Issue link: https://www.e-digitaleditions.com/i/1248960
16 Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING 2020 P h a r mTe c h . c o m Manufacturing A doption of single-use technology (SUT) by biopharma- ceutical manufacturers has been gaining momentum for many years. Existing automation and instrumentation technologies, however, need to be adapted for optimal compatibility with single-use configurations. Conventional fixed-in-place manufacturing methods use stain- less-steel technology (SST) bioreactor vessels, piping, and processing skids. These are readily compatible with standard instrumentation, usually connected into permanent fittings designed into the SST equipment. Users can remove, replace, calibrate, and sterilize instru- ments as needed. The preference, however, is to leave the instrumen- tation in service as long as possible. Because SUT methods rely on bags that are disposed after every batch or production run, a modified instrumentation approach is also required. Initial designs used disposable sensors or more tra- ditional sensors that needed to be installed prior to every run, sani- tized, and removed afterward. Both options present problems, negat- ing some SUT advantages. For these reasons, suppliers have developed a new category of sensors and fittings to address the needs of SUT processing. These components are based on traditional technologies and use standard signaling means for reliable and accurate measurement, but they have specific perfor- mance features so end users can take advantage of their SUT operations. Instrumenting single-use systems Some typical measurements for biopharmaceutical processes include pressure, dissolved oxygen (DO), and pH. Designers may incorpo- rate redundant measuring to ensure a single instrument failure or calibration problem does not waste a batch. Brandon Haschke is a product manager for Emerson's Rosemount instrumentation business. GRISPB - STOCK.ADOBE.COM Instrumenting Single-Use Processes Brandon Haschke Single-use processing requires instruments providing the accuracy of traditional technologies but configured in form factors designed specifically for this service.