Sterile Products

Dr. Gregory A. Sacha

James (Jamey) K. Jarman

Course description

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 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.

“Great course. Practical detail was given by instructors. Class size allowed for very engaging lecture. All questions were addressed.”

–  D.E., Piedmont Animal Health

Upon completion of this course, you will be able to:

• Define the unique characteristics of sterile dosage forms, how these characteristics are achieved and maintained
• Examine approaches to formulation and process development for parenteral products that include small and large molecules
• Describe the aseptic manufacturing processes and all unit operations involved in sterile product manufacturing and control, including sterilization, filtration and lyophilization
• Outline the facility, personnel, and microbial control requirements, fostering an appreciation of the distinctive requirements of sterile products and acquaintance with quality control procedures and international regulations
• Define the factors affecting aseptic technique and demonstrate the technique