Dynamic Engineering Under Tight Deadlines

Reliable Container Closure Integrity Testing (CCIT) solutions secure absolute sterility for a diverse vial portfolio and require a system engineered for deep operational robustness and flawless mechanical stability. This was the scope of a renowned pharmaceutical CDMO from Europe.

Our client recently required a high-performance, deterministic container closure integrity testing (CCIT) solution. Because speed-to-market was a critical priority for their upcoming production schedules, the project required a highly compressed engineering and delivery timeline.

During the initial design phase, the client identified opportunities to further optimize their process by introducing advanced technical features. In traditional machine manufacturing, incorporating new requirements mid-project can create engineering bottlenecks. The goal was to seamlessly integrate these sophisticated enhancements while strictly safeguarding the original, ambitious delivery deadline.

Our engineering approach is built on the principle that standard machine frameworks should serve as adaptable, future-proof platforms. When the CDMO team shared their new ideas for the machine, our engineering and project management teams partnered closely with them to initiate rapid design reviews.

By leveraging modular engineering principles across both our mechanical assemblies and control architecture, we were able to adapt to the client's expanding vision on the fly. This collaborative solution design process allowed us to absorb the new features smoothly, delivering a tailor-made machine without the long lead times usually associated with custom modifications.

The completed leak detection rotary platform R DPX was precisely configured to support the client's diverse vial portfolio, delivering robust performance numbers:

• Format Versatility: Fully equipped to process both 6R and 20R vials.
• High Throughput: Operates reliably at a throughput of 300 vials per minute.
• Inspection Grid: Features 36 testing stations integrated onto a continuous rotary carousel.
• Detection Threshold: Identifies leaks down to 10 μm

To meet strict deterministic leak detection standards non-invasively, the R DPX utilizes a pressure decay method.

Vials enter a custom-fit, hermetically sealed test chamber where a precise differential pressure profile is applied. Once the environment stabilizes, the system isolates the chamber and tracks the internal pressure over a millisecond window. If a crack, capillary pathway, or stopper defect exists, gas escapes into the lower-pressure zone. High-resolution differential transducers instantly detect this minute pressure drop. Any vial breaching the validated threshold is automatically redirected to a secure reject lane, ensuring absolute quality control.

Thanks to a highly collaborative effort, the leak detection solution was delivered precisely on schedule. The machine is now in full commercial production.

Client Testimonial:

"First of all, on behalf of our team, I would like to thank you all very much. From the very beginning, you were always accessible and provided us with all the technical (and non-technical) explanations we needed: what we could expect from the new machine, what we should pay special attention to in the design, and what is important in the process.

I want to emphasize that communication was always seamless, and all questions and requirements were handled with great attention to detail and outstanding friendliness. The quality and technical depth of the documentation we received was, and will continue to be, a massive support for the flawless execution of all our required operational and validation activities."

This text was generated in part with the support of AI. The content has been reviewed for accuracy.