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Extractable & Leachable are one of the most important factors necessary to ensure the chemical safety and stability of containers. In recent years, the types of containers to be tested and the level of testing required by the authorities have increased rapidly.
Since 2017, Stevanato Group has partnered with Nelson Labs to provide not only high-quality containers but also a wide range of analytical services to pharmaceutical companies around the world. In particular, the increase in interest in E&L in Japan has been remarkable, and E&L cannot be ignored not only by pharmaceutical companies expanding globally, but also by pharmaceutical companies targeting only the Japanese domestic market. Ompi Japan Co., Ltd., the Japanese branch of the Stevanato Group, supports communication between Nelson Labs and pharmaceutical companies (test outline, schedule adjustment, explanation and discussion of test reports, sample transportation, etc.).
In this webinar, we will explain in Japanese the basic concept of E&L for primary packaging containers and important items in the test design.