People want it all, don’t they? The type of cars many drive is one indicator. Crossover vehicles have become a very popular vehicle segment. They offer: practicality while still maintaining a cool factor; spaciousness with decent fuel efficiency; and car-like handling with the safety of all wheel drive for slippery conditions. In much the same way, parenteral manufacturers are seeking availability of filling lines to do the equivalent of the routine drive to work, as well as the weekend camping outing on the unpaved road.
Flexibility has become a strong business driver, especially for clinical and small scale operations. Having the ability to fill vials for liquid or lyophilized products, as well as filling syringes and cartridges all on one line, enables clinical operations to support product pipelines and contract manufacturers to handle whatever small manufacturing requests may come their way.
As we saw during the IPS Interphex tours in 2014, equipment vendors in recent years have made significant progress in developing their designs for flexible filling lines. It is an exciting time when some of the first lines are being validated. Increases in orders and inquiries for new lines are proof that flexible configurations will become more of a standard offering and are here to stay.
Flexibility is a good thing but we know that, like the crossover vehicle, a flexible filling line may not offer sports car performance or the ability to plow through a foot of snow with confidence. Some important points to understand when considering a facility with flexible technology include:
• Most designs today are using nested, pre-sterilized components in tubs. Vial suppliers have started offering the most common vial sizes but are still catching up with the full size range.
• It is not feasible to perform 100% check weighing on systems that maintain vials in the nested format, similar to syringes.
• Designs with most flexibility usually end up bigger and more expensive.
As with any solution, it is important to understand the benefits and challenges of flexible filling technology. The good news is that several quality vendors offer sound solutions.