A Q&A with Claire Miskelly, Head of Sales at Sepha
As oral solid dosage (OSD) manufacturing looks ahead to 2026, commercial and operational priorities are shifting. Pharmaceutical manufacturers and CDMOs are under increasing pressure to accelerate timelines, expand outsourcing models, and scale efficiently, all while navigating tighter regulatory scrutiny, rising expectations around data integrity and growing environmental and sustainability commitments
At Sepha, these pressures are reflected daily in conversations with customers across global markets. Claire Miskelly, Head of Sales at Sepha, shares her perspective on how OSD manufacturing priorities are changing, and what this means for packaging integrity testing as the industry looks toward 2026.
Claire Miskelly (CM): OSD remains the backbone of pharmaceutical production, but the environment around it is becoming more complex. Customers are being asked to move faster, manage more outsourced relationships, and still demonstrate robust, defensible quality practices.
What’s really changing is how interconnected these pressures have become. Speed, outsourcing, and data integrity are no longer separate considerations. Together, they’re shaping purchasing decisions and forcing manufacturers and CDMOs to think more strategically about how scalable and inspection-ready their operations really are.
In that context, package integrity testing is becoming more strategic. It is no longer viewed purely as a final quality checkpoint, but as a function that supports regulatory confidence, operational efficiency, and manufacturing models that can scale with demand.
CM: While 21 CFR Part 11 has been established for many years, the way it’s being examined is changing. Customers are very aware that inspections are going deeper, not just asking whether systems are validated, but how data actually holds up in real operational use.
Inspectors are looking at how data is generated, reviewed, and relied upon when decisions are made. That has direct implications for packaging integrity testing. Traditional, probabilistic, or operator-dependent methods can introduce variability that becomes difficult to justify when audit trails and traceability are closely scrutinised.
Deterministic approaches to container closure integrity testing generate objective, measurable results that integrate more naturally into Part 11–aligned electronic quality systems. From what we see, this is becoming increasingly important for customers who want confidence that their data will stand up during inspection.
CM: There’s a strong push to reduce development timelines and accelerate batch release, but speed achieved through inconsistent quality testing rarely delivers long-term benefits.
Packaging integrity testing sits at a critical junction. It’s the final confirmation that a product will remain protected throughout its shelf life, so the results have to be reliable, and they have to be available without delay.
Deterministic CCIT methods support this by delivering consistent, reproducible outcomes. That reduces re-testing, deviation management, and lengthy investigations, which are often what slow production down in practice.
When quality data is robust and immediately defensible, it actually enables faster decision-making. That’s why we increasingly see packaging integrity testing viewed as a facilitator of predictable, first-time-right release strategies rather than a barrier to speed.
CM: Outsourcing adds complexity very quickly. CDMOs are managing more products, more customers, and more regulatory expectations, often across multiple sites and regions.
In those environments, packaging integrity testing becomes highly visible. Manufacturers need to demonstrate that quality standards are applied consistently, regardless of product or customer. Variability in testing approaches, or reliance on highly operator-dependent methods such as blue dye ingress, can introduce risk, particularly when inspections compare practices across portfolios or sites.
Standardised, deterministic CCIT approaches help establish a common quality baseline. By embedding objective measurement into packaging integrity testing, CDMOs can reduce reliance on individual interpretation and present a more consistent quality philosophy to both regulators and clients.
CM: The trends shaping OSD manufacturing aren’t driven solely by new technologies or regulations. They reflect a growing need to align data integrity, operational speed, and outsourced manufacturing models in a way that’s sustainable.
We’re seeing more customers factor ESG commitments into capital investment decisions. That includes looking at how equipment and quality processes contribute to waste reduction, energy efficiency, and long-term operational sustainability.
Packaging integrity testing plays a critical role in bridging those priorities. As expectations around data integrity continue to rise and timelines tighten, quality strategies need to be robust enough to withstand scrutiny without introducing inefficiency.
Non-destructive, deterministic package integrity testing offers a practical way to achieve that balance. By reducing reliance on destructive sampling, it supports consistent data generation while limiting unnecessary product waste. For manufacturers and CDMOs, this means stronger inspection readiness, more predictable release processes, and measurable progress toward sustainability objectives.
Package integrity testing must extend beyond confirming container closure. It should deliver reliable, objective data that quality teams can confidently defend, while supporting efficient, scalable production. Sepha supports pharmaceutical manufacturers and CDMOs with deterministic packaging integrity testing solutions designed to meet these demands, helping organisations align data integrity, operational efficiency, sustainability goals, and regulatory confidence.