Determination of Acceptance Criteria for Cleaning Validation (CV) Studies

ORAL PRODUCTS
Equipment Details

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V-Mixer Equipment Name Equipment Location Solid Block (Mixing Room: 05)
Cleaning Validation Details

SB-MIX-02 Equipment ID Equipment FunctionPowder Mixing

ABC-Cleaning of V-Mixer-Rev01 Cleaning SOP Validation Protocol ABC-CV-Cleaning validation protocol for V-Mixer-Rev00
Details for calculation of Acceptance Criteria

Manual Cleaning Type Validation Incharge Ovais

Sampling Method Product A Product B1 I K N LD50 Value SF D RF

Swab Sampling Product Abc Tablets Product G Tablets 50.000 mg/day 240000.000 Units/Batch 15.000 Kg/Batch 740.000 mg/kg 0.00100 10.000 mL 70.000%

Acceptance Criteria Dose, Toxicology, 10ppm & Visual Active (Product A) Mefenamic Acid Product B2 Product E Tablets 16.000 Units/day J 5000.000 cm² L 25.000 cm² U 70.000 Kg W 0.00100 RAF 5.000 μg/cm² VRL V 50.000 L
Cleaning Validation Acceptance Criteria MACO (mg/batch)
800 700 600

INSTRUCTIO INSTRUCTIO Fill in all the Fill in all the n (read the com (read the com

Cleaning Validation Acceptance Criteria

INSTRUCTI INSTRUCTI Select the a Select the ac chart) from chart) from t

mg/batch

Criterion Dose 10 ppm Visual Limit Toxicological Acceptance Limit
Compilation

MACO (mg/batch)Limit/surface area Analytical Limit 750.000 mg/batch 150.000 μg/cm² 262.500 μg/mL 150.000 mg/batch 30.000 μg/cm² 52.500 μg/mL 25.000 mg/batch 388.500 mg/batch 25.000 mg/batch 5.000 μg/cm² 77.700 μg/cm² 5.000 μg/cm² 8.750 μg/mL 135.975 μg/mL 8.750 μg/mL

500 400 300 200

Compiled by Checked by Date Compiled

Ovais Mr Manager October 15, 2009

100 0 Dose 10ppm Visual Tox.

100 0 Dose 10ppm Visual Tox.

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