This article discusses an integrated quality/manufacturing approach to ensure the integrity of single-use biocontainers.

Pharmaceutical Processing: Continuous Quality Verification as a Control Strategy for Biocontainers

This Pharmaceutical Processing article discusses a fresh approach to the industry’s discussion around the need to test the integrity of single-use systems, such as biocontainers and tubing assemblies, used in the processing of biopharmaceutical solutions. The reactive approach that attempts to test quality in at the end of biocontainer manufacturing, or post assembly operations, is unlikely to become the answer when it comes to ensuring robust single-use process solutions. With the advent of the ICH Q8 guidance and ASTM E2500 much has been written about its fundamental premise of building quality into a system, i.e. Quality by Design (QbD), versus testing or inspecting it in, commonly referred to as Quality by Inspection (QbI). QbD concepts are not new and have seen tangible implementations in other process industries that require a high level of product robustness. The QbD/QbI discussion can be expanded to the manufacture of single-use products and parallels can be drawn between the control strategies utilized by single-use manufacturers and those applied by drug manufacturers. This article delves further into this approach as a strategy for ensuring quality.