Risk-based cleaning validation, considering the PDE concept and product and system bracketing, guarantees the effectiveness and reproducibility of the cleaning process and keeps the cost of even complex approaches within limits.

Cleaning in the pharmaceutical environment, especially in manufacturing of medicinal products and medical devices, requires a high level of chemical, pharmacological, and process knowledge. The type, quantity, and source of possible contaminations as well as cross-contaminations influence the reproducibility of the cleaning process. In pharmaceutical production, and especially in multipurpose facilities, cleaning procedures must be validated according to national and internation ...