Determination of Acceptance Criteria for Cleaning Validation (CV) Studies

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ORAL PRODUCTS

Equipment Details
Equipment Name V-Mixer Equipment ID SB-MIX-02
Equipment Location Solid Block (Mixing Room: 05) Equipment FunctionPowder Mixing

Cleaning Validation Details

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
INSTRUCTI
INSTRUCTIO
Details for calculation of Acceptance Criteria
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Sampling Method Swab Sampling Acceptance Criteria Dose, Toxicology, 10ppm & Visual
Product A Product Abc Tablets Active (Product A) Mefenamic Acid
Product B1 Product G Tablets Product B2 Product E Tablets
I 50.000 mg/day J 16.000 Units/day
K 240000.000 Units/Batch L 5000.000 cm²
N 15.000 Kg/Batch U 25.000 cm²
LD50 Value 740.000 mg/kg W 70.000 Kg
SF 0.00100 RAF 0.00100
D 10.000 mL VRL 5.000 μg/cm²
RF 70.000% V 50.000 L INSTRUCT
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Cleaning Validation Acceptance Criteria Cleaning Validation Acceptance Criteria
Criterion MACO (mg/batch) Limit/surface area Analytical Limit
MACO (mg/batch)

mg/batch
Dose 750.000 mg/batch 150.000 μg/cm² 262.500 μg/mL
10 ppm 150.000 mg/batch 30.000 μg/cm² 52.500 μg/mL 800

Visual Limit 25.000 mg/batch 5.000 μg/cm² 8.750 μg/mL 700

600
Toxicological 388.500 mg/batch 77.700 μg/cm² 135.975 μg/mL
500
Acceptance Limit 25.000 mg/batch 5.000 μg/cm² 8.750 μg/mL
400
300
Compilation
200
Compiled by Ovais 100
Checked by Mr Manager 0

Date Compiled October 15, 2009 Dose 10ppm Visual Tox.

100
0
Dose 10ppm Visual Tox.