I am required to perform a cleaning validation of a glassware washer and I am trying to determine the worse case product that I can use for the validation. I have a list of around 150 different drugs.
What is the best way to determine the worst case drug?
[quote=Charlene]I am required to perform a cleaning validation of a glassware washer and I am trying to determine the worse case product that I can use for the validation. I have a list of around 150 different drugs.
What is the best way to determine the worst case drug?[/quote]
Hi
What instrument are you using for analysis?
I shall be using an HPLC for quantification.
However, I am trying to determine a set of criteria that would help me to determine the worse case.
Will you be analyzing the waste water or swabbing the washer and items in the washer (or both)?
I shall probably be rinsing the glassware after the cleaning cycle and analyse
Hi
Cleaning validation is a long and complex procedure. What is the purpose for this cleaning validation? Are you only interested in the cleanliness of the glassware?
Have you considered: the active you will be carrying out method development/recoveries on? The HPLC method? Swabbing? TOC? Solubility?
It’s very difficult to suggest a method without a comprehensive description of what you are doing, what you want to achieve and the time/resources you have to do this.
Are you able to provide more information?