Single-Use Solutions (SUS) for biopharmaceutical processing are becoming increasingly popular with the industry. That´s a fact. More and more companies are adopting SUS, the sceptics are being converted and a widening array of SUS are being designed and produced to enable this. Tapping into that momentum, several of the factories of the future are already being designed fully single-use from the start. Existing traditional stainless steel facilities are left with two options: stay on “Team Stainless“ or begin the process of incorporating single-use elements into their existing process paths and becoming part of the migration towards hybrid facilities.
More and more companies are opting for option two. What lies behind this massive shift? There are obvious downsides to the process of transitioning from on to the other – for example temporary reduced production efficiency, a significant financial investment and time committed to training the workers on the new equipment. Also, of course the fears that are most often associated with single-use everywhere, such as concerns about their durability, the cost of consumables and the presence of extractables to name a few.
There are benefits to hybrid facilities, though, ones that must greatly outweigh the stress or expense of making the move. Even considering the transformation underway – there are long term gains, that compensate for the temporary disruption and help improve manufacturing efficiencies for years to come. On top of that list: no further need for CIP or SIP processes.
Traditional stainless systems require regular maintenance, which is not needed with the disposable product-contact materials. Liners can be swapped between batches, the process lines only need to be offline for a minimal amount of time and the disposables can be tossed after each batch. The tanks, pumps and piping not to mention cleaning chemicals and massive quantities of purified water that accompany CIP and SIP are no longer needed. This allows for more flexible facility design when new projects are mapped out, extra space and significantly reduced energy use all the while reducing the upkeep costs for the formerly all-stainless facilities.
So, while, the transition will cost time and money, it will ultimately alleviate the bottlenecks that accompany the production in a fully stainless facility. Hybrid facilities provide a solid compromise for those wanting to optimize manufacturing, but not rebuild as single-use from scratch or move altogether. SUS are customizable and can be simple to install and operate, such as the ARTeSYN Process Module, that can be installed to reduce the hold-up volumes associated with traditional stainless-steel systems.
All in all, hybrid facilities can offer an optimal middle ground alternative to a fully disposable flex-factory. It combines the sturdiness of traditional stainless solutions with the innovative efficiency of single-use. Knowing what you know now, which team would you prefer to be on…?
By Liis Oblikas and Michael Gagne