By Tim Sandle

Published in: IVT Blog

Published on: January 27, 2022

Introduction: Regulators require pharmaceutical products that are injected into the human body (which are by inference sterile products) to be free of visible particulates (1). This is because the presence of visible particulates in injectable products may affect patient safety. There are various controls that need to be built into the manufacturing process to minimize the possibility of particle and particulate formation. These controls will begin with product development and proceed to manufacturing controls. In terms of ‘testing,’ this is based on visual inspection techniques, conducted as part of batch release and for stability samples (and retained samples in the event of a customer complaint). Any identified particulates need to be identified, investigated, and corrected. Following this, a preventative action should be put in place to prevent recurrence.

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