Sterile Products: Formulation, Manufacture and Quality Assurance

Parenteral product development and aseptic manufacturing can be intimidating to people new to the topics. The approach to formulation and process development is substantially different than for oral and topical medications. Product development and manufacturing must consider how all of the manufacturing processes align to ensure chemical, physical, and microbiological stability with particular attention to proper aseptic technique. This 18-hour accredited course introduces participants to aseptically manufactured products, routes of administration, and how routes of administration and other requirements affect product development. Interactive discussions are encouraged to ensure questions about the manufacturing processes are raised and different experiences are shared. Demonstrations and practice are offered for gowning, reconstitution of a freeze-dried solid, and preparation of an infusion using proper aseptic technique.