Chemical Compatibility Testing
Evaluate the Compatibility of Product Contact Components
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
Thorough Assessment
Selecting and qualifying a filter device or single-use assemblies requires a thorough assessment of the chemical and physical compatibility of the components that are in contact with the drug product. The assessment considers:- Filter and single-use system construction materials
- Process fluid formulation
- Processing conditions
- Regulations governing manufacturing region and intended market.
- From a compatibility certification report based on existing compatibility data which 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
- To testing on full scale devices comparing product performance attributes before and after exposure to your product and under your processing conditions