Filter Compatibility Testing
Highly Sensitive Testing of Both Membrane and Device
To comply with GMP guidelines worldwide and the US 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 when they come into contact with drug product.
The testing shows the filters and single-use assemblies are:
- Fit for use
- Compatible with your process and drug product
Failure to properly assess compatibility could lead to delays in process development and the drug approval process, or compromise the quality of the drug product.
Selecting and qualifying a filter device or single-use assemblies requires a thorough assessment of the chemical and physical compatibility of the components that come into contact with the drug product. The assessment considers:
- Filter and single-use system construction materials
- Process fluid formulation
- Processing conditions
- Regulations – applicable by manufacturing region and intended market
To confirm compatibility, our Validation Specialists collect the necessary information from you about your process and drug product. This includes:
- Evaluating any possible interaction between the filter device components/materials and the product formulation
- Referencing compatibility tables generated by manufacturers of the elastomers and polymers used in O-rings, gaskets and seals commonly found in filter devices
- Referencing well-established compatibilities for commonly used membrane materials
- Resolving specific questions by testing
Our highly sensitive testing protocol:
- Exposes both membrane filters and a sample of the filter device to the drug product
- Relies on changes to the drug product’s specific bubble point to determine compatibility
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- Put your filters to the compatibility test with BioReliance® Validation Services.