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USP <382> functional testing solutions

Unbiased, regulatory‑ready results for your fully assembled drug‑filled systems

PROBLEM STATEMENT

Why USP <382> compliance has become a critical bottleneck

Pharmaceutical companies must demonstrate the functional suitability of the elastomeric components used in parenteral packaging systems as defined by the USP <382> standard. However, executing these tests internally is often difficult, as selecting the correct test setup, ensuring regulatory conformity, coordinating multiple stakeholders, and operating specialized lab equipment can introduce significant risk, effort, and delays. Companies need a reliable, unbiased way to generate compliant data without burdening internal resources.

CHALLENGES

Common issues with USP <382> testing

USP <382> requires that functional testing is performed on the final-use configuration, which includes the complete container‑closure system filled with the actual drug product or a qualified proxy. This requirement significantly raises the technical and operational burden, and many laboratories are not equipped to handle drug products safely, cannot run tests with filled systems, or lack the controlled environments needed for compliant execution. These constraints will create critical gaps that slow down or even block the compliance process.

Testing is complicated by final-use requirements

USP <382> testing must be performed on the fully assembled, filled system, rather than empty or water-filled components. This increases the complexity of test selection and setup since the parameters may change significantly once the system contains a drug product or proxy. Many labs are not prepared to adapt their test designs to filled containers, leading to inaccurate or non‑compliant results.

Limited lab capabilities for handling drug products or proxies

The requirement to test the filled system demands special handling capabilities, including test environments, dedicated workflows, and safety measures for drug products or surrogates. Most laboratories lack these facilities, particularly when handling biologics or sensitive formulations, making USP <382> compliance either impractical or impossible.

Operational bottlenecks due to drug-product handling

Managing the logistics, safety protocols, and documentation for drug product test samples adds significant operational overheads. Many teams struggle to coordinate product shipment, storage conditions, stability timelines, and sample tracking, all of which are essential for USP <382> compliance.

Rising expectations for unbiased, third‑party verification

Since USP <382> testing is now more complex and more directly tied to regulatory filings, authorities increasingly expect independent, third‑party results. Internal labs often lack the independence, capabilities, or equipment required to produce credible data packages, making external support essential.

THE SOLUTION

SCHOTT Pharma’s integrated USP <382> testing service

We provide an end‑to‑end third‑party testing service that covers the entire USP <382> workflow, from test plan creation to final report. Our FDA‑registered, ISO‑accredited laboratory, and experienced functional testing specialists ensure accurate, regulatory‑compliant results for elastomeric components and full container systems (syringes, vials, cartridges).

Five testing requirements ensure that primary packaging materials maintain drug integrity and patient safety:

Package integrity and CCI testing (USP <1207>): Ensures sterility protection and prevents contamination.
Coring and fragmentation analysis (ISO 11608‑3, USP <788>, USP <381>): Minimizes particulate contamination risk.
Penetration force, self‑sealing, and spike‑retention testing: Ensures ease of use and functionality, and confirms closure reliability post-penetration.
Plunger functionality testing (ISO 11040‑4/-6/-8, ISO 21881, ISO 7886‑1): Break‑loose force, glide force, and plunger seal integrity testing to evaluate ease of drug administration and ensure leak-proof operation.
Tip cap and needle shield removal force (ISO 11040‑4/-6/-8): Ensures usability and sterility preservation.

Explore functional testing Explore CCI testing

USP <382> functional testing in action

Explore how industry-standard elastomeric components in 3 ml ready-to-use cartridges perform under real-world conditions. Our whitepaper presents data-driven results from comprehensive USP <382>-aligned testing, including fragmentation, CCI, leakage, resealability, and break-loose force, referencing all relevant ISO standards.

Whitepaper thumbnail: From fragmentation to break-loose force: A complete USP <382> assessment in parenteral delivery systems

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ADVANTAGES

Our comprehensive USP <382> testing services offer an end-to-end solution – handling the process from test selection to final documentation.

Your simple path to compliance

We create a tailored test plan

You send us your drug product

We test the complete system

You receive a regulatory‑ready report

This way, we eliminate bottlenecks, ensuring that your primary packaging meets regulatory expectations efficiently and reliably.

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Drug-product handling

Specialized workflows, dedicated test setups, and strict safety measures for handling drug products or proxies throughout the testing process.

System‑level test expertise

Evaluation of the full container‑closure system to deliver realistic performance data and enable root‑cause analysis across elastomer and glass/polymer components.

Independent documentation

Third‑party, objective results supported by structured documentation packages that meet the expectations of authorities and accelerate review processes.

Reduced operational burden

Streamlined end-to-end process, from tailored test planning to final reporting, reducing internal workload and minimizing cross‑functional coordination effort.

GET IN TOUCH

Marius Römer

Product Manager Services

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