Cleaning Vali...
INSTRUCTI
INSTRUCTIO
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Equipment Name DHM Equipment ID DHM No.1
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Equipment Locati R. 36 Equipment Func Powder Mixing
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SF 0.10000 RAF 1.00000
D 10.000 mL VRL 5.000 g/cm
RF 70.000% V 50.000 L INSTRUCT
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mg/batch
Dose 5.000 mg/batch 1.000 g/cm 1.750 g/mL
10 ppm 150.000 mg/batch 30.000 g/cm 52.500 g/mL 160.000
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Determination of Acceptance Criteria for Cleaning Validation (CV) Studies
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ORAL PRODUCTS Dose 10ppm Visual
Caption Description
Product A Product to be cleaned (worst case product for CV studies)
Product B1 Product with largest maximum daily dose value
Product B2 Product with smallest batch size
I Smallest strength of AI in Product A manufactured
J Maximum number of dosage units of product B1 taken/day
K Number of dosage units per batch of final mixture of Product B1
LD50 Value Lethal Dose 50 for active ingredient in Product A
W Average human body weight
L Equipment surface area in common between Product A & B1
N Batch size of Product B2
U Area of the surface swabbed (i.e. swab surface area)
RS Surface area of the rinsed surface
V Total volume of rinse solvent used
SF Safety factor (for Dose Criterion)
RAF Risk assessment factor (for toxicological criterion)
D Volume of desorption solution
RF Recovery Factor (obtained from recovery studies)
VRL Visible Residue Limit (obtained from spiking studies)
Formulae use...
ORAL PRODUCTS