Merck

Chemical Compatibility Testing

Scientist at bench performing qualification testing

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:

  • Construction materials
  • Process fluid formulation
  • Processing conditions
  • Regulations governing your manufacturing region and intended market

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.