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Chapter 3: Nanoparticle Sterility and Sterilization of Nanomaterials

    https://doi.org/10.1142/9789813140431_0003Cited by:8 (Source: Crossref)
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    Abstract:

    Nanotherapeutics (NTs) are complex systems with multiple components, each of which could be susceptible to the damaging effects of the sterilization procedure in a different way. Sterilization by autoclaving could result in heat-induced chemical and physical changes in NTs and sterilization by gamma irradiation could induce free radical formation, which could result in immediate chemical changes as well as impact the stability of the product. A suitable battery of tests needs to be utilized during developmental studies to understand the impact of sterilization. The panel of analytical methods must be appropriate for monitoring the physical and chemical changes to NTs. Due to the impact of sterilization, it is necessary to perform all characterization studies after sterilization procedures and to establish a stability program suitable for the detection of chemical degradants during the shelf-life of NTs.