Originally published September 1997
TECHNICAL PAPER SERIES
The volume of plastics used to produce disposable medical devices and supplies is projected to grow to more than 1.6 billion pounds by the year 2000.1 Efforts aimed at conserving resources and containing costs have encouraged device manufacturers to seek alternative materials that can meet device performance requirements while using less material. Fabricators will look for opportunities to reduce the thickness, weight, or volume of device components without compromising the structural integrity or functionality of the device. For disposable devices and supplies, a reduction in raw materials will result in a direct reduction of waste.
Flexible polyvinyl chloride is one of the largest-volume film materials used in the manufacture of medical devices, and thus presents a significant opportunity for both raw material and waste reduction. Because PVC film provides a wide array of functional performance characteristics at a low cost, alternative materials will need to offer similar performance at comparable cost. Performance properties of PVC important to the medical device industry include its long, successful track record in medical applications; a breadth of properties achievable by compounding; the ability to be fabricated by RF welding and solvent bonding; the ability to be sterilized by autoclave, ethylene oxide (EtO), or gamma (although some yellowing can occur with gamma); a wide service temperature; durability and chemical resistance; and good breathability, elasticity, and clarity.2,3
Recent developments in metallocene single-site catalyst technology make possible precise control of molecular architecture and enable the production of polyolefin resins with very low densities and narrow molecular-weight distributions. Metallocene-catalyzed polyethylene copolymer resins (mPE) are currently being made with specific gravities in the range of 0.860.92 and comonomer content of 045%. Polyolefin plastomer resins formulated as ethylene-octene copolymers with less than 20% comonomer (produced by Dow Chemical Co., Midland, MI) have demonstrated enhanced toughness, sealability, clarity, and elasticity.
The toughness of mPE resins can allow for thinner, lighter-weight films, and the lower density of the mPE films results in a higher yield than is possible with PVC, producing more film area per pound. Very stable following sterilization by either radiation or EtO, mPE films provide good low-temperature flexibility and impact resistance, and have a low seal-initiation temperature. The lower melt temperatures of the mPE resins (less than 110°C) make these films inappropriate for products requiring autoclave or high-temperature steam sterilization.4
This study was designed to test the suitability of films made using mPE resins as alternatives to flexible PVC films for medical device and appliance applications. Films used in this study were fabricated from ethylene-octene copolymer mPE resins with specific gravities between 0.880.90 and comonomer content of 1220%.
Table I lists the four film types evaluated in this study. They included two mPE films with different densities and two medical-grade PVC films that were designated by the manufacturer for use in medical collection or drainage bags. The mPE films used were 0.25 and 0.15 mm (10 and 6 mil) thick, and the PVC films were 0.18, 0.20, 0.23, and 0.25 mm (7, 8, 9, and 10 mil) thick. Since the films were embossed on one surface, thickness was reported as a nominal thickness per ASTM E 252.5
Standard physical properties evaluated for all films included tensile strength, elongation, modulus, tear resistance, puncture resistance, and barrier characteristics. The films were conditioned according to ASTM D 882 and then tested following the ASTM method, as shown in Tables I, II, III, and IV.
The puncture-resistance test conducted on the film material is similar to ASTM D 3763, but is run at a lower impact speed. One sheet of film is held in a clamp that has a circular opening 45 mm (1.8 in.) in diameter. A 12.7-mm-diam (0.5-in.) spherical probe attached to a load cell on a moving cross-member is pushed through the film at a speed of 500 mm/min (20 in./min), and the resulting total energy per unit area required to puncture the film is recorded.
For the purposes of this study, liquid-collection bags were chosen as a typical medical device application. The bags are commonly made from two sheets of film welded together around the perimeter, with an inlet port sealed into one end; they may also include an outlet port and a means of measuring the volume of the liquid contents. For this study, bags were made using two rectangular plies of film totaling 432 cm2 (0.5 sq ft) each.
The collection bags were made using radio-frequency (RF) welding to bond the perimeter. PVC films and other polymers with high dielectric loss factors respond to RF energy and are commonly fashioned with RF welding equipment; however, mPE films and other low-loss polymers do not respond well to conventional RF welding. Successful RF welding of mPE films requires the addition of a mechanical "catalyst" to the existing RF equipment. The mPE bags for this study were produced using RF welding equipment (stabilized at 27.12 MHz) that had been modified with a reusable catalyst film by Plastics Welding Technology (Indianapolis). Hot-bar or impulse heat-seal equipment can also be used to form mPE films into devices.
The British Standards Institution (BSI) has developed a performance standard for liquid collection bags (BS 7126 and ISO 8669) that includes test methods for determining resistance to bursting (part 101, appendix G) and resistance to impact damage (part 101, appendix H).6 The method for determining resistance to bursting involves filling a bag with its rated volume of water (or 90% of its reference volume), sealing any openings, and placing the bag horizontally under a flat rigid plate on which weight is added to impose a 350-N (78.7-lb) force on the filled bag. After the load is applied for 1 minute, the bag is examined for leakage or bursting. The method for determining resistance to impact damage involves filling the bag to 50% of its reference volume and sealing it without entrapping air in it. The bag is then dropped from a height of 500 mm (19.7 in.)so that the bottom hits a hard surfaceand examined for leakage or bursting. The reference volume for the bags used in this study was 1240 ml; they were filled with 1116 ml of water for the bursting test and with 620 ml of water for the impact test.
The burst strength of the finished bags was tested by filling them with air at a controlled pressure and flow rate and measuring the time required to fill each bag to the point of failure. Bags fabricated with two 432-cm2 plies of film were inflated with air at a rate of 5.36 L/min and a line pressure of 0.083 MPa (12 psi) until they burst.
The results of the physical property tests are shown in Table II for the mPE films and in Table III for the PVC films. For the physical properties tested, the mPE films demonstrated similar or superior results when compared with the PVC film of the same thickness. Significant differenceswhen the mPE films showed property improvements of greater than 50% over the PVC filmwere seen in results of the elongation, toughness, tear-strength, and puncture-resistance tests.