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SEDL / STP / STP1260-EB
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STP1260
Validation Practices for Biotechnology Products
Shillenn JK
Pages: 155
Published: 1996
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The first reference source of its kind dedicated to current innovative approaches to high standard validation practices for biotechnological uses in the pharmaceutical industry. 12 comprehensive peer-reviewed papers cover the following critical areas: Facilities and Equipment Validation; Process Validation and Planning; and Calibration and Change Control.
Table of Contents
Commissioning Major Pharmaceutical Manufacturing Facilities
Fay S., Howard T., Stevens W.
Validation of Filters Used for Sterilizing Liquids
Cole S., Geerligs G., Howard G., Jaenchen R., Martin J.
Points to Consider Before Validating a Liquid Nitrogen Freezer
Karpinsky J., Simione F.
Standards and Practices for Computer Validation and System Definition
Bluhm A., Stotz R.
Validation Studies in the Regeneration of Ion-Exchange Celluloses
Jones R., Levison P., Pathirana N., Streater M.
Sensitivity Considerations in Hydrophobic Filter Integrity Testing
Hubbert M., Scheer L., Steere W.
Designing Validation into Chromatography Processes
Sofer G.
Developing Procedures to Meet GMP Requirements
Malooley M.
Process Development, Scale-Up and Validation of a Recombinant E. Coli-Based Fermentation Process
Garcia L., Hassler R., Seely R., Sniff K., Young M.
A New Methodology for Quality Control Testing of Biological and Recombinant Products
Chaiko D., Zaslavsky B.
Validation of Disinfectants Used in Biotechnology Facilities
Richter S.
Staying in Control — Ongoing Calibration and Change Control Practices
Busfield J.
Committee: E48
Paper ID: STP1260-EB
DOI: 10.1520/STP1260-EB
ISBN-EB: 978-0-8031-5322-6
 ASTM International is a member of CrossRef.
0-8031-2405-8
978-0-8031-2405-9
STP1260-EB
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