For years, the defining spec on a pharmaceutical blister line came down to a single number: how many blisters it could turn out in a minute.
High-output platforms now run well past 600 blisters per minute, yet three equipment manufacturers say the question customers now lead with has changed. The priority is no longer how fast the line runs, but how efficiently it adapts to a shifting mix of products, formats, and materials.
“At Körber we increasingly support customers who are no longer running stable high-volume campaigns, but high-mix portfolios with frequent product changes,” René Schubert, product manager packaging Germany at Körber Business Area Pharma says.
For Schubert, the move toward flexibility-driven performance has caused a clear shift in customer requirements. He says increasing customer needs include reliable, repeatable changeovers, high overall equipment effectiveness across multiple products, and integration into digital production environments.
Of the requirements Schubert names, overall equipment effectiveness (OEE) has become the figure customers weigh most heavily.
“High output is still relevant, especially for blockbuster products, but in most projects, we see that OEE is now the leading KPI,” Schubert says.
He says a focus on OEE has resulted in customers prioritizing stable uptime across shifts, fast restart after product changes, and consistent quality regardless of format or material.
In practice, he says, that means a line running slightly below maximum speed can generate more value than a peak-performance system if it delivers higher availability and flexibility.
The focus on flexibility isn’t unique to Körber. At Romaco Pharmatechnik GmbH, optimizing OEE has moved to the center of both new machine development and the retrofitting and upgrading of existing systems, says Ralph Augenstein, Director of Sales.
He says OEE has garnered more attention over the years, resulting in Romaco focusing its attention on the low- and medium-speed ranges as the areas where squeezing more availability and performance out of a line matters most.
But none of this means speed has stopped being a selling point.
Demand for high-speed blister lines remains strong where performance is the priority, Augenstein says, particularly for the primary and secondary packaging of high-revenue blockbuster products that run 24/7 and earn back their investment through high utilization.
IMA Safe, a division of IMA Pharma, weighs the trade-off in reverse—flexibility leads, but the company notes rising demand for lines that deliver it alongside high speed.
What's driving that reordering is visible one step upstream, in how much—and how often—the product on the line changes.
Romaco completes format changes in under 30 minutes on its low- to medium-speed lines.Romaco Pharmatechnik GmbH
Small batches, consistent changeovers
The push toward flexibility stems from batches getting smaller. Personalized medicine, orphan drugs, and clinical supply are all driving shorter production runs, and in some cases a single line now changes over between products several times in a day.
That frequency turns changeover time into one of the most consequential numbers on the line. Every switch between formats is downtime, and on a high-mix schedule those minutes accumulate fast.
Both Körber and Romaco have implemented quick changeover windows. Romaco completes format changes in under 30 minutes on its low- to medium-speed lines, and Körber targets 15 to 30 minutes for repeatable formats.
But Schubert argues the raw number misses the more important gain. “The key improvement is not just speed, but first-time-right changeovers without iterative adjustments,” he says.
However, complex format families still take longer, Schubert says.
Körber addresses the trend toward short production runs by adapting machine design. The manufacturer focuses on recipe-driven machine control through HMI, guided and toolless changeover concepts, and predefined process parameter sets for validated products.
For Romaco, minimizing downtime begins with collection and visualization of production data and extends to maintenance planning. Augenstein says this happens by preparing machines—both mechanically and electronically—for frequent product changes.
“Good accessibility, format sets with few and lightweight components, automatic station control systems, and a well-thought-out hygienic design are just a few of the measures that can improve OEE,” Augenstein says.
IMA Safe has pushed the same logic into its secondary packaging equipment, developing a new automatic size-changeover cartoner family aimed at cutting production downtime.
Beyond shorter runs and faster changeovers, other pressures are shaping blister machinery. As blister materials change, the equipment has to change with it.
A more complicated problem than ‘plug-and-play’
Körber targets quick changeovers at 15 to 30 minutes for repeatable formats.Körber Pharma
Recyclable mono-materials—PP, PE, and PET-based films—are becoming more prevalent in blister packaging. But to run these materials without sacrificing speed or seal quality, machinery has to adapt.
“From our experience, mono-materials are less a ‘plug-and-play’ topic than often discussed—they require deep process understanding,” Schubert says.
According to Schubert, mono-materials call for precise thermal control in forming and sealing, stable web handling, and validated parameter windows for each material type.
