Optimizing the sterilization of PLGA scaffolds for use in tissue engineering.

There are few suitable techniques available to sterilize biodegradable polyester three-dimensional tissue engineering scaffolds because they are susceptible to degradation and/or morphological degeneration by high temperature and pressure. We used a novel polyllactide-co-glycolide) scaffold (Osteofoam) to determine the optimal sterilization procedure--i.e. a sterile product with minimal degradation and deformation. Initial studies, found that an argon plasma created at 100W for 4min was optimal for sterilizing Osteofoam scaffolds without affecting their morphology. The RFGD plasma sterilization method was compared to two well-established techniques--ethylene oxide (ETO) and gamma-irradiation (gamma)--which were in turn compared to disinfection in 70% ethanol. Disinfection in 70% ethanol serves as a useful control because it affects neither the morphology nor the molecular weight of the polymer: yet, ethanol is unsuitable as a sterilization method because it does not adequately eliminate hydrophilic viruses and bacterial spores. The three sterilization techniques, ETO, gamma and RFGD plasma, were compared in terms of their immediate and long-term effects on the dimensions, morphology, molecular weight and degradation profile of the scaffolds. Scaffolds shrank to 60% of their initial volume after ETO sterilization whereas their molecular weight (Mw) decreased by approximately 50% after gamma-irradiation. Thus, both ETO and gamma-irradiation posed immediate problems as sterilization techniques for 3-D biodegradable polyester scaffolds. During the in vitro degradation study, all sterilized samples showed advanced morphological and volume changes over time relative to ethanol (EtOH) disinfected samples, with the greatest changes observed for gamma-irradiated samples. ETO, RFGD plasma sterilized and EtOH disinfected samples showed similar changes in Mw and mass over the 8-week time frame. Overall, of the three sterilization techniques studied, RFGD plasma was the best.