This half-day workshop focuses on practical approaches to managing contamination risks associated with material flow and transfer within GMP cleanroom environments, in alignment with the expectations of EU GMP Annex 1 and Contamination Control Strategy (CCS) principles.

Participants will gain a structured understanding of material transfer pathways from warehouse to critical cleanroom zones, with emphasis on identifying contamination risks across cleanroom grades and implementing effective mitigation strategies.

The session will also cover key considerations in surface cleaning and disinfection programs, including disinfectant selection, contact time, residue management, and integration of sporicidal agents.

Through a combination of classroom learning and interactive group exercises, attendees will apply concepts to realistic scenarios, including material transfer risk mapping and cleaning program design. Practical demonstrations may further illustrate best practices in wiping techniques and material handling.

This workshop is designed to bridge regulatory expectations with real-world application, equipped participants with practical tools and frameworks to strengthen their contamination control strategies.

3. From Frozen Drug Substance to Final Fill: Risk‑Based Validation, Filter Consistency & Integrity Testing for Annex 1‑Ready Operations - hosted by SARTORIUS

The EU GMP Annex 1 revision reinforces contamination control as a central pillar of sterile manufacturing, requiring a holistic, risk-based approach across all process steps. As single-use technologies expand from freeze–thaw and formulation to filtration and final filling, manufacturers must rethink how process design, validation, and compliance are integrated within flexible and modular facilities.

Key expectations now extend beyond traditional aseptic control to include integrity assurance, material compatibility under challenging conditions such as freeze–thaw, effective implementation of PUPSIT, and robust supplier quality and data integrity frameworks. At the same time, contamination control strategies (CCS), barrier technologies, and environmental and process monitoring must be consistently demonstrated in an inspection-ready manner.

This workshop brings together practical insights into building end-to-end, risk-based processes. We will explore how to align frozen drug substance handling, filtration, and filling operations within a coherent and defensible CCS, while ensuring process robustness, filter performance consistency, and reliable integrity testing.

Participants will gain a clear perspective on designing compliant, efficient, and resilient single-use operations that safeguard product quality, operator safety, and patient protection in line with evolving regulatory expectations.

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