Materials of Alexey Shipunov

Minot State University. Department of Biology
Marine Biological Laboratory
University of Idaho, Moscow
Moscow South-West High School
Royal Botanic Gardens, Kew
Russian botanical forum
SBO
Russian Botanical Society
Botanical Society of America
R-Russian project
Moscow Society of Naturalists
VZMSh
Moscow State University, Biological department

English | Russian

“It Changed Our Rejection Rate Completely”: How Custom Blister Packaging Solved a European Pharma’s Pain Points

“We were throwing away nearly one out of every twelve blisters – and that’s after we’d already inspected them,” recalls the quality manager of a mid‑sized pharmaceutical company based in the Netherlands. “Our pill blister pack line was running at 92% yield, and we knew we could do better.” The company, which supplies both prescription and OTC medicines to pharmacies across Europe, had been using standard off‑the‑shelf blister formats for years. But as regulatory pressure for child‑resistant closures increased – especially under the EU’s new packaging directives – the old tooling simply couldn’t keep up.

The team had tried tweaking sealing temperatures and dwell times, but nothing brought the failure rate below 8%. The problem wasn’t just financial; it was a patient‑safety risk. A poorly sealed blister can lead to moisture ingress, reduced shelf life, and, worst of all, a child accessing medication. The company needed a fundamental change – not just a process adjustment. That’s when they began exploring custom blister packaging that could be tailored to each product’s exact cavity geometry and sealing requirements.

“It wasn’t just about fixing a defect,” the quality manager added. “We wanted a solution that would make the pack feel premium, consistent, and trustworthy – because that’s what patients and pharmacists expect.”

The Problem: Inconsistent Seals and an 8% Rejection Rate

The company’s production line was producing over 20,000 blisters per hour, and about 8% of them ended up in the reject bin. The issues weren’t always the same: sometimes the lidding foil peeled away too easily; other times the thermoformed cavities were slightly distorted, making the tablets rattle. “It was frustrating because the root cause kept shifting,” says the production engineer. “One week it seemed like the humidity, the next it was the film roll tension.”

For a company serving pharmacy blister packs that must pass EU FMD and child‑resistance tests, an 8% rejection rate is a serious business risk. Not only did it eat into margins – roughly €150,000 in raw material waste per year – but it also delayed shipments when rejects were caught late. The quality team was spending 20% of their time on manual inspection, a cost that never showed up on the P&L. “We knew there had to be a better way,” the engineer says. “We just didn’t know how far a truly custom blister could take us.”

Interestingly, the same thermoforming technology used for these blister medicine packs is also employed for products like Funko Pop deluxe protectors, where precision fit and visual clarity matter. But in pharma, the stakes are infinitely higher – a tiny leak can compromise sterility.

The Solution: Custom Thermoformed Blister Packs Designed for Compliance

The company partnered with a blister packaging specialist (whose proprietary process we’ll call ‘PreForm’) that offered fully customizable thermoformed blister packs designed around each product’s specific cavity depth, draft angles, and sealing profile. Instead of choosing from a catalog of standard tooling, the team sent their actual tablet dimensions, material specifications, and desired peel‑force range. The supplier then built prototype tools using CNC‑machined aluminum molds – a process that took about three weeks per product.

The first round of prototypes revealed an unexpected problem: the sealing temperature curve that worked for the machine’s standard tooling was too aggressive for the new custom cavities. “We had to back off the heat by about 15°C and extend the dwell time by 0.2 seconds,” explains the process engineer. “It sounds minor, but it changed the entire cycle time calculation.” After three iterations, the seals passed the EU child‑resistance test (F‑15 standard) with a comfortable margin. The rejection rate on the pilot run dropped to 1.2%.

One design choice that made a big difference was adding a subtle debossing around the cavity perimeter. It didn’t affect the pack’s structural performance, but it gave the lidding foil a clean, consistent tear path. “That kind of detail is what separates a good pack from a great one,” says the designer involved. “It’s the tactile feel that tells a pharmacist ‘this pack was made with care.’”

The Outcome: 40% Less Scrap, 60% Fewer Customer Complaints, and a Much Happier QA Team

After a full rollout across four of the company’s top‑selling SKUs, the numbers spoke clearly. Overall scrap from the blister line fell from 8% to 1.8% – a reduction of nearly 40% in material waste. Customer complaints related to seal integrity dropped by 60% in the first six months. The quality manager estimates that the manual inspection burden decreased by half, freeing up two operators for other tasks.

But the most surprising benefit came from an unexpected angle: the new custom blister packaging actually shortened the changeover time between product runs. Because the tooling was precisely matched to each product’s cavity geometry, the machine could be set with fewer trial‑and‑error adjustments. Changeover went from averaging 45 minutes to just under 25. “We didn’t plan for that,” admits the production engineer. “It was a pleasant side effect.”

The initial investment in custom tooling was about €35,000 per product, with a payback period of roughly 14 months. Three years later, the company has standardized on fully customized blister formats for all new product introductions. “If I had one piece of advice for other pharma companies,” says the quality manager, “it would be to stop treating blister packaging as a commodity. Spend the time upfront to design a pill blister pack that truly fits your product – the ROI is real, and the patients feel the difference.”

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A. Shipunov

Everything published within this Web site (unless noted otherwise) is dedicated to the public domain.

Date of first publication: 10/15/1999