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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:
Depending on the process requirements the following validation options are available:
During validation, our philosophy is to mimic the process as closely as feasible.
Contact us for full details and for validation of your process.