Customer Service:
Mon - Fri: 8:30 am - 6 pm EST


PDA TR 64-2013

Active Temperature-Controlled Systems: Qualification Guidance

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. The temperature within a temperature-controlled vehicle; temperature-controlled ocean container; active unit load device (ULD); or walk-in, temperature-controlled stores (e.g., a cold room, refrigerator, freezer, or standalone unit) is expected to be maintained: Reliably and consistently through the period in which the product is stored within the controlled environment (i.e., over time); In compliance with the product requirements for temperature at all locations in which the product might be stored (i.e., temperature and location or storage boundary)

Content Provider
Parenteral Drug Association [pda]

Document History
We have no document history for this standard.
Included in Packages
This standard is not included in any packages.
Amendments & Corrections
We have no amendments or corrections for this standard.

As the voice of the U.S. standards and conformity assessment system, the American National Standards Institute (ANSI) empowers its members and constituents to strengthen the U.S. marketplace position in the global economy while helping to assure the safety and health of consumers and the protection of the environment.