Originally Published MDDI June 2002
BULLETIN BOARD
A new compounding facility has 15-million-lb production capacity. A manufacturing facility producing polyethylene and polypropylene compounds used in medical applications offers updated compounding technologies. Alloy Polymers Inc. (Richmond, VA; 804/232-8000) has also adopted specialized operating procedures, quality control audits, and operator and supervisor training at the new facility. The site's secure environment features two 90-mm Werner-Pfleiderer ZSK twin-screw extrusion lines and customized material-handling and -feeding systems. Facility design and operation meet industry and regulatory standards and comply with FDA's CGMPs.
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Polymer withstands high pressures in tubing assemblies.
A high-performance thermoplastic, polyaryletherketone (PEEK), provides a higher tensile strength than most plastics, permitting quick-disconnect tubing assemblies made from the material to be bent to fit any application. PEEK manufactured by Victrex USA Inc. (Greenville, SC; 800/842-8739) also enables the transport of viscous fluids at pressures of up to 2000 psi. Super-thin-wall designs aid in handling high pressures. Quick-disconnect assemblies are considered disposable, but can be sterilized before use since PEEK's semicrystalline structure provides resistance to sterilization cycles operating at temperatures of 280ºF. In addition, PEEK prevents carryover from sample to sample; there is no chemical reaction between a tested sample and a reagent, which makes the polymer suitable for use in in vitro diagnostic tubing assemblies.Thermoplastic elastomer alloys improve molding performance. Thermoplastic vulcanizate (TPV) extends processing and injection molding capabilities. Compared with styrenic-based thermoplastic elastomers (TPEs), Versalloy XL 9000 TPV features lower compression set values, improving on processing efficiency. Manufactured by Alliance Alloys LLC (Leominster, MA; 978/534-7216), XL 9000 enhances moldability through its elastomeric performance and uniform shrinking behavior. Other characteristics of TPV include color uniformity; Shore A hardness values of 45, 55, and 70; a rubberlike tactile appeal; and processability in styrenic TPE and TPV tooling. The Versalloy line also offers durability and resistance to chemicals, abrasion, high temperatures, and compression.
Parylene film sterilization methods reviewed. Specialty Coating Systems (SCS, Indianapolis; 800/356-8260) has conducted a series of tests to determine the effects of common sterilization methods on parylene coatings. Laboratory-assisted test procedures included steam autoclave, gamma and E-beam radiation, H202 plasma, and EtO methods. Several parylene N and C samples were analyzed for changes in dielectric strength, water-vapor transmission, coefficient of friction, and tensile properties. Parylene, a pinhole-free protective film, is used in a wide range of medical applications, including electronic pressure sensors, cardiac assist devices, prosthetic components, catheters, and needles and cannulae. Poststerilization test results are available for reference by SCS customers through the company's FDA device and drug master files.
Standards compilation focuses on radiation curing technology. A handbook focusing on the growing technology of radiation curing is now available. Manual 45, Radiation Curing of Coatings was written by Joseph V. Koleske of Consolidated Research Inc. and compiled by ASTM International (West Conshohocken, PA; 610/832-9585). Useful as a resource for scientists, technologists, laboratory technicians, and managers in the field of radiation curing of coatings, adhesives, inks, and sealants, Manual 45 is application-specific and written in a straightforward style. Data presentations rely more on written explanations than figures and tables. Available as a companion to Manual 45, ASTM Standards Related to Testing of Radiation Cured Coatings outlines ASTM procedures, test methods, and guides on radiation curing of coatings.
Short-lead-time process for small-part micromolding is launched. A process suited for part sizes of 0.33 to 1.31 oz in medium to large quantities can cut lead time to market by half, according to the molder. The Micro-Cell micromolding process, developed by PTI Engineering Plastics Inc. (Clinton Township, MI; 586/263-5100), uses a closed-loop system to convey raw material to molding machines by way of a material-handling machine. Mold changes are performed in less than 10 minutes; part runners and residual regrind are nonexistent. Optimal cavitation calculated at 60–75% utilization per job reduces downtime, and few mold cavities are needed due to the size of the Micro-Cell machine, producing lower defect rates. Like conventional runnerless molds, Micro-Cell molds are built with updated CAD/CAM/CNC equipment. PTI offers in-house tooling, standard mold bases, and unit mold frames to reduce tooling costs.
Copyright ©2002 Medical Device & Diagnostic Industry
