Steam and dry heat sterilization of biomaterials and medical devices

Rogers, William J.

doi:10.1533/9780857096265.20

Cited by 42 publications

(36 citation statements)

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“…The current accepted sterility assurance level (SAL) is limited to 10 −6 (no more than one viable microorganism in one million parts of final product is allowed [24]). Given the nature of action of the different forms of sterilization, they can also attack the materials by the same mechanisms, resulting in hydrolysis, oxidation, chain scission, and depolymerization [20–22, 25–27]. Ozone gas sterilization is a method with potential interest because of its low cost, it does not leave toxic residues and it can be applied to thermosensitive materials [28–32].…”

Section: Introductionmentioning

confidence: 99%

About the Sterilization of Chitosan Hydrogel Nanoparticles

et al. 2016

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In the last years, nanostructured biomaterials have raised a great interest as platforms for delivery of drugs, genes, imaging agents and for tissue engineering applications. In particular, hydrogel nanoparticles (HNP) associate the distinctive features of hydrogels (high water uptake capacity, biocompatibility) with the advantages of being possible to tailor its physicochemical properties at nano-scale to increase solubility, immunocompatibility and cellular uptake. In order to be safe, HNP for biomedical applications, such as injectable or ophthalmic formulations, must be sterile. Literature is very scarce with respect to sterilization effects on nanostructured systems, and even more in what concerns HNP. This work aims to evaluate the effect and effectiveness of different sterilization methods on chitosan (CS) hydrogel nanoparticles. In addition to conventional methods (steam autoclave and gamma irradiation), a recent ozone-based method of sterilization was also tested. A model chitosan-tripolyphosphate (TPP) hydrogel nanoparticles (CS-HNP), with a broad spectrum of possible applications was produced and sterilized in the absence and in the presence of protective sugars (glucose and mannitol). Properties like size, zeta potential, absorbance, morphology, chemical structure and cytotoxicity were evaluated. It was found that the CS-HNP degrade by autoclaving and that sugars have no protective effect. Concerning gamma irradiation, the formation of agglomerates was observed, compromising the suspension stability. However, the nanoparticles resistance increases considerably in the presence of the sugars. Ozone sterilization did not lead to significant physical adverse effects, however, slight toxicity signs were observed, contrarily to gamma irradiation where no detectable changes on cells were found. Ozonation in the presence of sugars avoided cytotoxicity. Nevertheless, some chemical alterations were observed in the nanoparticles.

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Section: Introductionmentioning

confidence: 99%

About the Sterilization of Chitosan Hydrogel Nanoparticles

et al. 2016

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“…To be effective, SH sterilization requires precise control over the duration, temperature, and pressure. The recommended settings for SH sterilization are 15 min at 121–124°C, but alternative conditions with higher temperatures and lower times can be used . These conditions cause the destruction of microorganisms through irreversible denaturation of vital cell components (enzymes and structural proteins).…”

Section: Sterilization Methodsmentioning

confidence: 99%

“…The sterilization chamber is generally equipped with a system that ensures the even distribution of heat. In addition to sterilization (temperature range of 170–190°C), DH can be used for depyrogenation (at temperatures >250°C) . The microbial inactivation mechanism is the oxidation of cell components .…”

Section: Sterilization Methodsmentioning

confidence: 99%

“…This method is generally used for sterilizing heat resistant materials (e.g., silicone, glass, and metal). The advantages of DH is that it is simple method that can be used for sterilizing products that steam cannot penetrate (e.g., oils, powders, and cross‐linked implants impermeable to steam/gas) . However, the higher temperatures and longer processing times required can lead to melting, distortion, and degradation.…”

Section: Sterilization Methodsmentioning

confidence: 99%

“…In addition to sterilization (temperature range of 170-1908C), DH can be used for depyrogenation (at temperatures >2508C). 28,30 The microbial inactivation mechanism is the oxidation of cell components. 28,31 For process validation, it is recommended to use Bacillus subtilis spores as the challenge biologic indicator strain.…”

Section: Steam Heatmentioning

confidence: 99%

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Sterilization of hydrogels for biomedical applications: A review

et al. 2017

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Despite the beneficial properties and outstanding potential of hydrogels for biomedical applications, several unmet challenges must be overcome, especially regarding to their known sensitivity to conventional sterilization methods. It is crucial for any biomaterial to withstand an efficient sterilization to obtain approval from regulatory organizations and to safely proceed to clinical trials. Sterility assurance minimizes the incidence of medical device-related infections, which still constitute a major concern in health care. In this review, we provide a detailed and comprehensive description of the published work from the past decade regarding the effects of sterilization on different types of hydrogels for biomedical applications. Advances in hydrogel production methods with simultaneous sterilization are also reported. Terminal sterilization methods can induce negative or positive effects on several material properties (e.g., aspect, size, color, chemical structure, mechanical integrity, and biocompatibility). Due to the complexity of factors involved (e.g., material properties, drug stability, sterilization conditions, and parameters), it is important to note the virtual impossibility of predicting the outcome of sterilization methods to determine a set of universal rules. Each system requires case-by-case testing to select the most suitable, effective method that allows for the main properties to remain unaltered. The impact of sterilization methods on the intrinsic properties of these systems is understudied, and further research is needed. © 2017 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 106B: 2472-2492, 2018.

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A new era for sterilization based on supercritical CO₂ technology

et al. 2019

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The increasing complexity in morphology and composition of modern biomedical materials (e.g., soft and hard biological tissues, synthetic and natural‐based scaffolds, technical textiles) and the high sensitivity to the processing environment requires the development of innovative but benign technologies for processing and treatment. This scenario is particularly applicable where current conventional techniques (steam/dry heat, ethylene oxide, and gamma irradiation) may not be able to preserve the functionality and integrity of the treated material. Sterilization using supercritical carbon dioxide emerges as a green and sustainable technology able to reach the sterility levels required by regulation without altering the original properties of even highly sensitive materials. In this review article, an updated survey of experimental protocols based on supercritical sterilization and of the efficacy results sorted by microbial strains and treated materials was carried out. The application of the supercritical sterilization process in materials used for biomedical, pharmaceutical, and food applications is assessed. The opportunity of supercritical sterilization of not only replace the above mentioned conventional techniques, but also of reach unmet needs for sterilization in highly sensitive materials (e.g., single‐use medical devices, the next‐generation biomaterials, and medical devices and graft tissues) is herein unveiled.

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Steam and dry heat sterilization of biomaterials and medical devices

Cited by 42 publications

References 1 publication

About the Sterilization of Chitosan Hydrogel Nanoparticles

About the Sterilization of Chitosan Hydrogel Nanoparticles

Sterilization of hydrogels for biomedical applications: A review

A new era for sterilization based on supercritical CO₂ technology

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Steam and dry heat sterilization of biomaterials and medical devices

Cited by 42 publications

References 1 publication

About the Sterilization of Chitosan Hydrogel Nanoparticles

About the Sterilization of Chitosan Hydrogel Nanoparticles

Sterilization of hydrogels for biomedical applications: A review

A new era for sterilization based on supercritical CO2 technology

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A new era for sterilization based on supercritical CO₂ technology