Why high-barrier film supply is still one of pharma’s biggest risks
In pharmaceutical packaging, high-barrier films are often treated as a solved problem. The materials are well understood. Performance data is established. Specifications are locked.
And yet, for many pharmaceutical manufacturers, accessing high-barrier films remains one of the most persistent sources of risk in the supply chain.
The issue is no longer about whether a film can meet moisture or oxygen requirements. It’s about how reliably that film can be sourced, converted, and delivered—especially in a market still shaped by capacity constraints, longer lead times, and shifting regulatory expectations
And yet, for many pharmaceutical manufacturers, accessing high-barrier films remains one of the most persistent sources of risk in the supply chain.
The issue is no longer about whether a film can meet moisture or oxygen requirements. It’s about how reliably that film can be sourced, converted, and delivered—especially in a market still shaped by capacity constraints, longer lead times, and shifting regulatory expectations
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The hidden complexity behind “high-barrier”
High-barrier pharmaceutical films—whether Duplex, Triplex, or HBC structures—are inherently more complex than standard thermoformable materials.
They rely on multiple production steps, often spread across different facilities or suppliers:
•Substrate production
•Barrier coating
•Lamination or finishing
•Final slitting and qualification
Each step introduces variability. Each handoff adds time. And when those steps are managed independently, the risk compounds.
What appears on paper as a single material is, in practice, a coordinated manufacturing sequence that must stay aligned to maintain performance and delivery timelines.
•Substrate production
•Barrier coating
•Lamination or finishing
•Final slitting and qualification
Each step introduces variability. Each handoff adds time. And when those steps are managed independently, the risk compounds.
What appears on paper as a single material is, in practice, a coordinated manufacturing sequence that must stay aligned to maintain performance and delivery timelines.
Lead times: the risk multiplier
Over the past several years, pharmaceutical manufacturers have adjusted to longer lead times across many categories. High-barrier films, however, have been particularly exposed.
Why?
Because delays don’t just affect one operation. A disruption in coating capacity or finishing availability can cascade through the entire structure, pushing deliveries out by weeks—or longer. For products supporting commercial supply, clinical timelines, or launch readiness, those delays quickly become business risks.
In many cases, the problem isn’t a lack of demand forecasting or internal planning. It’s the reality that fragmented sourcing models were never designed for speed or resilience.
Why?
Because delays don’t just affect one operation. A disruption in coating capacity or finishing availability can cascade through the entire structure, pushing deliveries out by weeks—or longer. For products supporting commercial supply, clinical timelines, or launch readiness, those delays quickly become business risks.
In many cases, the problem isn’t a lack of demand forecasting or internal planning. It’s the reality that fragmented sourcing models were never designed for speed or resilience.
Performance consistency still matters
Even when supply is available, consistency remains critical.
High-barrier films are selected to protect sensitive formulations from moisture ingress and environmental exposure over their full shelf life. Variability in coating quality, substrate sourcing, or processing conditions can impact performance—sometimes subtly, sometimes significantly.
That’s why reliability isn’t just about delivery dates. It’s about ensuring that each lot performs the same way as the last, without unexpected deviations that trigger additional testing, investigation, or qualification work.
High-barrier films are selected to protect sensitive formulations from moisture ingress and environmental exposure over their full shelf life. Variability in coating quality, substrate sourcing, or processing conditions can impact performance—sometimes subtly, sometimes significantly.
That’s why reliability isn’t just about delivery dates. It’s about ensuring that each lot performs the same way as the last, without unexpected deviations that trigger additional testing, investigation, or qualification work.
Regulatory pressure hasn’t eased
At the same time, regulatory expectations around pharmaceutical packaging have not relaxed. If anything, scrutiny around material traceability, change control, and long-term supply assurance has increased.
Manufacturers are being asked not only to validate packaging systems, but to demonstrate confidence in the supply models behind them. That includes understanding where materials are produced, how changes are managed, and what safeguards exist if something goes wrong.
A packaging solution that performs well in isolation but lacks supply stability can quickly become a liability.
Manufacturers are being asked not only to validate packaging systems, but to demonstrate confidence in the supply models behind them. That includes understanding where materials are produced, how changes are managed, and what safeguards exist if something goes wrong.
A packaging solution that performs well in isolation but lacks supply stability can quickly become a liability.
Rethinking access, not just materials
The industry’s focus has traditionally been on selecting the “right” high-barrier structure. Increasingly, the more important question is:
What is the most reliable way to access that structure-consistently, predictably, and at scale?
This shift in thinking is driving renewed attention toward coordinated production models that reduce fragmentation, minimise handoffs, and bring greater transparency to lead times and availability.
Rather than treating substrate production, barrier coating, and finishing as separate sourcing decisions, manufacturers are looking for approaches that align these steps into a single, managed flow.
What is the most reliable way to access that structure-consistently, predictably, and at scale?
This shift in thinking is driving renewed attention toward coordinated production models that reduce fragmentation, minimise handoffs, and bring greater transparency to lead times and availability.
Rather than treating substrate production, barrier coating, and finishing as separate sourcing decisions, manufacturers are looking for approaches that align these steps into a single, managed flow.
A more coordinated approach to high-barrier supply
Recognising these challenges, coordinated supply models like BarrierXpress are emerging to help pharmaceutical manufacturers reduce uncertainty around high-barrier film access. By aligning substrate production, barrier coating, and finishing within a defined manufacturing flow-and pairing that with clearly defined lead times-these approaches are designed to simplify sourcing while maintaining the performance expectations high-barrier applications demand.
For teams navigating tight timelines or complex qualification paths, rethinking how high-barrier films are accessed can be just as important as deciding which structure to use.
For teams navigating tight timelines or complex qualification paths, rethinking how high-barrier films are accessed can be just as important as deciding which structure to use.
Looking ahead
High-barrier films will remain essential to protecting sensitive drug products. But the way those films are sourced and supplied is evolving.
Manufacturers that move beyond fragmented models-and toward more integrated, coordinated approaches-are better positioned to reduce risk where it matters most: time, consistency, and confidence in supply.
Manufacturers that move beyond fragmented models-and toward more integrated, coordinated approaches-are better positioned to reduce risk where it matters most: time, consistency, and confidence in supply.
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