Packaging
FreeThink is the leading laboratory for scientific determination of primary packaging for stability:
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Data-driven packaging decisions made in <6 weeks
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Evaluations based on moisture, oxygen and light protection versus product sensitivity for solid and liquid products
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Can balance packaging costs against performance criteria without package screening
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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.