I have this case:
I must to do cleaning validation for an echipment for extraction-concentration, I have an extractor and an concentrator.
I have manufactoring an extract concentrate vegetale, I have an vegetable plant and solvent: aqua, I do extraction , and concentration par evaporation and I get an vegetable aqueous solution.
My question is wich is my level of cleaning validation and what limits of acceptance I have.
I must have < 10ppm residuu in another product or
Product change over Acceptance limit Validation
Precursor to final step API 10 ppm – 100 ppm YES
1/100 – 1/1000 dose
Precursor to intermediate 100 ppm – 1000 ppm YES/NO
of an API
Later step to earlier step Visibly clean or 1000 ppm NO
of the same API
Early step to early step
of of the same API
Precursor to chemical Visibly clean NO
THANK YOU VERY MUCH!
Mihaela Baciu!