Haltbarkeitsanforderungen

Haltbarkeitsanalyse (shelf-life analysis) describes the study of how long a product remains within defined quality and safety limits under specified storage conditions. It is applied in fields such as food, pharmaceuticals, cosmetics, and chemicals. The aim is to determine or estimate a product’s shelf life and to establish storage recommendations and labeling.

Methods used in Haltbarkeitsanalyse include real-time stability testing, where products are observed under normal conditions for the duration of their expected life, and accelerated stability testing, which uses higher temperatures or humidity to speed up degradation. Data from chemical, physical, sensory, and sometimes microbiological measurements are analyzed to model deterioration rates. Predictive models, including kinetic analyses and, in some cases, the Arrhenius equation, may be employed to extrapolate results to realistic storage scenarios. The outcome is a defined shelf life or time frame during which the product is expected to remain within specification, along with recommended storage conditions.

Regulatory and labeling contexts vary by jurisdiction. Some regions require safety-critical dates such as a use-by date, while others distinguish between dates related to safety and those related to quality (for example, best-before). Documentation of shelf-life studies supports regulatory compliance, product development, and consumer information.

Packaging, formulation, and storage conditions significantly influence shelf life. Haltbarkeitsanalyse is typically part of a broader quality management system, including HACCP-based programs and ongoing stability monitoring. Limitations include dependence on assumed storage conditions; deviations can shorten the actual usable period, making periodic revalidation advisable.