The past several years have witnessed a significant increase in the rate of adoption for single-use disposable systems for aseptic fill/finish applications. Paralleling recent advances in flexible aseptic filling lines, single-use disposable systems (SUDS) for aseptic fill/finish facilities promise increased flexibility and streamlined operations. SUDS also offer significant reductions in facility risk profile, by eliminating the risk of cross-contamination and by offering increased sterility assurance.
The technology adoption curve is moving from the innovator phase to the early adoption phase, with more and more companies choosing to adopt single-use technology. These technologies are being deployed for scale-up and clinical operations as well as for commercial operations. Flexibility in size for these process systems facilitates scale-up and tech transfer activities and reduces capital investments. Unknown design factors such as the final production quantities required are easily addressed using these systems, since the scale of the system can be easily adjusted once these factors are defined.
As we saw during the IPS Technologies Tours at INTERPHEX in 2014, equipment vendors in recent years have made significant progress in tailoring their systems to incorporate SUDS. A great example is the development of improved, integrated peristaltic filling systems for commercial-scale applications. These filling systems readily incorporate single-use components, eliminate manual cleaning and sterilization steps, and reduce upfront capital costs associated with multiple re-usable fluid path set-ups.
Like the old saying, “Anything worthwhile requires hard work,” adoption and deployment of SUDS requires cross-functional organizational alignment, planning and execution. For single-use technology, areas of focus include the following:
- R&D and QA/QC activities to select primary and alternate vendors, to test product compatibility, and to develop and qualify test methods.
- QA activities to audit and qualify potential vendors and to develop In-Process test methods and limits for use of single-use systems.
- Supply chain and operational activities to ensure supply security and to identify cost-shifting from capital equipment costs to operational costs.
- Engineering and validation activities to specify, select, test and validate appropriate equipment and systems.
In spite of the organizational effort required, SUDS offer compelling advantages for aseptic fill/finish operations. Implementation of these technologies is no longer a question of “will this technology work?,” but rather a question of “is our company capable of developing and deploying this technology?”
The answer to the first question, based on the number of systems successfully deployed, is a resounding Yes!! The answer to the second question is one that every company needs to answer for itself.
This article originally appeared as a supplement to the 2015 IPS Technologies Tours at INTERPHEX.