Packaging

FreeThink is the leading laboratory for scientific determination of primary packaging for stability:

 

  • Data-driven packaging decisions made in <6 weeks

  • Evaluations based on moisture, oxygen and light protection versus product sensitivity for solid and liquid products

  • Can balance packaging costs against performance criteria without package screening

  • Can rapidly assess potential issues with extractables and leachables

 

The details:

FreeThink determines the appropriate packaging for products based on permeability to moisture and oxygen, and product sensitivity. Clients can optimize for cost-effectiveness with confidence of passing shelf-life requirements.

    Sensitivity to Moisture and Oxygen

  • Designed accelerated stability studies on loss of assay, formation of degradation products, change in appearance or change in dissolution are rapidly completed at the FreeThink Laboratories.
    Moisture Sorption Isotherms

  • One element in the determination of packaging for solids (and some liquids) is understanding how moisture equilibrates as a function of relative humidity.
  • FreeThink scientists determine moisture sorption isotherms using a Dynamic Vapor Sorption (DVS) apparatus.
    Moisture and Oxygen Permeability

  • Another critical component is the package permeability to key elements, including moisture and oxygen.
  • FreeThink determines the Moisture Vapor Transmission Rate (MVTR) and Oxygen Transmission Rate (OTR) for customer packaging.
  • This is measured on the actual packaging as a function of temperature using gravimetric (for moisture) or sensor-based (for oxygen) methods.

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Packaging Determination

  • Experimental results are analyzed using FreeThink’s ASAPprime® software to determine the direct impact of packaging on shelf-life based on the degree to which the packaging provides protection and the sensitivity of the particular product to moisture and oxygen.
  • Determine which specific options of bottles (size, type, tablet or capsule count, presence of desiccants or oxygen absorbers), blisters (material) or other storage containers will provide adequate shelf-life in each climatic zone.
  • FreeThink offers extensive expertise in how best to use packaging for appropriate stability, keeping in mind the implications of packaging costs for the sponsor company.
  • By streamlining package selection, product development can be accelerated and made more efficient.

Package Testing

  • FreeThink can package products (non-GMP) for small-scale testing.
  • Capabilities include bottles, ampules, blisters and pouches.
  • Packaging screening/confirmation studies at FreeThink can often be started very quickly, require relatively little product, and cost less than studies carried out at commercial packaging facilities.
  • FreeThink studies can control many factors such as oxygen level, bottle cap torque and secondary packaging materials.

Did you know…?

Clinical use periods have been accepted by health authorities using just ASAPprime® modeling.

Learn more here.