PubMed · 13568800
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M EISENBUD, J H HARLEY. 1958-08-22. Long-term fallout.. https://doi.org/10.1126/science.128.3321.399
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Gamma irradiation is a widely adopted method for terminal sterilization of medical devices; however, its application to collagen-based extracellular matrix (ECM) materials remains limited due to radiation-induced degradation of structural integrity and mechanical performance. Here, we present an engineered terminal-processing strategy that combines oxygen controlled gamma irradiation (25-30 kGy) with post-irradiation dry-heat annealing to preserve ECM functionality while achieving effective sterilization. By modulating oxygen availability during irradiation, this approach alters radical reaction pathways, suppresses oxygen-mediated oxidative degradation, and generates a metastable radical-containing intermediate, which is subsequently converted into a structurally stabilized collagen network through thermal annealing. As a result, the treated matrices preserved ECM integrity and recovered clinically relevant mechanical properties. Furthermore, the process achieved cumulative viral reductions exceeding 6 log10 across a representative panel including enveloped and non-enveloped DNA and RNA viruses, demonstrating compatibility with sterility assurance and viral safety requirements for biologically derived medical devices. Notably, preliminary observations indicate that mechanical integrity can be partially preserved even at elevated irradiation doses up to 50 kGy, suggesting potential applicability to sterilization validation frameworks requiring higher assurance levels. Overall, this work establishes a mechanistically grounded terminal-processing paradigm that enables control of radical fate, decouples sterilization efficacy from material degradation, and integrates sterilization, viral safety, and functional preservation into a unified and scalable framework for collagen-based biomaterials. This concept repositions gamma-irradiation from a purely degradative process to a controllable tool for tuning collagen structure and performance.
The degradation of polyvinyl alcohol (PVA) by gamma-ray irradiation was investigated. Degradation efficiency of PVA was influenced by several factors, such as initial PVA concentration, dose rate, pH, and the addition of H2O2. The degradation kinetics depended on initial PVA concentration and dose rate. At a relatively lower PVA concentration, e.g., 180 mg/L, and a higher dose rate, e.g., 55.7 Gy/min, the degradation followed pseudo-first-order kinetics. On the contrary, at a higher PVA concentration, e.g., 500 mg/L, but a lower dose rate, e.g., 12.1 Gy/min, a pseudo-zero-order reaction occurred. The removal of PVA was more effective under acidic or alkaline conditions than that under neutral conditions. At a certain dose rate there was an optimal dosage of H2O2 to facilitate the degradation of PVA. For instance, at a dose rate of 17.2 Gy/min, the optimal H2O2 dosage was found to be about 2.5 mmol/L. Radical scavenging experiments, total organic carbon determination, and FTIR analysis on the degradation products demonstrated that PVA radiolysis was initiated by *OH and H*, leading to chain scission and formation of ketones/enols. Ultimately, complete mineralization of PVA was achieved.
In order to examine the initiation mechanism of delamination in ultrahigh molecular weight polyethylene (UHMWPE) knee components, a bi-directional sliding fatigue test was performed for three types of UHMWPE specimens: nonirradiated, gamma-irradiated (25 kGy) and gamma-irradiated (25 kGy) with 0.1% vitamin E added. Sliding surfaces of post-tested UHMWPE specimens were observed using an optical microscope and a scanning electron microscope. Also, surface roughness was measured at the sliding surfaces of UHMWPE specimens. Delamination was observed only in gamma-irradiated specimens. A networked structure of surface asperity that resembled grain boundary was observed prior to delamination in gamma-irradiated specimens. Surface roughness in the gamma-irradiated specimens, higher than in any other specimen, showed a rapid increase prior to delamination. Detailed observation using an optical microscope and a scanning electron microscope showed microscopic crack initiation along subsurface grain boundaries in gamma-irradiated specimens. These results suggest that subsurface crack initiation is a precursor of delamination and is accelerated by oxidative degradation due to gamma irradiation. Of the three types of specimens, UHMWPE with vitamin E added showed the lowest surface roughness values at all measuring points. The addition of vitamin E is effective in improving wear resistance and fatigue performance of UHMWPE.