Ethylene oxide's role as a reactive agent during sterilization: Effects of polymer composition and device architecture

Phillip, Edward; Murthy, N. Sanjeeva; Bolikal, Durgadas; Narayanan, Pallassana; Kohn, Joachim; Lavelle, Linda; Bodnar, Stanko; Pricer, Kurt

doi:10.1002/jbm.b.32853

Cited by 33 publications

(35 citation statements)

References 15 publications

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“…12 EtO alters scaffold properties by penetrating into polymeric networks and reacting with chemical groups. 13 Given the translational nature of tissue-engineering research and constant innovation in polymer systems and their processing technologies, the issue of sterilization needs to be periodically revisited. In this study, we systematically explore the feasibility of using peracetic acid (PAA) as a chemical sterilant for polymeric tissue-engineered scaffolds and compared it with two accepted methods of sterilization (EtO and autoclaving) and a high-level disinfectant (80% ethanol).…”

Section: Introductionmentioning

confidence: 99%

Peracetic Acid: A Practical Agent for Sterilizing Heat-Labile Polymeric Tissue-Engineering Scaffolds

Yoganarasimha

Trahan

Best

et al. 2014

Tissue Engineering Part C: Methods

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Advanced biomaterials and sophisticated processing technologies aim at fabricating tissue-engineering scaffolds that can predictably interact within a biological environment at the cellular level. Sterilization of such scaffolds is at the core of patient safety and is an important regulatory issue that needs to be addressed before clinical translation. In addition, it is crucial that meticulously engineered micro- and nano- structures are preserved after sterilization. Conventional sterilization methods involving heat, steam, and radiation are not compatible with engineered polymeric systems because of scaffold degradation and loss of architecture. Using electrospun scaffolds made from polycaprolactone, a low melting polymer, and employing spores of Bacillus atrophaeus as biological indicators, we compared ethylene oxide, autoclaving and 80% ethanol to a known chemical sterilant, peracetic acid (PAA), for their ability to sterilize as well as their effects on scaffold properties. PAA diluted in 20% ethanol to 1000 ppm or above sterilized electrospun scaffolds in 15 min at room temperature while maintaining nano-architecture and mechanical properties. Scaffolds treated with PAA at 5000 ppm were rendered hydrophilic, with contact angles reduced to 0°. Therefore, PAA can provide economical, rapid, and effective sterilization of heat-sensitive polymeric electrospun scaffolds that are used in tissue engineering.

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Section: Introductionmentioning

confidence: 99%

Peracetic Acid: A Practical Agent for Sterilizing Heat-Labile Polymeric Tissue-Engineering Scaffolds

Yoganarasimha

Trahan

Best

et al. 2014

Tissue Engineering Part C: Methods

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“…Furthermore, ethylene oxide can react with amide, carboxyl, and carbonate functional groups on polymer chains, which could also impact drug release from polymeric scaffolds. 39 In fact, Phillip et al demonstrated esterification of PLGA samples following EtO treatment, which could also be a mechanism of the attenuated burst release observed in this study. 39 Philip et al also displayed enhanced smoothing on the surface of PLGA implants treated with EtO indicating that total surface area involved in hydrolytic degradation could be a factor involved in the delayed burst release observed in our EtOsterilized groups.…”

Section: ■ Discussionmentioning

confidence: 76%

“…39 In fact, Phillip et al demonstrated esterification of PLGA samples following EtO treatment, which could also be a mechanism of the attenuated burst release observed in this study. 39 Philip et al also displayed enhanced smoothing on the surface of PLGA implants treated with EtO indicating that total surface area involved in hydrolytic degradation could be a factor involved in the delayed burst release observed in our EtOsterilized groups. 39 Other authors have also demonstrated that EtO sterilization can alkylate amines and decrease protein functionality, thus it is possible that the slightly decreased bioactivity in EtO implants observed in this study is due to a decrease in functional protein at the surface of the microspheres.…”

Section: ■ Discussionmentioning

confidence: 76%

“…39 Philip et al also displayed enhanced smoothing on the surface of PLGA implants treated with EtO indicating that total surface area involved in hydrolytic degradation could be a factor involved in the delayed burst release observed in our EtOsterilized groups. 39 Other authors have also demonstrated that EtO sterilization can alkylate amines and decrease protein functionality, thus it is possible that the slightly decreased bioactivity in EtO implants observed in this study is due to a decrease in functional protein at the surface of the microspheres. 40,41 However, future work is needed to assess the mechanism by which growth factor release is altered with ethylene oxide sterilization.…”

Section: ■ Discussionmentioning

confidence: 79%

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Ethylene Oxide Sterilization Preserves Bioactivity and Attenuates Burst Release of Encapsulated Glial Cell Line Derived Neurotrophic Factor from Tissue Engineered Nerve Guides For Long Gap Peripheral Nerve Repair

Bliley¹,

Sivak²,

Minteer³

et al. 2015

ACS Biomater. Sci. Eng.

