334 Pages
by
CRC Press
336 Pages
by
CRC Press
Also available as eBook on:
Increasingly, pharmaceutical scientists must not only be specialists in their field but must also be familiar with legislation that governs the use of equipment in their industry. The regulation of test and measuring equipment changes continually as new regulations are introduced and new equipment is developed. 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.
Introduction, T. Kowalski, Sartorius Limited
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
Control of Test and Measuring Equipment in a Quality System: Balances and Scales in GLP/GMP/ISO9000, S. Weyhe, Sartorius, AG
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
Summary
Bibliography
Expression of Uncertainty for Displayed Net Values, J. Ober, Sartorius, AG
Quantities Influencing Uncertainty of Measurement
Determination of the Components
Calculation of the Uncertainty
Uncertainty in Practical Use
Summary
Reference
Software Validation, B.A. Wichmann, National Physical Laboratory, UK
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
References
Errors Associated with Weighing, C. Jenkins, Kent Scientific Services
Errors Caused by Weighing Instruments
Errors Caused by Environmental Effects
Errors Caused by Other Effects
References
Weights and Weighing Machines, M.J. Buckley, South Yorkshire Standards Unit
Metrology and Standards
Mass Standards and Weights
Weighing Machines
Weighing in the Pharmaceutical Industry, T. Scorer, Glaxo Wellcome
The Pharmaceutical Industry
Check-Weighing
The Regulatory Environment
Non-Automatic Weighing Instruments Directive
Evaluation of Methods for Estimating the Uncertainty of Electronic Balance Measurements, J.P. Clark and A.H. Shull, Westinghouse Savannah River Company
Weight Measurement Terminology
Summary
References
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
Control of Test and Measuring Equipment in a Quality System: Balances and Scales in GLP/GMP/ISO9000, S. Weyhe, Sartorius, AG
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
Summary
Bibliography
Expression of Uncertainty for Displayed Net Values, J. Ober, Sartorius, AG
Quantities Influencing Uncertainty of Measurement
Determination of the Components
Calculation of the Uncertainty
Uncertainty in Practical Use
Summary
Reference
Software Validation, B.A. Wichmann, National Physical Laboratory, UK
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
References
Errors Associated with Weighing, C. Jenkins, Kent Scientific Services
Errors Caused by Weighing Instruments
Errors Caused by Environmental Effects
Errors Caused by Other Effects
References
Weights and Weighing Machines, M.J. Buckley, South Yorkshire Standards Unit
Metrology and Standards
Mass Standards and Weights
Weighing Machines
Weighing in the Pharmaceutical Industry, T. Scorer, Glaxo Wellcome
The Pharmaceutical Industry
Check-Weighing
The Regulatory Environment
Non-Automatic Weighing Instruments Directive
Evaluation of Methods for Estimating the Uncertainty of Electronic Balance Measurements, J.P. Clark and A.H. Shull, Westinghouse Savannah River Company
Weight Measurement Terminology
Summary
References
Biography
Tony Kowalski
