A study investigated the influence and correlation of critical process parameters for the optimization of in-process curing.
Previous studies with EUDRAGIT NM 30 D showed that storage stability can be achieved with in-process curing at specific conditions. The aim of this study was to identify and investigate the influence and correlation of critical process parameters for the optimization of in-process curing.
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Understanding the Variability in Bioburden Test Results in Biomanufacturing
May 7th 2025This article explores the impact of test volume, microbial distribution, and dilution errors on bioburden testing variability. It presents statistical approaches to estimate percentage error and discusses strategies to optimize microbial enumeration techniques in biopharmaceutical quality control.