TR 2019/215: Evaluation of Removal and Insertion Force for 4040/40 Lyophilization Stoppers

Lyophilization stoppers are fully seated into the vial by the lowering of chamber shelves after the lyo process is completed, thereby establishing the initial seal. The stopper insertion force must be sufficiently low to be compatible with the maximum force exerted by the shelves in the lyophilization chamber. This technical report presents and summarizes the results of the testing of stopper removal and insertion forces of 4040/40 lyo stoppers.