Parker Hannifin Corporation
Parker Medical Grade ALC Polyurethane.
Parker Hannifin Corporation, the global specialist in motion and control technologies, has created a medical grade polyurethane that not only displays characteristic polycarbonate resistance to oxidation and alcohol swelling, but also demonstrates expanded resistance to environmental stress cracking.
Developed by the Engineered Polymer Systems (EPS) Division of Parker, the product, called Parker Medical Grade ALC Polyurethane, is an aliphatic polycarbonate-based thermoplastic polyurethane designed for use in medical and life science applications.
ALC polyurethanes are non-yellowing, color-matchable, thermoplastic polyurethanes available in clear or radiopaque grades. Characteristics and advantages include: USP Class VI certified; biocompatible and biostable – passes cytotoxicity and indirect hemolysis tests; expanded resistance to chemical attack for better in-body integrity; softens in the body; enhanced reliability and processing consistency over currently available polyurethanes for increased yields; excellent mechanical properties; able to be compounded with custom colorant and radiopaque fillers; manufactured in an ISO-certified clean room environment.
Medical applications for Parker ALC polyurethanes include: vascular access devices; cardiovascular treatment devices; disposable surgical supplies; tracheotomy devices; urological devices; dialysis devices; and feeding tubes.
“Parker’s new ALC polyurethanes offer a proven advantage over competitive products,” commented Arlo McGinn, PhD, Parker EPS Senior Chemist. “Many medical grade urethanes, including ALC polyurethane, are now made with aliphatic polyurethane instead of the old standard, aromatic polyurethane, because of yellowing and carcinogenic concerns. The aliphatic polyurethanes have lower mechanical properties than aromatic but degrade to potentially safer end products, do not discolor upon exposure to light, and also show enhanced resistance to hydrolytic decomposition. However, along with the decreased mechanical properties, aliphatic polyurethanes are more prone to a physical degradation process – termed environmental stress cracking – than their aromatic counterparts.
“Parker has successfully addressed this issue through its proprietary formulation and advanced manufacturing processes,” said McGinn. “We analyzed the performance of several aliphatic polycarbonate urethanes, including our ALC polyurethanes and two competitors. Upon exposure to alkaline conditions, differences in tube performance within the ALC class were compelling: the competitive ALC urethane tubes quickly degraded and failed due to the effects of environmental stress cracking. During the same time period, however, Parker’s ALC formulation showed no significant change after initial softening over the course of the testing, and demonstrated enhanced resistance to environmental stress cracking.”
Parker ALC polyurethanes may be extruded as well as injection molded. Extrusion configurations can be single lumen or multi lumen, as well as tapered (bump) or coextruded.
Polyurethane materials are specified for medical device components due to their ability to meet the stringent performance, biocompatibility, and sterilization requirements of the applications in which the devices are used. Parker offers single-source engineering, production, validation, and complete project management to effectively deliver USP Class VI certified medical grade thermoplastic polyurethane tubing and other products for medical devices that demand precision and consistency. Expanded capabilities include ISO Class 7 and Class 8 clean room manufacturing. Registrations include ISO 13485 and ISO 9001.