Cleaning Validation Protocol — Equipment Residue Limits

1. Acceptance Criteria

Criterion	Limit	Method
Visual inspection	No visible residue	Visual
Active residue (peptide)	≤10 ppm	Swab + HPLC
Cleaning agent residue	≤10 ppm	Swab + TOC
Microbial (Rinse water)	≤10 CFU/100 mL	Membrane filtration

2. Worst-Case Product Selection

Worst-case = least soluble peptide at highest concentration processed.

Factor	Consideration
Solubility	Poorest solubility → hardest to clean
Potency	Lowest limit of detection
Batch size	Largest batch size in shared equipment

3. Sampling Methods

Method	Surface	Recovery	Application
Swab	Stainless steel, glass	70 – 90%	Direct surface
Rinse	Pipelines, hold tanks	60 – 80%	Large surface areas
Coupon	Test plates	Known reference	Method validation

4. Validation Schedule

Phase	Frequency
Initial validation	3 consecutive successful runs
Revalidation	After equipment modification
Periodic review	Annually