Proven CCIT methods

for global regulatory compliance

No one in pharmaceutical manufacturing wants to lose valuable product to leakage—or face regulatory delays due to flawed packaging. Yet container closure integrity is exactly what stands between a safe, effective drug and a costly, contaminated risk. You need to prove, with absolute confidence, that nothing harmful can get in or out across your product’s entire shelf life. And you need to do it with methods that meet evolving regulatory expectations, while staying efficient, cost-effective, and on schedule.

The Eurofins BioPharma Product Testing (BPT) network of laboratories offers extensive Container Closure Integrity Testing (CCIT) methods globally—each carried out by skilled scientists using state-of-the-art technologies to support your product and packaging specifications. Whether you require non-destructive methods for stability studies, deterministic methods for precision, or probabilistic approaches to meet legacy standards, our specialists guide the right choice for your application. Our full-spectrum CCI testing capabilities includes eight techniques: Vacuum Decay, Pressure Decay, High Voltage Leak Detection (HVLD), Helium Leak Detection, Oxygen Headspace Analysis, Dye Ingress, Microbial Ingress and Microbial Aerosol Challenge Testing. 

Our scientists are more than operators—they’re CCIT experts, with 17+ years of experience, highly proficient in packaging science, regulatory demands, and the nuances of various closure systems. We work closely with your teams to provide timely consultation, custom protocol design, and compliant execution every step of the way. Our techniques accommodate various packaging configurations, with methods capable of minimising the number of samples required for testing.

Methods

Deterministic methods



Expand_img

Vacuum decay
Instrumentation: VeriPac 455-M5 Vacuum Decay
Description: Measures leaks by vacuum decay based upon ASTM F2338. This system can detect leaks down to approximately 5 microns by measuring a change in vacuum pressure over time. Pressure transducers detect changes in vacuum pressure  resulting from gas flow through leaks for both gross and micron sized leaks during two consecutive test cycles.
Best application: This technology is suitable for leak testing on container/closure systems such as syringes and vials. Because this method is non- destructive to the sample under test, it is a great option for leak testing both before and during stability studies.

Pressure decay
Instrumentation: TM Electronics BT Integra Burst ™, Creep and Leak Tester
Description: Measures leaks by pressure decay based upon ASTM F2095.
Best application: This technology accommodates both seal and package integrity testing for flexible packaging, such as bags and pouches. This is a destructive test.

High voltage leak detection
Instrumentation: E-Scan 655 MicroCurrent High Voltage Leak Detector (HVLD)
Description: Detects package defects using an electrical current.
Best application: This technology is suitable for use with liquid-filled parenteral drug product glass vials and syringes, where the packaging is far less conductive than the liquid inside.

Oxygen headspace
Instrumentation: FMS-760 Oxygen Headspace Analyzer
Description: Uses Frequency Modulation Spectroscopy (FMS) to detect oxygen in the headspace of transparent rigid containers and measures rise or fall in the oxygen levels in the container’s headspace to identify a potential leak. It can also be used to determine the rate of oxygen permeation into a sealed container over time.
Best application: Because this method is non-destructive to the sample under test, it is ideal for leak testing parenteral containers both before and during stability studies. This technology is also used during package development to verify inherent package integrity and maximum allowable leakage limit (MALL) through leak rate modeling.

Helium leak detection
Instrumentation: SIMS 1284+ Helium Mass Spectrometer – Tracer, Gas Detection, Vacuum Mode and Sniffer Mode
Description: Measures leaks based upon ASTM F2391 and E499. Quantitates the flow rate of helium from leaks in packaging after having been charged with helium as a tracer gas. If a defect is present, the helium is then drawn out of the packaging through the defect by vacuum and detected using a mass spectrometer. This method is the most sensitive option, allowing for the detection of defects as small as 0.2 microns in a matter of seconds.
Best application: This technology is suitable for package development to verify inherent package integrity and maximum allowable leakage limit (MALL). This technique is applicable to a wide variety, of package types, can isolate and identify leak location, and can directly measure leak flow rates.

Probabilistic methods

Expand_img

Dye Ingress Testing
Sample and positive control packages are fully submerged in a dye bath. A vacuum pressure of about 0.5 atmospheres is applied for a specific amount of time, samples are returned to atmospheric pressure, and then a positive pressure of about 2 atmospheres may be applied for a specific amount of time. The packages are then visually compared to a sensitivity solution of a known concentration of dye to evaluate the samples for the presence of dye inside the packages. Alternatively, the solutions inside the packages can be tested for the presence of dye using a UV/Vis spectrophotometer.

Microbial Immersion Testing
Generic in-house methods are available and may be customized based on individual testing requirements. Techniques offered include Vacuum, Static, or Challenge Organism.

Microbial Aerosol Challenge Testing
Generic in-house methods are available and may be customised based on individual testing requirements. Techniques offered include Vacuum, Static, or Challenge Organism. Vacuum or Static techniques utilise a 0.4 m3 air-tight test room connected with thermo-stated aerosol delivery system.