MilliporeSigma Bio-Expo Live February 2025: Upstream Bioprocessing

Increasing validation requirements, coupled with the rise of Quality by Design (QbD) and Process Analytical Technologies (PAT), have intensified scrutiny of sterile process sampling by regulatory bodies. Traditional sampling methods, such as glass bottles and Steam-in-place (SIP) stainless steel valves, have reached their limits as closed sampling methods gain prominence. Transitioning to closed sampling systems not only enhances contamination control and patient safety but also streamlines the entire process by minimizing the risk of contaminating the process fluid. Regulatory authorities now mandate compliance in various aspects related to drug sampling methods.

This presentation will review the benefits of implementing a closed and sterile sampling system, such as NovaSeptum®, to improve sampling procedures and meet regulatory expectations.