In a significant leap forward for medical product safety, SGS, the global leader in testing, inspection, and certification, has introduced a cutting-edge test to assess the quality and integrity of pharmaceutical containers, specifically those utilized for vaccines.
The newly implemented technology, at the SGS laboratory in Villeneuve-la-Garenne (92), specializes in quality control for the pharmaceutical industry. This innovation addresses the unique challenges posed by flexible membrane containers, crucial for maintaining sterility in pharmaceutical products.
Stéphane LOGASSI, Manager of the SGS France laboratory, expressed the importance of the breakthrough, stating, “This new test enables us to meet the challenges of detecting leaks and preserving the integrity of pharmaceutical products, and is a major step forward for SGS.”
Since its initiation in September 2023, the test has undergone more than 500 assessments and over 10 method validations, showcasing its reliability and effectiveness. As the pharmaceutical industry faces concerns related to micro-leakage, contamination, and product degradation, this new integrity control system is positioned as a game-changer.
The procedure involves subjecting each pharmaceutical container to a dedicated vacuum machine, employing various methods based on the container type, such as the helium test or microcurrent test. This meticulous process identifies any material fragility, ensuring a thorough assessment of the risk of degradation.
With 35 experts conducting tests at the Villeneuve-la-Garenne laboratory, SGS plays a pivotal role in guaranteeing the integrity of pharmaceutical containers. With ambitions to extend its presence to at least 5,000 pharmaceutical industry sites across Europe, SGS solidifies its commitment to conformity and quality in the pharmaceutical sector. The company’s proactive approach is expected to contribute significantly to the enhancement of medical product safety in the coming years.
Learn more about Container Closure Integrity Testing