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Cleaning Validation MACO Swab Rinse Ovais

The document provides details for cleaning validation of a V-Mixer including the cleaning SOP, validation protocol, sampling method, acceptance criteria of dose, toxicology, and visual limits, and calculated acceptance limits for dose, 10ppm, visual, and toxicological criteria.

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Osama Mahmoud
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134 views2 pages

Cleaning Validation MACO Swab Rinse Ovais

The document provides details for cleaning validation of a V-Mixer including the cleaning SOP, validation protocol, sampling method, acceptance criteria of dose, toxicology, and visual limits, and calculated acceptance limits for dose, 10ppm, visual, and toxicological criteria.

Uploaded by

Osama Mahmoud
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as XLS, PDF, TXT or read online on Scribd
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Equipment D...

Determination of Acceptance Criteria for Cleaning Validation (CV) Studies


Add Company Name/Logo Here
ORAL PRODUCTS

Cleaning Vali...
Equipment Name V-Mixer Equipment ID SB-MIX-02
Equipment Location Solid Block (Mixing Room: 05) Equipment FunctionPowder Mixing
Compilati...

Details for ca...


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...
INSTRUCTI
INSTRUCTIO
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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

Cleanin...
SF 0.00100 RAF 0.00100
D 10.000 mL VRL 5.000 μg/cm²
RF 70.000% V 50.000 L INSTRUCT
INSTRUCTI
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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 800.000
700.000
Visual Limit 25.000 mg/batch 5.000 μg/cm² 8.750 μg/mL
600.000
Toxicological 388.500 mg/batch 77.700 μg/cm² 135.975 μg/mL
500.000
Acceptance Limit 25.000 mg/batch 5.000 μg/cm² 8.750 μg/mL
400.000
300.000
200.000
Compiled by Ovais 100.000
Checked by Mr Manager 0.000

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


100.000
0.000
Dose 10ppm Visual Tox.

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