Cleaning Validation for Solvents used in the manufacturing process

GOOD VALIDATION PRACTICE (cGVP) CLEANING VALIDATION
1

Hi all,

Should we assess for the solvents used in the manufacturing process, eg Toluene. Should limits be calculated using maco - or how should I go about setting limits for Solvent Levels.

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Dear dancetoes,

in my opinion you should assess for the solvents used in the manufacturing process, especially less volatile solvents like Toluene. A good starting point to set acceptance levels would be ICH Q3C and USP <467>.

Best regards

Alfred

3

I think u should use cleaning solvent which is already used in the process or select solvent which have low toxicity value and your product is highly soluble. This would b helping to control solvent traces from product

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Avoid class I and II residual solvents as defined in USP <467>. Carryover acceptance limits are calculated using the ADE (acceptable daily exposure). This applies to solvents that are used as cleaning agents, since residues may be present in the drug product.

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The best cleaning solution is made up of your process stream (if possible) without cleaning agents.
Next best is process fluid with cleaning agents
Worst is using a cleaning solution which is different than normal process fluid (it sounds like this is the process you have).

That being said, there is a calculation using LD50 to determine allowable caryover limit (mACO) to test for cleaning agents which are not part of your normal process…

Google LD50 Cleaning Validation, and you’ll get a bunch of hits.