Shelf life
Shelf life is the period during which a product, such as a chemical, reagent, or biopharmaceutical, maintains its specified quality, stability, and efficacy under defined storage conditions.
What determines shelf life?
Shelf life is established through rigorous stability testing under controlled conditions, including temperature, humidity, and light exposure. For chemical reagents and biologics, this involves monitoring degradation products, potency loss, and physical changes over time. Regulatory guidelines, such as those from the European Pharmacopoeia (EP) and the USP, require manufacturers to define shelf life based on real-time and accelerated stability studies. The shelf life is typically validated through data collected over months or years, ensuring that the product remains within specified limits for purity, concentration, and function.
How is shelf life managed in procurement and lab settings?
In B2B procurement, shelf life is a critical factor when selecting suppliers and placing orders, especially for time-sensitive materials like enzymes, antibodies, or cell culture media. Procurement teams often prioritise products with extended shelf life and clear expiry dates to reduce waste and ensure continuity of research. Laboratories use inventory management systems to track expiry dates, often implementing a 'first expiry, first out' (FEFO) policy to minimise the risk of using expired materials. For regulated environments, such as clinical trials or pharmaceutical manufacturing, shelf life documentation must comply with GMP and ISO standards.
Related concepts
Shelf life is closely linked to stability, expiry date, storage conditions, and batch testing. Understanding these interrelated factors ensures reliable results and regulatory compliance.