In fast-paced pharmaceutical manufacturing, testing container closure integrity (CCI) is essential for product safety, regulatory compliance, and brand reputation. But as production speeds increase, leak testing often becomes a bottleneck. Traditional setups can’t always keep up without compromising on sensitivity or risking false results.
To meet these challenges, a new model for scalable, high-throughput CCI testing is emerging. And it does more than just solve for speed.
Modular, Multi-Station Leak Testing
One of the most effective ways to scale CCI testing without sacrificing precision is through a modular, multi-station approach. Instead of relying on a single test chamber that runs sequentially, parallel test stations allow for multiple containers to be tested simultaneously.
This parallel architecture increases line speed without reducing sensitivity, and can be configured for vacuum decay, pressure decay, or helium leak testing depending on the application. Whether running syringes, parenteral vials, or blister packs, modular test stations ensure that scale does not come at the expense of confidence.
Designed for Compliance
Modern pharmaceutical operations must adhere to some of the world’s most rigorous regulatory standards. Nolek systems are designed with full compliance in mind, supporting ISO 13485, USP <1207>, and EU GMP Annex 1. This ensures that CCI testing processes are deterministic, repeatable, and audit-ready across all stages of production.
Each Nolek solution comes validation-ready, with IQ/OQ/PQ documentation to help quality teams meet regulatory expectations faster and with less overhead.
Reducing Cost, Waste, and Risk
High-speed testing is not just about efficiency — it’s also about financial performance. When implemented properly, scalable CCI systems help reduce:
- False rejections that lead to unnecessary product loss.
- Manual rework, which ties up operator time and increases risk.
- Maintenance overheads, especially when outdated systems struggle to deliver consistency.
- CAPEX waste, by investing in solutions that are future-proof and expandable as needs evolve.
With modular systems, pharma manufacturers can start small and expand as demand grows, all while keeping validation and calibration routines consistent.
Integration Without Disruption
Flexible integration is at the core of our system design. Whether retrofitting an existing line or building from scratch, these systems are engineered to fit within existing layouts, cleanroom requirements, and automation platforms.
More importantly, they are backed by a support team that understands validation timelines, equipment qualification, and production changeover.
Final Thoughts
Scaling CCI testing does not have to mean compromising on accuracy. By investing in modular leak testing systems that align with global regulations and come validation-ready, manufacturers can protect product integrity, reduce operational risks, and unlock greater throughput, while controlling total cost of ownership.
When every unit matters and every cycle counts, this model is not just efficient, it’s strategic.
