Test Method

Why: to test the potential migration of small amounts of substances from the primary packaging material to the formulation.

When: before the placing on the market of the cosmetic product and while development or GMP random controls.

How: The environmental conditions and the periodicity of the analysis can be the same as those mentioned for the formulation Stability Studies.
In this test, several alternative containing materials are analyzed to determine which is most suitable for the product.

Types of containing material and main evaluations:

 

1. Cellulose Packaging

  • Examples: cartridges, trays, displays and cardboard packages.
  • What is evaluated:
  • alterations in the paper and formulation structure, checking for possible migration of components that could contaminate the product (e.g.: sachets);
  • physical-chemical stability of the packaging;
  • alterations in the formulation – appearance, color, odor, among others;
  • appearance and functionality of the package;
  • barrier function (e.g., permeation of oil, water or gases);
  • metal determination, whenever applicable.

 

2. Metal Packaging

  • What is evaluated:
  • delamination, when applicable;
  • corrosion;
  • alterations in the formulation – appearance, color, odor, among others;
  • appearance and functionality of the package;
  • formula reaction;
  • polish or resin integrity (internal and external);
  • metal determination, whenever applicable;
  • functionality.

 

3. Plastic Packaging

  • Examples: Polypropylene (PP), high density Polyethylene (PEAD), low density Polyethylene (PEBD), Polyethylene Terephthalate (PET), Polystyrene (PS) and Poly vinyl chloride (PVC).
  • What is evaluated:
  • alterations in the formulation – appearance, color, odor, among others;
  • appearance and functionality of the package;
  • interaction and migration of components between package and porosity to water vapor;
  • light transmission;
  • heat-sealing (whenever applicable);
  • deformity (collapse or bending).

 

4. Glass Packaging

  • What is evaluated:
  • alterations in the formulations – appearance, color, odor, among others;
  • appearance and functionality of the package;
  • mechanical resistance of the package.

 

5. Pressurized packaging

  • The evaluations must be in conformity with the characteristics of the previously evaluated materials and also consider the influence of the propellant on the formulation and on the package materials.
  • What is evaluated:
  • performance of the product in accordance with its functionality;
  • corrosion and electrolysis of the package;
  • internal and external polish control (porosity), whenever applicable;
  • homogeneity of coatings and linings – bubble formation, fissures and corrosion;
  • performance of the valve and it’s components;
  • presence of electrolytes, odor and formulation precipitation.

 

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