Recovery Factor Determination in Cleaning Validation

Definition:
Recovery Factor (RF) is the percentage of analyte recovered from a surface during cleaning validation studies. It helps to account for possible losses during swabbing/rinsing and analytical testing, ensuring accurate estimation of residue levels.

Steps for Recovery Factor Determination:

1. Surface Selection:

   • Choose representative surfaces (stainless steel, glass, plastic, etc.) used in equipment manufacturing.

2. Spiking Procedure:

   • Known amount of the analyte (API, detergent, or cleaning agent) is spiked onto the surface.

   • Allow drying to mimic real contamination conditions.

3. Swabbing/Rinsing:

   • Perform swabbing/rinsing with validated technique, using suitable solvent and swab material.

4. Extraction:

   • Swabs are extracted in diluent/solvent to transfer the analyte.

5. Analysis:

   • Analyze using validated method (HPLC, TOC, GC, etc.).

6. Calculation of Recovery Factor (RF):

   Recovery Factor (%)=Amount RecoveredAmount Spiked×100\text{Recovery Factor (\%)} = \frac{\text{Amount Recovered}}{\text{Amount Spiked}} \times 100Recovery Factor (%)=Amount SpikedAmount Recovered​×100

Acceptance Criteria:

• Generally, 70–120% recovery is considered acceptable (industry practice).

• Recovery studies must be performed in triplicate or more for consistency.

• Worst-case conditions (hard-to-clean surface, low recovery analyte) should be evaluated.

Importance in Cleaning Validation:

• Ensures accurate estimation of residues.

• Adjusts analytical results for recovery correction.

• Demonstrates robustness of swabbing/rinsing technique.

• Regulatory requirement (FDA, EMA, WHO, ICH).

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