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Calibration in the pharmaceutical laboratory

Langue : Anglais

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Couverture de l’ouvrage Calibration in the pharmaceutical laboratory
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

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