Eurofins Lancaster Labs offers several options for container-closure integrity testing
By Jennifer M. Roark, Manager, Chemistry and Container Testing, Eurofins Medical Device Testing,
Container-closure integrity testing (CCIT) is required by the US and EU regulatory agencies in lieu of sterility testing to ensure a product’s continued sterility, safety, and quality throughout shelf life. While sterility testing is important, it has limitations such as it is destructive to the sample, requires a product fill that is supportive of microbial growth, will only detect viable microorganisms present at the time of the test, and contamination can cause false positive results. Eurofins offers the full suite of USP <1207> probabilistic and deterministic technologies for CCIT, and provides consultation so that clients may choose the most appropriate and compatible CCIT methodology for each product-package system.
In addition to microbial immersion, dye immersion, and bubble emission testing, Eurofins offers full method development, validation, and routine testing services for the following USP <1207.2> deterministic methodologies. All deterministic technologies are non-destructive to the sample with the exception of Helium Leak Detection.
- Pressure/Vacuum Decay measures a change in pressure over time, which correlates with leak size. This technology is suitable for use with rigid or flexible packages containing small molecule liquid or lyophilised products. The sensitivity is approximately 5 microns.
- High-Voltage Leak Detection (HVLD) uses an electrical current to detect leaks. This technology is suitable for use with large and small molecule liquid-filled parenteral drug products packaged in both vials and syringes. The sensitivity is approximately 2 microns.
- Oxygen Headspace Analysis measures the concentration of oxygen in the headspace of transparent rigid containers. A change in the oxygen concentration over time indicates a leak. This technology is suitable for use with lyophilised parenteral drug products or any product packaged with an alternate gas overlay, such as nitrogen or argon. The sensitivity is less than 0.2 microns.
- Helium Leak Detection quantitates the flow rate of helium tracer gas from defects in packaging. Helium is drawn through the defect by vacuum and detected using a mass spectrometer. This method is the most sensitive option, allowing for the detection of leak rates as small as 10-10 mbar.L/s.
A well-executed container-closure integrity study ensures that patients receive sterile, safe, and quality medications.
For more information, visit: www.Eurofins.com/Medical- Device.