Smithers provides USP <382> testing services to support pharmaceutical and medical device manufacturers in evaluating elastomeric closure performance. Testing can be conducted to assist with product development, design verification, or regulatory compliance.
What is USP <382>?
USP <382>, Elastomeric Closure Functionality in Injectable Pharmaceutical Packaging/Delivery Systems, defines methods for assessing the functional suitability of elastomeric components under real-use conditions. These closures must maintain container integrity, enable drug administration, and perform reliably throughout the product lifecycle.
USP <382> separates functional testing from USP <381>, which will continue to focus solely on material characteristics. The updated approach aligns with international ISO standards and regulatory expectations, emphasizing lifecycle-based evaluation of component configurations.
Test Capabilities
Smithers performs the full range of functional assessments outlined in USP <382>, as well as additional evaluations based on ISO and compendial references. Core capabilities include:
- Penetrability
- Fragmentation
- Self-sealing ability
- Resealability
- Container closure integrity (CCI)
- Coring
- Glide and plunger force measurement
- Retention force for tip caps and needle shields
- Performance after simulated shipping
Tests can be conducted under cGMP conditions and tailored to support design verification, process validation, or regulatory filing requirements. Smithers also offers custom test method development to address unique product and system configurations.
Components Tested:
USP <382> applies to elastomeric components used in a wide range of container–closure and drug delivery systems. Components subject to evaluation include:
- Vials and bottles: Closures and stoppers designed for puncture by hypodermic needles or spikes
- Prefilled syringes: Plungers, tip caps, and needle shields
- Cartridges: Rear plungers and pierceable septa
- Pen injectors and auto-injectors: Plunger stoppers and internal seals
- Single-use syringes: Piston elements within the barrel
- Film-based IV bags: Elastomeric septa integrated into access ports
- Blow-Fill-Seal (BFS) systems: Elastomeric liners embedded in plastic caps
Testing is performed on the complete packaging configuration, considering both the elastomer and its interaction with associated delivery mechanisms such as needles, cannulas, or spikes.
Expert Support for USP Testing
Smithers brings decades of experience in pharmaceutical packaging and delivery system testing. Our laboratories operate under cGMP and ISO-accredited quality systems, and we work closely with clients to develop and execute tailored test strategies that align with regulatory expectations and product development goals.
With a strong understanding of both technical performance requirements and evolving compendial standards, Smithers provides guidance and testing that support functional verification across the entire product lifecycle.
