Cleaning validation- discussion

(Md.Asif Hussain) #1

1.What is Riboflavin coverage study?
2.if the residue not meeting the acceptance criteria what shall be done? How to proceed?
Thanks

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(Md.Asif Hussain) #2

Dear All,

1.What is mock soiling, what should be the batch size in general?
2. What is general difference between ADE & PDE

Thanks

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(Md.Asif Hussain) #3

Dear All,
1.What is periodic cleaning verification and when and why it should be done?
2. What is the criteria for cleaning and assessment for product non contact parts?

Thanks

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(Albert Groeneveld) #4

Which application are you using Riboflavin for?

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(ussidaho) #5

The intention of conducting Riboflavin coverage study defined as Fluorescence test for examination of
cleanability in for low-germ or sterile process technologies. In brief it includes three subsidiary tests as follows;

  • Weak point test
  • Cleanability test
    -Optimization test
    If the cleanability test for the component being examined is failed, you’re supposed to follow the deviation management instructions and conduct a root cause analysis to identify the cause of this failure.The test is then repeated after correction measures have been carried out (e.g. modification of
    the cleaning procedure) and possibly coordination with the client. The new test conditions must be
    documented.
    When carrying out the weak point test it may occur that it is not the associated criterion of quality that is
    met, but rather that of the cleanability test. In this case, it is recommended to mutually acknowledge the
    weak point test as cleanability test.
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