Cleaning Validation – Rinsing Test

Test Description
This test is to be conducted to document the validation of Total Organic Carbon (TOC)
analysis method for use in measuring samples for cleaning validation. A parallel analysis
of rinse samples will be carried out and compared using TOC and High Performance
Liquid Chromatography (HPLC) analysis. Standard solutions will be applied to stainless
steel plates, dried and the residue removed by rinsing using an appropriate solvent
(usually water). Assessment of Linearity, Accuracy (recovery), LOQ, LOD and precision
of the rinsing method will be determined.
2. Test Objective
1. Determine the linearity and precision of a series of standards rinsed from a stainless
steel plate or container and measured by TOC and HPLC over a known concentration
range.
2. Determine the accuracy (recovery) of a series of standards rinsed from a stainless
steel plate or container and measured by TOC and HPLC over a known concentration
range.
3. Determine the Limit of quantitation and limit of detection of a series of standards
measured by TOC and HPLC over a known concentration range.
4. Determine correlation between HPLC and TOC analysis.
5. Determine the final HPLC and TOC rinsing limits based on recovery studies.