Enhanced USP 788 Sub-Visible Particle Analysis Using Fluid Imaging Microscopy

By Thomas M. Canty, P.E. and Paul J. Oï¾’Brien

INSTRUMENTS PARTICLES PHARMACEUTICALS STANDARDS USP

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Abstract

The United States Pharmacopeia (USP) standard 788 (USP 788) (1) describes a lab-based imaging microscopy test for particulate detection in injectable solutions. The test is subjective with respect to the operator performing it, and it does not lend itself to use in the field. Advances in imaging technology are enabling the test to be performed in an objective manner, and in the field where it can be used to confirm the purity of process water and process systems that are used to manufacture pharmaceutical products. Injectable solutions are prevalent in the treatment and prevention of disease in human patients. The absence of particulate in any form, solid, gels, and crystals, for example, is critical in protecting the patient from side effects that these particles can cause. Particles in the blood stream can clog capillaries as well as accumulate in the liver and other major organs, leading to debilitating effects on the patient (2). This article will focus on the analysis of pure water, and pure water systems that are used in the manufacturing processes of pharmaceutical solutions.

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