Lifesaving and life extending technologies are evolving around the world. The base materials used in the production of such devices are often overlooked and taken for granted despite being the backbone of the technology. Many times, engineering decisions are made based on previous personal history with any given material be it Nylon or PTFE or HDPE. The limitations of the base materials are often understood but the ability to customize those properties is not. On many occasions project teams choose previously used, well-known materials, however via a short conversation with Compounding Solutions your eyes can be opened up to so much more! Tens of thousands of unique materials exist, each of which can be compounded to modify its properties. Hard or soft, compliant or rigid, clear or colored, lubricious or tacky qualities can all be imparted via a huge range of additives.
A quality that nearly all device companies search for is a USP VI or ISO 10993 certification on the materials. Generally, this approach is followed because it is thought that this will lead to an FDA approval based on that rating. Anything but that is the case. FDA device review is done as an agglomeration rather than piecemeal. While the constituents may be USP VI the entire device is not. An overloading within the assembly of any given component can push cytotoxicity levels over acceptable limits.
Compounding Solutions stays very close to the medical device industry working with our customers from the R&D process through the final FDA reviews and market launch. Throughout this process, we focus on the feedback the reviewers are passing along. With this knowledge, we can help guide you to select the most appropriate components for your custom compound.
Compounding Solution’s compounding process is done in our controlled environment production area (White room) which ensures that all our medical grade polymers and compounds will be made with the highest quality and purity in mind. It is designed to minimize exposure to airborne particulates, common contaminates, and moisture. Beginning in October 2011, manufacturing of our medical grade compounds was transferred to our “White Room” compounding area. Responding to the needs of our customers as well as industry demands for cleaner manufacturing environments, we set out to complete a massive facility expansion centered on a new manufacturing area meeting the needs of the medical compounding market.
Our “White Room” is the largest production facility of its kind. To ensure a clean environment, the “White Room” includes an Air Lock with a positive pressure environment, sealed and polished concrete floors, HEPA filtered air exchange with humidity and temperature controls, and epoxy coated wall surfaces to repel dust and allow for easy cleaning of all surfaces. Great care was taken in designing our “White Room” to minimize all potential sources of product contamination. From point of use dust collectors, to underground energy sources, we have ensured that every compound manufactured in our “White Room” will be of the highest quality and purity.
|If You Have Questions About the Components In Your Device And Want To Make Sure You Are Well Positioned For Your Review And Subsequent Market Launch, You Should Speak With Us Today! …Contact Us|