J Bergum’s scientific contributions

USP general chapter Containers-Performance Testing < 671 > was revised recently, and this Stimuli article explains how and why the revisions to <671> were made. The new method in the proposed revision to < 671 > provides a test for determining the moisture vapor transmission rate (MVTR) of the container-closure system. This test is capable of differentiating among high moisture barrier container-closure systems and is more relevant to the needs of the pharmaceutical industry than the original method described in the current <671>. This new method is both reliable and reproducible. The test conditions used are the same as the accelerated stability storage conditions described in ICH Q1A(R2).1 In addition, a justification is provided for the use of MVTR per unit dose (MVTR/m, where m = mass of the dosage unit) to allow comparison of the moisture-barrier properties of different container-closure systems used for packaging finished oral solid dosage forms. With knowledge of 1) the MVTR for the container-closure system and 2) the performance of the product on stability measures, a proven acceptable range (PAR) for MVTR/m can be established. For container-closure systems that do provide an adequate moisture barrier, the MVTR/m can be used to justify a change in packaging without having to undertake costly stability studies. Much of the information in support of the comments in this Stimuli article were generated by the Container-Closure Working Group in the Product Quality Research Institute, which is sponsored by the American Association for Pharmaceutical Sciences. The authors thank the Working Group, PQRI, and AAPS for the information and effort.