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Acceptance Criteria for batch to batch cleaning of same API

What are the factors needs to be considerd during fixation of limit for batch to batch cleaning of same API.

Rajeev:confused:

There is no guidelines available specifying batch to batch cleaning.

First of all the equipment should be visually clean.
Secondly, you can keep the acceptance criteria of 100 ppm (General max. limit mentioned in APIC cleaning validation guide for product change over cleaning).

Also please ensure the following,

  1. Ensure that no impurity is increasing from the degradation of API under stress conditions like water hydrolysis, acid degradation or base degradation (if you are cleaning with acid or base). If any impurity (known /unknown) is increasing that might act as seed material in next batch.
    (this data you can get from specificity study performed during method validation of API)
  2. Check whether the API is changing its form on interaction with cleaning agent.
  3. Also ensure the absence of cleaning agent after cleaning.
  4. If the product is not stable at room temperature number of batches per campaign shall be fixed based on the study.
  5. If the product is microbial growth promoting number of batches per campaign shall be fixed based on the study.
    Regards
    Satish Dange
    +919912074873

I think it should be 500 ppm