Stability Testing /Shelf Life Substantiation

This process will help substantiate expiration dating through shelf life and ensure the finished formula and packaging meets the desired expectations.

Gemini offers stability & trend analysis programs for the items that we manufacture. This process will help substantiate expiration dating through shelf life and ensure the finished formula and packaging meets the desired expectations. Our stability chambers are calibrated for both Real-Time and Accelerated stability environments according to USP & ICH guidelines. Testing protocols are designed to evaluate products under various environmental conditions over a specific period of time depending on the client’s needs.

Accelerated studies take place over a shorter duration to help estimate shelf life and utilize elevated stress conditions such as increased temperature & humidity. These studies are also helpful to track any degradation that may occur along with the rate of degradation to help improve formulations. Gemini leverages decades of experience and data from hundreds of OTC Drug and Nutritional products to assist with formulation and “best use” dates when needed.

Products designated for export may have specific stability requirements. For these products Gemini has dedicated stability chambers that can be calibrated to the necessary climatic zone. These zones include climates that are (Temperate), (Mediterranean/Subtropical), (Hot/Dry), and (Hot/Humid, Tropical). Regardless of where the product is being sold globally, Gemini has you covered.