Cleaning Validation for Biologicals


I carry out cleaning validation on pharmaceuticals containing API actives. We are currently in the process of manuafcturing a product where the protein is the active molecule. I am of the understanding that because this product is biological in nature that cleaning validation would have to be performed following the cleaning of this product? If this is the case, is TOC a sufficient method for analysis of the protein after cleaning? For method developement, would the protein need to be denatured & then analysed on TOC because this product would be cleaned by CIP & manual cleaning therefore would potentially be affected by heat.

Appreaciate any feedback because this is a new area for me.

Kind regards

Bruce Neagle

• [FONT=inherit]Yes you will still have to demonstrate that your cleaning program, procedures and SOPs are effective in removing residues of this biological. TOC is just a tool. Remember though that it may not be sensitive enough and that your MACO predetermined acceptance criteria should be based on activity not 10 ppm (mg/Kg)[/font]