To comply with Good Manufacturing Practice (GMP) guidelines worldwide, as well as the U.S. Code of Federal Regulations, physical and chemical compatibility testing is necessary to prove that filters and single-use systems used in biopharmaceutical manufacturing are not reactive, additive, or absorptive upon contact with drug product. Our testing services can establish that your filters and single-use assemblies are fit for use, fully compatible with your process and drug product.
We make a thorough assessment of filter devices and single-use assemblies to support your selection and qualification process, taking into consideration such physical compatibility factors as:
Our chemical compatibility testing can be performed on a wide array of products that come into contact with your process or drug product. Tailored to your needs, the recommended approach can take varied forms.
To learn more about our industry-leading validation services for biopharmaceutical manufacturers, look into these specialized capabilities performed at our laboratories worldwide.
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