Körber's response centers on material-specific process know-how, flexible machine design that can accommodate different products, and process validation support built into customer projects. That support matters because the technology is still maturing.
“While initial solutions already show good results, including running on existing lines in certain cases, robust high-speed industrial operation is still evolving, especially for more demanding applications,” Schubert says.
For Romaco, accommodating mono-material films on blister machinery begins with trial and error.
“Test, test, test—when it comes to innovative packaging materials, it’s crucial to test them as often as possible with as many products as possible,” Augenstein says. “With sustainable films, the process parameters generally need to be adjusted to accommodate packaging materials that are sometimes very thin and lightweight.”
He points out that temperature control during cavity forming and blister sealing differs for mono-material films compared to traditional laminated films.
Bridging that gap is the work of Romaco's format centers, where the company's specialists test and commission new films across a range of machines. Augenstein says the knowledge that accumulates there benefits both customers and film manufacturers with expertise that proves valuable as mono-materials gain ground.
Just how much adjustment mono-materials demand is itself a point of difference among the makers. Where Romaco and Körber emphasize the process rework these films require, IMA Safe reports a smoother path on its own equipment.
The company's blister machine portfolio is fully compatible with PVC-free and recyclable films, and IMA Safe says it continues to refine the pairing of material and technology so customers can run those films on standard equipment with minimal or no adjustment.
Underpinning that work is OPENLab, the company's internal chemical laboratory, which studies the films that customers and material suppliers bring forward and helps fine-tune the fit between a given substrate and the machine meant to run it.
But materials aren’t the only part of the blister line caught between promise and proof. Artificial intelligence sits in the same space, between what it promises and what it reliably delivers.
Where AI earns its place
Augenstein says AI only makes sense when it generates real added value. One place he says this is clearly happening is visual blister inspection.
Romaco uses AI 3D image analysis to check tablets and capsules for parameters like color, shape, and breakage. This algorithm also handles the introduction of new products, which Augenstein says significantly reduces manual sources of error in the training process.
“During production, AI object recognition significantly improves the false-positive rate—a metric that measures how often good blisters are incorrectly rejected and defective blisters are not identified,” Augenstein says. “Thanks to the image analysis algorithms, a backlight unit is no longer required.”
Additionally, he says Romaco’s blister inspection system features an integrated chatbot to assist operators with machine error messages.
Körber reiterates that obvious AI value is in vision systems and quality assurance. Schubert says proven use cases for the company include in-line inspection systems, detection of subtle defects in real time, and reduction of false rejects and operator dependency.
Schubert also says Körber continues to innovate its AI uses with data-driven condition monitoring and early-stage predictive maintenance approaches. However, it’s important to note that these uses are not mature.
The gaps that remain
Asked what pharmaceutical customers need that the industry hasn't fully delivered, the three makers point to a related cluster of shortfalls—most of them variations on the same tension between capability and simplicity.
Customers want faster changeovers and simple operation at the same time, Schubert says, but delivering both at once demands intelligent system design, digital support tools, and clear operator guidance rather than one purchased at the cost of the other.
IMA Safe says automation of manual operations—material loading and changeover—and deeper AI integration remain the capabilities customers most want to see mature.
Romaco points to line clearance as a capability still waiting for a reliable automated answer. Augenstein says a handful of AI-based systems already exist, but none has become widely adopted in practice. The appeal is that visual object recognition is one of the few places where an AI system's performance can be checked.
“With machine learning, the line-clearance process would become faster and more reliable, as sources of manual error would be significantly reduced,” Augenstein says. “The issue of AI-based line clearance is therefore being raised more and more often.”
But the features that distinguish a top line today won't distinguish it for long.
Schubert expects several features that still set lines apart to settle into baseline expectations within the next 18 to 24 months: fully connected lines integrated into manufacturing execution systems (MES), recipe-driven and guided operation that holds up across shifts and operators, advanced vision systems performing 100% inspection with intelligent defect detection, and the material flexibility to run both conventional and recyclable substrates.
Augenstein sees the same trajectory in AI-based blister inspection specifically. The technology is being implemented mainly in Asia today, he says, but capabilities that gain traction in export-heavy pharmaceutical markets have a way of becoming the global standard.
IMA Safe expects flexibility in handling different product types, paired with speed, fast size changeover, and automation to become standard.
