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supercritical carbon dioxide sterilization

Gerrit J Van de Pol, Fiona Bonar, Lucy J Salmon, Justin P Roe, Leo A Pinczewski
PURPOSE: To examine the histologic properties of supercritical carbon dioxide (sCO2 )-sterilized bone allograft for tunnel grafting and determine in vivo graft quality, as well as graft incorporation and remodeling, in 2-stage revision anterior cruciate ligament (ACL) surgery. METHODS: Histologic evaluation was performed in 12 subjects undergoing 2-stage revision ACL reconstruction. In the first stage, the femoral and tibial tunnels were debrided, tunnel dimensions were measured, and tunnels were grafted with sCO2 -sterilized bone allograft...
March 2018: Arthroscopy: the Journal of Arthroscopic & related Surgery
Ryan S Hennessy, Jason L Go, Rebecca R Hennessy, Brandon J Tefft, Soumen Jana, Nicholas J Stoyles, Mohammed A Al-Hijji, Jeremy J Thaden, Sorin V Pislaru, Robert D Simari, John M Stulak, Melissa D Young, Amir Lerman
Current research on valvular heart repair has focused on tissue-engineered heart valves (TEHV) because of its potential to grow similarly to native heart valves. Decellularized xenografts are a promising solution; however, host recellularization remains challenging. In this study, decellularized porcine aortic valves were implanted into the right ventricular outflow tract (RVOT) of sheep to investigate recellularization potential. Porcine aortic valves, decellularized with sodium dodecyl sulfate (SDS), were sterilized by supercritical carbon dioxide (scCO2) and implanted into the RVOT of five juvenile polypay sheep for 5 months (n = 5)...
2017: PloS One
F Scognamiglio, M Blanchy, M Borgogna, A Travan, I Donati, J W A M Bosmans, M P Foulc, N D Bouvy, S Paoletti, E Marsich
Sterilization methods such as ɣ-irradiation, steam sterilization and ethylene oxide gas treatment can have negative effects on molecular structure and properties of polysaccharide-based biomaterials. In this perspective, the use of supercritical carbon dioxide (scCO2 ) has been proposed as an alternative method for biomaterial sterilization. In this work, chemical, mechanical and biological properties of polysaccharidic membranes for surgical applications were investigated after sterilization by scCO2 . Four sets of sterilizing conditions were considered and SEC analyses were performed in order to identify the one with lower impact on the polysaccharidic matrix of membranes (alginate)...
October 1, 2017: Carbohydrate Polymers
Selcan Guler, Bahar Aslan, Pezhman Hosseinian, Halil Murat Aydin
Tissue engineering approaches utilize both natural and synthetic materials in the repair and regeneration processes. A naturally sourced material for this purpose is required to be free from any antigenic matter such as cells or cellular components. Decellularization of tissues may be achieved through chemical or physical removal agents. Supercritical carbon dioxide (sc-CO2) has been used on the purpose of removing bioburden from tissues and offers an alternative to the traditionally used treatment methods...
September 2017: Tissue Engineering. Part C, Methods
Ryan S Hennessy, Soumen Jana, Brandon J Tefft, Meghana R Helder, Melissa D Young, Rebecca R Hennessy, Nicholas J Stoyles, Amir Lerman
OBJECTIVE: The goal of this research project encompasses finding the most efficient and effective method of decellularized tissue sterilization. BACKGROUND: Aortic tissue grafts have been utilized to repair damaged or diseased valves. Although, the tissues for grafting are collected aseptically, it does not eradicate the risk of contamination nor disease transfer. Thus, sterilization of grafts is mandatory. Several techniques have been applied to sterilize grafts; however, each technique shows drawbacks...
February 2017: JACC. Basic to Translational Science
Yongsheng Dong, Hua Jiang
High environmental pressure exerts an external stress on the survival of microorganisms that are commonly found under normal pressure. In response, many growth traits alter, including cell morphology and physiology, cellular structure, metabolism, physical and chemical properties, the reproductive process, and defense mechanisms. The high-pressure technology (HP) has been industrially utilized in pressurized sterilization, synthesis of stress-induced products, and microbial/enzymatic transformation of chemicals...
