Stability studies determine whether a product retains its properties over time and under different storage conditions. They form the basis for shelf-life declarations for pharmaceuticals, cosmetics, food, and many chemical products.
Scope
Test protocol: A definition of which product will be tested, in which packaging, under what conditions (long-term, accelerated, intermediate), and at what time points.
Automatic sample collection schedule: The system automatically generates the relevant sample and analyses when a given time point arrives. Missing a time point may invalidate the entire study.
Climate cabinet management: Cabinet locations, occupancy, temperature and humidity records, identification of studies affected in case of deviations.
Trend and shelf-life forecasting: Graphical and statistical evaluation of time series results; estimation of the time to reach specification limit.
Packaging comparison: Comparing the effect of different packaging types on product stability.
Working report: Compiling all data from protocol to outcome in a single document.
Why a separate discipline?
Stability studies take years and generate hundreds of sample-time point combinations. When managed with a spreadsheet, the most common problem is missing a time point : the 12th-month sample isn't taken because no one reminds, leaving the study incomplete. In a system-based study, this schedule runs automatically.