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What is Cleaning Validation?

The regulatory definition of cleaning validation objective is to: “Ensure that a specific cleaning process will consistently clean to predetermined limits so as to prevent contaminants from adversely affecting the safety and quality of the next product manufactured." This is essentially the process of ensuring that there is no product cross-contamination from the previous product run or clean-in-place (CIP) regime.

Why do we do it?

Ultimately the exclusion of undesired contaminants from a product is the focus of all activities in a manufacturing facility. Demonstrating cleaning validation is a regulatory requirement put in place for the control of product quality and safety as part of good manufacturing process (GMP). There are a number of regulatory authorities that require and expect to see a documented and validated cleaning program to be in place and in use. Some of these regulatory bodies/guidelines are as follows:

  • Eudralex – Annex 15
  • ICH Q7 – 12.7 Cleaning validation
  • Health sciences Authority 2008/PICS Recommendations

How can we help assure compliance?

We have a wealth of knowledge and experience in performing analysis of cleaning validation samples at Honeyman. This assessment can be performed non-specifically using cGMP Total Organic Carbon (TOC) analysis of rinse water or swab samples. HPLC can also be utilized for the determination of residual compound cleaning validation samples. We are capable of performing:

  • TOC analysis of cleaning validation samples (typically swabs and rinse samples) on our Shimadzu TOC analyser. This method uses high-temperature combustion detection.
  • Specific contaminant assessment using High Performance Liquid Chromatography (HPLC)

All analysis is done in accordance with pre-determined limits defined by the client. 

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