by Tony Kowalski

• Provides insight into mass measurement and associated errors
• Explains how to establish an acceptable level of confidence in the test and measuring equipment being used
• Surveys current good practice in software engineering and relates this practice to application involving scientific instruments
• Contains detailed information on key quality related issues
• Includes contributions from international experts in the field
• Presents the latest GLP/GMP/ISO 9000 standards

Calibration in the Pharmaceutical Laboratory provides general background on laboratory balances and precision scales, insight into mass measurements and associated errors, and detailed information on key quality issues associated with weighing. Managers responsible for QC and QA will find this book an invaluable tool when setting out SOPs for balances and scales used throughout the manufacturing and testing process.

Contents

1. Introduction
   • The Laboratory Balance
   • Printed Results
   • Data Communications Via a Personal Computer
   • Software Integrated into Balances
   • Moisture Analyzers
   • Calibration of Micropipettes in a Quality System Using a Balance and PC
   • Intrinsically Safe Weighing Equipment for Hazardous Areas
   • Commissioning of Balances
   • Appendix 1.1: Determination of the Minimum Sample Weight According to the USP

2. Control of Test and Measuring Equipment in a Quality System: Balances and Scales in GLP/GMP/ISO9000
   • Motivation
   • Selection of Suitable Test and Measuring Equipment
   • Determination of the Uncertainty of Measurement
   • Calibration and Adjustment
   • Traceability of a Measurement
   • Documentation
   • Defining the Interval of Confirmation

3. Expression of Uncertainty for Displayed Net Values
   • Quantities Influencing Uncertainty of Measurement
   • Determination of the Components
   • Calculation of the Uncertainty
   • Uncertainty in Practical Use

4. Software Validation
   • Software Use
   • Risk Factors
   • Integrity Assessment
   • Software Development Practice
   • Conclusions
   • Acknowledgements
   • Appendix 4.A: Check-Lists
   • Appendix 4.B: Some Example Problems
   • Appendix 4.C: Recommended Software Engineering Techniques

5. Errors Associated with Weighing
   • Errors Caused by Weighing Instruments
   • Errors Caused by Environmental Effects
   • Errors Caused by Other Effects

6. Weights and Weighing Machines
   • Metrology and Standards
   • Mass Standards and Weights
   • Weighing Machines

7. Weighing in the Pharmaceutical Industry
   • The Pharmaceutical Industry
   • Check-Weighing
   • The Regulatory Environment
   • Non-Automatic Weighing Instruments Directive

8. Evaluation of Methods for Estimating the Uncertainty of Electronic Balance Measurements
   • Weight Measurement Terminology

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