Package and Device Testing
Drug product packaging must be able to withstand the effects of manufacturing, storage, transportation and distribution from the point of manufacture/packaging to the end user. A robust design preserves the package integrity, protects the primary product, preserves critical labeling and patient information and can function easily for the end user. We provide testing for a wide range of products, from over-the-counter (OTC) products such as aspirin and topical creams, to prescription drugs such as tablets, capsules and liquids, to sophisticated drug delivery devices.
Selecting and validating appropriate packaging for OTC products, biologics and pharmaceuticals can be a challenge for any engineer. With a consultative approach, we offer a wide variety of testing options when it comes to package testing — be it support for new product launch, FDA or ISO compliance or a cost reduction or packaging sustainability initiative.
Our cGMP, FDA-registered and ISO 17025-accredited laboratories provide integrated services for primary container and packaging performance testing for the world’s leading pharmaceutical and biotech manufacturers. Our one-stop-shop suite of services includes testing to support your products from development to market.
Our package testing laboratory provides distribution simulation services in accordance with the most current test methods from ASTM and ISTA such as ASTM D4169, ASTM D7386 and ISTA Series 1, 2, 3 and 4 Tests. Laboratory distribution simulation testing provides a uniform and repeatable way of evaluating drug product packaging designs by employing standardized equipment and procedures to subject packaging to anticipated hazards that may occur with routine distribution of packaged products.
Our container testing laboratory offers comprehensive qualification testing for all primary container components — plastics, glass and elastomeric closures. Our cGMP laboratory can assist with all testing required for regulatory compliance to USP, EP and JP standards for container permeation testing, material identification testing, extractables testing and functionality testing.
Container Closure Integrity Testing
Our container integrity testing laboratory offers numerous state-of-the-art options for leak testing and assessing pharmaceutical package integrity per USP <1207>. Our container closure integrity testing helps optimize sealing parameters, evaluate container storage temperature impact, replace sterility tests for product stability batches, screen production lots for faulty packages and support regulatory submission applications for product commercialization around the world.
Shelf Life Testing
We provide product storage programs that help ensure product safety throughout the product’s shelf life. From accelerated aging, real-time aging, freeze/thaw and full ICH stability programs (including support for controlled substances), we have the capacity to support shelf life testing for materials, products and packaging systems.
Visual Inspection and Functional Testing
Our experts provide attribute inspection services for container and product defects, routine QC dimensional testing and essential performance and functionality testing for prefilled syringes and other drug delivery devices.
Packaging Materials Barrier Properties
We offer numerous tests to characterize adsorption, dissolution, diffusion and desorption of packaging materials, including oxygen transmission rate (OTR) per ASTM D3985 or ISO 15105-2 and water vapor transmission rate (WVTR) per USP <671>, ASTM F1249, D7709, ISO 15106-2 and ASTM E96. These barrier properties tests help you plan the optimal packaging material choice for specific applications to maximize preservation and prolong the shelf life of your product.
Our Container Closure Integrity Testing (CCIT) services range from routine testing to in-depth method development and validation specifically tailored to you and your package system.
Our Container Testing Center of Excellence brings multiple dimensions of experience to each container testing program. Staff members with specific areas of expertise are always available to consult on your testing needs so that you can be sure the right testing methods are deployed for your product.
Employ our CCIT programs to:
- Characterize your packages and materials
- Optimize sealing parameters
- Evaluate package storage temperature impact
- Replace sterility tests for product stability batches
- Screen production lots for faulty packages
- Support regulatory submission applications for product commercialization around the world.
We deliver accurate, sensitive and reliable data for definitive container closure integrity verification, assuring packages meetthe highest degree of product protection. We offer numerous state-of-the-art programs for assessing package system integrity, including all required instrumentation for deterministic test methods as outlined in USP <1207>.
Our container closure integrity experts provide advanced seal-quality inspection of your pouches and tray seals to ensure the integrity of your packaging.
We use airborne ultrasound technology to assess seal quality in conditions where seals have defects but do not leak. Areas with poor seal quality typically have gas pockets, which reduce the amount of ultrasound passing through the seal area. Another type of defect, such as foreign material in the seal area, may increase overall transmittance of ultrasound.
Data is presented quantitatively or in the form of a qualitative pass, warn or fail if method development is performed and we can offer a high-resolution digital image of the seal quality from multiple scans.
Comprehensive method development and validation services are also available, as well as routine testing of samples in a cGMP environment.