1:30 pm – 2:00 pm:
T15-Medical Plastics: Materials and Processing for Medical Applications
(Moderators: Louis Somlai and Ajay Padsalgikar)-Room S320B

1:30 pm – 6:00 pm:
KEYNOTE: Opportunities and Obstacles for Plastic Primary Packaging in Drug Delivery Devices

Sarah Clark, Chief Engineer and Leader of the Materials Engineering Team, Eli Lilly and Company
Drug delivery devices like multi-dose pens and auto-injectors help patients manage their conditions in the comfort of their own homes. The drug inside these devices is traditionally packaged in a glass cartridge or syringe. Polymer containers are available alternatives for drug delivery devices but their substitution for glass containers is complicated by regulatory, cost, and practical drug filling process considerations. This talk will highlight the current state of polymer drug container technology, identify situations when glass packaging issues are solved by polymer containers, and review the key selection, processing, and regulatory requirements polymers must meet in this demanding application.

2:00 pm – 2:30 pm:
Establishing Polymer Equivalency Process for Medical Device Application

Shantanu Shivdekar, Boston Scientific
Polymer material selection for new medical device applications and also sustaining existing business presents challenge due to wide range of polymer manufacturer, grades available in the market. In addition, changing business climate results in acquisition of large corporations; causing consolidation of businesses and obsolescence of polymer grades. New methodology was presented to systematically analyze various factors for polymer equivalency. Besides engineering specifications, business factors with weighting/scoring approach were introduced to capture overall impact on business. Physical, mechanical, thermal property evaluation of polymers helps compare various resin grades available. Evaluation of Design and Process impact captures any potential risk to design, process or patient. As in many cases, changing polymer results in regulatory submission which may be lengthy process for medical device applications. In case of new product development, capturing overall impact assures new device development process can be completed in timely manner.

2:30 pm – 3:00 pm:
High Performance Polymers for Medical Devices

Marissa Tierno, Fluortek, Inc.
Demand for high performance polymeric materials and composites continues to increase for the Medical Device Industry as minimally-invasive procedures gain popularity. With a vast library of available types and grades, polymers offer design flexibility for a wide range of applications, allowing for the development of customized solutions based on the critical design requirements for a product or application. A variety of considerations influence polymer selection such as performance, biocompatibility and other regulatory requirements, ease of secondary processing for finishing operations such as bonding or shaping or molding, among other specifications. Minimally-invasive, image-guided techniques require X-ray detection for intraoperative guidance and maneuvering. Since polymers are X-ray transparent, radiopaque (RO) fillers are incorporated into polymer matrices through compounding processes. Such mixing processes produce uniform mixtures consisting of polymer(s), functional additive(s), filler(s), yielding customized polymer compounds. This presentation reviews how high-performance polymers and their compounds meet increasingly challenging design requirements for use in medical devices.

3:00 pm – 3:30 pm:
EVA Polymer as a Platform for Advanced Drug Delivery

Don Loveday, Celanese
Ethylene Vinyl Acetate Copolymer: Review of high value pharmaceutical applications The potential for use of polymers in controlled drug delivery systems has been long recognized. Since their appearance in the literature, a wide range of degradable and non-degradable polymers have been demonstrated in drug delivery. The significance and features of ethylene-vinyl acetate (EVA) copolymers in initial research and development led to commercial drug delivery systems. This review examines the breadth of EVA use in drug delivery, and will aid the researcher in locating key references and experimental results, as well as understanding the features of EVA as a highly versatile, biocompatible polymer for drug delivery devices.

