Wearables have to be just that—wearable. So the components inside, including those containing the drug they are delivering, must fit into a product that is portable, durable, and convenient enough for patients to wear.
These devices can present engineering challenges. “The products themselves are becoming increasingly more sleek (i.e., smaller),” says Dan Snyder, technical sales manager for Plastikos Inc., an injection molding company manufacturing custom components for drug-delivery devices. “The components inside of these devices require extremely tight tolerances (0.001 in. in plastic). This can be challenging with building a multi-cavity tool that will produce millions of parts annually.”
Plastikos and its sister mold-making company Micro Mold are reporting success in molding disposable cartridge components out of cyclic olefin polymer (COC). Commercial projects include components for wearable drug-delivery devices for pain medication and insulin, such as insulin pumps, Snyder tells PMP News. The company also reports evaluating COC use in other drug-delivery applications.
A recent project entailed designing and constructing multi-cavity molds that include up to 32 cavities with fully interchangeable inserts among all cavities, Plastikos reports. Every cavity on each mold was designed and built with a cavity pressure sensor that monitored every production cycle to reduce the risk of shipping a single defective part.
“In these highly demanding applications, we are able to push the limits in terms of precision molding because of the broad material and process know-how we bring to the table,” said Rob Cooney, manufacturing manager for Plastikos, in a statement. Micro Mold and Plastikos maintain a medical molding room controlled through an ISO 7 cleanroom (Class 10,000) with press tonnages ranging from 88T - 220T.
Last year, Plastikos shipped almost eight million parts molded from TOPAS cyclic olefin copolymer (COC) from TOPAS Advanced Polymers. “We have worked closely with Plastikos for several years now, and are very impressed with their ability to scale up incredibly precise designs to meet the needs of healthcare device makers,” added Timothy Kneale, president of TOPAS Advanced Polymers Inc., in the statement.
Snyder calls TOPAS COC “a well-respected material because of its drug compatibility and other high-performance attributes.” According to TOPAS, the material offers a non-ionic, minimally reactive surface, and the non-polar substrate does not promote adsorption, denaturation, aggregation, or precipitation.
Are you up to speed on the recently finalized USP Chapter <661> Containers-Plastics? To help you understand how these changes might impact packaging development and testing, we've invited Desmond G. Hunt, PhD, USP's Senior Scientific Liaison, to speak June 16 at EastPack in “Materials Qualification & Performance: How Will Changes to USP Chapters Impact Packaging Professionals & Drug-Delivery Device Design?” Following his presentation, Hunt will join the panel discussion: “Putting the Changing USP Packaging Chapters to Work” moderated by Dwain L. Sparks, Strategic Advisor & Expert Consultant, YourEncore (Eli Lilly & Co. Retiree). They’ll be joined by Dan Malinowski, Senior Director of Package Technology & Innovation, Pfizer; and Brandon Zurawlow, Associate Director of Container Qualification & CCIT, Whitehouse Laboratories, a division of AMRI.