清洁验证计算实例.pdf

: TOC MACO APIC (Active Pharmaceutical Ingredients Committee a Sector of CEFIC) “Guidance on Aspects of Cleaning Validation in Active Pharmaceutical Ingredient Plants”Pharmaceutical Ingredient Plants” Published in Dec 2000 can be accessed at: /pub/4CleaningVal9909.pdf GEAI/Cleaning Validation ©2009General Electric Company. All rights reserved: 2 (ARL) : ARL = ADI x SBS x SA x RF x CF x TOCF A B A A MDD * x SSA x V B (“ARL”) (“ARL”) ,”” . GEAI/Cleaning Validation ©2009General Electric Company. All rights reserved: 3 ARL –() ARL = ADI x SBS x SA x RF x CF x TOCF A B A A MDD * x SSA x V B : A – B – 1) ARL API A Acceptable Residue Limit(), (mg API A/L, ppm) 2)2) ADIADIA API AAPI A((µg)µg) 3) SBSB API B * (kg) 2 4) SA (cm ) 5) RFA API A, ,API A 6) CF = 1000(:) 7) MDDB API B (mg) 2 8) SSA (cm ) 9) V iTOC(L) 10) TOCFA API A, TOC,APIA, *See detailed explanation on next slide GEAI/Cleaning Validation ©2009General Electric Company. All rights reserved: 4 ARL MDD” API . ,API,.: TTC” ARL , ADI API. A API ,API A ,A.