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Synthetic nerve guides are widely utilized to reconstruct peripheral nerve defects that are less than three centimeters. However, there are no clinically available nerve guides that are approved to promote repair over long gaps (>3 cm). Many currently available guides are unable to sustain large defect regeneration either because of limitations in fabrication or short degradation times in vivo. Furthermore, current clinically available nerve guides do not contain neurotrophic factor delivery systems to promote nerve tissue regeneration over long gaps. The purpose of this paper is to describe the manufacturing parameters and sterilization procedures of a 5.2 cm poly(caprolactone) nerve conduit with embedded polymeric microspheres that encapsulate glial cell line-derived neurotrophic factor (GDNF) for implantation into a preclinical rhesus macaque 5 cm median nerve defect model. Nerve conduits were sterilized with room temperature ethylene oxide (RT EtO) and assessed for morphology as well as maintenance of porosity. Release kinetics and bioactivity of GDNF were also assessed in RT EtO sterilized guides. Scanning electron microscopy indicated that RT EtO treatment did not affect morphology and porosity percentage of nerve guides. Furthermore, RT EtO had no effect on GDNF bioactivity based on Schwannoma cell migration studies. RT EtO guides exhibited significantly slowed GDNF release compared to GDNF release from nonsterile guides indicating that EtO treatment may enhance the long-term delivery kinetics of GDNF from polymeric microspheres within the nerve guide.

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“…Although one study 14 has reported that ethylene oxide could change plastic structures, sterilization of plastic materials with ethylene oxide gas is generally accepted as a standard sterilization procedure in healthcare facilities. 10,15 The average VAS score for patient discomfort in our study in the plastic bag group (5.33) was significantly higher than that in the commercially available hygienic sheath group (3.03).…”

Section: Discussionmentioning

confidence: 99%

Infection control and patient discomfort with an alternative plastic barrier in intraoral digital radiography

Charuakkra¹,

Prapayasatok²,

Janhom³

et al. 2017

Dentomaxillofacial Radiology

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Objectives: (1) To compare the efficacy of a commercially available hygienic sheath and an alternative plastic bag in preventing contamination of the imaging plate during intraoral radiography and (2) to compare patient discomfort when using the hygienic sheath and the plastic bag. Methods: 60 sterilized Size 2 imaging plates covered with either the hygienic sheath (n 5 30) or the plastic bag (n 5 30) were used to simulate digital periapical radiographic examination in 30 volunteer patients. After disinfection, each plate was swabbed. The swabbed medium was then plated on trypticase soy agar and incubated. Bacterial colonies were counted. Patient discomfort was assessed using a visual analogue scale (VAS) score. The comparison of the number of bacterial colonies and VAS scores between the two groups was tested by paired t-test at p , 0.05. Results: There was no significant difference in the number of bacterial colonies between the two groups (p 5 0.745). Of all the plates, 10% plates yielded bacterial colonies. The mean count of bacterial colonies for both groups was 10-20 CFU ml 21 . However, there was a significant difference between VAS scores for the two systems (p 5 0.000). The mean VAS scores (range 0-10) for patient discomfort for the hygienic sheath group and the plastic bag group were 3.03 and 5.33, respectively. Conclusions: Based on the design of this study, the alternative barrier provided similar results to those commercially available. Regarding the type of barrier envelope, the hygienic sheath induced less discomfort than the plastic bag.

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Ethylene oxide's role as a reactive agent during sterilization: Effects of polymer composition and device architecture

Cited by 33 publications

References 15 publications

Peracetic Acid: A Practical Agent for Sterilizing Heat-Labile Polymeric Tissue-Engineering Scaffolds

Peracetic Acid: A Practical Agent for Sterilizing Heat-Labile Polymeric Tissue-Engineering Scaffolds

Ethylene Oxide Sterilization Preserves Bioactivity and Attenuates Burst Release of Encapsulated Glial Cell Line Derived Neurotrophic Factor from Tissue Engineered Nerve Guides For Long Gap Peripheral Nerve Repair

Infection control and patient discomfort with an alternative plastic barrier in intraoral digital radiography

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