Cleaning Validation Limits or Acceptance Criteria

Before the cleaning validation limit is assessed and applied, an analytical method validation is required for sensitivity, specificity, and recovery. The sampling of the cleaned surface with a suitable swab material or rinse solvent is an important step to calculate the cleaning validation limit.

Generally, predefined areas (usually 10 cm × 10 cm) are swabbed or rinse samples are collected with a known volume of solvent. The formulas used to calculate the swab or rinse limit for each MACO are as follows:

For each method of calculation, the lowest MACO value and cleaning limit are obtained and proposed as acceptance criteria for cleaning validation. 

For most cases, the selection of the limit is based on patient safety; however, there are other factors that could impact the selection, requiring further assessment. The technical and quality persons are responsible for the final decision with appropriate justification.

MACO Calculation Formulas

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Reference: ISPE

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