In-House Packaging & Stability Assessment

Scope of assessment: this is an optional additional layer of testing that can be used for qualitative supporting information for product stability and packaging compatibility upon finalizing the development of your formulation and packaging selection. Not a Substitute for ICH or Long-Term Stability. This is a cost-effective, brand-friendly method to catch obvious packaging or formula incompatibilities, separation risks, or label failures before investing in large-scale production or formal lab testing. However, not suitable for Regulatory filings (OTC, EU, APAC), Shelf-life labeling (e.g., “12M PAO” claims), Clinical claims (e.g., “preservative-free and stable”).

• As part of this assessment we will manufacture a full-size unit of your final approved formula and run the unit through a series of  tests and assessments and provide a final report documenting our findings.
• A label mockup printed in the actual selected label material can be added as an option for a full mockup unit if a physical assessment of the compatibility of the packaging and label materials is required or desired.
• The total duration of the assessment is approximately 8 weeks (1 additional week will be necessary in case of mockup label printing).

Assessment steps:

• Initial Physical & Chemical Integrity Checks– from a pre-seal product sample we will perform in-house pH testing, centrifuge testing and thermal stress test (54°C for 24 hours) and one final centrifuge testing after the 24-hour thermal stress test. This step is already included as the final portion of our the standard Product Development process.
• 2-week Thermal Stress Test – Exposure to 54°C* continuously for two weeks. * target temperature may be adjusted according to the specific formulation if lower temperature thresholds are recommended.
• Storage Test – The test unit will be stored sealed for four weeks under standard warehouse conditions.
• Packaging Compatibility Check – The sealed container and label (when applicable) will be inspected for any visible changes in shape and, for non-opaque containers, a visual inspection of the product inside will be performed and the observations will be recorded.
• Final Physical & Chemical Integrity Checks – After the initial six weeks of thermal stress and storage, a sample will be drawn from the container for additional in-house pH testing, centrifuge testing and thermal stress test (54°C for 24 hours) and one final centrifuge testing after the 24-hour thermal stress test, followed by a 3rd party lab microbiology analysis.
• Final Client Review – The tested unit will be shipped to you via parcel, for your own visual evaluation. Additional ordered units, if any, will be shipped sealed. One unit will be unsealed as samples will be taken from it for the assessment.

This assessment aims to provide qualitative insights into packaging durability and product integrity under real-world conditions. This assessment can provide additional insights for products that are expected to settle or separate over time.

While not a substitute for certified laboratory testing, it serves as a practical tool for brands looking to refine their packaging choices and gain early qualitative performance insights.