November 2016: World Journal of Microbiology & Biotechnology
Jenna L Balestrini, Angela Liu, Ashley L Gard, Janet Huie, Kelly M S Blatt, Jonas Schwan, Liping Zhao, Tom J Broekelmann, Robert P Mecham, Elise C Wilcox, Laura E Niklason
Lung engineering is a potential alternative to transplantation for patients with end-stage pulmonary failure. Two challenges critical to the successful development of an engineered lung developed from a decellularized scaffold include (i) the suppression of resident infectious bioburden in the lung matrix, and (ii) the ability to sterilize decellularized tissues while preserving the essential biological and mechanical features intact. To date, the majority of lungs are sterilized using high concentrations of peracetic acid (PAA) resulting in extracellular matrix (ECM) depletion...
March 2016: Tissue Engineering. Part C, Methods
Hyong Seok Park, Jungwoo Yang, Hee Jung Choi, Kyoung Heon Kim
Present sterilization methods for biofilms in medical devices have limitations. Therefore, an alternative sterilization method using supercritical carbon dioxide (SC-CO2) was tested on Candida albicans biofilms. The effect of varying pressure, temperature, and treatment time on the inactivation of C. albicans spores in suspensions and in biofilms was examined. The parameters such as treatment time, pressure, and temperature that led to the complete inactivation of C. albicans biofilms ranged 5-20 min, 100-200 bar, and 35-45 °C, respectively...
September 2015: Bioprocess and Biosystems Engineering
Anne Bernhardt, Markus Wehrl, Birgit Paul, Thomas Hochmuth, Matthias Schumacher, Kathleen Schütz, Michael Gelinsky
The development of bio-resorbable implant materials is rapidly going on. Sterilization of those materials is inevitable to assure the hygienic requirements for critical medical devices according to the medical device directive (MDD, 93/42/EG). Biopolymer-containing biomaterials are often highly sensitive towards classical sterilization procedures like steam, ethylene oxide treatment or gamma irradiation. Supercritical CO₂ (scCO₂) treatment is a promising strategy for the terminal sterilization of sensitive biomaterials at low temperature...
2015: PloS One
Jennifer L Wehmeyer, Shanmugasundaram Natesan, Robert J Christy
Numerous techniques have been reported for preparing and sterilizing amniotic membrane (AM) for use in clinical applications. However, these preparations either do not produce completely sterile tissue or are detrimental to molecules unique to the tissue matrix, thus compromising beneficial wound-healing properties of the AM graft. The objective of this work was to produce a sterile human AM tissue graft using a novel preparation technique involving supercritical carbon dioxide (SCCO2). AM tissue was subjected to various sterilization treatment groups that optimized the duration of exposure to SCCO2 and the amount of peracetic acid (PAA) required to achieve a sterility assurance level of 10(-6) log reduction in bacterial load...
July 2015: Tissue Engineering. Part C, Methods
Nicholas Russell, Alain Rives, Matthew H Pelletier, Tian Wang, William R Walsh
Bone allografts are used to replace bone that has been removed or to augment bone tissue in a number of clinical scenarios. In order to minimize the risk of infection and immune response, the bone is delipidated and terminally sterilized prior to implantation. The optimal method for bone graft sterilization has been the topic of considerable research and debate. Recently, supercritical carbon dioxide (SCCO(2)) treatments have been shown to terminally sterilize bone against a range of bacteria and viruses. This study aimed to evaluate the effect of these SCCO(2) treatments on the anisotropic mechanical properties of cortical bone...
March 2015: Cell and Tissue Banking
Nick Russell, Alain Rives, Nicky Bertollo, Matthew Henry Pelletier, William Robert Walsh
The optimal sterilization method for load bearing allografts remains a clinical concern. Recently, supercritical carbon dioxide (SCCO2) treatments have been shown to be capable of terminally sterilizing a range of bacteria and viruses, while preserving the static mechanical properties of cortical bone. This study evaluated the effect of SCCO2 treatment compared with two doses of gamma irradiation, on clinically relevant dynamic mechanical properties of cortical bone. Quasi-static testing was also performed to compare the impairment of treatment...
June 21, 2013: Journal of Biomechanics
Franca Zani, Cristina Veneziani, Elena Bazzoni, Loretta Maggi, Giovanni Caponetti, Ruggero Bettini
Glucocorticosteroids, a class of drugs widely used in the treatment of allergies, airways inflammation and inflammatory ocular diseases, are often difficult to sterilize due to their inherent sensibility to heat or irradiation induced degradation. Being often in form of suspension, obviously the final medicinal product cannot be sterilized by filtration. The effectiveness of supercritical CO2 (SC-CO2) based method for the sterilization of food and biomedical materials is well documented in the literature. Few reports are available on the sterilization of drugs especially in powder form with SC-CO2...
