PDA TR 90

This document focuses on contamination control practices against microbial and other adventitious agents, pyrogens such as endotoxin, and foreign particulate matter foreign particulate matter in the manufacture of sterile drugs, low bioburden drug substances, and nonsterile drugs that are vulnerable to contamination. Yet, the principles presented in this technical report can be applied more widely to any drug manufacturing or compounding process.

Secondary and tertiary packaging considerations, chemical contaminants including product cross-contamination, and inherent particulate matter are out of the scope of this technical report.