May 20, 2026 | 1:00 PM ET
Overview:
Cleanroom ISO classification is a foundational decision that directly impacts facility design, GMP manufacturing operations, and regulatory outcomes in biotech and pharmaceutical environments. This is especially critical in cell and gene therapy, viral vector, API, mRNA, and sterile ATMP manufacturing, where product protection, biohazard containment, and operator safety must be carefully balanced.
In this webinar, we’ll explore how ISO classification strategy shapes key aspects of cleanroom design, including process layout, HVAC system design, air change rates, pressurization schemes, and airlock sequencing in Biosafety Level and OEB-driven environments.
Key Learning Objectives:
- Understand how ISO classification drives cleanroom containment, HVAC system approach, pressurization strategies, airlock scheme, and GMP manufacturing quality
- Identify compliance, cross-contamination and operational risks caused by misaligned ISO classification strategies in ATMP manufacturing cleanrooms
- Recognize the relationship between process operations, contamination risk, and ISO classification selection through early planning to support inspection readiness
Speakers:
Matthew Dean (RA, NCARB, LEED GA)
Director of Process Architecture, AES Clean Technology, Inc
With nearly two decades of experience, Matthew is a highly specialized Process Architect focusing on cGMP design strategies and implementing regulatory guidance practices into the design of research, clinical trial, pilot and commercial scale manufacturing pharmaceutical facilities. Matthew leads the Compass Conceptual Design program by bringing a broad breadth of knowledge of vaccine production, fill-finish, OSD, bulk bio-tech, Cell and Gene Therapeutics and compounding process technologies to clients to define end user requirements. Encompassing detailed knowledge of viral vector processes, bio-safety containment and occupational exposure bands enables Matthew to deliver compliant design strategies to clients. He thoroughly defines the interrelationships between the client’s process and the facility requirements that integrate into fit for purpose turnkey cleanroom solutions to support clients in starting on the right path for a successful project.
Andrew Garber (PE)
Mechanical Engineering Manager, AES Clean Technology, Inc.
Andrew has a strong technical and regulatory knowledge in designing and delivering aseptic and cGMP facilities to comply with quality and regulatory compliance requirements. As a Mechanical SME with extensive life science design and construction experience, Andrew provides a customer-centric approach that considers the end user of his work. This includes tailoring projects to meet both internal and external clients’ needs and anticipating future requirements to deliver adaptable and durable solutions.