Analysis of Cleaning Validation Compounds using the TOC Fusion Analyzer
By taking an active approach to prevent cross-contamination in pharmaceutical and cosmetic production, international agencies such as the USFDA, ICH, EC, Health Canada, and the WHO have established regulations and guidelines for effective cleaning and sanitization.1-6 With the potential side effects due to exposure, limiting carry-over of residual compounds into subsequent batches is crucial.
“Equipment and utensils shall be cleaned, maintained, and sanitized at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.”7
“Production equipment should be thoroughly cleaned on a scheduled basis.”8
This study focuses on the analysis of cleaning validation samples using TOC without carryover concerns, negative impacts on precision or accuracy and the ease of developing a method for such analysis.
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