Sterility is required for medical devices use in invasive medical procedures, and for some situations in the food industry. Sterilization of heatsensitive or porous materials or devices, such as endoscopes, porous implants, liquid foodstuff, and liquid medicine, poses a challenge to current technologies. There has been a steady interest in using high-pressure carbon dioxide as a process medium for new sterilization technology. Among the potential advantages are that CO 2 may sterilize at low temperatures. This paper is a review of the technical and patent literature, including analysis of the microorganisms studied, important operating parameters, and deactivation mechanisms. The current research status and challenges are summarized at the end of this paper.

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It was hypothesized that supercritical carbon dioxide (SC-CO(2)) treatment could serve as an alternative sterilization method at various temperatures (40-105 degrees C), CO(2) pressures (200-680 atm), and treatment times (25 min to 6 h), and with or without the use of a passive additive (distilled water, dH(2)O) or an active additive (hydrogen peroxide, H(2)O(2)). While previous researchers have shown that SC-CO(2) possesses antimicrobial properties, sterilization effectiveness has not been shown at sufficiently low treatment temperatures and cycle times, using resistant bacterial spores. Experiments were conducted using Geobacillus stearothermophilus and Bacillus atrophaeus spores. Spore strips were exposed to SC-CO(2) in commercially available supercritical fluid extraction and reaction systems, at varying temperatures, pressures, treatment times, and with or without the use of a passive additive, such as dH(2)O, or an active additive, such as H(2)O(2). Treatment parameters were varied from 40 to 105 degrees C, 200-680 atm, and from 25 min to 6 h. At 105 degrees C without H(2)O(2), both spore types were completely deactivated at 300 atm in 25 min, a shorter treatment cycle than is obtained with methods in use today. On the other hand, with added H(2)O(2) (<100 ppm), 6 log populations of both spore types were completely deactivated using SC-CO(2) in 1 h at 40 degrees C. It was concluded from the data that large populations of resistant bacterial spores can be deactivated with SC-CO(2) with added H(2)O(2)at lower temperatures and potentially shorter treatment cycles than in most sterilization methods in use today.

A novel approach to property enhancement of poly(l-lactic acid) (PLLA) through the use of perfluoropolyether (PFPE) enchainment is described. Segmented copolymers (FluoroPLA) exhibit tailored surface properties with reasonably high molecular weights and low polydispersities compared to PLLA alone using standard ring-opening polymerization procedures in the presence of tin catalysts. Low loadings of PFPE content (ca. 1−5 wt %) decreases surface energies compared to PLLA from 35 to 38 to 15−18 mN/m2, similar to values reported for poly(tetrafluoroethylene). Ultimate strain studies of FluoroPLA fibers and films have shown a dramatic increase (>300% elongation) over PLLA. This new class of polymer may further expand the use of renewable resources in a variety of applications such as flame retardants, chemical resistant fibers and/or fabrics with tailorable surface energies and wetting properties.

This article concisely reviews the effects of sterilization on the mechanical properties and surface chemistries of implantable biomaterials. This article also summarizes the biological effects of the sterilization-related changes in the implant. Because there are so many different types of implant materials currently in use (including metals, polymers, and diverse biological materials), the response of tissue to these different materials varies dramatically. This review further discusses the effects of sterilization on in vivo and in vitro tissue response specifically to implantable metals and polyethylene, with the possibility of future biocompatibility testing of the implants sterilized with supercritical phase carbon dioxide sterilization.