146 - Lyophilization/Freeze-Drying, Filling, Sublimation, Disorption, Backfilling, Stoppers, Vacuum and Water's Triple Point with David Simoens

Let's Combinate - Combining Drugs and Devices

On this episode, I was joined by David Simoens, Founder of Life Science Professionals Inc.

David walks through the freeze drying(lyo) process, primary drying via sublimation, secondary drying through desorption, and final steps such as backfilling and stoppering. David also explores the different considerations for lyophilization, the impact of various drugs on the process, types of stoppers, and differences between lyophilized and liquid-filled vials. David shares insights on the technical aspects, including pressure, temperature, and time management, as well as equipment considerations and challenges in the lyophilization cycle. 00:00 Introduction and Guest Introduction 01:21 Podcast Overview and Purpose 02:12 Importance of Lyophilization 03:04 Lyophilization Process Explained 04:35 Vial Filling and Stoppering Differences 09:44 Freeze Drying Process 15:45 Primary and Secondary Drying 16:56 Backfilling and Final Steps 30:20 Equipment and Technology 34:41 Conclusion and Guest Contact Information

David Simoens is a certified Project Management Professional with over a decade of project management, engineering, and validation experience. David has a strong, professional background in aseptic fill/finish, lyophilization, cytotoxic and high potency, process development, radiopharmaceuticals and enterprise quality management systems. Mr. Simoens assisted in C&Q standardization and implementation on a global level guided by ASTM E2500 and assisted in development of content for the ISPE Baseline Volume 5 guide. He led an effort to assess, pilot, implement and go-live with an electronic engineering platform for several global sites. David has designed, installed, and tested several commercial size Freeze-Dryers and Automated Loading Systems. He managed a month shutdown for one of the largest products on market. David has led high profile NPI launches for a large pharmaceutical company. Currently, he is supporting a team responsible for delivering a complex formulation system and leading strategy/operations for a midsized consulting company. David can be reached on linkedin ⁠here⁠ or at [e-mail]

**About David Simoens:**

David Simoens is a dedicated Project Management Professional with a proven track record in the pharmaceutical industry. In October 2023, he made the pivotal decision to transition from a C-Suite role at a consulting firm to embark on an entrepreneurial journey. David takes pride in being the founder of Life Science Professionals, LLC; a consulting firm committed to excellence in project management, engineering, and quality within the life sciences sector.

**Key Specializations:**

- Aseptic Fill/Finish including Lyophilization

- New Product Introductions

- Cytotoxic and High Potency Environments

- Integrated Commissioning, Qualification, Validation

- Radiopharmaceuticals

- Business growth and optimization

- Enterprise Quality Management Systems

- Career coaching

**Contact Information:**

For all business inquiries, please reach out to David and his team at [e-mail]. For information requests, email them at [e-mail]. Feel free to connect and message him on LinkedIn.