Introduction to Softgel Manufacturing and Controls

Softgel dosage forms represent a modern take on the traditional tablet product, the most common type of pharmaceutical products produced. In the patient’s hand, a softgel can seem like a simple product not knowing there are numerous complexities that go into its manufacture. But for the manufacturer, without a clear understanding of the science behind the ingredients or the expertise in the manufacturing process, unacceptable finished products may be produced. This 2.5-hour accredited training course first covers the critical product/ process design components for Softgels and the rotary die process. After reviewing the design requirements, the process set up, in process controls and adjustments required to meet the product design objectives are considered. In process testing and process feedback adjustments are reviewed on a best practices basis. Aspects of formulation of fill and shell and material transfer systems are reviewed. The program concludes focusing on defect elimination: Leakers and investigating issues of content uniformity.