Extractables and Leachables Testing for Medical Applications
By: Michael Ruberto, Ph.D. Material Needs Consulting, LLC.
The materials used to fabricate container closure systems (CCS), medical devices, and processing equipment are often polymers, such as plastic or elastomers (rubber), as opposed to the traditional 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 which could be used as a form of labeling or coding of various types of processing components. 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.