EZ-fill® Cartridges Design History File retrospective project and Engineering Verification Testing results

Stevanato Group ability to properly address, in a competitive and efficient way, the international markets of healthcare products is traduced in a quality production associated with recollection and organization of the relevant documentation. EZ-fill® cartridges are products sold on the market by the company since 2014 and, in this work, the discussion of the recent creation of the documentation is treated. This approach is therefore retrospective and consequently addressed as: EZ-fill® Cartridges Design History File Retrospective Project. In this optic, the study of the cartridges requirements is highly significative, and their performances must be well known. For this reason, the evaluation of two particularly important requirements, leakage and resealability, is reported in the present work. Therefore, leakage and resealability tests, with SG proprietary method FTL_2, have been performed on 19 cartridges categories, each one of them subjected to different sterilization cycle parameters, to evaluate the performance of cartridges correlated to their seal. The conclusion of the DHF and the analysis of all the requirements with highlight on leakage and resealability properties of EZ-fill® cartridges confirm the safety and reliability of these products. The results of the tests allowed to conclude that all the categories perform similarly despite the different sterilization cycle parameters. The results are more than sufficiently acceptable for the market standard and confirmed that the company standard cycle of sterilization is adequate.