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Determination of Acceptance Criteria for Cleaning Validation (CV) Studies

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Cleaning SOP ABC-Cleaning of V-Mixer-Rev01 Cleaning Type Manual
Validation Protocol ABC-CV-Cleaning validation protocol for V-Mixer-Rev00 Validation Incharge Ovais

Clea...
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Sampling Method Rinse Sampling Acceptance Criteria Dose, 10ppm and Visual
Product A Product Abc Tablets Active (Product A) Mefenamic Acid
Product B1 Product G Tablets Product B2 Product E Tablets
I 300.000 mg/day J 1.000 Units/day
K 200000.000 Units/Batch L 267838.000 cm²
N 2340.000 Kg/Batch RS 25.000 cm²
LD50 Value W

Cleanin...
SF 0.01000 RAF 0.00100
D 10.000 mL VRL 100.000 μg/cm²
RF 95.000% V 500.000 L INSTRUCT
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Criterion MACO (mg/batch) Limit/vol. of rinse Analytical Limit

Analytical Limit (μg/mL)
Dose ### 0.112 μg/mL 0.106 μg/mL
10 ppm 23400.000 mg/batch 0.004 μg/mL 0.004 μg/mL 0.120

μg/mL
Visual Limit ### 0.005 μg/mL 0.005 μg/mL 0.100

Toxicological 0.080
Acceptance Limit ### 0.004 μg/mL 0.004 μg/mL
0.060

0.040

Compiled by venu 0.020

Checked by 0.000

Date Compiled October 15, 2009 Dose 10ppm Visual

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Dose 10ppm Visual