The Challenging Requirements Of Integrating Disposable Sensor Technology
By Karl Schick, Innovation Manager
Sensors designed for incorporation into disposable purification platforms, i.e. single-use tangential flow filtration (TFF), single-use normal flow filtration (NFF) or disposable chromatography must meet a number of challenging requirements.
Single-use platforms for downstream purification typically consist of an integrated assembly of filter elements or columns, flexible tubing, plastic connectors and bags, segments of peristaltic pump tubing as well as sensors. Such assemblies are designed and pre-assembled for a specific purification process and a given, maximum process volume. Special aseptic plastic connectors are used to hook up to external, single-use bioreactors and/or buffer solutions. In the final configuration, all elements of the purification platform are presterilized, assembled and operated as a closed system.
Single-use purification assemblies are typically custom-manufactured and gamma irradiated at 30-40 kGy to ensure sterility of the integrated assembly. Alternative sterilization approaches are available utilizing “steam-through” connectors as well as steam sterilized, disposable purification assemblies. Ethylene oxide sterilization used less frequently because of potential contamination by residual ethylene oxide.