroButton serial communication & power interface
• PC Computer

Procedure Summary:

Temperature calibration and calibration verification (PBC-Temp calibration system can perform automatically up to 20 PyroButtons calibration in parallel):

1. Program the temperature calibration data-acquisition requirements for each of the PyroButton to be calibrated
2. Fix/snap each of the PyroButtons into the button-holder of the PBC calibrator
3. Start the PBC temperature calibration protocol according to the applicable SOP (i.e., the required temperature intervals)
4. PBC program shall indicate the end of the calibration cycle
5. Generate BLF files for each of the PyroButton
6. Program the temperature calibration verification data-acquisition requirements for each of the PyroButton
7. Verify the calibration
8. Generate the Certificate of Calibration

Results/Example: demonstration from the calibration/verification at 0°C

Interpretation:

1. Non-calibrated PyroButton temperature accuracy has met the specification (± 0.5).
2. Calibrated PyroButton temperature accuracy has met the specification (± 0.1).

Performance Qualification (PQ) of PyroButtons

PQ evaluates the state of statistical control of each PyroButton relative to its specification. PQ Control Charts are determined for the following Critical Control Parameters:

1. Temperature
   • Correction factors at each temperature
   • Fit factors of the piece-wise linear calibration curves for the temperature range
2. Humidity:
   • Fit factors of the calibration curve