Now specific and relevant toxicological data have to be used to recalculate exposure limits, in order to define if a product can be manufactured in a shared equipment, manufacturing line or even in the same premises than others.
We offer tailored services in this area including:
Risk assessment for the introduction of a new API in an existing plant or for the re-evaluation of existing shared premises.
Toxicological reports supporting NOAEL and related data as the basis for PDE/ADE calculations. Reports are reviewed and signed by a qualified expert toxicologist.
Update the cleaning validation policy with the toxicological criteria.
Cleaning validation protocols and reports.
Cleaning procedures optimisation: performance and use of water.