Chemical and Thermal Evaluation of Commercial and Medical Grade PEEK Sterilization by Ethylene Oxide

Abstract

Many polymers have been used as biomaterials due to their physicochemical characteristics and structural versatility. However, usage on the human body requires sterilization in order to prevent microbial contamination and diminish the risk of rejection or inflammation. This study presents the use of thermogravimetric analysis (TGA) as an alternative to monitor the presence of residual ethylene oxide from polymers sterilization processes. This is a simple technique and does not require sample preparation stages which can imply in some ethylene oxide loss. Ethylene oxide has been used to sterilize polymeric biomaterials, but with restrictions in the amount used due to the difficulty in removing the toxic waste after the sterilization procedure. Samples of commercial (PEEKc) and medical (PEEKm) grade poly(ether ether ketone) (PEEK) were manufactured in the form of cylindrical tubes, hygienized and sterilized with ethylene oxide. PEEKs showed no chemical changes, but exhibited thermal changes by TGA, which evidenced weight loss between 100 and 500°C that was attributed to the removal of residual ethylene oxide, so this technique, at a 10°C•min -1 heating rate, can be used to monitor the sterilization processes.

Biocompatibility Assessment of Poly(lactic acid) Films after Sterilization with Ethylene Oxide in Histological Study In Vivo with Wistar Rats and Cellular Adhesion of Fibroblasts In Vitro

“…After hygienization, the PLA films were sterilized with ethylene oxide following the mechanical aeration process, hyperventilation, and natural aeration for 24 hours (in an accredited company in the city of Caxias do Sul, Brazil). The hygienization and sterilization parameters used in this study were also applied in other studies of the group [16,17]. According to the FDA (1978), aeration for 96 h at room temperature is recommended for all polymers, except for poly(vinyl chloride) (PVC).…”

Designing of an Advanced Compression Bioreactor with an Implementation of a Low-Cost Controlling System Connected to a Mobile Application

“…The bioreactor prototype was utilized to test the size of components, the design for the assembly and disassembly. Afterwards, all the components of the bioreactor chamber were produced using medical-grade thermoplastic polyetheretherketone (PEEK), which is an inert and biocompatible material showing excellent mechanical and chemical resistance [12,13]. The main base of the bioreactor to stabilize the entire device was produced with aluminum material.…”

Drug Micro-Carriers Based on Polymers and Their Sterilization

“…Although this method has disadvantages such as the degradation of the polymer chain, it can be applied to materials that cannot withstand high temperatures. The main disadvantages are the high flammability, mutagenic properties, the possibility of forming toxic residues in the treated materials and limited penetration capability in the polymer [255][256][257][258].…”