The Importance of Swab Recovery Rate Testing for Compounds

This time, we will discuss the feasibility testing of swab recovery rates for compounds. This test is designed to verify the recovery rate of Total Organic Carbon (TOC) analysis when dealing with low-solubility compounds or in cases where the cleaning process may be inadequate.

Determining Solubility

The process begins with determining the solubility. The compound is added to low TOC water, stirred, and sonicated to confirm its solubility.

Swab Recovery and Measurement Process

Next, a swab is used to wipe the surface of the coupon, and the swab tip is folded into a vial. Shaking the vial vigorously before analysis ensures proper preparation for accurate recovery rate calculations. The sample is then measured using a TOC analyzer, and the recovery rate is calculated based on the results.

Worst-Case Assumption and Validation

This test assumes a worst-case scenario where cleaning performance parameters are not met or are uncontrolled, validating the effectiveness of TOC analysis. This allows for precise detection of compound residues and helps improve the cleaning process.

Summary and Contribution to Quality Control

Thus, swab recovery rate testing for compounds is positioned as an important part of quality control in the pharmaceutical industry. Through such testing, we aim to continue providing safer and more effective products.

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