An essential element in preventing contamination and cross contamination between manufacturing runs, cleaning validation is a critical function in pharmaceutical manufacturing. Regulatory agencies have placed great emphasis on demonstrating that cleaning processes are effective, and our validation services are a vital part of this.
Cleaning validations typically require chemical analysis of swabs and rinses to help identify the presence of residual materials and contaminants.
These validation test results can be expressed as a limit test, or cover a range of analyte concentrations. Once the most effective cleaning process has been identified, and the methodology validated, the process needs to be confirmed via routine QC testing.
Whilst Chromatography techniques can provide quantitative determination of specific analytes, it is often more economical to apply Total Organic Carbon as a more comprehensive screening technique and reverting to GC or HPLC if results from the Total Organic Carbon are out of specification.
Explore some of the techniques we commonly use for cleaning validations: