In cleaning validation we just proving that, the cleaning procedure is efficient to remove drug substance or API (Active Pharmaceutical Ingredient), for which we already know the maximum allowable dose / toxic dose, etc. If it is assured that cleaning has been done with water or suitable agent in which the "tree nut" is soluble and if its not API than should not be issue as per my understanding.
------------------------------
Gaurang Bhavsar
Edison NJ
United States
------------------------------
Original Message:
Sent: 07-Mar-2017 13:58
From: Susan Jackson
Subject: Cleaning Validation versus verification
I work in a facility that has non dedicated equipment.
We run cosmetics, dietary supplements and are going to do sunscreen shortly which come under OTC.
We are putting togethser a cleaning validaation program.
My specific question is when running a Dietary supplement that can contain an allergen such as "treenuts" How do I validate the cleaning if rthere is not a specifc testing ket available for the specifc tree nut I am trying to validate the cleaning for?
Such as coconuts.
I have found a protein swab that can verify the removeal of proteins, will this be sufficient in this instance.