Pfeiffer Vacuum offers a wide range of different leak testing methods to address the multitude of challenges within the pharmaceutical industry as there is no one solution that fits all different challenges connected to a specific product. We can support you during the complete CCIT process definition and integration and also provide GMP support in regards to method and product validation as well as IQ/OQ (Installation Qualification/Operational Qualification) including the needed documentation for all our test methods.
Thereby our non destructive and deterministic test method offers a number of benefits to help you to efficiently and safely replace your destructive dye or ingress test.
The following overview gives you an impression of our portfolio of leak testing methods.
Helium Leak Detection
Pfeiffer Vacuum helium leak detection solutions are perfect for MALL (maximum allowable leak limit) testing in the pharmaceutical industry. In order to ensure a correct measurement, it is very important to manage the tracer gas concentration during the measurement. This is especially tricky when handling vials or other sealed packages. Therefore, Pfeiffer Vacuum offers complete solutions including tracer gas handling and charging, as well as adaptations for your packaging and test chambers.
Our USP 1207 and ASTM (F-3287-17) recognized Mass Extraction Technology works on the principle of rarefied gas flow. Testing takes place in vacuum conditions to attain higher sensitivity. This patented technology type of testing is particularly suitable for pharmaceutical packaging such as IV-bags, pouches or glass vials. Larger defect and defects as small as 1 μm can be detected with this method. The technology is thereby suitable for laboratory applications as well as for the use in production environment allowing stability control as well as automated 100% testing (also in inline machines). FDA laboratories in the US and major pharmaceutical companies have been using the Mass Extraction instruments for over 10 years.
Optical Emission Spectroscopy
The Optical Emission Spectroscopy Instrument used in the AMI test systems measures leak tightness using a patented process that does not require a tracer gas. Instead, this method uses the existing gas mixture in the cavities inside the packaging to perform high-sensitivity testing over an extended measuring range. Thereby the AMI has the ability to differentiate gas species that are typical to pharmaceutical products. The procedure offers great flexibility and can test a variety of different packaging types such as blister packs, pouches, vials and plastic bottles and can also test multiple samples at the same time. The wide measuring range of the AMI offers higher sensitivity than conventional tests, starting from 0.5 μm (and smaller) respectively leak rates of down to 1·10-6 mbar l/s, but can also identify gross leaks as for example a completely open container. As a result, the AMI device can perform gross and fine leak testing in just one device. The procedure delivers deterministic test results with high repeatability, irrespective of the user, and with reliability and accuracy that within the range of USP 1207.1. It can be used in laboratory testing as well as IPC (In Process Control) during production testing. Depending on the packaging simultaneous testing of multiple parts at the same time is possible.
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