The Essential Equations and Formulas for Cleaning Validation
1. Acceptance Value (AV) calculation formula:
AV = (Σ |C – T|) / n x 100
where AV is the acceptance value, C is the concentration of the analyte in each sample, T is the target concentration, and n is the number of samples analyzed.
Reference: United States Pharmacopeia (USP) General Chapter <1225> Validation of Compendial Procedures.
2. Cleaning Verification Limit (CVL) calculation formula:
CVL = (MAC x BS x SF) / SA
where CVL is the cleaning verification limit, MAC is the maximum allowable carryover limit for a specific analyte, BS is the batch size, SF is the safety factor, and SA is the surface area of equipment contact.
Reference: European Medicines Agency (EMA) Guideline on Setting Health Based Exposure Limits for Use in Risk Identification in the Manufacture of Different Medicinal Products in Shared Facilities.
3. Swab Recovery calculation formula:
Swab Recovery (%) = (Amount Recovered / Amount Spiked) x 100
where Swab Recovery is expressed as a percentage, Amount Recovered is the measured amount of analyte recovered from a spiked surface, and Amount Spiked is the known amount of analyte spiked onto the surface.
Reference: FDA Guidance for Industry – Bioanalytical Method Validation.
4. Analytical Method Detection Limit (MDL) calculation formula:
MDL = 3.3 x SD / S
where MDL is the method detection limit, SD is the standard deviation of replicate measurements of a blank sample, and S is the slope of a calibration curve.
Reference: United States Environmental Protection Agency (EPA) Method Detection Limit Guidance Document.
5. Rinse Sample Concentration calculation formula:
Rinse Sample Concentration = [(C1 x V1) + (C2 x V2)] / (V1 + V2)
where Rinse Sample Concentration is the concentration of the analyte in the rinse sample, C1 and C2 are the concentrations of the analyte in two separate aliquots, and V1 and V2 are the volumes of the two aliquots.
Reference: Pharmaceutical Inspection Co-operation Scheme (PIC/S) Guide to Good Manufacturing Practice for Medicinal Products.
Please note that these formulas are general examples and may vary depending on specific cleaning validation requirements and guidelines.
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