Sterilization Procedures and Biocompatibility

Rodríguez‐Benot, Alberto; Santamaría, Rafael; Martín‐Malo, Alejandro; Aljama, Pedro

doi:10.1159/000060240

Cited by 8 publications

(5 citation statements)

References 33 publications

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“…An effective industrial method for medical products sterilization is the use of γ‐radiation 1. This method is advantageous because it is economically feasible for large‐scale sterilization of products in sealed packages 2, 3.…”

Section: Introductionmentioning

confidence: 99%

“…An effective industrial method for medical products sterilization is the use of ␥-radiation. 1 This method is advantageous because it is economically feasible for large-scale sterilization of products in sealed packages. 2,3 Among synthetic materials, polyether-urethanes have been considered to be suitable for various biomedical applications because of their biocompatibility, biodegradability, and controlled microstructure and properties.…”

Section: Introductionmentioning

confidence: 99%

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Effect of different γ‐irradiation doses on cytotoxicity and material properties of porous polyether‐urethane polymer

et al. 2006

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Biomaterials respond to sterilization methods differently. Steam sterilization might decrease the performance of thermoplastic polyether-urethane (TPU); however, the effect of different gamma-radiation doses on this polymer is contradictory in present literature. The purpose of this study was to investigate the differences between irradiative doses in comparison with steam sterilization on a porous TPU scaffold produced by a new processing method. No significant differences in the surface chemical structure were found with attenuated total reflectance Fourier transform infrared spectroscopy (ATR-FTIR) analysis when comparing with the sterilization methods. The molecular weight (M(w)) had a net increase from 11.5 +/- 0.039 to 13.2 +/- 0.072 kDa by gamma-sterilization from 10 to 60 kGy. The samples that were irradiated (>60 kGy) had also an increase in polydispersity index (PDI; 1.45 +/- 0.007) in comparison with the nonsterile ones (1.31 +/- 0.017), which indicate branching. Liquid chromatography/mass spectroscopy (LC/MS) analysis showed that there was a correlation between the concentration of the breakdown product, methyl dianiline, and cytotoxicity. The concentration of this compound was found to be four times higher in steam-sterilized sample (1.3 +/- 0.01 ppb) compared with that of the polymer sample gamma-sterilized at 10 kGy (0.3 +/- 0.01 ppb). The cytotoxicity of TPU was found to decrease with higher radiation doses, and was significantly higher for the steam-sterilized samples. It is recommended that TPU produced with the described foaming method should be sterilized by gamma-irradiation at 25 kGy or higher doses.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Effect of different γ‐irradiation doses on cytotoxicity and material properties of porous polyether‐urethane polymer

et al. 2006

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“…However, common methods of sterilization (autoclaving, irradiation, ethylene oxide) may induce changes that may affect mechanical resistance or performance [ 10 ], and it is necessary to find ways to minimize these effects. Ethylene oxide is a colorless and flammable gas which is widely used for the sterilization of medical equipment, but there are reports of negative effects on some materials, such as the production of a toxic chemical residue, ethylene chlorohydrin, requiring a period for aeration of the material for its elimination [ 11 , 12 , 13 ]. The same response, however, is less frequent in groups sterilized by gamma radiation, since it is free of residues and it is a more advantageous method [ 11 ].…”

Section: Introductionmentioning

confidence: 99%

In Vitro Evaluation of Acellular Collagen Matrices Derived from Porcine Pericardium: Influence of the Sterilization Method on Its Biological Properties

Grandis

Miotto²,

Genaro³

et al. 2021

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The aim of this study were characterize acellular collagen matrices derived from porcine pericardium (PP) and to evaluate their properties after sterilization by ethylene oxide and gamma ray. PP matrices were subjected to alkaline hydrolysis (AH), and samples were characterized for biological stability, membrane thickness measurements, differential scanning calorimetry (DSC) and scanning electron microscopy (SEM). Subsequently, the matrices were frozen, lyophilized and sterilized by ethylene oxide or gamma radiation. For in vitro assays, CHO-K1 cell culture was used and evaluated for cytotoxicity, clonogenic survival assay, genotoxicity and mutagenicity. Analysis of variance (ANOVA) was used, followed by Dunnett’s post-test, with a significance level of 5%. After AH, there was no significant change in matrix thickness. The relative biodegradability of the material after implantation was observed. Morphology and dimensions had small changes after AH. As for cell viability, none of the tested matrices showed a statistically significant difference (p > 0.05; Dunnett) regardless of the sterilization method. Furthermore, it was found that PP matrices did not interfere with the proliferation capacity of CHO-K1 cells (p > 0.05; Dunnett). As for genotoxicity, when sterilized with ethylene oxide (NP, P12 and P24), it showed genotoxic potential, but it was not genotoxic when sterilized by gamma radiation. No mutagenic effects were observed in either group. PP-derived collagen matrices hydrolyzed at different times were not cytotoxic. It is concluded that the best method of sterilization is through gamma radiation, since no significant changes were observed in the properties of the PP matrices.

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“…Clinicians became aware of the importance of dialyser rinsing immediately before HD to remove the major part of residual ETO [4]. However, high energy irradiation carries the risk of membrane degradation, which might cause important and undesired changes in membrane properties, such as dimensional stability, mechanical resistance and hydraulic and diffusive permeability [5,6]. Meanwhile, alternative sterilization modes, such as steam sterilization have been suggested [7,8].…”

Section: Introductionmentioning

confidence: 99%

Cytotoxic effects exerted by polyarylsulfone dialyser membranes depend on different sterilization processes

et al. 2009

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Polyarylsulfone group is one of the most important polymeric materials used in the biomedical field, due to its excellent properties, such as good thermal, chemical, and mechanical stability. There are three important polyarylsulfone polymers, all of which have excellent electrical properties: polysulfone (PSu), polyarylsulfone (PAS) and polyarylethersulfone (PAES). All these polymers have excellent creep, radiation and high temperature resistance. In this study, we aimed to determine the effect of three sterilization processes (steam, ethylene oxide and gamma rays) on cytotoxicity of polyarylsulfone dialysis membranes. Ten long-term dialysis patients and ten age-matched healthy controls were enrolled in our study. We analysed (1) serum effect on cultured endothelial cell viability using MTT assay and (2) lipid peroxidation assessed by serum malondialdehyde (MDA) formation at the beginning (T0), the middle (T2) and the end (T4) of haemodialysis (HD) session. Our results clearly showed that steam-sterilized membranes improve endothelial cell viability when compared to ethylene oxide or gamma rays-sterilized ones. Moreover, there is a increased generation of MDA in patients sera during HD session. The serum MDA concentration was about 3, 6 and 10 times higher, respectively, for steam, ethylene oxide and gamma rays sterilization procedures when compared to the MDA amount in healthy subject sera. We concluded that using steam instead of ethylene oxide or gamma rays for sterilization may improve the biocompatibility of polyarylsulfone membranes.

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Sterilization Procedures and Biocompatibility

Cited by 8 publications

References 33 publications

Effect of different γ‐irradiation doses on cytotoxicity and material properties of porous polyether‐urethane polymer

Effect of different γ‐irradiation doses on cytotoxicity and material properties of porous polyether‐urethane polymer

In Vitro Evaluation of Acellular Collagen Matrices Derived from Porcine Pericardium: Influence of the Sterilization Method on Its Biological Properties

Cytotoxic effects exerted by polyarylsulfone dialyser membranes depend on different sterilization processes

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