Why can preservation fail when the incoming assay passes?
Assay checks the incoming material. Partitioning in the emulsion, packaging and use affect the finished product. Raw material purity alone cannot establish adequate preservation.
Link the challenge test to formulation and packaging
Verify whether the product is a single substance or a blend. Have a qualified laboratory perform the applicable challenge test on the complete formulation in the intended packaging. Reassess after changes to either.
Can a blended preservative replace another at equal weight?
Identify each active component and reassess the complete formulation. Emulsion products: Perform the project-approved preservative challenge test on the complete formulation. Water-based cleaners: Compare preservation performance and odor after changes in packaging, pH or surfactants.
Checking Purity and Specified impurities
Purity (% by mass): State the chromatographic method and peak integration basis. Specified impurities (mg/kg): List each requirement for the destination market and grade. Preservative challenge test result (Project criterion): Specify the method, sampling time and final packaging.
What to record
- Active composition
- Formulation revision
- Packaging
- Challenge test method
- Acceptance result
Technical references
Products and processes
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