Parylene Coatings for Pharmaceutical Containers and Delivery Devices Lonny Wolgemuth Specialty Coating Systems Email: LWolgemuth@scscoatings.com
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Biography Lonny Wolgemuth is Sr. Medical Market Specialist for Specialty Coating Systems. His responsibilities include expansion of SCS’ medical markets activities and new medical applications for Parylene conformal coatings. Wolgemuth has been active in the medical device industry for over 35 years, with experience ranging from in-hospital clinical engineering to product management, market management and national technical support management for international medical device manufacturers in patient monitoring, wound care and patient temperature management. He has been active in technical medical device standards writing committees for patient temperature management devices, and has testified before FDA device classification panels (tcPO2 monitoring devices). Wolgemuth obtained his Bachelor of Science in Engineering degree at Purdue University in Indiana, and holds a Master in Business Administration degree from the State University of New York at Buffalo, New York. Company Profile Specialty Coating Systems is the industry leader in providing Parylene equipment and coating solutions. SCS coats medical devices … from stents, ICDs, pacemakers and neurostimulators to cochlear and ocular implants to o-rings, valves and tracheostomy tubes in Class 5, 6 and 7 cleanrooms. Headquartered in Indianapolis, Indiana, USA, SCS has 9 coating centers around the world to meet medical device manufacturers’ global presence.
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Abstract Conformal coatings are routinely used in various industries to modify the surface properties of numerous materials. However, a special level of sophistication is required for pharmaceutical container or delivery device coating processes. Whatever the pharmaceutical application, the coating must achieve the desired results without adversely affecting component, container, contents … or the patient. Parylene (poly[para-xylylene]) is a thin, continuous, inert, transparent, biocompatible conformal coating that meets many of these performance requirements. Parylene is applied in room temperature vacuum deposition chamber by a process known as vapor deposition polymerization (VDP). The coating process involves the spontaneous re-sublimation of a vapor formed by heating a powdered, dry precursor material. The vapor converts to an inert polymer coating on target surfaces in a dry, solvent and catalyst-free process. Parylene provides useful barrier properties per unit thickness, as well as extreme chemical inertness and freedom from extractables or leachables. The coating itself is also free of catalytic, solvent and plasticizer residuals. It is used protect both containers and pharmaceuticals as well as control the delivery rates of drugs.
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