2022
DOI: 10.1021/acsabm.2c00793
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Sterilization of Polymeric Implants: Challenges and Opportunities

Abstract: Degradable and environmentally responsive polymers have been actively developed for drug delivery and regenerative medicine applications, yet inadequate consideration of their compatibility with terminal sterilization presents notable barriers to clinical translation. This Review discusses industry-established terminal sterilization methods and aseptic processing and contrasts them with innovative approaches aimed at preserving the integrity of polymeric implants. Regulatory guidelines, fiscal considerations, … Show more

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Cited by 9 publications
(11 citation statements)
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“…Generally, the two primary classes of polymers are categorized according to how long they last under physiological conditions based on their biodegradability and stability in in vivo environments . Biostable polymers, such as polytetrafluoroethylene (PTFE), poly­(methyl methacrylate) (PMMA), ultrahigh molecular weight polyethene (UHMWPE), and polyether ether ketone (PEEK), have exceptional stability when implanted in the body . While the biodegradable polymers progressively degrade into biocompatible compounds in the biological milieu of the host body, these substances include polyglycolic acid (PGA), polylactic acid (PLA), polycaprolactone (PLC), and polylactic- co -glycolic acid (PLGA).…”
Section: Polymer-based Hip Implantsmentioning
confidence: 99%
See 2 more Smart Citations
“…Generally, the two primary classes of polymers are categorized according to how long they last under physiological conditions based on their biodegradability and stability in in vivo environments . Biostable polymers, such as polytetrafluoroethylene (PTFE), poly­(methyl methacrylate) (PMMA), ultrahigh molecular weight polyethene (UHMWPE), and polyether ether ketone (PEEK), have exceptional stability when implanted in the body . While the biodegradable polymers progressively degrade into biocompatible compounds in the biological milieu of the host body, these substances include polyglycolic acid (PGA), polylactic acid (PLA), polycaprolactone (PLC), and polylactic- co -glycolic acid (PLGA).…”
Section: Polymer-based Hip Implantsmentioning
confidence: 99%
“…PTFE’s mechanical strength is insufficient compared to other biostable polymers. Table depicts the general mechanical properties of PTFE. Typically, adding foreign materials is the primary tool for enhancing the mechanical properties of these polymers.…”
Section: Polymer-based Hip Implantsmentioning
confidence: 99%
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“…One critical point of the translation of therapeutic implants to the clinic is showing feasibility of sterilization. 27 Ionizing radiation in the form of gamma irradiation is one of the most common sterilization techniques for medical devices, including UHMWPE implants. The structure and longevity of many materials comprised in implants, especially polymeric components, can be significantly affected by irradiation.…”
Section: Introductionmentioning
confidence: 99%
“…One critical point of the translation of therapeutic implants to the clinic is showing feasibility of sterilization . Ionizing radiation in the form of gamma irradiation is one of the most common sterilization techniques for medical devices, including UHMWPE implants.…”
Section: Introductionmentioning
confidence: 99%