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PDA Technical Report No. 64 (TR 64) Active Temperature-Controlled Systems: Qualification Guidance (single user digital version)

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  • Table of Contents

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:

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  1. Introduction
  2. Glossary of Terms
  3. Overview of Active System Operating Characteristics
  4. Qualification of Active Temperature-Controlled Transportation Systems
  5. Temperature-Controlled Trucks and Trailers
  6. Temperature-Controlled Ocean Containers
  7. Active Ulds
  8. Temperature-Controlled Storage Warehouses/Rooms
  9. Conclusions
  10. References
  11. Additional Supporting Documents

Figures and Tables Index

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