Achieving an 89% reduction in contamination risk
We're looking forward to the conversation at the ISPE Annual Meeting & Expo 2026 in Washington, DC.
PM Group and Takeda will share a practical case study on how risk-based design and standardization can strengthen reliability in biologics manufacturing.
As multi-product facilities increasingly adopt single-use systems to support flexibility, rapid changeovers, and scalability, ensuring sterility and operational consistency remains a key challenge. Manual interventions and non-standardized designs can introduce variability, increase contamination risk, and impact supply reliability.
In this session, PM Group's Tim Lash and Voke Dortie, together with Takeda's Swathi Karthik, will present a risk-based approach developed and implemented in a live commercial facility. Using a quasi-quantitative risk-scoring framework, the team evaluated sterile boundary risks and compared existing configurations with a standardized modular design.
The approach reduced system complexity, minimized interventions, and delivered an estimated 69% reduction in contamination risk. The resulting design can be scaled across multiple products and implemented with minimal operational disruption, helping create more resilient, efficient, and reliable manufacturing systems.
Come and join us:
Stream: Systems That Deliver ReliablyDate: Tuesday, 20 October 2026
Time: 11:30 AM - 12:00 PM
Speakers: Tim Lash (PM Group), Voke Dortie (PM Group), Swathi Karthik (Takeda)
