Container Closure Integrity Testing (CCIT) is one of the most effective methods used by manufacturers to ensure that their products are sterile until the point of use. Testing the integrity of container closures determine if they can maintain a sterile barrier against potential contaminants that might impair the quality of the final pharmaceutical and biological products. There are several ways to perform tests on the integrity of container closures, each having advantages and limitations of its own. For instance, methods such as dye ingress and microbiological ingress damage the test samples. Therefore, manufacturers choose deterministic methods such as helium leak detection for package integrity testing.
Helium leak testing is the process of identifying leaks in some type of sealed or enclosed systems by utilizing helium as a "tracer" gas and monitoring the concentration of the gas as it leaves as a result of a leak. In this method, the package is helium-filled and placed under vacuum. A helium leak detector is used to monitor the volume of helium that is leaving the package quantitatively. The result is expressed as leak rate.
Helium Leak Detector
Helium leak detector, commonly referred to as a Mass Spectrometer Leak Detector (MSLD), is used to identify leaks that enter or leave a system or containment device and to measure its size. Helium, the tracer gas, is introduced into a test component that is attached to the leak detector. The system allows the helium that is leaking through the test portion to enter, and this partial pressure is monitored. The results are then displayed on a meter.
For a number of reasons, helium is the ideal tracer gas to locate leaks. It is non-toxic, inert, non-condensable, non-flammable, and just traces of it are often found in the atmosphere (5 ppm). Helium is a gas that quickly passes through leaks due to its tiny atomic size. The only non-inert molecule smaller than helium is hydrogen. It comes in several size cylinders and is also relatively inexpensive.
Explain Various Calibration Standards Offered by PTI's Helium Leak
PTI's Helium Leak offers complete sets of calibrated helium leak standards in addition to instruments and accessories to provide routine usage, daily performance verification or system suitability checks, and scheduled qualifications.
Internal Leak Standards:
An internal helium leak standard is included with every PTI SIMS 1915+ leak detection system. This apparatus is calibrated to discharge a certain amount of helium at a defined leak rate. It is utilized either on demand for a point-of-use auto calibration before analysis or automatically by the instrument on each day of usage.
External Leak Standards:
Every external helium leak standard developed by PTI's Helium Leak releases helium at a known leak rate, much as the internal leak standards. They attach to the test port, much like a sample fixture would be mounted to the system, rather than residing inside the instrument. The external nature of these leaks makes them perfect for routine PV or SS activities as well as qualification activities to assess the accuracy of the system. It is possible to perform an industry-standard, multi-point check across leak rate ranges of interest, since external leak standards are accessible in a variety of leak rates.
With every new instrument purchase, PTI's Helium Leak provides the following Internal and External Leak Standards (with certifications of calibration):
- External Helium Leak Standard E-6 3 x 10 -6.
- Internal Leak Standard - Set at E-7 1 x 10 -7.
- External Helium Leak Standard E-7 3 x 10 -7.
- External Helium Leak Standard E-8 3 x 10 -8.
A certificate of calibration that details the standards to which the leak was tested and the tolerance range for which that leak is certified should be attached to every calibrated helium leak. PTI's Helium Leak provides both external and internal leak standards with certificates of calibration.
