Pharmaceutical packaging is changing fast. New delivery systems, novel polymers, foil-free blisters, and advanced sterile formats are reshaping how manufacturers design, qualify, and monitor container closure integrity. As these formats evolve, traditional leak testing approaches often struggle to keep up, leading to gaps in sensitivity, validation complexity, or difficulties integrating equipment into modern filling and packaging lines.
This article explores how emerging packaging formats are reshaping CCI expectations and how deterministic, non-destructive leak testing is adapting to support the next generation of sterile and semi-sterile products.
Why Packaging Innovation Demands New CCI Approaches
Manufacturers today face increasing pressure to:
- Reduce packaging waste and move away from aluminium and foil
- Transition to polymer-based vials and BFS containers
- Support modern drug types such as biologics and combination products
- Combine lightweight materials with long shelf-life stability
- Build flexible lines capable of handling multiple formats
These changes introduce new behaviours during leak testing. Thin-walled polymers deform differently under pressure, BFS seams behave differently from crimps, and foil-free designs require more sensitive verification.
Key Emerging Packaging Formats and Their CCI Challenges
1. Blow-Fill-Seal (BFS) Containers
BFS is expanding across ophthalmic, inhalation, and sterile unit-dose medicines. Its advantages include sterility by design and reduced operator handling, but leak testing must account for:
- Weld and seam irregularities
- Material flexibility that influences pressure profiles
- Multi-cavity production that requires consistent repeatability
Deterministic vacuum and pressure decay methods offer a clean, rapid approach suited to BFS lines. Nolek’s dry methods avoid the contamination risks associated with liquid-based tests, making them ideal for sterile BFS environments.
2. Foil-Free and Reduced-Foil Blister Packs
Sustainability efforts are pushing blister designs away from traditional aluminium layers. New laminates and polymers behave unpredictably with dye ingress or visual inspection, requiring more sensitive and repeatable testing.
Deterministic systems can measure micro-leaks in these new laminates without the operator subjectivity inherent in probabilistic tests.
3. Polymer-Based Vials and Ready-To-Use Containers
Polymers such as COC and COP are gaining traction for biologics due to their break-resistance and clarity. However, polymers expand and contract more readily than glass, influencing leak test dynamics.
Nolek’s Custom Engineered Solutions (CES) are tailored to specific material characteristics, ensuring reliable thresholds and repeatability even with flexible or temperature-sensitive packaging.
4. Flexible Parenteral Packaging
Soft containers, IV bags, and flexible infusion systems are increasingly used in hospitals and home care. Their flexibility creates unique challenges:
- Variable surface tension
- Stress-dependent leak behaviour
- Difficulty using destructive tests without damaging samples
Non-destructive decay methods detect leaks without puncturing or distorting the container, protecting valuable sterile product.
How Deterministic Leak Testing Supports the Next Generation of Formats
Emerging packaging demands technology that can adapt quickly and perform reliably under varied conditions.
Modern deterministic CCI systems deliver:
- High sensitivity suited to micro-leak risks associated with new materials
- Quantitative outputs suitable for USP <1207> compliance
- Fast cycle times required for high-throughput BFS and multi-format operations
- Stability in cleanroom environments where contamination must be avoided
- Full electronic traceability aligned with GMP expectations
Our systems include CFR Part 11-ready data logging to ensure secure, audit-ready records, critical as packaging formats grow more complex .
Why Nolek Is Well Positioned for Emerging Packaging Demands
Pharma manufacturers navigating the shift toward novel formats benefit from partners able to tailor systems rather than force standard equipment into non-standard applications.
Nolek’s CES platform offers:
- Custom engineering matched to specific packaging geometries and material behaviours
- High-sensitivity, dry test methods that avoid contamination risks
- Cleanroom-compatible designs ideal for sterile environments
- Validation-heavy documentation support, easing the burden on internal QA and regulatory teams
- In-house developed instruments that deliver stable, repeatable results consistently across long production cycles
These strengths allow manufacturers to adopt innovative packaging formats without compromising CCI performance or slowing production.
Wrapping Up
As pharma packaging continues to evolve, container closure integrity strategies must evolve with it. Emerging formats introduce new risk profiles, material behaviours, and testing requirements, but deterministic leak testing provides the sensitivity, repeatability, and compliance confidence needed to stay ahead.
With custom-engineered solutions designed for modern GMP environments, we can help manufacturers adopt next-generation packaging formats while protecting product integrity, patient safety, and operational efficiency.
