Proper swab sampling is essential for effective cleaning validation in pharmaceutical manufacturing. Adhering to standardized procedures ensures accurate residue detection, reproducibility, and regulatory compliance.
Standard Operating Procedures:
Swab Selection: Use sterile, low-lint swabs compatible with the surface material and residue type. Pre-wet if necessary for better recovery.
Define Sampling Areas: Measure and mark specific areas (usually in cm²) to maintain consistency and reproducibility.
Sampling Technique: Wipe in a consistent pattern (e.g., horizontal then vertical strokes) applying uniform pressure to maximize residue collection.
Handling and Storage: Place swabs in clean, labeled containers immediately after sampling to prevent contamination and ensure traceability.
Analytical Testing: Analyze collected swabs using validated methods such as TOC, HPLC, or residue-specific assays to quantify residues accurately.
Documentation: Record all sampling locations, techniques, and analytical results to support regulatory compliance and audit readiness.
Following these standardized swab sampling procedures ensures reliable cleaning validation, reduces variability, and strengthens compliance with GMP requirements, safeguarding product quality and patient safety.