For pharmaceutical and biopharmaceutical manufacturers, scaling up production has typically meant large, 5000+ liter stainless steel bioreactors for the process. These require cleaning and sterilization between batches. Market demands are driving the need for more flexibility with smaller batches. Single-use technologies (SUT) are being applied to bioreactors to address these demands and reduce the cost and time associated with cleaning and sterilization operations.
Michael opens highlighting the costs of traditional stainless-steel (SST) bioreactors.
Even ignoring the initial costs of SST equipment fabrication and installation, operating costs remain quite high since cleaning and sterilizing operations require significant support infrastructure. Equipment and fittings must be cleaned-in-place (CIP) or cleaned-out-of-place (COP) for each batch.
After cleaning, this equipment:
…must be sterilized-in-place (SIP) with steam, another energy-intensive operation.
From a flexibility standpoint:
…there is little or no plant layout flexibility. Small batches and trial runs are frequently not feasible or cost-effective. Looking forward, SST is not well suited for supporting the future wave of small batch and personal medicines.
Advantages of SUT technology:
…such as disposable bioreactor bags, obviate many of the problems experienced with SST equipment and provide other advantages. Chief among these is the fact that single-use bioreactor bags arrive pre-assembled and pre-sterilized from the original equipment manufacturer (OEM).
A large challenge includes:
…the integration of measurement instrumentation in the bioreactor. The sensor element portion of an instrument must contact the product via a fitting in the single-use bag, so this interface must be carefully evaluated. The instrument’s other main component, the transmitter, is not in contact with the process media and thus remains the same for both traditional and single-use processing methods.
Two common measurements include pH and dissolved oxygen (DO). In SUT:
…the entire pH sensor must be suitable for a whole production run because it is in direct contact with the process media.
The Rosemount 550pH single-use sensor designed for SUT applications, are designed to match the two-year shelf life of the SUT bioreactor bags. They are:
…stored retracted and wetted within a chamber containing a stable, proprietary buffer delivering a two-year shelf life.
For single-use dissolved oxygen measurement, a Rosemount 550DW single-use dissolved oxygen sensor adapter provides:
…a fitting with a permeable oxygen membrane, so the sensor has no direct contact with the process media.
Read the article for more on how these sensors are used to improve the flexibility and scalability of pharmaceutical and biotech manufacturing operations.
Visit the Life Sciences & Medical section on Emerson.com for more on these and other technologies and solutions for pharmaceutical and biotech manufacturers. You can also connect and interact with experts in the Life Sciences in the Life Sciences group in the Emerson Exchange 365 community and/or at the September 23-27 Emerson Exchange conference in Nashville.