Acrylic Polymer Helps Neo Natal CPAP Device
Rockaway, NJ - Airways Development, LLC has chosen CYROLITE GS-90 acrylic-based multipolymer compound for molding the neo natal swivel connector on its new Clarissa Infant Nasal CPAP assembly. In addition to providing a balance of properties for superior medical device designs, CYROLITE GS-90 compound is contact compatible for a range of treatments. This helped win quick approval from FDA for Airways Development to market its new medical device in the United States.
The Clarissa is a continuous positive airway pressure (CPAP) device used for treating neonatal and infant patients in hospitals and other institutional environments. The swivel made with CYROLITE GS-90 compound adjusts to patient movements, preventing any discomfort or danger while the device is in operation.
Airways Development needed a transparent compound that was tough, bondable, and easy to process. An important factor for the company, however, was the compound's biocompatibility data. Using other materials, such as polypropylene-based compounds, would have delayed FDA approval due to biocompatibility challenges.
"CYROLITE GS-90 compound was the right choice for the Clarissa connector," reports Robert Landis, Vice President, Product Development for Airways Development. "Its biocompatibility data helped expedite the FDA approval process, and we were able to bring a safe product to market more quickly."
The Clarissa is a new style of infant nasal CPAP assembly designed to minimize flow resistance, maintain nasal tissue integrity for increased patient comfort, and maximize device stability for ease of positioning. It can be used with any infant ventilator in the CPAP mode, and attaches to standard 10mm infant ventilator breathing circuits.
Manufactured by CYRO Industries, North America's leading producer of acrylic molding and extrusion compounds, CYROLITE GS-90 compound is gamma, e-beam, and EtO sterilizable. The compound is used to mold a range of medical devices, including IV adaptors and filter housings, luers, IV connectors and accessories, spikes, check valves, Y-sites, cassettes, blood handing components, and catheter accessories.
Manufacturers need to assess the potential of leachables in device development and manufacturing, and chemical compatibility is a critical consideration. CYROLITE GS-90 compound is contact compatible for a range of pharmaceutical treatment drugs and carriers, fulfilling requirements of the United States Pharmacopoeia (USP) 26, National Formulary 21, 2003 <661> "Physiochemical Tests – Plastics."
The suitability of any CYRO compound in given end-use environments is dependent upon various conditions, including, without limitation: chemical compatibility, temperature, part design, sterilization method, residual stresses, and external loads. Manufacturers are responsible for evaluating final products under actual end-use requirements and for adequately advising and warning purchasers and users thereof.
SOURCE: CYRO