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- Packaging Component Testing
Packaging Component Testing
USP-aligned packaging component testing for pharmaceutical products, ensuring safety, stability, and compliance.
About Packaging Component Testing
Packaging plays a critical role in pharmaceutical products, directly impacting stability, quality, and product integrity. Since drug containers remain in continuous contact with the product throughout its lifecycle, any chemical incompatibility or material instability can lead to contamination and affect therapeutic performance.
Packaging component testing evaluates materials for chemical compatibility, physical integrity, and environmental resistance to verify that packaging systems protect product integrity without compromising safety or performance. From raw material selection to final packaging, each stage is carefully assessed to maintain consistent quality and regulatory compliance.
Why it matters?
Poorly designed or incompatible packaging can lead to contamination, degradation, leakage, interaction risks, or reduced product efficacy. This test helps manufacturers verify material compatibility, container integrity, environmental resistance, and overall packaging performance under real-world conditions. It also supports regulatory compliance while helping ensure products remain protected, identifiable, and stable during storage, transportation, and patient use.
Testing Types
Scientific testing services designed to support reliable and compliant products
USP 〈661.1〉 Plastic Materials of Construction
Helps evaluate the composition and chemical safety of plastic materials used in pharmaceutical packaging to reduce the risk of harmful substances impacting product quality.
USP 〈661.2〉 Plastic Packaging Systems for Pharmaceutical Use
Designed to evaluate complete plastic packaging systems for compatibility with drug products, supporting product stability, safety, and performance throughout the lifecycle.
USP 〈87〉 Biological Reactivity Tests, In Vitro
Helps assess the biological response of packaging materials when exposed to cell cultures, verifying that materials are non-toxic and suitable for pharmaceutical applications.
USP 〈660〉 Containers – Glass
Supports evaluation of glass containers for chemical resistance, durability, and hydrolytic stability to help maintain product integrity during storage and use.
USP 〈671〉 Containers – Performance Testing
Designed to evaluate packaging performance under mechanical and environmental stress conditions, helping verify durability during transportation, handling, and storage.
USP 〈670〉 Auxiliary Packaging Components
Assesses secondary packaging components such as closures and liners to help verify safety, functionality, and product compatibility.
Key Advantages
At PLS Analytical, studies are conducted in a cGMP-compliant environment using USP-aligned methodologies to assess material compatibility, integrity, and performance. Our integrated capabilities help identify contamination, degradation, and interaction risks early while delivering reliable, submission-ready data for audits, quality programs, and regulatory requirements.
Ensuring product integrity
Validated testing confirms that packaging systems maintain stability, sterility, and product quality from manufacturing to end use.
Regulatory compliance and readiness
Testing is aligned with USP and global regulatory requirements, supporting documentation for submissions and audits.
Resources
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Contact Us
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Connect with our team for reliable scientific and regulatory-focused testing support.
Address
40E Cotters Lane, Suite A, East Brunswick, NJ-08816
Telephone
+1 (732) 698-5050Our Methods
Robust testing services for transformative outcomes
