Selecting and Validating Detergents for CIP Applications- An ... - A3P

Validating detergentsAnalytical methods• Validated analytical methods– Specific• E.g. HPLC– Non specific• E.g. TOC, Conductivity• Provides upper limit value• Example– TOC of swab sample = 0.8 ppm– %C of detergent = 20%– Therefore, maximum cleaner in sample = 0.8 ppm / 0.20 = 4 ppm– Compare to acceptance limitKirsch R.B. “Validation of Analytical Methods Used in Pharmaceutical Cleaning Assessment and Validation”,Supplement to Pharm Tech, 40-46 (1998)“Points to Consider for Cleaning Validation”, PDA J of Pharm Sci. & Technol, Tech Rep #29,Vol 52, No 6, (1998)