Common use of Cleaning Validation Clause in Contracts

Cleaning Validation. DSM is responsible for ensuring that adequate cleaning is carried out between lots of different products to prevent contamination. Data should be available to support the campaign of lots of the same product and the type of cleaning that will be performed in between manufacturing of the same product. Barrier will provide information (i.e. LD50, toxicity, solubility, lot size, fill volume, product min dose/70Kg patient) and establish cleaning limits with DSM assistance.