Extractables & Leachables

The materials used to fabricate container closure systems (CCS), medical devices, and processing equipment are often polymers, such as plastic or elastomers (rubber), rather than metal or glass. Polymers offer more versatility, since they are light-weight, flexible and much more durable than their traditional counterparts. Additives can be incorporated into polymers to give them clarity that rivals that of glass, or to add color to the materials, or that can give the polymer a desired physical property. However, given all of the positive attributes that polymers possess, there are also some negatives to consider when working with them in medical applications. In the presence of heat, light, oxygen and various external influences, such as sterilization, polymers can degrade over time if not properly stabilized. This degradation can manifest itself as cracking, discoloration, or surface blooming/exudation and can severely impact the mechanical properties of the polymers.

Our extensive plastics characterization experience is the backbone of our Extractables & Leachables testing regiment. This knowledge serves as a solid foundation for our experts to characterize container closure systems quickly and efficiently for leachables. We follow Product Quality Research Institute (PQRI) best practices to ensure all studies are thorough and compliant. While a proven testing process is the starting point, each project benefits from our scientific experience and ability to customize methods and develop the best testing solutions.