Direct swab method procedure using TOC-V and SSM-5000A

Significance of Direct Swab TOC Analysis in Cleaning Validation

Effective detection of residual carbon on equipment surfaces is essential in pharmaceutical batch processing to prevent cross-contamination and ensure product purity during cleaning validation processes.

Objectives and Scope of the Application Note

This document outlines a rapid surface sampling approach using glass fiber swabs and direct total organic carbon (TOC) measurement with the Shimadzu TOC-V series coupled to the SSM-5000A module.

Methodology and Instrumentation

The technique employs carbon-free quartz microfibre swabs to collect residues from production surfaces directly. After heat-treatment to remove background carbon, swabs are wetted or loaded with calibration standards and inserted into the SSM-5000A sampling boat. The TOC-V analyzer with solid sampling module allows seamless switching between aqueous and solid measurements via a valve and uses dual NDIR tandem cells—a long path for high sensitivity in aqueous samples and a short path optimized for solids.

Key Results and Discussion

Validation experiments demonstrated detection limits down to 1 µg/L total carbon for swabs processed with the high-sensitivity long cell. Recovery of glucose standards confirmed linear response across the tested range. The direct analysis avoided solvent extraction steps, reducing sample preparation time and potential contamination.

Benefits and Practical Applications

• Eliminates solvent extraction for swab samples.
• Enhances sensitivity for low-level residues.
• Streamlines cleaning validation workflows.
• Facilitates rapid decision-making in quality control.

Future Trends and Opportunities

Integration with automated cleaning stations, miniaturization of sampling modules, and advanced data analytics for predictive maintenance represent potential developments. Expanding the method to diverse industries, including food and biotechnology, can further broaden applicability.

Conclusion

The direct swab TOC procedure using TOC-V and SSM-5000A offers a robust, sensitive, and efficient means to verify cleaning efficacy on production surfaces, supporting regulatory compliance and product safety.

Reference

Shimadzu Application Note SCA 130 030