alexa The relative safety of gamma-ray, autoclave, and ethylene oxide gas sterilization of thermosetting polyurethane.
Pharmaceutical Sciences

Pharmaceutical Sciences

Pharmaceutical Regulatory Affairs: Open Access

Author(s): Shintani H, Shintani H

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Abstract Sterilization of polyurethane (PU) produces 4,4'-methylenedianiline (MDA), a known carcinogen, and various other compounds. The relationships of the components of PU to the formation of these compounds by sterilization were studied. Specimens of PU fabricated from different combinations of isocyanates and polyols were obtained from dialyzers. The molecular weight of the particular polyol was found to influence the production of MDA by sterilization. Sterilization also produced many unidentified compounds. MDA production was not always associated with the production of the other compounds. Compared with gamma-ray irradiation and ethylene oxide gas (EOG) sterilization, autoclave sterilization eluted more hydrophilic compounds. This phenomenon was significant for PUs produced from smaller-molecular-weight polyols. The combination of autoclave sterilization and a PU produced from a larger-molecular-weight polyol is recommended to minimize the production of potentially toxic compounds. Of the techniques studied, EOG sterilization produced the least amounts of MDA and the other compounds, but the residue of EOG is itself problematic. The risk posed by the amounts of MDA extracted was not significant, but the biological safety of the other compounds remains to be determined.
This article was published in Biomed Instrum Technol and referenced in Pharmaceutical Regulatory Affairs: Open Access

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