Potential interactions between drug products, container closure systems, and manufacturing process contact materials are an important regulatory consideration for pharmaceutical and biopharmaceutical companies. Every drug application must demonstrate that the proposed container closure system is safe and suitable for its intended use.
In accordance with current Good Manufacturing Practice (cGMP) requirements under 21 CFR Part 211.94(a), drug product containers and closures must not be reactive, additive, or absorptive in a manner that could affect the safety, identity, strength, quality, or purity of the product. Extractables and leachables (E&L) studies are therefore performed to identify and evaluate potential chemical contaminants or impurities that may be introduced during manufacturing or storage.
With over three decades of experience in E&L testing, VIMTA is one of the pioneers and preferred testing partners in this domain. Our state-of-the-art laboratories are equipped with LC-MS/MS, GC-MS, and ICP-MS technologies to accurately identify compounds that may migrate into a product during its lifecycle. We offer customized, protocol-driven E&L studies to help ensure regulatory compliance and patient safety. Our scientific team has successfully completed more than 2,000 E&L studies across a wide range of product categories, with data accepted by regulatory authorities in the United States and Europe.
