Effects of batch to batch variations and test methodology on degree of crystallinity and melting temperature of UHMW-PE as measured by differential scanning calorimetry.

The thermal and structural analysis of a total 22 batches from three medical grade ultrahigh molecular weight polyethylene (UHMW-PE) resins was determined using the DSC method. Batch to batch variations of approximately 5% were obtained for the melting temperature and the degree of crystallinity. The variations correlated both to the changes caused by gamma-irradiation sterilization and subsequent aging, and to the differences in DSC results obtained from various laboratories on materials believed to exhibit essentially similar clinical performances. Varying the sample weight from 4.4 to 27.1 mg resulted in a significant relative increase of 5% in the degree of crystallinity. The study shows that the standard double melting/recrystallisation procedure for DSC evaluation produces variations in the melting behaviors of approximately the same magnitude as those indicated by batch lot or sterilization/aging.