Regulatory-compliant leak detection and barrier testing

When the sterility or integrity of a container closure system is compromised, even the most promising therapy is at risk. Whether you're developing parenteral drugs, biologics, or sensitive formulations, the ability to identify leaks or weaknesses in your packaging, and to characterize materials and chemicals with potential to migrate through barriers of a packaging component or system, is vital - not just for patient safety, but also for compliance with USP <1207>, European Pharmacopeia (EP), and FDA requirements.

For drug developers, especially those navigating complex regulatory pathways or short development timelines, identifying leaks or packaging failures late in the process can disrupt progress, increase costs, and put patient safety at risk. For many small to medium manufacturers, knowing exactly when and how to involve a testing partner can be just as challenging.

The Eurofins Medical Device Services network of laboratories offers a full suite of Container Closure Integrity Testing (CCIT) services designed to meet these challenges. Our experts support clients at all stages, from method development to ongoing batch release, with both deterministic and probabilistic testing approaches to provide regulatory confidence and operational clarity.

Our testing services ensure your packaging maintains a sterile barrier throughout the product’s shelf life, aligns with regulatory expectations, and protects the efficacy and safety of your drug product. We evaluate elemental and biological compositions of materials and testing of various shapes, sizes, thicknesses, and compositions for plastics, and test a wide range of packaging formats, including vials, syringes, screw-cap bottles, and auto-injectors using state-of-the-art instruments and validated protocols.

Whether you're facing pressure from regulatory timelines or need clarity on test selection, Eurofins Medical Device Services can help. Our global reach and local support put expert advice, rapid turnaround, and unmatched technical capability within reach.

Protect your product with reliable container closure integrity testing.

Methods

Laboratory professional wearing a white lab coat, blue gloves, and safety glasses standing beside a stainless steel work surface, reaching up to operate a wall-mounted lab instrument in a clean, well-lit laboratory environment.

Deterministic testing technologies

  • Helium Leak Detection (SIMS 1284+): The most sensitive test available, identifying leaks as small as 0.2 microns using tracer gas detection.
  • High Voltage Leak Detection (HVLD) (E-Scan 655): Ideal for liquid-filled glass vials and syringes, detecting defects via electrical current.
  • Oxygen Headspace Analysis (FMS-760): Detects oxygen ingress using Frequency Modulation Spectroscopy, useful before and during stability studies.
  • Pressure Decay (TM Electronics Integra): Suitable for flexible packaging like pouches and bags, this is a destructive method.
  • Vacuum Decay (VeriPac 455-M5): Non-destructive testing for vials and syringes, detecting leaks as small as 5 microns.
Laboratory professional wearing safety glasses, a white lab coat, and blue gloves placing a small sample onto a compact analytical instrument, with the Eurofins logo visible on the coat in a clean lab setting.

Probabilistic testing methods

  • Dye Ingress Testing: Visual or spectrophotometric evaluation of dye penetration under vacuum and pressure conditions.
  • Microbial Immersion & Aerosol Challenge: Customised methods to challenge container sterility using vacuum, static, or organism exposure.