Requalification is often viewed as a critical – though inconvenient – disruption in pharmaceutical operations, essential for ensuring product quality, consistency, and safety. But beyond its compliance function, this planned downtime presents a strategic opportunity to rethink packaging processes and implement innovative solutions that enhance sustainability and efficiency, explains Ian Chapman
Pharmaceutical companies are facing mounting environmental pressure. According to American Pharmaceutical Review it is estimated that pharmaceutical manufacturing contributes roughly 52 million tonnes of CO₂ annually via packaging and operations. The implications are not only regulatory and financial; consumer and investor scrutiny is also driving change. Consumers are increasingly assessing companies’ environmental performance and approximately 70% are willing to pay more for sustainable packaging options.
Together, these factors are driving soaring demand for sustainable pharmaceutical packaging, with the market set to soar from USD 92 billion in 2024 to USD 372 billion by 2034, at a CAGR of 15%. This surge underscores that sustainability is no longer optional – it’s essential.
Eliminate packaging waste
The challenge for pharmaceutical manufacturing goes beyond a shift towards sustainable packaging materials: long-standing packaging practices contribute to excess waste and unused resources. The use of pre-printed materials, risk-averse stock levels, and inefficient changeovers remains widespread. Even worse, when regulators change requirements or artwork evolves, entire batches of packaging often become obsolete overnight.
Volatility within supply chains also adds to the challenge: pharma manufacturing increasingly demands agile models that support small batch sizes and late-stage customisation. Embracing inline digital printing systems lets manufacturers print on demand, eliminating stockpiles and mitigating wastage. For example, using blank foils with inline digital print not only removes the need for pre-printed stock but also reduces inventory complexity. Many manufacturers over order between 15% and 20% of pre-printed foils for each product line, resulting in significant waste – an inefficiency eradicated by blank-foil workflows.
Improve regulatory agility
Inline digital printing systems also support pharmaceutical manufacturers to achieve the agility demanded by constantly evolving regulations and local adaptations to support a global market. To avoid expensive and frustrating bottlenecks, pharmaceutical packaging processes must adapt swiftly, avoiding lengthy changeovers or new tooling.
Leveraging adaptable digital technology allows updates to languages, graphics, or regulatory text to be made in real time, enabling smaller batch runs, localisation, and rapid adaptation. Modern connected solutions offer cloud-enabled capabilities that can minimise downtime and accelerate time-to-market, crucial for both patient needs and regulatory demands.
Catalyst for innovation
Requalification inevitably causes disruption. The smart approach is to treat it not as downtime, but as a strategic opportunity for continuous improvement.
Requalification is an ideal time for manufacturers to modernise with inline digital printing systems in order to align packaging with ESG goals, operational resilience, and regulatory demands. And collaboration is critical: partnering with experts who bring validated pharmaceutical technology, and a cooperative approach helps ensure scalability, accelerated ROI, and reduce risk.
Another powerful benefit is that digitalisation dramatically reduces lead times for artwork changes. Historically, approvals and printing could take weeks or months. Digital workflows, however, can compress this timeline – getting lines back up and running and revenue flowing again, much faster.
Future-proof packaging
Requalification does not have to mean falling behind. In fact, if treated strategically, it can accelerate the transformation of pharmaceutical packaging operations into a more efficient, sustainable, and future-proof state.
The industry is moving – regulations, markets, technologies are evolving. Research from Mordor Intelligence states that the digital packaging printing market is forecast to grow from USD 34 billion in 2025 to USD 56 billion by 2030, a CAGR of over 10%. More brands are moving away from analogue prints to plate-less workflows to enable mass customisation, reduce waste, and simplify changeovers.
By taking the opportunity to upgrade technologies and workflows during the requalification window, pharmaceutical manufacturers can reduce waste, improve responsiveness, and build long-term operational resilience.
Ian Chapman is Strategic Manager – Digital Coding at Domino Printing Sciences.
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