Dear All,
I have to validate the frequency cleaning cycle during campaign process, I still have to decide if I will validate against time or number of batches.
what do you suggest?
furthermore I was wondering in case of BIOTECH can somebody confirm me that it is suggested to clean after every single batch? if yes is there any guideline? law that I can consult for support
Thank you
GioDes
In Biotechnology products sepecially recombinant products cleaning is very essential after every batch. The Biological product degrades fast in atmosphere after few hours as these products are metabolites from natural or recombinant bcateria. These products either will be protiens , polysccharides or starches or Glycoprotiens etc.
You have to asses the protein or residual active material content after cleaning of every batch along with residual content of the cleaning agent or detergent.
Recently a comprehensive document is released by Parenteral Drug association.
Technical Report No:49
Points to consider in Biotechnology Cleaning and Validation
Released in 2010