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Requalification: How Can Pharma Manufacturers Turn Planned Downtime into an Upgrade Window?

  • By Domino Printing Sciences
  • November 13, 2025
  • Life Sciences
  • Insights

Requalification is often seen as a critical, though inconvenient, disruption in pharma operations to ensure product quality, consistency, and safety. When viewed beyond its compliance function, this planned downtime offers a valuable opportunity to rethink and upgrade packaging processes and take advantage of innovative solutions that offer enhancements to sustainability and efficiency.

By upgrading technologies and workflows during this window, pharma manufacturers can reduce waste, improve responsiveness, and build long-term operational resilience.

How Can On-Demand Digital Printing Help Eliminate Packaging Waste in Pharma?

Long-standing packaging practices within pharma manufacturing include pre-printed materials, risk-averse stock levels and inefficient changeovers – all contribute to excess waste and unused resources. When regulators change requirements or artwork evolves, entire batches of packaging may become obsolete overnight.

Embracing inline digital printing 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 overorder between 15% and 20% of pre-printed foils for each product line, resulting in significant waste – an inefficiency eradicated by blank-foil workflows.

Moreover, the sustainable pharmaceutical packaging market is 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.

How Do Digital Packaging Systems Improve Regulatory Agility?

Constantly evolving regulations and local adaptations to support a global market means packaging must adapt swiftly, without lengthy changeovers, new tooling, or production hold-ups, to ensure it doesn’t become a frustrating bottleneck.

Inline digital systems provide this agility. Updates to languages, graphics, or regulatory text can be made on the fly, 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.

The broader shift to digital packaging is reflected in market trends, 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.

How Can Requalification Be Used as a Catalyst for Innovation in Pharma Packaging?

Requalification will always cause disruption – it’s unavoidable. The smart approach is to treat it not as downtime, but as a strategic opportunity for continuous improvement.

This is an ideal time for manufacturers to modernise with digital 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.

Why is Sustainable, Agile Packaging Essential for Pharma Manufacturers Today?

  • Environmental pressure is mounting. According to American Pharmaceutical Review it is estimated that pharma contributes roughly 52 million tonnes of CO₂ annually via packaging and operations. Consumer preferences reflect this urgency, with approximately 70% willing to pay more for sustainable packaging options.
  • Market dynamics are shifting. The sustainability sector for pharma packaging is growing rapidly indicating not just regulation, but consumer demand and investor scrutiny driving change.
  • Operational flexibility is a competitive edge. In today’s volatile regulatory and supply environment, agility isn’t optional – it’s essential to achieve the small batch sizes and late-stage customisation requirements in today’s market.

How Can Requalification Help Future-Proof Pharmaceutical Packaging Operations?

Requalification doesn’t have to mean falling behind. In fact, if treated strategically, it can accelerate the transformation of your packaging operations into a more efficient, sustainable, and future-proof state. The industry is moving – regulations, markets, technologies are evolving.

Are you ready to turn this rare window into a leap forward? Learn more about how inline digital printing systems can help to unlock traceability, patient engagement, and compliance.

Need more information?

Contact us about our innovative and award-winning printing and marking solutions. Get in touch

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