Cleanroom ISO Classification: The Framework for Containment in a Cleanroom
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.
Attendees will learn why early alignment between process operations, containment strategy, and regulatory expectations is essential when working with biohazardous materials, high-potency compounds, and patient-specific therapies. Without this alignment, organizations risk costly redesigns, operational inefficiencies, and compliance challenges.
We’ll also examine how misaligned classification decisions can limit manufacturing flexibility, increase operator exposure risk, and weaken containment strategies.
Drawing on real-world project experience across viral vector and cell processing facilities, this session will demonstrate how integrating ISO classification into early design phases supports effective containment, cross-contamination control, and inspection readiness. The webinar will emphasize practical approaches to aligning cleanroom infrastructure with process needs to help you build safe, compliant, and scalable ATMP manufacturing operations that meet both current and future goals.
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
