ARTICLES BY FRED A. ROWLEY
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6/5/2024
Are you having content uniformity issues in oral solid dosage manufacturing? Your slide gates and valves might not be in the best position with relationship to the powder feeder.
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2/12/2024
As recently as Nov. 2023, the topic of how pre-compression tablet thickness is viewed raised its head once again in an FDA inspection at a generic pharmaceutical company in India. This control is available on all modern tablet presses, yet instructions for its use are vague. This article shares how to use this control correctly and to be better prepared for an agency inspection.
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7/20/2023
Three serious issues have arisen in using tablet press automatic weight control systems. For example, we may encounter excessive start-up sampling when manufacturing small batch sizes, resulting in exceeding the maximum allowable loss and triggering an investigation. This expert discusses this point and two other issues.
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4/21/2023
Over the past few years, the FDA investigators in India have shifted their focus away from laboratory and data manipulation and toward a closer look at tablet press operations. The new interest centers on critical process parameters, the automatic weight control system, and more.