Regulatory authorities require proof that lyophilisation cycles are developed logically, and that they demonstrate uniformity. One measure of uniformity is residual water content throughout a batch. The amount of moisture remaining will be influenced by a number of factors including vial location, self content, product formulation and the cycle conditions. In this study, conducted by Isobel Cook and Kevin Ward from BTL, and Derek Duncan from Lighthouse Instruments, residual moisture content across a freeze dryer shelf was mapped using Frequency Modulated Spectroscopy and Karl Fischer.
Tags: FMS, headspace moisture analysis, karl fischer, Lighthouse, lighthouse instruments, moisture mapping, shelf mapping