Choose from several Container Closure Integrity Testing options
by Jen Roark, Manager, Eurofins Medical Device Testing
The Chemistry and Container Testing group at Eurofins Medical Device Testing has recently purchased a VeriPac 455-M5 vacuum decay instrument from Packaging Technologies and Inspection (PTI). This equipment can perform leak testing on container/closure systems such as syringes, vials, and pouches. Historically, container closure integrity testing has been performed by either dye immersion (tracer liquid) or by microbial challenge, which are considered by USP to be probabilistic tests. Movement away from probabilistic test methods to more deterministic methods is the focus of the new USP general chapters <1207.1>, <1207.2>, and <1207.3>, which became effective on August 1, 2016, in the first supplement of USP 39 – NF 34.
Per USP <1207.2>, the vacuum decay technique is a deterministic method for detecting leaks. The test is based upon ASTM F2338-09. This technique is nondestructive to the sample and is sensitive enough to detect leaks down to approximately 5-10 microns. Because the test is non-destructive, the same sample can be used for other laboratory tests typically required during stability studies once the vacuum decay test has been performed. This option reduces the amount of valuable finished drug product required for stability testing. Traditional dye immersion or microbial challenge methodologies are destructive to the samples under test, and typically require a significant number of units for method development and validation.
In addition to vacuum decay, the group has also purchased several other pieces of equipment to support container closure integrity testing. The following techniques will be rolled out over the next several months.
- The E-Scan 655 MicroCurrent High Voltage Leak Detector (HVLD) from PTI uses an electrical current to detect package defects. This technology is suitable for use with liquidfilled parenteral drug product containers and syringes, where the packaging is far less conductive than the liquid inside.
- The FMS-760 Oxygen Headspace Analyzer from Lighthouse Instruments, LLC uses frequency modulation spectroscopy (FMS) to detect oxygen in the headspace of transparent rigid containers. A rise or fall in the oxygen levels in the container’s headspace indicates a leak. This technique is completely non-destructive to the sample under test, and is a great option for leak testing parenteral containers both before and during stability studies. It can also be used to determine the rate of oxygen permeation into a sealed container over time.
- The TM Electronics BT Integra Burst, Creep and Leak Tester measures leaks by pressure decay based upon ASTM F2095. Eurofins has purchased this equipment to accommodate both seal strength and package integrity testing for flexible packaging, such as bags and pouches. This technique is destructive to the container under test.
- Helium Mass Spectrometry as described in USP <1207.2> as “Tracer Gas Detection, Vacuum Mode,” quantitates the flow rate of helium from leaks in packaging after having been flooded 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.