PDA publishes new guidance on active (powered) temperature-controlled equipment

Active Temperature-Controlled Systems: Qualification Guidance (Technical Report No. 64) is the latest in a series of documents being published by the Parenteral Drug Assn. (Bethesda, MD) on managing cold-chain processes in pharma distribution. The document was written by a group of industry representatives, then vetted in the internal PDA Advisory Board. Definitions, qualification procedures, documentation requirements and recommended practices are covered.

The casual observer might think of “active” temperature-controlled devices as primarily the small- to multiple-pallet-sized containers that include internal refrigeration or heating systems—especially the “unit load devices” (ULDs) used in aircraft. But in fact, as TR 64 details, both ocean-going containers (which range from 20 to 40 ft long) and trucks themselves are “active” systems and are dealt with in the report. However, as the report’s introduction notes, “some air carriers are claiming that the aircraft cargo hold can serve as an active temperature-controlled system for cargo that is less sensitive to temperature variations (e.g., for products that are stable in a controlled room temperature range of 15ºC to 25ºC with allowable excursions). Although the temperature inside many current aircraft compartments can be regulated, aircraft themselves are not designed as tem¬perature control systems. Thus, they are not discussed as such in this guidance.”

The report is free to PDA members, and can be purchased for $250 at the PDA bookstore.