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

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Validating detergentsAcceptance criteria• Calculate and establish limits for productcontact surfaces and rinse samples– Concentration in subsequent product (ppm)– MAC, maximum allowable carryover (mg)– Amount per surface area (µg/cm 2 )– Amount in rinse water (µg/mL)– Amount in analytical swab sample (µg/mL):21)8**>*2+*+!!(,%$,--.&
Validating detergentsSampling–Cleanliness evaluated by• Validated sampling methods–Rinse–Swab• Visual examination– Varies with residue, substrate, distance, angle,light intensity, observerKirsch R.B. “Validation of Analytical Methods Used in Pharmaceutical Cleaning Assessment andValidation”,Supplement to Pharm Tech, 40-46 (1998)“Points to Consider for Cleaning Validation”, PDA J of Pharm Sci. & Technol, Tech Rep #29,Vol52, No 6, (1998)
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: Validating detergentsAcceptance cri
Page 19 and 20: Summary• Factors to consider when

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

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