Featuring contributions from 25 specialists, this book provides a single-source reference on the design of systems, qualification of equipment, calibration and certification. It covers explicit procedures for the validation of systems required in the preparation of aseptic and nonaseptic pharmaceutical products. Topics include installation qualification, operational qualification, and change control, F, D, and Z values, steam sterilization-in-place technology and validation, sterilization methods, protocols that allow procedures to be applied directly, obstacles that may be encountered at any stage of the validation program and suggested the solutions.
Validation of Pharmaceutical Processes
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Most Helpful Customer Reviews
1 of 1 people found the following review helpful:
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This review is from: Validation of Pharmaceutical Processes: Sterile Products, Second Edition, Revised and Expanded (Hardcover)
I thought this book was excellent, it was exactly what I was looking for in terms of sterile products validation
0 of 2 people found the following review helpful:
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Validation of medical devices?,
By A Customer
This review is from: Validation of Pharmaceutical Processes: Sterile Products, Second Edition, Revised and Expanded (Hardcover)
I was looking for more information on medical devices than was provided and greater detail on the statistical methodology used to validate which was especially sketchy, especially at such a steep price.
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Inside This Book
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First Sentence:
The prime objective of anyone working in a pharmaceutical plant, whether in production or quality control, is to manufacture consistently products of the requisite quality at the lowest possible cost. Read the first page Key Phrases - Statistically Improbable Phrases (SIPs): (learn more)
automatic ice bath, minimum sterilization dose, poststerilization integrity, dye leak test, bacterial retention testing, effective calibration program, penetration thermocouples, microbial retention testing, bioburden cycles, cleanroom surfaces, control system validation, parenteral industry, filter extractables, reject zone efficiency, sample probe inlet, flame sterilizers, fraction negative method, pharmaceutical water systems, heat distribution studies, heat penetration studies, process functional requirements, condensate retention, final installation site, less critical environments, batch sterilizer Key Phrases - Capitalized Phrases (CAPs): (learn more)
Parenteral Drug Association, New York, Pharm Technol, Parenter Sci Technol, United States Pharmacopeia, Institute of Environmental Sciences, Supplier Design, Pharm Sci Technol, New Jersey, Pharm Eng, Bull Parenter Drug Assoc, Pharmaceutical Manufacturers Association, Marcel Dekker, Operations Design, Tag Number, Pharmacopeial Forum, Mack Publishing, Tech Monogr, Technical Services, Federal Register, Scale Division, Tech Rep, Code of Federal Regulations, Environ Sci, European Community New!
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Front Cover | Table of Contents | First Pages | Index | Back Cover | Surprise Me!
The prime objective of anyone working in a pharmaceutical plant, whether in production or quality control, is to manufacture consistently products of the requisite quality at the lowest possible cost. Read the first page Key Phrases - Statistically Improbable Phrases (SIPs): (learn more)
automatic ice bath, minimum sterilization dose, poststerilization integrity, dye leak test, bacterial retention testing, effective calibration program, penetration thermocouples, microbial retention testing, bioburden cycles, cleanroom surfaces, control system validation, parenteral industry, filter extractables, reject zone efficiency, sample probe inlet, flame sterilizers, fraction negative method, pharmaceutical water systems, heat distribution studies, heat penetration studies, process functional requirements, condensate retention, final installation site, less critical environments, batch sterilizer Key Phrases - Capitalized Phrases (CAPs): (learn more)
Parenteral Drug Association, New York, Pharm Technol, Parenter Sci Technol, United States Pharmacopeia, Institute of Environmental Sciences, Supplier Design, Pharm Sci Technol, New Jersey, Pharm Eng, Bull Parenter Drug Assoc, Pharmaceutical Manufacturers Association, Marcel Dekker, Operations Design, Tag Number, Pharmacopeial Forum, Mack Publishing, Tech Monogr, Technical Services, Federal Register, Scale Division, Tech Rep, Code of Federal Regulations, Environ Sci, European Community New!
Books on Related Topics | Concordance | Text Stats Browse Sample Pages:
Front Cover | Table of Contents | First Pages | Index | Back Cover | Surprise Me!
Citations (learn more)
This book cites 40
books:
See all 40 books this book cites
3
books
cite this book:
- Sterilization Technology by Robert F. Morrissey on page 553, page 554, and page 701
- Validation of Aseptic Pharmaceutical Processes by Frederick J. Carleton on page 350, page 409, and page 581
- Pharmaceutical Water Systems by Theodore H. Meltzer on page 279, and page 350
- Kirk-Othmer Encyclopedia of Chemical Technology (Kirk 5e Print Continuation Series) (Volume 4) by Kirk-Othmer on page 524, and page 525
- Juran's Quality Control Handbook by J.M. Juran on page 761, and page 787
See all 40 books this book cites
- Drugs-From Discovery to Approval by Rick Ng on page 245
- Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries, Second Edition by Syed Imtiaz Haider on page 1116
- Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics (Drugs and the Pharmaceutical Sciences) by Carmen Medina on page 126
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