PDA Technical Report No. 64 (TR 64) Active Temperature-Controlled Systems: Qualification Guidance (single user digital version)
- Published
- Oct 2013
- ISBN
- 9780939459612
- Pages
- 58
- PDA Item Number
- 43509
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- Format
- PDF Single user
- Member Price
- $180.00
- Nonmember Price
- $325.00
- Government Price
- $180.00
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Fundamental to any temperature-controlled process is the expectation that materials that are stored and shipped within a controlled environment are maintained within a defined temperature range. Typically, this temperature range is within the recommended product storage requirements derived from stability data.
This guidance discusses the process of qualifying actively controlled spaces that are designed to maintain a stable and uniform temperature around the cargo for the duration of transportation or storage at any temperature range.
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Table of Contents
Table of Contents:
Click here to download >>> Detailed Table of Contents- Introduction
- Glossary of Terms
- Overview of Active System Operating Characteristics
- Qualification of Active Temperature-Controlled Transportation Systems
- Temperature-Controlled Trucks and Trailers
- Temperature-Controlled Ocean Containers
- Active Ulds
- Temperature-Controlled Storage Warehouses/Rooms
- Conclusions
- References
- Additional Supporting Documents
Figures and Tables Index
About the Authors
Anthony Bantug, Baxter BioScience
John Bratz, Sensitech
Boriana Cavicchia, PricewaterhouseCoopers, LLC
Alan Davis, Johnson & Johnson
John Dobbins, Pfizer
Chris Fore, Envirotainer
Geoffrey Glauser, Conceptual Mindworks Inc.
Joel Glende, Abbott Laboratories
Jason Heberle, TCP Reliable
William Helsby, Novartis (Liverpool)
Suzan Lanz, Savient Pharmaceuticals, Inc.
Gerry Marasigan, SNC-Lavalin Pharma
Peter Mirabella, QProducts & Services
Lisa Moher, Sanofi
Eric Newman, Falvey Cargo Underwriting
Richard Peck, Sensitech
Mark Pietropola, Great American Lines, Inc.
Chris Renz, Genentech
Edward J. Smith, Ph.D., Packaging Science Resources, LLC
Dave Ulrich, Abbvie
Erik J. van Asselt, Ph.D., Merck, Sharp & Dohme B.V. (MSD)