Extractables & Leachables Studies

During manufacturing of medical devices, many compounds are intentionally added as colorants, coatings, impact modifiers while others may be picked up inadvertently during processing or may be a by-product of degradation during storage, transportation or sterilization. The Extractables and Leachables (E&L) testing identifies chemical compounds in medical devices that could be potentially harmful to end users, and is an essential pre-requisite for device testing as per recent guidelines.

With close to two decades of experience in E&L testing, VIMTA has been the pioneer and most preferred testing partner in this domain. Our state of the art laboratories are equipped with large fleet of LCMS/MS, GCMS/MS and ICPMS to accurately identify the chemical compounds that may leach from the product during usage. At VIMTA, we offer customized protocol driven E&L testing services to help you ensure that your product meets applicable regulations requirements and is safe for the patients. Our experienced scientific team has performed more than 500 E&L studies for various product categories and is fully conversant with applicable standards and regulatory requirements. Our data has been submitted to, and well accepted by, US and European regulatory authorities.