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: