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Validation Practices for Biotechnology Products Shillenn JK Pages: 155       Published: 1996

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Table of Contents

Commissioning Major Pharmaceutical Manufacturing Facilities
Fay ST, Howard TP, Stevens WT

Validation of Filters Used for Sterilizing Liquids
Martin JM, Cole S, Geerligs G, Howard G, Jaenchen R

Points to Consider Before Validating a Liquid Nitrogen Freezer
Simione FP, Karpinsky JZ

Standards and Practices for Computer Validation and System Definition
Stotz RW, Bluhm AR

Validation Studies in the Regeneration of Ion-Exchange Celluloses
Levison PR, Streater M, Jones RMH, Pathirana ND

Sensitivity Considerations in Hydrophobic Filter Integrity Testing
Steere WC, Scheer LA, Hubbert M

Designing Validation into Chromatography Processes
Sofer GK

Developing Procedures to Meet GMP Requirements
Malooley MJ

Process Development, Scale-Up and Validation of a Recombinant -Based Fermentation Process
Sniff KS, Garcia LA, Hassler RA, Seely RJ, Young MD

A New Methodology for Quality Control Testing of Biological and Recombinant Products
Zaslavsky BY, Chaiko DJ

Validation of Disinfectants Used in Biotechnology Facilities
Richter SG

Staying in Control Ongoing Calibration and Change Control Practices
Busfield JT

Committee: E48
Paper ID: STP1260-EB
DOI: 10.1520/STP1260-EB

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STP1260-EB