PDA Technical Report 82: Practical advances in programmable device architectures

If you work in Quality Control, Process Development, or Regulatory Affairs for sterile injectable drugs, is not optional reading—it is essential.

Guiding the development of scientifically sound hold-time studies.

: Studies should simulate actual product storage conditions—typically refrigerated (2–8°C) and/or room temperature.

For more information, the full text of PDA Technical Report 82 is available through the PDA Bookstore and Technical Report Portal. PDA members receive 30 days of free access to new technical reports upon publication. Professionals interested in contributing to the ongoing revision can apply through the PDA peer reviewer volunteer opportunity portal.

The PDA first published Technical Report 82 in 2015, with the aim of providing a detailed framework for evaluating sterile compounding facilities. The report was developed by a team of experts with extensive experience in sterile compounding, facility design, and regulatory compliance. TR 82 provides guidance on the key elements of sterile compounding facilities, including design, construction, and operation.

If you are looking for specific, detailed information on how to conduct a study in accordance with this report, I can provide a step-by-step guide to the testing protocols mentioned in the document.

: LER studies should begin as early as possible in the development lifecycle, ideally at least one year before process performance qualification (PPQ) batches. This timeline allows sufficient opportunity to identify and resolve LER issues before registration.

PDA Technical Report 82 dives into the latest improvements in programmable device architectures, highlighting practical design patterns, performance benchmarks, and deployment lessons for embedded and edge systems. The report covers:

LER is primarily driven by the synergistic effect of two common formulation components: