Course Description

Sterile Products: Formulation, Manufacture and Quality Assurance

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Course ID 435

In-Person Course

Who Should Attend?
This intensive course is intended for those new to the topics of parenteral product development and aseptic manufacturing and those needing a refresher on the topics as well as those seeking confirmation of acceptability of existing practices. It will be of particular value to those in:

  • Research
  • Development
  • Production
  • Quality Assurance and Control

高h文 Those who wish to broaden their appreciation of these technologies and review the latest developments, as well as managers who have responsibility for a broader base of activities will find the course of interest.

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 18-hour course delivered over four consecutive days 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.

Special Demonstration by


Virtual hands-on microscopy demonstrations by on the use of microscopes involving sterile filters and the examination of particulates.

Course Director
Dr. Gregory A. Sacha; Senior Research Scientist

Dr. Gregory A. Sacha, is a Senior Research Scientist for Baxter BioPharma Solutions in Bloomington, IN. He received a BS in Pharmacy from Butler University in 1993 and earned a PhD in Industrial and Physical Pharmacy from Purdue University in 1999. Dr. Sacha specializes in the formulation of sterile solutions and lyophilized solids for large and small molecules. His research includes thermal characterization of pharmaceutical solutions, development and optimization of lyophilization cycles, and identification of particles through microscopic and spectroscopic methods. Dr. Sacha is experienced in technology transfer, scale-up and process improvement for solid oral and parenteral manufacturing processes and has presented lectures for this course since 2005 in Europe and the United States.

Additional Faculty
James K. (Jamey) Jarman is a Technical Transfer Project Manager for Baxter BioPharma Solutions in Bloomington, Indiana. He has over 20 years of pharmaceutical manufacturing experience, specifically in the area of sterile parenteral manufacturing. Mr. Jarman’s areas of focus have included aseptic filling operations for both vial and syringe products, suspension filling, lyophilized product manufacturing, formulation activities, equipment and component preparation, and capping operations. He also has experience in quality assurance, regulatory auditing, and technical transfer activities.

Mr. Jarman received his BS degree from Indiana State University in 1990.

Ruben Nieblas, currently a technical sales representative for McCrone Microscopes & Accessories.

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