Cleaning Validation: ARV Triple Combo (EFV, MTB, TDF)

GOOD VALIDATION PRACTICE (cGVP) CLEANING VALIDATION
1

Good Day;

We manufacture a finished product that has been identified as a cleainng validation marker product in our Granulation area. It is a triple combo ARV. We currently employ an automated wash cycle (combination of hot and cold water, pressurised between 2 - 5 bar) using a hydroxide-based detergent that is supported by a manual cleaning process for small parts using a neutral detergent. We are currently struggling to achieve consistent cleaning, with API residues being inconsistently removed, leading to equipment having to be re-washed and continually re-tested. This is not ideal as and causes long changeover times. The problem is exacerbated by the fact that the product is run over fairly long and intense campaigns. I have two questions:

  1. Has anybody had a similar experience with cleaning validation of ARVs? How was it addressed and what detergent chemistry was applied? were any additives required?
  2. Any advice on how to establish a campaign cleaning strategy?

Any advice/assistance would be highly appreciated.

Regards

2

Hi ,
pls check the

  1. Chemical nature of your API, and its solublity profile, also try with different solvents
  2. Always hydroxide detergents are not helpful, sometimes it may form a Complex which is tuf to clean than the API, the cleaning agent shall be changed

if any thing wrong pls correct me…

Regds,
Ramajayam