Packaging & Container Closure Testing
Packaging systems can affect product quality through material interaction, chemical migration, compatibility, and container related risks.
Teleios supports analytical investigations of packaging and container closure components for pharmaceutical and related products.
What We Can Support
- Glass components
- Plastic packaging
- Elastomers and closures
- Container closure materials
- Material characterization
- Chemical compatibility studies
- Extractables related investigations
- Packaging related impurity investigations
Typical Analytical Questions
- Is the packaging material compatible with the product?
- Could the container contribute an observed impurity?
- What compounds may migrate from the packaging material?
- Does a packaging change require additional analytical assessment?
Analytical Approach
Testing is selected for the material type and product contact scenario, using organic and elemental techniques together with compatibility and extractables related investigations.
Regulatory & Compendial Framework
Depending on the program, material, and intended use, studies may consider:
- Applicable USP packaging and container chapters
- USP <1663> and <1664> for relevant extractables and leachables assessments
- Product specific regulatory expectations
- Container closure and material suitability requirements
Not every listed framework applies to every study. Applicable expectations depend on product type, development stage, route of administration, material, intended use, and jurisdiction.