scholarly journals Ethylene Oxide Gas Sterilization of Medical Devices

2017 ◽  
Vol 22 (1) ◽  
pp. 1-16 ◽  
Author(s):  
HIDEHARU SHINTANI
Keyword(s):  
Ethylene Oxide ◽  
Medical Devices ◽  
Ethylene Oxide Gas

Kinetics of Ethylene Oxide Desorption from Sterilized Materials

2013 ◽  
Vol 96 (1) ◽  
pp. 33-36 ◽  
Author(s):  
Gisela C Mendes ◽  
Teresa R S Brandão ◽  
Cristina L M Silva
Keyword(s):  
Ethylene Oxide ◽  
Medical Devices ◽  
Polymeric Materials ◽  
Fickian Diffusion ◽  
Oxide Content ◽  
Transfer Behavior ◽  
Kinetics Of ◽  
Diffusion Mass ◽  
Ethylene Oxide Gas ◽  
By Products

Abstract Ethylene oxide gas is commonly used to sterilize medical devices, and concerns about using this agent on biological systems are well-established. Medical devices sterilized by ethylene oxide must be properly aerated to remove residual gas and by-products. In this work, kinetics of ethylene oxide desorption from different sterilized materials were studied in a range of aeration temperatures. The experimental data were well-described by a Fickian diffusion mass transfer behavior, and diffusivities were estimated for two textile and two polymeric materials within the temperature range of 1.5 to 59.0°C. The results will allow predictions of ethylene oxide desorption, which is a key step for the design of sterilization/aeration processes, contributing to an efficient removal of residual ethylene oxide content.

Evaluation of in vitro serial antibiotic elution from meropenem-impregnated polymethylmethacrylate beads after ethylene oxide gas and autoclave sterilization

2011 ◽  
Vol 24 (01) ◽  
pp. 39-44 ◽  
Author(s):  
C. Langston ◽  
S. Givaruangsawat ◽  
R. McLaughlin ◽  
L. A. Báez
Keyword(s):  
Ethylene Oxide ◽  
Statistical Difference ◽  
Concentration Level ◽  
Negative Control ◽  
Microbiological Assay ◽  
Zone Of Inhibition ◽  
Time Periods ◽  
Pmma Beads ◽  
Ethylene Oxide Gas

Summary Objectives: To determine the elution properties of meropenem and to compare the elutions of meropenem-impregnated polymethylmethacrylate (PMMA) beads without sterilization (P-M-C) to those sterilized with steam (P-M-A) and ethylene oxide gas (P-M-EO). Methods: A commercial bead mould was used to produce four groups of beads: one group without antibiotic (negative control), and three groups of meropenem-impregnated beads: P-M-C, P-M-A, and P-M-EO. The beads were placed in a phosphate buffered solution and eluent samples were collected. Concentrations of the antibiotic in eluent samples from the two sterilized groups and the control beads were determined using a microbiological assay at 1, 3, 6 and 12 hours and at 1, 2, 3, 6, 9, 12, 15, 18, 22, 26, and 30 days. Results: The microbiological assay resulted in no zone of inhibition at all time periods for the P-M-A samples and the samples of PMMA without antimicrobial. The meropenem concentration on the eluent remained above 4 mcg/ml for 15 days in the P-M-C group and until day 18 for P-M-EO group. There was no statistical difference in AUC0-∞ (p <0.318), however significance did occur for MRT (p <0.005) when comparing P-M-C and P-M-EO with the later being higher. Discussion: The meropenem incorporated in the PMMA beads eluted effectively and gradually decreased after the 24 hour peak, but remained above the concentration level of 4 mcg/ml for 15 days in the P-M-C group and until day 18 for P-M-EO group. Ethylene oxide does not adversely affect meropenem’s elution from PMMA beads.

Sterilization of Chitosan Membranes for Use as Biomaterial

2014 ◽  
Vol 805 ◽  
pp. 35-40 ◽  
Author(s):  
Imarally V.S.R. Nascimento ◽  
Rita de Cássia A. Leal ◽  
Marcus Vinícius Lia Fook ◽  
Roberta Costa Meira
Keyword(s):  
Ethylene Oxide ◽  
Ultraviolet Radiation ◽  
Physicochemical Properties ◽  
Functional Groups ◽  
Medical Devices ◽  
The Other ◽  
Complete Destruction ◽  
Chitosan Membranes

Sterilization is a procedure which promotes complete destruction or elimination of all forms of microorganisms. It is a fundamental stage in the processing of biomaterials, and functionality of any sterilization system must be determined by its effectiveness in exterminating microorganisms without harming or adversely affect the properties of medical devices. Some sterilization techniques can react with functional groups of the polymer leading to changes in the properties, affecting the biomaterial. This study aimed to develop chitosan membranes sterilize them by following methods: an autoclave, ethylene oxide, glutaraldehyde and ultraviolet radiation and characterized by FTIR, XRD and SEM. Based on the results of this study it can be concluded that the method of sterilization indicated for the membranes of chitosan is ethylene oxide because the other altered physicochemical properties thereof.

Gamma Irradiation and Ethylene Oxide in the Sterilization of Native Reindeer Bone Morphogenetic Protein Extract

2005 ◽  
Vol 94 (1) ◽  
pp. 67-70 ◽  
Author(s):  
T. Pekkarinen ◽  
O. Hietala ◽  
T. Jämsä ◽  
P. Jalovaara
Keyword(s):  
Ethylene Oxide ◽  
Gamma Irradiation ◽  
Bone Morphogenetic Proteins ◽  
Thigh Muscle ◽  
New Bone Formation ◽  
Morphogenetic Protein ◽  
Oxide Concentration ◽  
The Mean ◽  
Human Use ◽  
Ethylene Oxide Gas

Background and Aims: For human use, it is necessary to sterilize bone morphogenetic proteins (BMPs), in order to reduce the risk of infections and associated complications. We compared the effects of ethylene oxide and gamma irradiation in the sterilization of native reindeer BMP extract with regard to bone induction in the Balb/C mouse thigh muscle pouch model. Materials and Methods: BMP extract, sterilized with ethylene oxide gas (Steri-Vac 4XL' temperature 29°C, exposure time 4 h, ethylene oxide concentration 860 mg/l), or gamma irradiation at doses of 3.15 MRad was administered in implants containing 5 or 10 mg of BMP extract with collagen carrier. Non-sterilized collagen implants served as controls. New bone formation was evaluated based on the incorporation of Ca45 and radiographically three weeks after implantation. Results: The collagen was not able to induce new bone visible in radiographs. The mean Ca45 incorporation in the gamma sterilized group containing 5 mg of BMP extract was 30 % (p = 0.04) and that containing 10 mg of BMP extract was 60 % (p = 0.02) higher than seen in the corresponding ethylene oxide sterilized groups. The mean new bone areas were 45 % higher in the gamma sterilized groups than in the corresponding ethylene oxide sterilized groups, but the differences were not significant. The mean optical density of new bone in the gamma sterilized group containing 5 mg of BMP extract was 75 % (p = 0.00) and in that containing 10 mg of BMP extract was 70 % (p = 0.00) higher than seen in the corresponding ethylene oxide sterilized groups. Conclusion: Native reindeer BMP extract is more sensitive to the effects of ethylene oxide gas sterilization than gamma irradiation. These results suggest that gamma irradiation is recommendable for the sterilization of BMP extracts.

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