By Paul Priebe
There are many factors to consider when selecting an appropriate bag chamber for a single-use system to support your bioprocess. The task can seem overwhelming, so it is important to lean on stringent procedures to ensure a successful outcome.
ASTM E3051-16 Standard Guide for Speciﬁcation, Design, Veriﬁcation, and Application of Single-Use Systems in Pharmaceutical and Biopharmaceutical Manufacturing describes a rigorous process for implementation of single-use systems, which is intended to conform to regulatory requirements following a risk-based approach. The basic elements of E3051 can be applied to bag chamber selection for use in a single-use system. In this blog, we provide typical bag chamber-specific user requirements and the specific requirements relative to product quality and patient safety according to E3051. You can also review Qosina's bag chambers made from different materials, in many volumes, port configurations and types.