Navigating Recent Changes To USP <788>

By Lori Graybill, Manager, Medical Device Microbiology

Compendial standards rarely change without consequence for testing laboratories, and the recent revision to USP <788>, Particulate Matter in Injections, is no exception. Written by Lori Graybill, Manager of Medical Device Microbiology, this article examines what the updates mean in practice, particularly for laboratories working with small-volume injectable products.

A key change to the Light Obscuration Particle Count Test now permits testing of sample volumes between 1mL and 5mL when the standard 25mL requirement cannot be met, eliminating the need to pool large quantities of samples. The revision also reflects broader pharmacopeial harmonization efforts across USP, EP, and JP.

Understanding the scope of these changes and their testing implications is essential for laboratories managing compliance. Explore the full analysis to see how these updates may affect your testing approach.