TOC Analysis

GOOD VALIDATION PRACTICE (cGVP) CLEANING VALIDATION
1

Hi all,

I’m currently in the process of writing cleaning validation protocols for new cleanrooms and existing process equipment. For the equipment I intend to analyse the swab data by HPLC. For the cleanroom surfaces however, I was thinking of using TOC analysis. My questions are:

  1. How do I determine the LOQ for TOC analysis
  2. How do I obtain swab recovery % for use in TOC analysis, i.e. what must I coat the sample plates with when I will be analysing a mixture of carbon sources? How is the ratio of product and detergent determined and how do you know this is representative?

Thanks,

Josie