In ATDS, tiptop extends stability evaluation for freeze-dried and dual-chamber products into actual dispensing and use. We do this because a product passes through different states before activation and after mixing; evaluation needs to follow its formulation, packaging and handling together.
Before the product reaches the consumer
The framework proposes evaluation settings including long-term and accelerated storage, light exposure, freeze–thaw, temperature cycling and transport vibration. Specific projects select those relevant to the product. Packaging compatibility, adsorption, leachables, fill quantity and dose consistency also enter the design.
Freeze-dried systems additionally require attention to the protective system, freezing rate, primary and secondary drying, and residual moisture. We aim to connect process conditions with the state of the finished product, giving storage evaluations a clearly defined product to examine.
From separate storage to thorough mixing
Dual-chamber products require the chambers to be connected and their contents mixed at activation. ATDS therefore proposes evaluating fill amounts in each chamber, mixing time, completeness and uniformity, while considering differences in consumer handling.
These requirements bring research into the actual actions of use: whether the product mixes fully when instructions are followed, and how variations in handling affect mixing. Products studied and products placed on the market should use corresponding mixing methods.
The period after mixing is also part of evaluation
The framework proposes examining particle size or aggregation, markers, cargo, activity and the microbiological use period to evaluate the effective window after mixing. These are evaluation-design requirements proposed by ATDS; each product’s actual results are explained in its own documentation.
For current CELLshot products, our instructions are: store at room temperature before activation; after mixing the serum, we recommend using it up within one week. When first activating ExoSerum Pro, connect and thoroughly mix the 0.18 g of freeze-dried powder with 3.5 ml of EXP導入美容液Ⅰ before dispensing.
This is why we include in-use stability in ATDS 2026. The period after packaging is opened also belongs within our product responsibilities.