Aseptic Pharmaceutical Manufacturing II: Applications for the 1990s

Front Cover
Michael J. Groves, Ram Murty
CRC Press, May 31, 1995 - Medical - 520 pages
2 Reviews
Asceptic Pharmaceutical Manufacturing II explores the sophisticated technology, developments, and applications that allow aseptic processing to approach the sterility levels achieved with terminal sterilization. Written by experts in sterile manufacturing, this book covers aseptic technology, developments, and applications and makes a valuable contribution to understanding the issues involved in aseptic manufacture. Topics include the processing of biopharmaceuticals, lyophilization, personnel training, radiopharmaceuticals, hydrogen peroxide vapor sterilization, regulatory requirements, validation, and quality systems.
 

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Contents

Conclusions
8
iii
17
Regulatory Guidelines for Controlled
18
Federal Standard 209E
24
ASEPTIC PROCESSING OF HEALTHCARE
27
Good Manufacturing Practices Requirements
32
Regulatory Requirements for Controlled
38
Quality System Standards and Total
55
Microbiological Challenge Studies
226
Results
233
Discussion
240
Cell Bank
246
Fermentation
254
Purification
267
Summary
287
Application and Product Description
294

Summary
64
References
74
PRODUCTSA PENDING ISO DOCUMENT
81
Existing Guidelines on Aseptic Processing
96
VALIDATION OF ASEPTIC PROCESSES
101
Validation of Aseptic Filtration Processes
109
Validation of Media Sterilization
115
6
117
Spectrophotometric Methods
135
Immunological Methods
148
ASEPTIC PRODUCTION OF RADIOPHARMACEUTICALS
153
Radiopharmaceuticals
164
Quality Assurance
178
The Role of Management in Education
191
HandsOn Behavioral Training
208
Summary
214
Summary
308
Regulatory Background
318
ASEPTIC PACKAGING AND LABELING
337
Sterile Drug Formulations
346
Packaging Considerations
353
Sterile Packaging
362
Validation Considerations
401
Summary
408
Utilization of Hydrogen Peroxide Vapor
447
Future Prospects for Hydrogen Peroxide Vapor
464
Importance of a Microbiological Evaluation
470
Methodology and Instrumentation for Quantitation
481
Identification of Microbial Isolates from
487
Glossary
493
INDEX
499
Copyright

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