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Stability Test
Ensure Your Product Remains Safe and Effective Throughout Its Shelf Life
Stability testing demonstrates that a product maintains its quality, safety, and performance throughout its intended shelf life. For disinfectants and antiseptics, stability data are essential to ensure the product continues to deliver effective antimicrobial performance until the end of its stated shelf life.
Regulatory authorities commonly require stability data to support product registration and label claims.
At TECOLAB, we provide comprehensive stability testing services tailored to disinfectants, antiseptics, and other chemical products.
General Study Design
In a stability study, products are stored under defined environmental conditions or stress conditions. Samples collected at predetermined intervals are compared with the initial product to evaluate any changes in quality attributes, including:
Physical appearance
Chemical stability
Microbiological quality
Functional performance
Among these parameters, chemical analysis of the active ingredient is generally the most critical. According to the Australian Therapeutic Goods Administration (TGA) guideline, the active ingredient concentration should not decrease by more than 10% from its initial value, a criterion that is also widely adopted by many manufacturers.
Accurate determination of the active ingredient requires a suitable analytical method that has been properly validated. At TECOLAB, we can develop and validate analytical methods for various active ingredients. The validated methods and protocols can subsequently be transferred to manufacturers for routine in-house quality control.
Designing a Stability Protocol
1) Shelf-Life Stability
Shelf-life stability evaluates the quality of a product throughout its unopened shelf life.
The most reliable approach is the real-time stability study, where products are stored under their recommended storage conditions for the entire intended shelf life and periodically tested against the initial product.
However, for products with a shelf life of two years or longer, waiting until completion of a real-time study before registration is often impractical. Therefore, accelerated stability studies are commonly performed.
Accelerated studies store products under elevated temperatures for a shorter period to predict long-term stability under normal storage conditions. The storage conditions vary depending on regulatory requirements. For example:
- TGA: Storage at 10°C above the recommended storage temperature for 6 months, which may support a projected shelf life of up to two years.
- EU BPR: Accelerated storage studies are commonly performed using the CIPAC MT 46.3 method, with storage at 54 ± 2°C for 14 days.
Want to know how manufacturers prove the shelf life and stability of disinfectants?
Read our comprehensive guide to real-time and accelerated stability studies, shelf-life prediction, storage conditions, and regulatory requirements.
Manufacturers can typically submit accelerated stability data during product registration while continuing to generate real-time stability data, which can be submitted when available.
At TECOLAB, we can design a stability protocol tailored to your product and regulatory requirements, including:
- Storage conditions
- Study duration
- Number of production batches
- Sampling intervals
- Testing parameters
2) In-Use Stability (Opening Shelf Life)
Once a product is opened, its stability may change due to exposure to air, light, moisture, repeated handling, and microbial contamination. These factors may accelerate degradation of the active ingredient or reduce product performance.
Therefore, it is equally important to determine the product’s in-use shelf life.
For example:
- Disinfectant wipes: Repeated opening of the container may cause gradual evaporation of the liquid, reducing wipe wetness and potentially affecting antimicrobial efficacy.
- Concentrated instrument disinfectants: After dilution, manufacturers need to determine how many reuse cycles or how many days the working solution remains effective.
Such information is important not only for regulatory submissions but also for providing clear instructions to end users regarding safe and effective product use.
At TECOLAB, we can design in-use stability studies that closely simulate actual product usage, incorporating relevant environmental and handling conditions to generate scientifically robust data supporting product claims and regulatory submissions.
Partner with TECOLAB
Generate reliable stability data that supports product quality, regulatory compliance, and customer confidence.
Need help designing your stability study or selecting the appropriate testing protocol? Our experts are here to help.