ホワイトペーパー・Heartbeat検証によるGMP準拠の校正

■全13ページ

■目次

• P1：“Can I use Heartbeat Technology in a GMP environment?”
• P2：Regulatory compliance
• P3：Process validation
• P5：Calibration versus verification
• P6：How to calculate safety
• P8：What are typical Failures in Time (FIT) values?
• P9：Definition of categories according to IEC 61508
• P10：Applications
• P11：Impact on customer’s benefit
• P12：Audit safety
• P13：Summary – the benefits of Heartbeat Technology

■全48ページ

■目次

• P4：1.Self-calibration: how it works
• P6：2.Application examples
  2.1 Use in the fermentation process (pharmaceutics)
• P8：2.2 Use in the UHT process (dairy)
• P10：3.Increased process safety
• P12：4.Reduced uncertainty of measurement
• P14：5.Detection of sensor errors
  5.1 Offset error: change in the basic resistance R0
• P15：5.2 Slope error: change in temperature dependence A
• P16：5.3 Combination of errors
• P18：5.4 CvD coefficient B
• P20：6.Uncertainty of measurement of single-point calibration
• P22：6.1 Calibration results of the TrustSens
• P23：6.2 Configuring the warning and alarm limits
• P24：6.3 Suggestion for application in practice: ice point calibration
• P26：7.Uncertainty of measurement of a manual calibration
• P30：8.Accuracy and signal transmission
• P32：9.Enhanced functionality
  9.1 FDA-compliant data logging
• P34：9.2 Displaying the calibration data on site
• P36：10.Process safety and audit reliability
  10.1 Existing SOPs and the change management process
  10.2 Continuous process verification
• P37：10.3 Definition of the term "calibration"
• P38：10.4 Using TrustSens technology in a regulated environment
• P39：10.5 Good Practice Guide (GAMP) and the change process
• P40：11.Bibliography
• P42：12.Hygiene product portfolio