Calibration in the Pharmaceutical Laboratory

ISBN-13: 9781574910926 / Angielski / Twarda / 2001 / 336 str.

Kowalski Kowalski; Tony Kowalski; Tony Kowalski

Opis

Increasingly, pharmaceutical scientists must not only be specialists in their field but also must be familiar with legislation that governs the use of equipment in the industry. The regulation of test and measuring equipment changes continually as new regulations are introduced. 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 should find this book a useful tool in setting out SOPs for balances and scales used throughout the manufacturing and testing process.

Spis treści

Introduction, T. Kowalski, Sartorius LimitedThe Laboratory BalancePrinted ResultsData Communications Via a Personal ComputerSoftware Integrated into BalancesMoisture AnalyzersCalibration of Micropipettes in a Quality System Using a Balance and PCIntrinsically Safe Weighing Equipment for Hazardous AreasCommissioning of BalancesAppendix 1.1: Determination of the Minimum Sample Weight According to the USPControl of Test and Measuring Equipment in a Quality System: Balances and Scales in GLP/GMP/ISO9000, S. Weyhe, Sartorius, AGMotivationSelection of Suitable Test and Measuring EquipmentDetermination of the Uncertainty of MeasurementCalibration and AdjustmentTraceability of a MeasurementDocumentationDefining the Interval of ConfirmationSummaryBibliographyExpression of Uncertainty for Displayed Net Values, J. Ober, Sartorius, AGQuantities Influencing Uncertainty of MeasurementDetermination of the ComponentsCalculation of the UncertaintyUncertainty in Practical UseSummaryReferenceSoftware Validation, B.A. Wichmann, National Physical Laboratory, UKSoftware UseRisk FactorsIntegrity AssessmentSoftware Development PracticeConclusionsAcknowledgementsAppendix 4.A: Check-ListsAppendix 4.B: Some Example ProblemsAppendix 4.C: Recommended Software Engineering TechniquesReferencesErrors Associated with Weighing, C. Jenkins, Kent Scientific ServicesErrors Caused by Weighing InstrumentsErrors Caused by Environmental EffectsErrors Caused by Other EffectsReferencesWeights and Weighing Machines, M.J. Buckley, South Yorkshire Standards UnitMetrology and StandardsMass Standards and WeightsWeighing MachinesWeighing in the Pharmaceutical Industry, T. Scorer, Glaxo WellcomeThe Pharmaceutical IndustryCheck-WeighingThe Regulatory EnvironmentNon-Automatic Weighing Instruments DirectiveEvaluation of Methods for Estimating the Uncertainty of Electronic Balance Measurements, J.P. Clark and A.H. Shull, Westinghouse Savannah River CompanyWeight Measurement TerminologySummaryReferences

O autorze

Tony Kowalski