3:30 pm – 4:00 pm:
Chemical and Thermal Analysis of the Surface Extractives of Medical Tubing of A Poly(ether-b-amide) Copolymer Using FTIR, GPC, and DSC Methods

Xiaoping Guo, Abbott Laboratories
Medical tubing extruded of a commercially-available PEBA (poly(ether-b-amide)) copolymer resin, namely Pebax® 4033 SA01 MED, was surface-extracted using a typical nonpolar solvent, n-hexane. After the completion of solvent evaporation, the obtained extractive solution was dried into waxy specimens, which were then chemically characterized using ATR-FTIR (attenuated total reflectance-Fourier transform infrared spectroscopy) and GPC (gel permeation chromatography) methods. It is determined that the surface extractives of medical tubing contain the oligomeric polyether reactant residual existing in the PEBA resin and various low MW (molecular weight) species rich in polyether segments. Thermal analysis on the as-received tubing and the PEBA resin was conducted using DSC (differential scanning calorimetry) technique. The relevant results suggest that the surface extractives, though they are loosely attached onto the surface of medical tubing, are fully miscible with the bulk PEBA material upon melting. The mechanism for the formation of the surface extractives during tubing extrusion and applicable effects on post-extrusion process development for making medical devices are discussed.

4:00 pm – 4:30 pm:
Smart Material Selection for Quiet, Smooth-sliding Medical Devices Including New Color Concept

Bruce Mulholland, Celanese
Engineering polymers are increasingly recognized as replacements for metal and ceramics in medical and pharmaceutical devices such as injection pens, inhalers, lancing devices and surgical instruments. These devices contain moving parts that must function efficiently with a low coefficient of friction, low noise and no wear, starting with the first activation. Regulatory requirements must also be met and Celanese has developed the portfolio of Medical Technology grades to address this requirement. Medical device performance has to be achieved in complex design environments including movements against different types of materials that are operating across a range of temperatures and chemical environments and a range of speeds and forces in operation. Their light weight and dimensional accuracy is achieved through precision molding. This, combined with good sliding performance, distinguishes these plastics from metal. Furthermore, appearance and functional color techniques are necessary to ensure device functionality. For example, for the application of a marking on a device to assure correct calibration and dosing, appropriate Medical Technology polymers have to be applied. This paper reviews traditional polymers with and without external lubricants. It also gives an overview of tribologically modified polymers that operate effectively without the aid of external lubricants including a new concept for mass colored plastics.

4:30 pm – 5:00 pm:
Processing of TPUs for Medical Applications

Ian Pierson, Abbott
Thermoplastic polyurethanes (TPU) are a common choice as a biomaterial for many medical devices, especially devices requiring long term implantation. Many of the desirable properties of TPUs as biomaterials are directly related to their unique microstructure, containing both hard and soft polymer segments. However, this microstructure can be influenced by a number of factors present both before and during the device manufacturing process. Because components for medical device applications are held to a high quality standard that requires consistency between parts, changes to the polymer microstructure can have a significant impact on the completed part. Further complicating their processing, medical device parts are often smaller and require a lower throughput in production than non-medical device parts. In this study, the effects of storage conditions, drying conditions, and process settings were evaluated in order to understand how changes in these factors impact important material properties.

5:00 pm – 5:30 pm:
Antimicrobial Bi-layer Catheters – Extrusion and Performance

Timothy Largier, Foster Corporation
This study sought to produce effective antimicrobial catheters via bi- layer extrusion. Catheter samples were extruded with inner and outer layers of biocompatible thermoplastic polyurethanes (TPU). The inner layer of low durometer was compounded with PureEaseTM processing additive, and the outer tube with Agion® AD anti-microbial zeolite. Agion® concentration, outer layer tube thickness, and processing thermal history were considered. The antimicrobial bi-layer catheters were highly effective at inhibiting cell division and reducing the number of organisms by a 5 log reduction for CRE, and 3 log reduction for MRSA. The thickness of the outer tube did not influence the catheters antimicrobial effectiveness. It is concluded that bi-layer extrusion is a viable method for obtaining highly efficient, low-cost antimicrobial catheters.

5:30 pm – 6:00 pm:
Elastomeric to Engineered Thermoplastic Polyurethanes

Anthony Walder, Lubrizol
Medical device engineers found Thermoplastic Polyurethanes (TPU) quickly after their introduction almost 60 years ago. Some of the reasons for TPU acceptance are strength, biocompatibility and that they can be shaped using common melt processing techniques. Since the introduction of the first TPUs, different chemistries have involved under the TPU umbrella. The attributes of the various TPUs will be discussed in relationship to physical and chemical properties and application requirements.