The new cleanroom at our global headquarters in Salt Lake City, Utah, was designed for today's rigorous contamination control expectations, driven by EU GMP Annex 1. Learn More
With their flexibility and complex components, endoscopes present unique cleaning and disinfecting challenges. Endoscope manufacturers, regulatory bodies, and healthcare facilities are increasingly concerned about the spread of communicable diseases, including clinically relevant microorganisms, on reprocessed medical devices. The concern over...
Since Audrey Turley started her career 20 years ago at Nelson Laboratories, she has worked in various departments including bioburden, biocompatibility, and technical consulting. She has cross-trained in other sections and has performed IDs, air sampling in hospitals, hydrostatic pressure,...
The previous three posts addressed biocompatibility concerns of 3D printed devices considering additives to the raw materials, the material curing process, and post-printing finishing processes. Both thermoplastics and photopolymers contain additives (oligomers, plasticizers, preservatives, etc.) that are freshly redistributed through...
In the previous two posts, the biocompatibility of 3D printed devices was discussed with consideration for the possible compounds added to the raw materials for workability and the polymer precursors and byproducts associated with photopolymerized structures. In both of these...
The last blog post reviewed how 3D printed medical devices present unique challenges from a biocompatibility assessment perspective due to their highly customized material properties. Additives to raw materials used in 3D printing are required to enhance workability. For 3D...
