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Lectures on Numerical Methods in Bifurcation Problems
Methods for Finding Zeros in Polynomials
Lectures on Stochastic Flows and Applications
Educational Psychology by Edward L. Thorndike
The Last Days of Tolstoy by V. G. Chertkov
Globalization and Responsibility
Lectures on Siegel Modular Forms and Representation by Quadratic Forms
Lectures on Topics In One-Parameter Bifurcation Problems
History of the Incas by Pedro Sarmiento de Gamboa
Linear Algebra: Theorems and Applications
Lectures on Stochastic Differential Equations and Malliavin Calculus
A Short Biographical Dictionary of English Literature
Lectures on Sieve Methods and Prime Number Theory
Dollars and Sense by William Crosbie Hunter
The Theory of the Theatre by Clayton Hamilton
The Mathematics of Investment
Occupiers of Wall Street: Losers or Game Changers
The Solution of the Pyramid Problem
Lectures on Moduli of Curves
Walden by Henry David Thoreau
Methods for Finding Zeros in Polynomials
Lectures on Stochastic Flows and Applications
Educational Psychology by Edward L. Thorndike
The Last Days of Tolstoy by V. G. Chertkov
Globalization and Responsibility
Lectures on Siegel Modular Forms and Representation by Quadratic Forms
Lectures on Topics In One-Parameter Bifurcation Problems
History of the Incas by Pedro Sarmiento de Gamboa
Linear Algebra: Theorems and Applications
Lectures on Stochastic Differential Equations and Malliavin Calculus
A Short Biographical Dictionary of English Literature
Lectures on Sieve Methods and Prime Number Theory
Dollars and Sense by William Crosbie Hunter
The Theory of the Theatre by Clayton Hamilton
The Mathematics of Investment
Occupiers of Wall Street: Losers or Game Changers
The Solution of the Pyramid Problem
Lectures on Moduli of Curves
Walden by Henry David Thoreau
Useful Links
Parenteral Quality Control:Sterility, Pyrogen, Particulate, and Package Integrity Testing - Third edition
Posted on 2010-04-14
|
More by Michael J. Akers, Daniel S. Larrimore, Dana Morton Guazzo ISBN 0824708857 | 2003 | English Describes the most recent breakthroughs in the validation and execution of testing schemes for parenteral quality control. Emphasizes testing methodologies for the evaluation of package integrity, finished product contamination, and sterility. Contents Sterility Testing • Sterility and Sterility Test Regulations • Sampling for Sterility Testing • Culture Media • Time and Temperature of Incubation • Sterililty Test Methods • Sterility Retesting • FDA Guidelines on Sterility Testing • Sterility Testing of Different Sterile Products • Sterility Testing of Antibiotics and Proteins • Control in Sterility Testing • Validation of the Sterility Test • Limitations of the USP/NF Referee Sterility Test • Isolation Chambers and Robotic Sterility Test Units • Support Techniques and Procedures for Sterility Assurance • Alternatives to the Compendial Sterility Test Pyrogen Testing • History • Specific Requirements of the USP Rabbit Pyrogen Test • The Limulus Amebocyte Lysate Test • Modifications of Rabbit and LAL Tests for Pyrogens Particulate Matter Testing • Background of Particulate Matter Concerns in Parenteral Products • Nature and Source of Particulates • The Reality of Particulate Matter Contamination in Parenteral Solutions • Particulate Matter Standards • Visual Inspection: Manual Methods • Visual Inspection: Automatic Methods • Current Issues with Visible Particle Detection and Inspection Procedures • USP Test for Subvisible Particulate Matter in Large-Volume Injections for Single-Dose Infusion and Small-Volume Injections • Electronic Particle Counters • Light Obscuration Particle Count Test • Microscopic Particle Count Test • Automated Microscopic Particulate Matter Test • Comparison of Microscopic and Electronic Particle-Counting Methods • Current Issues with Electronic Particle Counters • Factors Affecting Accurate Particle Testing • International Compendia Standards for Particulate Matter Content in Parenteral Solutions Package Integrity Testing • Regulations and Guidances • Leakage • Establishing Leak Rate Specifications • Package Integrity Test Methods • The Changing Pharmaceutical Industry • Package Integrity and the Product Life Cycle Appendices 1. Example of Standard Operating Procedure for Sterility Testing by Direct Inoculation 2. Example of Standard Operating Procedure for Sterility Testing by Membrane Filtration 3. Aseptic Procedures at the Laminar Flow Workbench Link: http://rapidshare.de/files/34190459/PQC3.rar
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