There is a growing number of drug delivery devices being used in medicine and many incorporate biological materials and biologically active constituents. The fields of bioengineering and tissue engineering are generating these new medical devices that contain natural, synthetic or combination products, which assist the body in healing or regenerating tissue. NovaSterilis’ scCO2 sterilization process has been utilized to sterilize innovative regenerative materials, polymers, and biologic scaffolds, with little or no negative effects on the devices.

The list of materials and the combinations biological active agents continues to grow. As these products become more technical and refined, it becomes vital to utilize a sterilization process that maintains the physical characteristics and biologic qualities of the material being sterilized. The desire to produce materials that quickly integrate and support cell proliferation limits your sterilization choices; NovaSterilis has a growing data set that supports scCO2 sterilization for these types of materials.

Xenograft Materials

One of the fastest growing biomaterials used in regenerative medicine is xenograft tissue. These tissues originate from bovine, equine, ovine or porcine and are supplied in many different forms including powders, sheets, tubes, and gels, all of which are chosen to meet highly specific needs. Applications of xenografts include, but is not limited to; acellular dermis, bovine and porcine pericardium, fascia, porcine small intestine submucosa, bladder, heart valves and pure collagen.

Acellular dermis has a long history of abdominal wall repair but the product is also used for breast reconstruction and plastic surgery. Porcine small intestine submucosa (SIS) is widely applied in surgery and regenerative medicine with applications ranging from wound care to cardiac repair. Since many of these products are primarily used as surgical implants, sterilization is extremely important to protect patients and ensure successful surgical outcomes.

Current research is focused on biologic additives to or native nucleic acid based constituents in xenografts, which enhance patient recover times and outcomes. As researchers continue to fine tune material properties and explore the mechanism by which these materials work, it is clear that sterilization with ethylene oxide, steam, and radiation negatively impacts patient outcomes. Multiple papers have shown that scCO2 processing is superior for many of these materials1,2,3.

NovaSterilis is your partner in producing a product that most closely matches the native material so you don’t have to decide between sterilization and performance.

Polymers

Within the drug delivery market there is a growing use of biopolymers alone and in combination with synthetic polymers. The ability to tune polymer materials and new ways of processing these biopolymers is providing new opportunities to create specialized products. These specialized products are in need of a complimentary sterilization process.

There are many biopolymers commercially available; collagen, chitosan and alginates are among the most popular. Some biopolymers including collagen and alginates are very sensitive to heat and experience significant changes during sterilization, resulting in poor product performance. NovaSterilis scCO2 sterilization has been successfully used to sterilize collagen and alginates without detrimental effects to the product.

NovaSterilis also has successfully sterilized many synthetic or commercial polymers, including a NIH Phase ll grant for the sterilization of absorbable sutures. The work completed showed that not only could we sterilize the sutures and maintain the structural and mechanical characteristics, but also that the NovaSterilis process produced a suture that was less cytotoxic than current commercial sutures.

If you have, or are developing a product that needs to maintain physical or biochemical properties, or wish to use a more environmentally friendly process, please contact us to perform testing on your material. NovaSterilis is proud to be partnering with a number of leaders in the drug delivery and regenerative medicine community.

  1. RESEARCH ARTICLE Improved Sterilization of Sensitive Biomaterials with Supercritical Carbon Dioxide at Low Temperature; Anne Bernhardt*, Markus Wehrl, Birgit Paul, Thomas Hochmuth, Matthias Schumacher, Kathleen Schütz, Michael Gelinsky; Centre for Translational Bone, Joint and Soft Tissue Research, Medizinische Fakultät, Technische Universität Dresden, Dresden, Germany, Cleaning Technology Institute e.V., Krefeld, Germany) PLOS/ ONE
  2. Development of a Sterile Amniotic Membrane Tissue Graft Using Supercritical Carbon Dioxide; Jennifer L. Wehmeyer, PhD, Shanmugasundaram Natesan, PhD, and Robert J. Christy, PhD; TISSUE ENGINEERING: Part C, Volume 00, Number 00, 2015
  3. Inactivation of Bacterial Spores and Viruses in Biological Material Using Supercritical     Carbon Dioxide With Sterilant ; Qing-Qing Qiu, Patrick Leamy, Jennie Brittingham, Jason Pomerleau, Nimesh Kabaria, Jerome Connor;Department of Research, LifeCell Corporation, Branchburg, New Jersey 08876; Received 10 December 2008; revised 25 March 2009; accepted 15 April 2009