Quality and regulatory · Cleaning validation
For our multi-product facility we have to justify the worst-case marker and the limit.
Worst-case marker and cleaning limit for multi-product facilities, justified from tox and solubility.
Who needs this in your company
What we can do
We combine the toxicity and cleanability of your products into a worst-case ranking and derive the cleaning limit from PDE or TTC.
What you get
- Worst-case ranking of the products
- Proposed limit with data basis
Evaluated for you or done yourself
The same calculations, different ways to you. Which one fits, we work out in the intro call.
Evaluation report
You send the data, we deliver the reviewed report.
From EUR 1,490 net, typically 5 working days after complete data
Learn moreCovaSyn in your AI (MCP)
The same calculations directly in Claude, ChatGPT or your own AI.
Learn more
Limits of the result
- The PDE is set by your toxicologist.
More from this area
Mutagenicity and nitrosamines (ICH M7)
The authority wants to see our nitrosamine assessment, and external reports take weeks.
Learn moreStability, degradation, forced degradation
One result in our stability study looks different, and we do not know whether it is a trend or scatter.
Learn moreOOS, control charts, release data
An OOS result is holding the batch, and the investigation has been stuck for weeks.
Learn moreChange and comparability
The column is discontinued, the instrument is new, the supplier has changed: can we do this without revalidation?
Learn moreEcotox and product safety
We are missing environmental data for registration and the safety data sheet.
Learn more
Next step
Which case is on your desk right now?
30 minutes on Microsoft Teams with the CovaSyn team. If it is not a fit, we will say so.
