Validation Services for the Pharmaceutical Industry
Van Borselen Filters' polymeric and disposable cartridge filters meet international standards for safe application into pharmaceutical processes.
In addition, many pharmaceutical processes also require specific validation in order to guarantee the sterile filtration of a final product.
Van Borselen ensures that all validation studies are performed taking into account the critical parameters and worst-case conditions of these processes.
Our studies adhere to the standards and guidelines established by regulatory authorities (Food and Drug Administration (FDA) and EU) and the recommendations of the Parenteral Drug Association’s Technical Report No 26 ‘Sterilizing Filtration of Liquids’.
Our validation experience encompasses a broad range of injectable products and their manufacturing processes, these include:
aggressive-solvent and oil-based formulations
high viscosities and pressure differentials
exposure time of up to 80 hours
Depending on the process requirements the following validation options are available:
filter compatibility assessment
bacterial challenge testing
product wetted integrity test studies
During validation, our philosophy is to mimic the process as closely as feasible.
Contact us for full details and for validation of your process.