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Table Of Contents

Preface
INTRODUCTION
STERILITY AND STERILITY TEST REGULATIONS
SAMPLING FOR STERILITY TESTING
CULTURE MEDIA
TIME AND TEMPERATURE OF INCUBATION
STERILITY 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
Problem of Accidental Contamination
ALTERNATIVES TO THE COMPENDIAL STERILITY TEST
REFERENCES
Pyrogen Testing
HISTORY
THE LIMULUS AMEBOCYTE LYSATE TEST
Reaction Mechanism
Particulate Matter Testing
NATURE AND SOURCE OF PARTICULATES
PARTICULATE MATTER STANDARDS
VISUAL INSPECTION: MANUAL METHODS
VISUAL INSPECTION: AUTOMATIC METHODS
Autoskan System
ELECTRONIC PARTICLE COUNTERS
LIGHT OBSCURATION PARTICLE COUNT TEST
MICROSCOPIC PARTICLE COUNT TEST
AUTOMATED MICROSCOPIC PARTICULATE MATTER TEST
FACTORS AFFECTING ACCURATE PARTICLE TESTING
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
CONCLUSION
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12879652 Parenteral Quality Control

12879652 Parenteral Quality Control

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Published by Venkata Rama

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Published by: Venkata Rama on Aug 21, 2010
Copyright:Attribution Non-commercial

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10/25/2012

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