164 - Tiny Particles, Big Impact: Breaking down USP 788 & USP 790

What this episode covers

Subhi Saadeh, host of Let's Combinate and Quality Professional, explains the critical differences between USP 788 and USP 790 regarding particle testing for injectable drug products. He details the two methods for sub-visible particles—light obscuration and microscopic particle count—and the specific acceptance criteria for small and large volume parenterals. Saadeh also covers USP 790's requirement for 100% visual inspection, discussing the role of trained operators, light tables, and automated systems in ensuring patient safety by preventing embolisms and immune responses.