Cleaning validation completed across shared equipment
Ergopharm has completed cleaning validation across its shared equipment, calculating carry-over limits for each product changeover and demonstrating by recovery study that the cleaning procedure achieves them.
Shared equipment means the residue of one product can reach the next. Cleaning validation is the demonstration that it does not — not that the equipment looks clean, but that any residue remaining is below a limit derived from the pharmacology and dose of the substances involved, applied to the worst-case changeover in the matrix.
“Clean enough to look at is not a specification. Clean to a calculated limit is.”
Each limit is supported by a validated analytical method with a demonstrated recovery from the actual surface material, because a swab that recovers half the residue reports half the contamination. Visual inspection is retained as an additional check with a demonstrated visible-residue limit, not as the primary criterion.
Hold times are validated in both directions — the dirty hold before cleaning and the clean hold before use — since a clean vessel left standing is not indefinitely clean.
Key facts
- Limits
- Derived from pharmacology and dose, worst-case changeover
- Method
- Validated, with recovery demonstrated from the actual surface
- Visual check
- Retained with a demonstrated visible-residue limit
- Hold times
- Dirty-hold and clean-hold both validated