- Methods
- 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?
Packaging component testing is not optional for regulated drug products, it is a regulatory requirement. The FDA expects manufacturers to demonstrate container closure system suitability as part of NDA, ANDA, and IND submissions, supported by data aligned with USP and ICH Q1A standards.
Failures in packaging qualification, including undetected extractables, inadequate seal integrity, or incompatible closure materials can trigger data deficiency letters, submission delays, or post-market recalls. Early, systematic packaging testing generates the documentation your regulatory team needs before a submission gap becomes a commercial problem.
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
Explore our insights and successes
Contact Us
Let’s explore the right support for your product
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
