Silicone elastomers, foams, coatings, and adhesives are widely used in virtually all aspects of manufacturing, in construction, the automotive industry, and medical and personal care products. The properties that contribute to making silicones indispensable in many applications, such as their ability to repel water, their excellent heat stability and chemical resistance, are also responsible for the challenges that can arise working with silicone. Challenges can arise during production of cured silicones because they are formulated with defined amounts of catalysts, crosslinkers, polymers, and inhibitors that can be sensitive to different additives, processes, and environmental conditions.
Recently, a medical device manufacturer faced major delays in product delivery because of problems with cured silicone components. RJ Lee Group’s experts were contacted to determine the root cause of the problem. Our first step was to conduct a comprehensive assessment of the product’s life cycle so that we could design the proper studies to investigate the cause. Once we were able to understand the entire life cycle of the product and conduct targeted analyses, we determined that the problem arose as a result of an unreported formula change in the molds that were creating the silicone parts. This formulation change, though previously considered insignificant, threatened a major product launch and, potentially, consumer safety. Having identified the root cause, we then were able to work with the client to develop more robust raw material specifications and testing to ensure quality and reduce downtime in the future.