Cleaning validation- discussion

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

Dear All,

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

Thanks

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

Which application are you using Riboflavin for?

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.

Dear All,
How is the time frame for storage of uncleaned equipment is established and how it’s conducted and ideally how many batches should be considered?
Thanks

Dear All,

What are the types of swab stick we use for cleaning validation, is it acceptable to use different brand as used in recovery study --during analytical method.
Thanks

Dear All,

How you will certify and Define the acceptance criteria for removal of flavour and order from the equipment during CV?
Thanks

Dear All,

Change in source of API shall trigger cleaning Revalidation?
Thanks

All changes that may affect product quality or reproducibility of the process should be formally requested, documented and accepted. The likely impact of the change of facilities, systems and equipment on the product should be evaluated, including risk analysis. The need for, and the extent of, re-qualification and re-validation should be determined.

You need to take “Dirty Equipment Hold Time” study. The effectiveness of a cleaning procedure may depend on the properties of the dirty equipment as well as on the characteristics of residuals, whether they are fresh and still wet, or got dried after some time of holding. That means the hold time of dirty equipment should be chosen according to your needs. The hold time should be covered by your cleaning validation.
To avoid this effort, you can of course postulate that cleaning has to be done immediately (maybe within
few hours) after usage of the equipment.