Sterilization of macroscopic poly(l-lactic acid) porous scaffolds with dense carbon dioxide: Investigation of the spatial penetration of the treatment and of its effect on the properties of the matrix

Lanzalaco, Sonia; Campora, Simona; Brucato, V.; Pavia, Francesco Carfì; Leonardo, Elvira Rosalia Di; Ghersi, Giulio; Scialdone, Onofrio; Galia, Alessandro

doi:10.1016/j.supflu.2016.01.014

Cited by 18 publications

(15 citation statements)

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“…Lanzalaco et al sterilized poly( l ‐lactic acid) (PLLA) hydrogels for tissue engineering scaffolds using dense CO 2 . The group tested several conditions, varying the time, temperature, and pressure and using H 2 O 2 as an additive.…”

Section: Sterilization Of Hydrogel‐based Medical Devicesmentioning

confidence: 99%

“…Considering the effectiveness, intentional contaminations were performed with two challenging microorganisms. The authors reported that total sterilization of Escherichia coli was achieved after 5 min at 10 MPa and 40°C and that total sterilization of spores was achieved after 6 h of treatment at 30°C and 30 MPa in the presence of 200 ppm of H 2 O 2 or at 40°C and 30 MPa with no added peroxide …”

Section: Sterilization Of Hydrogel‐based Medical Devicesmentioning

confidence: 99%

“…In this work, all tests were conducted using "overkill" conditions; therefore, the effectiveness of the sterilization was assumed but not tested. Lanzalaco et al 65 sterilized poly(L-lactic acid) (PLLA) hydrogels for tissue engineering scaffolds using dense CO 2 . The group tested several conditions, varying the time, temperature, and pressure and using H 2 O 2 as an additive.…”

Section: Sterilization Of Synthetic Hydrogel Systemsmentioning

confidence: 99%

“…The authors reported that total sterilization of Escherichia coli was achieved after 5 min at 10 MPa and 408C and that total sterilization of spores was achieved after 6 h of treatment at 308C and 30 MPa in the presence of 200 ppm of H 2 O 2 or at 408C and 30 MPa with no added peroxide. 65 Karajanagi et al 66 conducted a study regarding the suitability of dense CO 2 treatment as a sterilization method for soft biomaterials. The authors used a poly(ethylene)-glycol (PEG) hydrogel and compared the effects of the novel method against conventional SH and gamma irradiation.…”

Section: Sterilization Of Synthetic Hydrogel Systemsmentioning

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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Section: Sterilization Of Hydrogel‐based Medical Devicesmentioning

confidence: 99%

Section: Sterilization Of Hydrogel‐based Medical Devicesmentioning

confidence: 99%

Section: Sterilization Of Synthetic Hydrogel Systemsmentioning

confidence: 99%

Section: Sterilization Of Synthetic Hydrogel Systemsmentioning

confidence: 99%

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Sterilization of hydrogels for biomedical applications: A review

et al. 2017

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“…ведутся исследования взаимодействия СК СО2 с микроорганизмами. В работах [18][19][20][21][22] показана эффективность и возможность использования этого метода в пищевой и фармацевтической промышленностях, как альтернатива традиционным методам стерилизации.…”

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Traditional and supercritical sterilization of medical devices

Gazizov¹,

Шамсетдинов²

2018

Тенденции Развития Науки И Образования

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Стерилизация медицинских изделий является одной из актуальных проблем в современной медицине. Разнообразие медицинского инструментария, наличие деталей в их конструкции из полимерных и других материалов, труднодоступность отдельных узлов для обработки, создают определённые сложности при стерилизации, а также в выборе оптимального метода в каждом конкретном случае. Принимая во внимание, что в России за последнее десятилетие наблюдается динамичный рост объемов производства одноразовых полимерных изделий медицинского назначения, то в данный момент это увеличение приближается к своему пределу по причине нехватки мощности стерилизационных центров в целом по стране и их полное отсутствие во многих регионах, в том числе, в Поволжье. В частности, с 2015 по 2018 год внутреннее производство медицинских изделий выросло более чем на 15%[1]. Например, на предприятиях Республики Татарстан производится более 3000 наименований медицинских инструментов, в том числе:  стоматологический инструментарий (твердосплавные боры и фрезы, алмазные головки, эндоканальные инструменты, микромоторы, турбинные, микромоторные наконечники);  микрохирургические инструменты и наборы;

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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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Sterilization of macroscopic poly(l-lactic acid) porous scaffolds with dense carbon dioxide: Investigation of the spatial penetration of the treatment and of its effect on the properties of the matrix

Cited by 18 publications

References 50 publications

Sterilization of hydrogels for biomedical applications: A review

Sterilization of hydrogels for biomedical applications: A review

Traditional and supercritical sterilization of medical devices

A new era for sterilization based on supercritical CO₂ technology

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Sterilization of macroscopic poly(l-lactic acid) porous scaffolds with dense carbon dioxide: Investigation of the spatial penetration of the treatment and of its effect on the properties of the matrix

Cited by 18 publications

References 50 publications

Sterilization of hydrogels for biomedical applications: A review

Sterilization of hydrogels for biomedical applications: A review

Traditional and supercritical sterilization of medical devices

A new era for sterilization based on supercritical CO2 technology

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A new era for sterilization based on supercritical CO₂ technology