Extruder Processing: Comparison of Single- And Twin-Screw Extruders for Optimal Solids Conveying, Melting, and Mixing

ISBN-13: 9781569908631 / Angielski / Twarda / 2022 / 220 str.

Gregory A. Campbell

Spis treści

• Part 1: Validation of Computerized Systems
• Recent Changes in Regulations and Regulatory Guidance
• Instrument Qualification, Computerized System Validation and Method Validation
• Regulatory Requirements for Computerized System Validation
• Computerized System Validation
• Writing the User Requirements Specification (URS)
• Auditing the System Supplier
• Installation Qualification and Operational Qualification (IQ and OQ)
• Performance Qualification (PQ) or End User Testing
• Part 2: Method Validation
• Measurement Errors and Uncertainty of Measurement
• Validation of Analytical Procedures and Methods
• Interlaboratory Studies in Thermal Analysis
• Method Development Through to SOP
• Practical Examples
• Appendix 1: 21 CFR Part 11 and EU GMP Annex 11
• Appendix 2: Basic Statistics
• Appendix 3: Standard Test Methods for Thermal Analysis

O autorze

Paul G. Andersen, Ph.D., is Process Technology Consultant at Coperion Corporation, Ramsey, NJ, USA. He was previously Director, Process Technology at Coperion, a position he held until 2016. In 2009/2010, he was President of the Society of Plastics Engineers (SPE). Gregory A. Campbell, Ph.D., is Chief Technical Officer at Castle Associates, Jonesport, ME. He was previously professor and departmental chair of chemical engineeering at Clarkson University, NY. He formerly directed a research group at GM Research and managed polymer fabrication at Mobil Chemical Research. He is a Fellow and former Extrusion Board Member of the Society of Plastics Engineers (SPE).