High flexibility, low TCO

As clinical trials grow in size, there is a growing demand for automated packaging solutions. But, with a vast array of dosages and requirements, running all formats on the same machine is far from a straightforward task. Christoph Hammer, CTO of Dividella, explains how the company's packaging machines can respond flexibly to these requirements.

Across the pharmaceutical industry, packaging is notoriously complex to produce. With safety top of the agenda, companies must also ensure their solutions are usable, long-lasting, eco-friendly and compliant. Moreover, as the market becomes more segmented, the need for secondary packaging is growing. Intent upon reducing time to market, companies need to be able to package new products on their existing machines without undue delay.

This applies no less in the case of clinical trials. Indeed, given that batches are smaller and more varied, the challenges are intensified further still. On one hand, packaging for each clinical trial protocol must be highly customised. On the other hand, as clinical trials grow in size, handcrafting is no longer an option. A wide array of requirements must be configurable on the machine.

"So far, a lot of the packaging for these studies has been made through manual production," says Christoph Hammer, CFO of Dividella. "But we're seeing clinical trials get bigger, and therefore automation becomes more of an issue. Machines need to be very flexible, because usually customers would like to run more than one product on their line."

"Sponsor companies are starting to recognise that clever packaging can increase patient adherence and lower the overall costs."

As a specialist in the packaging requirements of parenteral products, Dividella is well equipped to help. Based in the canton of St Gallen in Switzerland, the company boasts over 30 years' experience producing packaging solutinos for vials, syringes, injector pens, needles and ampoules for numerous applications across the pharmaceutical industry. Along with diagnostics, theranostics and personalised medicine, clinical trials are a key area of expertise.

"As part of the Körber Medipak Group, we focus on pharmaceutical packaging," says Hammer. "We can provide packaging solutions as well as machine solutions for all kinds of clinical trials."

Historically, sponsors were reluctant to invest in welldesigned packaging for the drugs being tested. Because relatively few drugs reach the stage of commercialisation, packaging was not seen as a priority and solutions were not always optimally designed. Luckily, there are signs the tide is turning. Sponsor companies are starting to acknowledge the benefits, recognising that clever packaging can increase patient adherence and lower the overall costs.

Tailor-made packaging
Customisability is key. Starting with the client specifications, Dividella's engineers design machines that are tailor-made to meet these needs, whatever the drug requirements or dosage titrations. These machines fall into two broad categories - TopLoading solutions and wallet machines.

"Our TopLoading cartoners are highly flexible, so you can use them for all kinds of products," says Hammer. "And on the wallet side, we have so-called box wallets, which are fully closed wallets. That's unique."

Dividella's NeoTOP system is a family of packaging machines developed to handle lots that vary in size. With NeoTOP 104 (a cartoner for partially automated processes), NeoTOP 804 (a high-output modular packing system) and NeoTOP 304 (a modular system for small lots), the range offers short conversion times, low-cost maintenance and an impressive cost-benefit ratio. It is suited to a wide range of formats and applications.

The NeoWallet system, meanwhile, is designed to create wallets/box wallets which, together with the product, form a single compact unit that is attractive and easy to use. With a nominal output of 80 packs a minute, this multifunctional system features fast format changes and promotes highly efficient production processes. It is ideal for the variable requirements of packaging for clinical trials.

Whole-lifecycle philosophy
Sustainability is a key concern, with a particular emphasis on reducing the use of plastics. "We use only cardboard as a packaging material," says Hammer. "Not only is the cost of the material lower, it's also possible to create smaller cartons, which means volume reduction and cost savings across the cold chain."

Inevitably, this entails reductions in the total cost of ownership. With an eye to the entire product lifecycle, Dividella does not just supply machines - it offers exemplary service too. Its optimised maintenance concept is designed to reduce unscheduled downtime, and its retrofits give customers access to additional functionalities as the machines are enhanced.

At the heart of the company philosophy lies a commitment to its customers, and a wish to exceed their expectations every time. "We do not make any compromises," Hammer says.