Abstract
Purpose: To evaluate the sterility and biological functionality of platelet lysate eye drops stored in BTI ophthalmic devices for PRGF delivery under different storage conditions and simulated use scenarios. Methods: Eye drops were prepared using platelet lysate and stored in BTI tubes under three different conditions: ≤-15 °C, 2-8 °C, and room temperature (RT) for 72 h. Simulated use was performed for 72 h with controlled drop dispensing. Bacterial contamination was assessed according to European Pharmacopoeia sterility testing principles. The biological activity of the eye drops was assessed using in vitro proliferation assays with primary human keratocytes (HKs) and human corneal epithelial cells (HCEs). Statistical analyses were performed to compare the effects of different storage conditions and application scenarios. Results: No bacterial contamination was detected in platelet lysate eye drops stored under any of the conditions tested, regardless of simulated use. Proliferation assays showed that eye drops enhanced the growth of HK and HCE cells compared to the control medium. No significant differences in proliferation were observed between storage conditions. Conclusions: Platelet lysate eye drops maintain sterility and biological functionality when stored in BTI ophthalmic devices at ≤-15 °C, 2-8 °C and RT for up to 72 h of simulated use. These results support the feasibility of using BTI eye drop devices in clinical settings while ensuring safety and efficacy.