PubMed · 13628776
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I P SHMELEV. 1959. [Radiotopography].. https://pubmed.ncbi.nlm.nih.gov/13628776/
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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.
A series of poly(lactide-co-glycolide) samples of compositions ranging from (75:25) to (65:35) to (50% (65:35):50% (50:50)) were gamma-irradiated under ambient conditions in air. The irradiation doses used were 15, 20, 25, and 30 kGy. The generation of radicals resulting from the gamma-irradiation was confirmed using EPR. Two major radical species were observed and identified as centered at alkyl and alkyl peroxy groups. The indication from the X-band (9 GHz) frequencies showed that alkyl radicals gave rise to a quartet hyperfine pattern. However, measurements performed at higher W-band frequencies (90 GHz) showed that the X-band spectra are actually a composite profile arising from a series of overlapping individual resonances. Using combined EPR and ENDOR (Electron-Nuclear DOuble Resonance) measurements, an alkyl peroxy radical was identified. For increasing glycolide concentration from 75:25 to the 50:50 blend, there was a factor of 7 increase in the concentration of radicals A and B. Furthermore, both radical species were found to be stable for several weeks after storage at ambient temperature conditions. At elevated temperatures and humidities, radical stability decreased--the decay rate was estimated at approximately 3x10(-8) mol K(-1). The stability characteristics of the radicals under different conditions are attributed to changes in the morphology of the polymer.
A GC-ICP-MS method based on extraction and alkylation of butyltins with sodium tetraethylborate was used to quantitatively assess the fate of these analytes in solutions and sediments following exposure to gamma-irradiation. The effects of a 2.5 Mrad sterilization dose on three butyltin species in both methanolic calibration solutions and in sediment matrices were investigated. Although significant losses of tributyltin (TBT, 90%), dibutyltin (DBT, 100%) and monobutyltin (MBT, 80%) were detected in standard solutions prepared in methanol following gamma-irradiation, no species inter-conversion occurred. Some degradation of TBT (38%) and DBT (32%) but no significant change in MBT content was found using a spiked sediment CRM HISS-1. Conversion DBT to MBT in spiked HISS-1 was deduced. Much smaller degradation of TBT (16% loss) and 10% loss of DBT by conversion to MBT (14% gain) was registered using a sediment blend of PACS-2 and HISS-1 (SOPH). Despite some initial losses of TBT and DBT due to irradiation, better than 2% RSD in both TBT and DBT concentrations measured in twelve different bottles of blended sediment SOPH were obtained, indicating the material may be considered homogeneous for these analytes. Results from a long-term five-year stability study of PACS-2 show that all three butyltins are stable during storage at 4 degrees C followed with 2.5 Mrad minimum dose of gamma-irradiation sterilization treatment.