Cleaning parameter

What should be limit of rinse water sample of mixing tank?

The rinse water cleaning limit of residues on the inner surface of mixing tank depends upon several factors such as,

  • Surface rea of mixing tank coming in direct contact with the product
  • Maximum allowable residue based on HBEL & Permitted Daily Exposure (PDE) limits through toxicology /pharmacological data of the API
  • Batch size of product
  • Group of equipment (equipment train) used to manufacture that product along with mixing tank
  • Cleanability & solubility characteristics of the API in the selected solvent for rinsing