Single-use bioprocessing technologies are, in general, cheaper to buy than traditional stainless steel bioreactors. But disposable systems introduce new “costs” in the form of supply chain dependencies and logistical challenges that must be managed at the facility design stage.
This note of caution was presented in a study by Swiss engineering consultancy Bideco that highlighted several design considerations firms opting for single-use tech should keep in mind, says lead author and head of operations and quality, Sven Kiesewetter.
“One big difference is that in the stainless-steel world almost everything is standardized and norms are available. Using single-use components will mean you also use the supplier’s standards, which is a loss of independence that could prove challenging if you source from multiple companies.”
Then there are also challenges associated with the materials from which single-use systems are made. The leachability and extractability of any plastics must be thoroughly assessed through experimentation prior to use, for example.
Another issue users of single-use tech face is the need to maintain stockpiles of systems, according to Kiesewetter, who adds, “The logistical part must not be underestimated. I am thinking here about questions like how big will the stock of single-use materials need to be to allow safe and continuous production? Then you also need to consider the logistic flows between warehouse and production area as well as waste flows.”
All these issues are best considered early on in the facility design phase, Kiesewetter says, citing single-use tubing as an example.
“In a biopharmaceutical manufacturing facility in which single-use technologies are used you need to prevent tubes, hoses, and cables touching the floor. Spending effort to design proper tube, hose, and cable guiding equipment should be considered.”
Companies also need to manage and plan for the flexibility introduced by single-use technologies.
“The design of all the different setups, i.e., the bags, the manifolds, the sterile connections, etc., have to be properly planned to meet the process requirements. Ideally these plans should allow a degree of flexibility that takes into account the differing requirements of alternative technologies, in case the manufacturer opts to switch systems at some point,” continues Kiesewetter.
Finally, the lack of cleaning is often cited as a major advantage single-use technologies have over stainless-steel reactors. But, while disposable systems do not generally undergo the time-consuming sterilization processes required for older tech, some treatment may still be needed.
“It is true that less, or sometimes zero cleaning in place is required in single-use or hybrid plants. But on the other hand, and sometimes time consuming, chemical sanitization is required to achieve functionally closed status,” notes Kiesewetter.