Laser-based Headspace Analysis as a Container Closure Integrity Testing Tool.
About the Webinar
Container Closure Integrity Testing (CCIT) has become a relevant topic in new regulatory documents like the USP1207 and the Annex 1 of the European Good Manufacturing Practice (GMP) guidelines. In view of this, the webinar shows the technologies available and their use. A detailed view is given to the technology, use and application of the Tuneable Diode Laser Absorption Spectroscopy (TDLAS) technology. The correct use during the container closure development and parenteral packaging process allows the TDLAS technology to be an accurate, reliable and fast CCIT tool. Relevant parameters are highlighted to define the process parameters for designing a highly sensitive leak-test method.
About Ronald Koch
Roland studied electrical engineering at the technical university of BASEL Switzerland. He has a wide experience in the field of industrial applications for testing and quality inspection for more than 20 years. He developed a variety of test systems, applications and machines for the pharma, food, metal can and automotive industry. TDLAS for the quality inspection of headspace inspection for pharmaceutical packaging, NIR Spectroscopy to characterize lyophilized drugs for their moisture and cake defects, high sensitive Microfocus x-Ray Technology to inspect pharmaceutical containers for smallest foreign particles , high speed x-Ray inspection up to a frame rate of 200 frames per second, Mass Spectrometry for sensitive leak testing in the industrial environment, NDIR Gas Sensing for leak testing, Pressure Change Methods for leak testing, Force Sensors for leak testing. He built up a validation team to implement the requirements for the qualification of pharmaceutical equipment according to the GAMP requirements. Since 2018 he is Senior Application and Sales Manager at GASPOROX, a Lund (Sweden) located company which is highly specialized in laser based non-destructive gas measurements of parenteral packages.
7 авг 2024
