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Questions & Answers about Cleaning Validation

Last September, ECA offered the first Cleaning Validation Online Training Course. After the session, participants had the opportunity to ask their questions, which the speaker Robert Schwarz answered, and a selection of these answers based on the speaker's experience have been published.

Throughout 14 questions, divided into two blocks, interesting topics were discussed:

       Details of visual inspection of surfaces.

-        How to analyze the most inaccessible areas of the equipment and when a risk assessment is necessary.

-        Applicability of PDE values and possibility of risk strategy when PDE is not necessary.

-        Risk revalidation when introducing a new API in a multi-purpose facility.

-        Clean Hold Time (CHT) and Sterile Hold Time (SHT).


-        Determination of the worst-case substance in the cleaning validation.

       Microbiological methods.

-        Determination of cleaning agent residue

       Regulatory requirements for recovery for swab tests during method validation.

You can consult all the Q&A through the following links:

·        Q&As Cleaning Validation - Part 1

·        Q&As Cleaning Validation - Part 2


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