Aseptic/Terminal Sterilization (TS) Formulation Suite Design

Salas O’Brien collaborated with a prominent pharmaceutical manufacturer to develop a formulation suite to prepare various aqueous active pharmaceutical ingredient (API) solutions for transfer to filling lines. Our team evaluated two potential locations for the suite and created conceptual layouts for each to optimize workflow while adhering to cGMP standards. Our design leveraged technology utilized in similar suites within the facility, housed 1,000 liter and 6,000 liter fixed stainless and glass-lined formulation tanks, and served portable sterile batch tanks. We developed process flow diagrams (PFDs) that outlined essential components, drafted comprehensive process descriptions, and compiled a priced equipment list that included the installation of a new TS135 fill line. Our process engineers collaborated closely with the client to determine recipes and cycle parameters, then led critical testing for product transfer activities and system studies.