Providing a well-written and easy-to-read review of the subject, this reference describes the most recent breakthroughs in the validation and execution of testing schemes for parenteral quality control. Emphasize testing methodologies for the evaluation of package integrity, finished product contamination, and sterility, the book is a guide to testing and assuring that products for injecting drugs are sterile, free from pyrogenicity, and free from particulate matter. The authors highlight methods that meet US and European standards, explain regulatory requirements and harmonization between various authorities, and review trends and recent developments in technology.
Parenteral Quality Control
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Inside This Book
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First Sentence:
Sterility, or freedom from the presence of viable microorganisms, is a strict, uncompromising requirement of an injectable dosage form. Read the first page Key Phrases - Statistically Improbable Phrases (SIPs): (learn more)
residual seal force, liquid tracer tests, leak rate specifications, critical work site, parenteral packages, microbial ingress, parenteral vials, sterility test samples, helium mass spectrometry, sterility test failure, sterility test media, microbial barrier properties, package integrity tests, sterility test method, parenteral industry, sterility test procedures, leak test methods, pyrogen test, sterility testing, cap anvil, integrity test methods, reject zone, helium leak rate, visible particulate matter, closure compression Key Phrases - Capitalized Phrases (CAPs): (learn more)
Drug Assoc, Coulter Counter, New York, Pharm Sci, Establishing Leak Rate Specifications, Interpharm Press, Mack Publishing, National Formulary, Federal Register, British Pharmacopoeia, Trypticase Peptone, Bureau of Biologics, Code of Federal Regulations, East Berlin, European Pharmacopeia, Federal Standard, Liberty Industries, Marcel Dekker, National Coordinating Committee, Sterile Drug Products Produced, Academic Press, Bacterial Endotoxin Test, Control of Particulate Matter Contamination, Disc Compression Halobutyl Discs, Disposition Date New!
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Front Cover | Table of Contents | First Pages | Index | Surprise Me!
Sterility, or freedom from the presence of viable microorganisms, is a strict, uncompromising requirement of an injectable dosage form. Read the first page Key Phrases - Statistically Improbable Phrases (SIPs): (learn more)
residual seal force, liquid tracer tests, leak rate specifications, critical work site, parenteral packages, microbial ingress, parenteral vials, sterility test samples, helium mass spectrometry, sterility test failure, sterility test media, microbial barrier properties, package integrity tests, sterility test method, parenteral industry, sterility test procedures, leak test methods, pyrogen test, sterility testing, cap anvil, integrity test methods, reject zone, helium leak rate, visible particulate matter, closure compression Key Phrases - Capitalized Phrases (CAPs): (learn more)
Drug Assoc, Coulter Counter, New York, Pharm Sci, Establishing Leak Rate Specifications, Interpharm Press, Mack Publishing, National Formulary, Federal Register, British Pharmacopoeia, Trypticase Peptone, Bureau of Biologics, Code of Federal Regulations, East Berlin, European Pharmacopeia, Federal Standard, Liberty Industries, Marcel Dekker, National Coordinating Committee, Sterile Drug Products Produced, Academic Press, Bacterial Endotoxin Test, Control of Particulate Matter Contamination, Disc Compression Halobutyl Discs, Disposition Date New!
Books on Related Topics | Concordance | Text Stats Browse Sample Pages:
Front Cover | Table of Contents | First Pages | Index | Surprise Me!
Citations (learn more)
This book cites 92
books:
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36
books
cite this book:
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- Good Manufacturing Practices for Pharmaceuticals: A Plan for Total Quality Control (Drugs and the Pharmaceutical Sciences Series, Vol 78) by Sidney H. Willig on 4 pages
- Modern Pharmaceutics by Gilbert S. Banker on 4 pages
- New Drug Approval Process, Fourth Edition, Accelerating Global Registrations (Drugs and the Pharmaceutical Sciences) by Richard Guarino in Front Matter (1), Front Matter (2), and Front Matter (3)
- Drug Stability: Principles and Practices (Drugs and the Pharmaceutical Sciences) by Jens T. Carstensen in Front Matter (1), Front Matter (2), and Front Matter (3)
- Pharmaceutical Process Validation: An International Third Edition (Drugs and the Pharmaceutical Sciences) by Robert A. Nash in Front Matter (1), Front Matter (2), and Front Matter (3)
See all 92 books this book cites
- Microbial Contamination Control in Parenteral Manufacturing (Drugs and the Pharmaceutical Sciences) by Kevin Williams in Front Matter, and page 88
- Encyclopedia of Pharmaceutical Technology: Volume 3 - Clinical Supplies to Dermal Diffusion and Delivery Principles (Pharmaceutical Technology Encyclopedia) by James Swarbrick on page 251, and page 280
- Encyclopedia of Pharmaceutical Technology: Volume 11 - Nuclear Medicine and Pharmacy to Permeation Enhancement through Skin (Pharmaceutical Technology Encyclopedia) by James Swarbrick on page 234, and page 235
- Pharmaceutical Process Validation: An International Third Edition (Drugs and the Pharmaceutical Sciences) by Robert A. Nash in Front Matter, and page 153
- Liquid and Surface-borne Particle Measurement Handbook by Knapp on page 152, and page 659
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