By Benjamin Voelcker, Product Manager of the MPM division for Maruho Hatsujyo Innovations
Determining ideal, per-product blister packaging solutions has been an ongoing challenge in the pharmaceutical and nutritional sectors for decades. Guesstimating – the so-called “eyeball test” – has its risks on both sides of the equation, as overpackaging wastes money and materials while underpackaging can leave products inadequately protected against moisture, oxygen or humidity.
While stability tests exist that can determine the just-right “Goldilocks Zone” – the precisely right barrier properties for a specific product – these can be costly, lengthy processes. Traditional blister prototyping with metal tooling also brings prohibitive delay and expense. But recently a new option has emerged: 3D printed tool prototyping.
3D printed tool prototyping produces sample blister cavities nearly identical to final production, saving time and money compared with traditional metal tooling prototypes and, of course, forced degradation analysis studies. The new service’s calling card is speed: the technology provides blister prototypes in days rather than weeks, allowing pharma companies to take a more expedient “try before they buy” approach to new or modified packaging platforms. The dramatically reduced cost also provides leeway to test multiple blister formulations to determine which is most suitable for particular medicines, medical devices or other high-end products.
This streamlined approach can have a direct impact not only on the bottom lines of pharmaceutical manufacturers, but also the health of consumers. Faster, cheaper blister prototyping has the ability to move more formulations from bottles to blisters – which have been proven to preserve the efficacy of medicine better than bottles. The United States in particular lags behind other major countries in terms of the percentage of prescription medicines packaged in blisters; this new technology can help close that gap significantly.
And for those medicines already in blisters, 3D printed tool prototyping can strengthen the overall packaging process by making it easier to find precisely the right barrier property, ending a protracted guessing game that can waste materials and money by overpackaging or, even worse, adversely impact product effectiveness via inadequate barrier protection.
Blister Prototyping: The Basics
Package prototyping is a crucial step in the life cycles of pharmaceutical products. The process allows manufacturers to make a replicable product sample (package and all) to support both internal inspection processes and, most importantly, external approval from brand owners and regulatory bodies like the Food & Drug Administration.
As with many products, it is best to make changes to a potential pain point as early in the development process as possible; generally speaking, the further one has to backtrack, the more time, money and other resources are sacrificed. This notion of “the earlier the better” is particularly relevant for blister packaging applications, as production tooling for blister machines can be especially expensive and come with 1–2 month lead times. This clunkiness has historically been an impediment to those testing cavity designs who wish to make changes quickly – recalibrations that consider both the properties of a particular film material and the overall behavior of the design itself.
To help mitigate tooling costs, many blister manufacturers opt for lighter-weight tooling comprising soft metals like aluminum, or scale the tooling down to a smaller size. While these actions save somewhat on material outlay, both the machining costs and the lead times are still quite substantial. In other words, metal tooling is a step in the right direction, but only a small one.
The solution for this stilted approach comes by embracing a technique that other industries have already discovered: Additive Manufacturing, which is simply a fancy way of saying “3D Printing.” The transformative approach to industrial production enables the creation of lighter, stronger parts and systems by adopting digital methods to replace traditional, analog ones.
When applied to blister packaging design, additive manufacturing cuts delivery times down to days instead of months. Once a suggested blister design has been established, an engineering solutions team designs 3D models of the tooling, and the specific infill densities and layer heights are relied upon to print tools out of ABS and PLA. This whole process takes about a week, at most.
The result is expedited – and, through the increased availability of trial and error tinkering, improved – barrier designs, childproofing and other blister packaging KPIs. These tests also allow for comparing the benefits of blister packaging over bottling as a packaging platform for given drugs; often, brand owners are shocked to learn how much efficacy they are sacrificing by leaving their products in bottles rather than blisters, which provide each dose its own secure headspace.
The future is now for blister packaging development. Reduced cost and expedited delivery – the proverbial having one’s cake and eating it to – is there for the embracing, and pharma companies that adopt 3D printed prototyping tools sooner rather than later stand to gain a competitive edge in packaging perfection and, through it, speed to market.
About the Author
Benjamin Voelcker is the product manager of the MPM division for Maruho Hatsujyo Innovations, the U.S. subsidiary of Maruho Corp. Ltd. For more information, visit www.mhi-innovations.com.