As a manufacturer of biopharmaceutical products, the chemical content, package integrity, and sterility assurance is critical to your processes to ensure the safety and robustness of the package, container and/or the single-use system used for the production process. Our comprehensive testing menu includes the necessary analytical chemistry services, product stability testing and validation programs. We will work with you to design customized product-specific testing programs that meet your needs and satisfy global regulatory requirements.
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Extractables & Leachables Testing
Toxicology Risk Assessment
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Product Packaging and Container/Closure
Our ISTA-certified laboratory offers testing services to ensure seal integrity and packaging compliance. We are also compliant to the guidelines established by CBER, CDER, USP, and ICH.
Accelerated and real-time aging, with capacity for a wide range of temperatures and humidity, is a key component to the testing necessary to fulfill regulatory requirements.
Manufacturers of biopharmaceuticals must examine the final container/package to evaluate the ability of the container to handle the necessary logistics to get the drug to the patient. We perform simulated distribution testing, which includes drop test, compression test, low pressure / high altitude (LPHA) test, concentrated impact test, and vibration testing.
Packages and containers of drug product must maintain sterility during production, shipping and the life of the product. After stability and transportation testing, we implement package, seal strength, and container closure integrity testing.
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