Sterilization of Implants and Devices

Lambert, Byron J.; Martin, Jeffrey W.

doi:10.1016/b978-0-08-087780-8.00125-x

Cited by 14 publications

(16 citation statements)

References 9 publications

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“…Irradiation is known to increase the temperature of formulations for a few seconds for e-beam sterilization (typically to 50 °C with polymeric materials) or a few hours for γ-sterilization (typically 30−40 °C). 73 The increase in temperature can be managed by processing at a reduced temperature, e.g., −78.5 °C with dry ice. The potential impacts of oxygen and humidity can be eliminated by vacuuming or flushing formulations with inert gas, such as nitrogen or argon.…”

Section: Terminal Sterilizationmentioning

confidence: 99%

Potential Roles of the Glass Transition Temperature of PLGA Microparticles in Drug Release Kinetics

et al. 2020

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Poly(lactic-co-glycolic acid) (PLGA) has been used for long-acting injectable drug delivery systems for more than 30 years. The factors affecting the properties of PLGA formulations are still not clearly understood. The drug release kinetics of PLGA microparticles are influenced by many parameters associated with the formulation composition, manufacturing process, and post-treatments. Since the drug release kinetics have not been explainable using the measurable properties, formulating PLGA microparticles with desired drug release kinetics has been extremely difficult. Of the various properties, the glass transition temperature, T g, of PLGA formulations is able to explain various aspects of drug release kinetics. This allows examination of parameters that affect the T g of PLGA formulations, and thus, affecting the drug release kinetics. The impacts of the terminal sterilization on the T g and drug release kinetics were also examined. The analysis of drug release kinetics in relation to the T g of PLGA formulations provides a basis for further understanding of the factors controlling drug release.

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Section: Terminal Sterilizationmentioning

confidence: 99%

Potential Roles of the Glass Transition Temperature of PLGA Microparticles in Drug Release Kinetics

et al. 2020

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“…Depending on the biomaterial and bioactive molecule involved, there may be ways to avoid degradation upon gamma-irradiation, such as using an antioxidant mixed with the drug. Apart from aseptic conditions, gamma-irradiation of the final product remains the best solution but exposes one of the disadvantages of developing bioactive implants as it is still a costly technique bringing its own risks [220].…”

Section: Manufacturing Considerationsmentioning

confidence: 99%

Biomedical Implants for Regenerative Therapies

Gonçalves¹,

Balestri²,

Reinwald³

2020

Biomaterials

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Regenerative therapies aim to develop novel treatments to restore tissue function. Several strategies have been investigated including the use of biomedical implants as three-dimensional artificial matrices to fill the defect side, to replace damaged tissues or for drug delivery. Bioactive implants are used to provide growth environments for tissue formation for a variety of applications including nerve, lung, skin and orthopaedic tissues. Implants can either be biodegradable or non-degradable, should be nontoxic and biocompatible, and should not trigger an immunological response. Implants can be designed to provide suitable surface area-to-volume ratios, ranges of porosities, pore interconnectivities and adequate mechanical strengths. Due to their broad range of properties, numerous biomaterials have been used for implant manufacture. To enhance an implant’s bioactivity, materials can be functionalised in several ways, including surface modification using proteins, incorporation of bioactive drugs, growth factors and/or cells. These strategies have been employed to create local bioactive microenvironments to direct cellular responses and to promote tissue regeneration and controlled drug release. This chapter provides an overview of current bioactive biomedical implants, their fabrication and applications, as well as implant materials used in drug delivery and tissue regeneration. Additionally, cell- and drug-based bioactivity, manufacturing considerations and future trends will be discussed.

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“…Diese Art der Sterilisation stellt mitunter das einfachste Verfahren dar, benötigt keine schädlichen Chemikalien und ist relativ kostengünstig [57]. Seit dem vergangenen Jahrzehnt findet zusätzlich die Sterilisation mittels Wasserstoffperoxid eine breitere Anwendung in der Klinik [61].…”

Section: Sterilisationsverfahrenunclassified

“…Komplexer werdende Medizinprodukte wie beispielsweise Drug-Delivery-Systeme mit aktiven, biologischen Wirkungsmitteln, bioresorbierbaren temperatursensitiven Polymeren oder strahlungssensitiver Elektronik werden auch in Zukunft die Anforderungen an Sterilisationsverfahren erhöhen. Dabei ist die Entwicklung wirkungsvoller und gleichzeitig werkstoffschonender Sterilisationsverfahren der Schlüssel, um aseptische Verarbeitungsschritte zu vermeiden und somit medizinische Therapieverfahren zu einem geringen Preis bei größtmöglicher Prozesskontrolle und Patientensicherheit anbieten zu können [61].…”

Section: Sterilisationsverfahrenunclassified

Werkstoffe/Biomaterialien in der interventionellen und operativen Medizin – eine kurze Übersicht und aktuelle Trends

et al. 2015

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Biomaterials play a major role in interventional medicine and surgery. However, the development of biomaterials is still in its early phases in spite of the huge progress made within the last decades. On the one hand, this is because our knowledge of the molecular and cellular processes associated with biomaterials is still increasing exponentially. On the other hand, a wide variety of advanced materials with highly interesting properties is being developed currently. This review provides a short introduction into the variety of materials in use as well as their application in interventional medicine and surgery. Also the importance of biomaterials for tissue engineering in the field of regenerative medicine and the functionalisation of biomaterials, including sterilisation methods are discussed. For the future, an even broader interdisciplinary scientific collaboration is necessary in order to develop novel biomaterials and facilitate their translation into clinical practice.

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Sterilization of Implants and Devices

Cited by 14 publications

References 9 publications

Potential Roles of the Glass Transition Temperature of PLGA Microparticles in Drug Release Kinetics

Potential Roles of the Glass Transition Temperature of PLGA Microparticles in Drug Release Kinetics

Biomedical Implants for Regenerative Therapies

Werkstoffe/Biomaterialien in der interventionellen und operativen Medizin – eine kurze Übersicht und aktuelle Trends

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