119 - What are the basics of Clean Rooms, RABS and Isolators in ISO14644 and EU Annex I? with David Simoens

Combinate Podcast - Combining Drugs and Devices

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

David discusses his broad background, including his roles in quality manufacturing, product development, and technical transfer. He delves into the differences between isolators and RABs—two types of equipment used in clean rooms, critical for sterile processing. David also starts to touch on the standards and parameters set by the EU and ISO, and he suggests various resources, including Annex one and the ISO 14644 standard, for learning more about sterile processing and clean room requirements.

01:01 Experiences in Clean Room

04:23 Exploring Clean Rooms

15:43 Differences Between Isolators and RABs

19:15 Different Types of Isolators

25:53 Understanding the Standards and Guidelines

28:36 How to Learn More About Clean Rooms?

30:13 Conclusion

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

**Entrepreneurial Venture: Life Science Professionals**

As the founder of Life Science Professionals, David leverages his extensive executive leadership and hands-on industry expertise to deliver tailored solutions. The firm specializes in guiding clients through the complexities of project management, engineering, and quality.

**Active Involvement in ISPE:**

Beyond his consulting work, David is deeply committed to advancing the industry through active participation in the International Society for Pharmaceutical Engineering (ISPE). Currently, he serves in key leadership roles, including:

- Secretary for the Global Project Management COP

- Secretary for the Great Lakes Chapter

- Steering Committee Member for Digital Validation

- Steering Committee Member for the Special Interest Group on AI and Machine Learning

- Participant in Mentorship Program with Women In Pharma

**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.