Working with injectables?

The Yokogawa Fluid Imaging Technologies FlowCam LO, distributed in the UK by Meritics Ltd, is a state-of-the-art tool revolutionising injectable drug delivery through advanced particle analysis and characterisation, aiding compliance with USP <788> standards for particulate matter in injections.

Injectable drugs, administered directly into the bloodstream, muscle, or tissue, must meet stringent quality standards to ensure safety and efficacy. The presence and nature of particulate matter are critical to their performance and safety.

The FlowCam LO, utilising Fluid Imaging Microscopy and Light Obscuration technologies, addresses this challenge by delivering detailed images and comprehensive analysis of particles within injectable formulations. This hybrid approach facilitates real-time monitoring and identification of particulates, from protein aggregates to contaminants, ensuring injectable drugs adhere to the highest quality standards outlined in USP <788>.

One of FlowCam LO’s key advantages is its ability to capture high-resolution images of particles as small as 2µm up to 100µm and analyse over 40 morphological characteristics. The integrated VisualSpreadsheet software allows users to sort, filter, group, and classify these images efficiently. Such detailed characterisation is essential for understanding the nature of particulates and developing strategies to minimise their presence in final products.

The automated capabilities of FlowCam LO streamline the analysis process, reducing time and labour in particle characterisation. This efficiency is crucial in a regulated industry where time-to-market and regulatory compliance are critical.

FlowCam LO supports the development of stable and effective injectable formulations. By providing detailed particulate profiles, researchers can optimise formulations to reduce particle formation, enhance drug stability, and improve patient outcomes.