Pharmaceutical Package Testing

Pharmaceutical Package Testing 2018-05-10T07:13:21+00:00

Drug product packaging must be capable of withstanding 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 easily be administered by the end-user. From simple 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 – Whitehouse Laboratories is happy to assist clients to better understand the testing requirements and the available test options.

Selecting and validating appropriate packaging for OTC, 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 / packaging sustainability initiative, Whitehouse Laboratories is your partner in supporting the packaging development process.

Our cGMP, FDA registered and ISO 17025 accredited laboratories are single source vendor for primary container and packaging performance testing for the world’s leading pharmaceutical and biotech manufacturers. Our ‘one-stop-shop’ service portfolio includes testing to support your products from development to market. A few of our routine pharmaceutical packaging test programs are summarize below.

Distribution Simulation

Our Package Testing laboratory provides distribution simulation services in accordance with the most current test methods from ASTM and ISTA (International Safe Transit Association) such as ASTM D4169, ASTM D7386 and ISTA 1, 2, 3 and 4 Series Tests. Laboratory distribution simulation testing provides a uniform and repeatable way of evaluating drug product packaging designs by utilizing standardized equipment and procedures to subject the packaging to anticipated hazards that may occur with routine distribution of packaged products.

Container Testing

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, Extractable 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>. Container Closure Integrity test programs established at Whitehouse Laboratories have been successfully used to 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

Our Laboratories provide product storage programs that help ensure product safety throughout the product’s shelf life. From Accelerated Aging (AA), Real Time Aging, Freeze/Thaw and full ICH Stability programs (including support for Controlled Substances), Whitehouse Labs has the chamber capacity to support materials, products and packaging systems shelf life testing.

Visual Inspection and Functional Testing

Our Laboratories provide attribute inspection services for container / product defects, routine QC dimensional testing and essential performance / functionality testing for prefilled syringes and other drug delivery devices.

Packaging Materials Barrier Properties

Our Laboratories offer numerous tests to characterize adsorption, dissolution, diffusion, and desorption of packaging materials, including Oxygen Transmission Rate or OTR via ASTM D3985 or ISO 15105-2 and Water Vapor Transmission Rate or WVTR via 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.

Whitehouse Laboratories is happy to assist customers to better understand the testing requirements, the available test options and how to execute pharmaceutical packaging testing projects on time and on budget. Whitehouse Laboratories is unique in the field of contract testing. No other package testing lab offers cGMP and ISO 17025 accredited services that cover the complete package system – from package development to market.

Whitehouse Laboratories is happy to assist customers to better understand the testing requirements, the available test options and how to execute packaging validation projects on time and on budget.

Have a question about Package Testing?

Contact Us or call 908-823-9336 about your next testing project.