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

In this episode, Subhi Saadeh delves into the specifics of USP chapters 788 and 790, which focus on the testing and acceptance criteria for sub-visible and visible particles in injectable drug products. He explains the importance of these standards in preventing health risks such as embolisms and allergic reactions. The episode outlines the methods used for testing, including light obscuration and microscopic particle count tests, as well as the required visual inspections for visible particles. Subhi also discusses the differences in scope between USP and ISO standards and emphasizes the critical role of operator training and clean handling practices in ensuring product safety.

00:00 Introduction to Today's Topic: Particles

00:48 Understanding USP and Its Role

02:52 Diving into USP 788: Sub-Visible Particles

05:40 Testing Methods for Sub-Visible Particles

07:00 Acceptance Criteria for Sub-Visible Particles

08:53 Exploring USP 790: Visible Particles

11:12 Inspection Techniques and Practical Considerations

12:50 Conclusion and Wrap-Up

Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.

For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.