Module 18 2021

Critical issues

Sterility and pyrogenicity Biocompatibility – ISO 10993-1 Compatibility of device with the cells ● Samples passed through system compared to a reference sample – Cell viability – Cell count – Potency – Incucyte – growth on recovery imaging Accuracy and precision No Human Factors testing required by FDA ● Justified as no critical tasks

TOPRA MSc Module 18: Drug Device Combinations and other Technology