Chemical Compatibility Testing
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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.
Thorough Assessment of Chemical and Physical Compatibility
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:
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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.
- A compatibility certification report based on existing compatibility data such as:
- Possible interaction between the product formulation and components or materials of the filter device
- Compatibility tables generated by manufacturers of the elastomers and polymers commonly used in filter devices
- Well-established compatibilities for commonly used membrane materials
- Test data to resolve specific questions
- Full-scale device testing, comparing product performance attributes before and after exposure to your product, under your processing conditions
Trust our Global Services Network
To learn more about our industry-leading validation services for biopharmaceutical manufacturers, look into these specialized capabilities performed at our laboratories worldwide.
- Single-Use and Filter Validation Services
- Bacterial Retention Testing
- Filter Integrity Testing
- Extractables and Leachables
- Validation Services Consultancy
- Validation Service Levels
Request a quote and get started today.
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