We have done all of our Cleaning validations with the same detergent used in all the equipment.
My question is: If we use other detergent different that the valilated, is it necesssary to re-validate all the cleaning validacion of all the equipment?
Thank you very much.
Hey Validation Analyst,
How have you validated? Is this manual cleaning or using a washer?
Also what industry is this for?
Good morning,
We do manual cleaning and it’s for farmaceutical industry.
Thank you very much
Do you have any scientific rationale for the cleaning agent you are currently using? In order to defend the cleaning you are doing, you will need empirical data that shows the effectiveness of the current cleaning agents. If you plan to change the cleaning agent, you will need to perform studies that demonstrate a more effective cleaning can be done with the new agent and it should be documented in a change control. The whole point is that you understand the cleaning process and the cleaning agents. I will warn you now, if you do not have the scientific data to support your program, be prepared to see lots of people like me in the near future…