Ink and Gum Migration Studies

The container closure systems not only serve various functional requirements, but are also important source of transmitting valuable and critical information about the product, its usage, and other information as mandated. Though printing is an integral part of displaying this information, leachables from printing and labels have been a concern for various regulatory bodies. It is therefore mandatory to ensure that the drug products are devoid of any contamination due to leaching of ink and gum.

With over three decades of experience in E&L testing, VIMTA has been the pioneers and most preferred testing partner in this domain. Our state of the art laboratories are equipped with HPLC, GC and LCMS 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 regulatory requirements and is safe for the patients. Our experienced scientific team has performed more than 500 E&L studies for various product categories and including ink and gum migration studies, 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.