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

More documents

Recommendations

Info

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)
Summary• Factors to consider when selectingcleaning agents• Chemistry, cleaning parameters based onlab studies• Issues in scale-up and cycle development• Cleaning validation acceptance criteria,sampling and analytical
Page 1 and 2: Selecting and Validating Detergents
Page 3 and 4: Selecting cleaning agentsIssues to
Page 5 and 6: Formulated detergentsBroad-spectrum
Page 7 and 8: Cleaning process parameters andfact
Page 9 and 10: Scaling up parameters100Manual Scru
Page 11 and 12: CIP cleaningWorst-case locations in
Page 13 and 14: Rinsability of formulated detergent
Page 15 and 16: Validating detergentsAcceptance cri
Page 17: Validating detergentsSampling-Clean

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

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?