Abstract
How sterilization techniques accurately affect the properties of biopolymers continues to be an issue of discussion in the field of biomedical engineering, particularly now with the development of 3D-printed devices. One of the most widely used biopolymers in the manufacture of biomedical devices is the polylactic acid (PLA). Despite the large number of studies found in the literature on PLA devices, relatively few papers focus on the effects of sterilization treatments on its properties. It is well documented in the literature that conventional sterilization techniques, such as heat, gamma irradiation and ethylene oxide, can induced damages, alterations or toxic products release, due to the thermal and hydrolytical sensitivity of PLA. The purposes of this paper are, therefore, to review the published data on the most common techniques used to sterilize PLA medical devices and to analyse how they are affecting their physicochemical and biocompatible properties. Emerging and alternative sterilization methods for sensitive biomaterials are also presented.
Highlights
Sterilization is a fundamental step in the manufacturing process of any biomaterial or medical device that will be in contact with the human body, as well as in the process of reusing medical instruments [1], to avoid any complications such as infections or rejections
Because absolute sterility cannot be verified, the statistical definition of sterility used in practice is based on the Sterility Assurance Level (SAL), which for any biomedical device should be limited to a SAL of 10−6, meaning that maximum one viable microorganism should be found in one million sterilized samples [4]
It is extensively proven that steam sterilization is not suitable for thermal and hydrolytic sensitive biomaterials because they do not tolerate the temperatures required during autoclaving [4]
Summary
Sterilization is a fundamental step in the manufacturing process of any biomaterial or medical device that will be in contact with the human body, as well as in the process of reusing medical instruments [1], to avoid any complications such as infections or rejections. Because absolute sterility cannot be verified, the statistical definition of sterility used in practice is based on the Sterility Assurance Level (SAL), which for any biomedical device should be limited to a SAL of 10−6, meaning that maximum one viable microorganism should be found in one million sterilized samples [4]. In addition to their effectiveness, sterilization methods should not cause significant changes in the physical, chemical, mechanical and biocompatibility properties of the material, that might produce adverse responses in the body or compromise its function [3]. Gamma irradiation can deteriorate polymers causing scission and cross-linking in polymer chains, resulting in decreased molecular weight and increased biodegradation rates [3]
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