Calibration in the Pharmaceutical Laboratory: 1st Edition (Hardback) book cover

Calibration in the Pharmaceutical Laboratory

1st Edition

Edited by Tony Kowalski

CRC Press

336 pages

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Hardback: 9781574910926
pub: 2001-12-31
$180.00
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eBook (VitalSource) : 9780429132766
pub: 2015-05-06
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Description

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.

Table of Contents

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

Subject Categories

BISAC Subject Codes/Headings:
MED071000
MEDICAL / Pharmacology
SCI013000
SCIENCE / Chemistry / General