The webinar, Conventional vs. Modular Design Build Cleanroom – A Clean & Clear Difference, is hosted by Mitchell Gonzales, Vice President of Process Technology and Josh Russell, Director of Project Development at AES Clean Technology
AES Clean Technology, the cleanroom design, manufacture and construction specialist, has hosted a free webinar with Cleanroom Technology to discuss conventional vs. modular cleanroom design, which is now available to watch at any time.
Modular cleanrooms have the ability to accelerate speed to patients, reduce project risk through schedule, cost, and qualification issues. Modular cleanrooms also add flexibility and maintain compliance as a result of their materials of construction which enables facility lifecycle value.
In spite of many modular approved facilities and widely accepted methodologies, some medicine manufactures still opt for conventional construction under the false pretense of cost savings. These organizations unknowingly incur risk in project timeline and longevity of their new facility.
(Left to right) Mitchell Gonzales, Vice President of Process Technology and Josh Russell, Director of Project Development, AES Clean Technology
Mitchell Gonzales is VP of Process Technology at AES Clean Technology. Mitch is a leader with 25+ years of progressive experience in the biotechnology, biosimilar, gene therapy, and pharmaceutical industries. His experience centers on aseptic biopharmaceutical operations (e.g., engineering, manufacturing, clinical development, supply chain, technical transfer), working for large and start-up companies. Mitch holds PMP and Six Sigma Green Belt certifications and has extensive global experience that includes two decades in the CMO/CDMO outsourcing industry. His achievements include multiple biopharmaceutical commercial launches for new and extension products.
Josh Russell has been involved in designing and implementing new and innovative technologies within the biopharmaceutical industry for more than 15 years. Josh’s primary interest and focus has been drug product manufacturing facilities and sterile products processing. He earned his Bachelor’s Degree in Mechanical Engineering from St. Martins University, and from there began designing and engineering industrial machinery for a variety of industries including; aerospace, hygiene and life sciences.
He quickly grew a passion for developing solutions that address the emerging challenges brought on by the biopharma industry’s shift toward more personalized patient specific therapies. He lead engineering teams that ultimately developed widely used adaptive robotic systems that leverage proven industry technologies used improve the safety and quality of sterile injectable products. As Director of Project Development, he leads our multidisciplinary teams to deliver dependable cleanroom facilities to clients throughout the life science industry.
The session covers:
- Conventional, Modular, Container
- The Design/Build engineering difference
- Clinical vs. commercial process alignment
- Demand vs. Supply (capacity)
- Design, construction, qualification
- Equipment acquisition & qualification
- Manufacturing site identification parameters
- Project critical path identification
- Facility design, installation & construction