June 25, 2013: International Journal of Pharmaceutics
Nicholas A Russell, Alain Rives, Matthew H Pelletier, Warwick J Bruce, William R Walsh
Load bearing bone allografts are used to replace the mechanical function of bone that has been removed or to augment bone that has been damaged in trauma. In order to minimize the risk of infection and immune response, the bone is delipidated and terminally sterilized prior to implantation. The optimal method for bone graft sterilization has been the topic of considerable research. Recently, supercritical carbon dioxide (SCCO(2)) treatments have been shown to terminally sterilize bone against a range of bacteria and viruses...
June 2013: Cell and Tissue Banking
Jahna Howell, Fengui Niu, Shannon E McCabe, Wei Zhou, Charles J Decedue
A process is described using supercritical carbon dioxide to extract organic solvents from drug solutions contained in 30-mL serum vials. We report drying times of less than 1 h with quantitative recovery of sterile drug. A six-log reduction of three spore types used as biological indicators is achieved with direct addition of peracetic acid to a final concentration of approximately 5 mM (~0.04 %) to the drug solution in the vial. Analysis of two drugs, acetaminophen and paclitaxel, indicated no drug degradation as a result of the treatment...
June 2012: AAPS PharmSciTech
Ivan Donati, Monica Benincasa, Marie-Pierre Foulc, Gianluca Turco, Mila Toppazzini, Dario Solinas, Sara Spilimbergo, Ireneo Kikic, Sergio Paoletti
The development of biomaterials endowed with bioactive features relies on a simultaneous insight into a proper terminal sterilization process. FDA recommendations on sterility of biomaterials are very strict: a sterility assurance level (SAL) of 10(-6) must be guaranteed for biomaterials to be used in human implants. In the present work, we have explored the potential of supercritical CO(2) (scCO(2)) in the presence of H(2)O(2) as a low-temperature sterilization process for thermoset materials and their bioactive surfaces...
April 9, 2012: Biomacromolecules
Hyong Seok Park, Hee Jung Choi, Kyoung Heon Kim
Supercritical carbon dioxide (SC-CO(2)) was used to inactivate fungal spores of Alternaria brassicicola. The inactivation conditions were optimized using response surface methodology (RSM). When the SC-CO(2)-entrainer (ethanol) system was applied to fungal spores, the treatment time required for the complete inactivation of fungal spores was substantially reduced.
January 2012: Journal of Microbiological Methods
Aleksandra Checinska, Ingrid A Fruth, Tonia L Green, Ronald L Crawford, Andrzej J Paszczynski
Novel noninvasive techniques for the removal of biological contaminants to generate clean or sterile materials are in demand by the medical, pharmaceutical and food industries. The sterilization method described here uses supercritical fluid carbon dioxide (SF-CO(2)) containing 3.3% water and 0.1% hydrogen peroxide (v/v/v) to achieve from four to eight log viability reduction of all tested microbial species, including vegetative cells, spores and biofilms. The sterilization method employs moderate pressure and temperature (80 atm, 50°C) and a short (30-minute) treatment time...
October 2011: Journal of Microbiological Methods
J J Schwiedrzik, K-H Kaudela, U Burner, P K Zysset
Tissue grafts are implanted in orthopedic surgery every day. In order to minimize infection risk, bone allografts are often delipidated with supercritical CO₂ and sterilized prior to implantation. This treatment may, however, impair the mechanical behavior of the bone graft tissue. The goal of this study was to determine clinically relevant mechanical properties of treated/sterilized human trabecular bone grafts, e.g. the apparent modulus, strength, and the ability to absorb energy during compaction. They were compared with results of identical experiments performed previously on untreated/fresh frozen human trabecular bone from the same anatomical site (Charlebois, 2008)...
June 1, 2011: Bone
Md Sohrab Hossain, Amutha Santhanam, N A Nik Norulaini, A K Mohd Omar
The management of clinical solid waste (CSW) continues to be a major challenge, particularly, in most healthcare facilities of the developing world. Poor conduct and inappropriate disposal methods exercised during handling and disposal of CSW is increasing significant health hazards and environmental pollution due to the infectious nature of the waste. This article summarises a literature review into existing CSW management practices in the healthcare centers. The information gathered in this paper has been derived from the desk study of open literature survey...
April 2011: Waste Management
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