Pharmaceutical packaging is under increasing pressure to adapt. The variety of versions, smaller batch sizes, additional market and language versions, as well as higher demands for traceability and labelling are changing processes. Packaging, once simply the last step before distribution, is becoming a process area where production, regulation, logistics, and data management converge.
This development is particularly evident in internationally oriented manufacturers, as well as in contract manufacturers and packers (CMOs and CPOs). They must master customer requirements, country layouts, batch information and short-term market allocations. The performance of a line is not solely determined by the number of units produced. The ability to implement frequently changing requirements in a controlled manner is equally important.
When pre-prints become a bottleneck
Classic packaging concepts often rely on pre-printed materials. Films, labels, or other pharmaceutical packaging materials are pre-printed with static information, stored, and fed to the line as needed. However, with the growing number of market and language versions, the quantity of storage units increases. Each additional version generates inventory, planning effort, and the risk that materials will not be available in time or can no longer be used.
Changes to artworks or regulatory requirements can render pre-printed materials obsolete, even if they are physically faultless. Added to this are the efforts involved in product and layout changes. Materials must be uniquely assigned, the line cleared, checked, and documented: line clearance in regulated environments is part of process safety and not a formal side step. Smaller batch sizes exacerbate the effect because setup and checking times carry more weight in short runs.
Hapa, a company within the Coesia Group, is a leader in the development of innovative printing technologies for the pharmaceutical industry. As a specialist in late-stage customisation and digital printing, the company offers solutions that can enhance flexibility, efficiency, and security in pharmaceutical packaging.
„In pharmaceutical packaging, the timing of decisions increasingly determines the manageability of variant diversity. Inline digital printing allows this decision to be brought closer to actual demand.“
James Freer, Head of Market Development at Hapa
Individualisation is migrating into the line
An early commitment to product information, language, or target market reduces flexibility. If demand or allocation changes, a seemingly stable inventory concept can quickly become an operational bottleneck. Inline digital printing shifts customisation closer to the packaging process. Instead of pre-printed materials for each market, manufacturers use standardised, unprinted or only partially prepared materials. The final information is applied during the ongoing process. This includes static layout components as well as variable data, such as batch information, expiry dates, codes, or market-specific labelling elements.
The difference lies less in the printing process and more in the process logic. Packaging is no longer assigned to a market early on via pre-printed packaging materials. The final identity is only created during the packaging process, when the relevant print data is applied directly to the respective packaging. This reduces the number of material variants. Changes to print content can be implemented via data flows and approvals without having to replace pre-printed stock.
In pharmaceutical applications, inline digital printing is used for blister films, labels, or as part of direct object printing, such as on blow-fill-seal containers. It is crucial that companies consider printing, data provision, and inspection together. Systems that print variable information but are not linked to order data, artwork management, and verification only solve part of the task.
For regulated applications, labelling quality remains central. Variable data must be legible, correctly placed, and traceable. Inspection systems, code readers, and track-and-trace functions are therefore part of the process architecture and contribute to record-keeping in the packaging process.
Decoupling production and variants
Late-stage configuration defers the final product or market assignment as late as possible. Standardised units can be manufactured, filled, sealed, or prepared without being assigned to a country, language, or market version. The final customisation only takes place once the actual demand is known.
Manufacturers retain the ability to flexibly allocate inventory for longer. CMOs and CPOs can differentiate customer orders later without having to organise upstream production steps separately for each variant. This decouples production more from variations in the final configuration. This is particularly relevant for the latter, as their performance depends on their ability to control and reflect changing customer, product, and market requirements.
The late decision-making process does not automatically reduce this complexity; rather, it shifts it. Digital print data, approvals, order information, and checking processes must be reliably controlled. Only then can late customisation result in a robust production concept.
The artwork will be used as a process reference
A key bottleneck is the handling of artworks. Pharmaceutical packaging is based on approved data, which must not be altered arbitrarily. If this data is used for digital printing processes, it must be clear how it is converted into print- and checkable formats without triggering unnecessary new approval loops. Templates can be created from existing files, in which variable fields, placeholders and codes are defined. The artwork remains the reference for printing and inspection. Variable data is added in a controlled manner and linked to the order.
This also changes the role of prepress. It becomes part of an integrated production workflow. Print data must be machine-readable, versioned, and clearly assigned to the respective order. Inspection becomes an integral part of the workflow. It not only checks the print image but works with the same reference data that controls the printing. „Investments in packaging printing must be sustainable in the long term today. How well printing, data, and inspection can be integrated into stable processes is crucial,“ emphasises Steve Manning, Sales Director Healthcare at Hapa.
Where late differentiation applies
Obvious applications include those with a high degree of layout and variant diversity. These include internationally distributed medicines, close-to-clinic products, blister packs, roll-fed labels, and packaging for syringes, vials, injectors, and inhalers. In such cases, each pre-printed variant generates its own inventory, releases, and changeover processes.
Even in aseptic or controlled production environments, inline digital printing can be relevant, provided it can be integrated mechanically and digitally. Here, printing systems must cope with vibrations, fit into tight line layouts and communicate with overarching production systems.
Another scenario is the differentiation of sealed blisters. If a blister pack is initially produced neutrally or standardised and printed later, market allocation is possible retrospectively. Production and final labelling occur at different times. This can simplify inventory management for manufacturers. For service providers, it can support the processing of various customer and market requirements.
Sustainability aspects are also addressed, for example, when digital printing solutions are used for mono-materials or when the elimination of pre-printed variants reduces material stocks. Less market- or language-specific packaging reduces the risk of being unable to use pre-printed material due to changes.
Late-stage customisation as a new packaging model
Inline digital printing brings customisation closer to actual demand and addresses a structural problem in pharmaceutical packaging. Variants are increasing, while processes need to become more flexible, documented, and secure.
Late-Stage Customisation provides the organisational framework for this by decoupling the production of standardised packaging units from their final market assignment. Digital workflows prevent a loss of control in this process. It is only the interplay of validated artwork, order-related data, inline printing, line control, and inspection that makes Late-Stage Customisation viable in a regulated environment.
Flexibility is not just created by faster machines or shorter changeover times, but also by later decisions within the process. The later a product is definitively assigned to a market, language or variant, the greater the scope for manoeuvre in production and logistics remains. Inline digital printing is part of this packaging model. It reacts to a variety of versions, smaller batch sizes and controlled labelling, while simultaneously reducing additional warehousing.
