Equipment D...

Determination of Acceptance Criteria for Cleaning Validation (CV) Studies

Add Company Name/Logo Here
ORAL PRODUCTS

Cleaning Vali...
INSTRUCTI
INSTRUCTIO
Fillin
Fill inall
allthe
the
Equipment Name DHM Equipment ID DHM No.1
(readthe
(read thecom
co
Equipment Locati R. 36 Equipment Func Powder Mixing
Compilati...

Details for ca...

Cleaning SOP ABC-Cleaning of V-Mixer-Rev01 Cleaning Type Manual
Validation ProtocoABC-CV-Cleaning validation protocol for V-Mixer-Rev00 Validation Incha Ovais INSTRUCT
INSTRUCTI

Clea...
Selectthe
Select theac
a
cleaning val
cleaning vali

Sampling Method Swab Sampling Acceptance CriterDose, 10ppm and Visual

Product A Soldextam Active (Product A)Dexametason
Product B1 cafmosol Product B2 obdhamin
I 0.500 mg/day J 2000.000 Units/day
K 200000.000 Units/Batch L 5000.000 cm
N 15.000 Kg/Batch U 25.000 cm
LD50 Value 3000.000 mg/kg W 70.000 Kg

Cleanin...
SF 0.10000 RAF 1.00000
D 10.000 mL VRL 5.000 g/cm
RF 70.000% V 50.000 L INSTRUCT
INSTRUCTI
Selectthe
Select theac
a
chart)from
chart) from

Criterion MACO (mg/batch)Limit/Surface Area Analytical Limit

MACO (mg/batch)

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

Visual Limit 25.000 mg/batch 5.000 g/cm 8.750 g/mL 140.000

120.000
Toxicological
100.000
Acceptance Limit 5.000 mg/batch 1.000 g/cm 1.750 g/mL
80.000
60.000
40.000
Compiled by Ovais 20.000
Checked by Mr Manager 0.000

Date Compiled October 15, 2009 Dose 10ppm Visual

 80.000
60.000

us
FormulaeDe
40.000
20.000
Determination of Acceptance Criteria for Cleaning Validation (CV) Studies
0.000 Add Company Name/Logo Here
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)

"Swab Sampling" Limits

Criterion
MACO (mg/batch) Limit/Surface Area Analytical Limit
Dose L1 = ((SF*I)*K)/J L2 = (L1*1000)/(L) L3 = L2*U*RF/(D)
10 ppm L4 = 10*N L5 = L4*1000/(L) L6 = L5*U*RF/(D)
Toxicological L7 = (((LD50*(W/2000))*RAF)*K)/J L8 = (L7*1000)/(L) L9 = L8*RF
Visual Limit L10 = (VRL*L)/1000 L11 = VRL L12 = VRL*U*RF/(D)
Determination of Acceptance Criteria for Cleaning Validation (CV) Studies
Add Company Name/Logo Here

Formulae use...
ORAL PRODUCTS

"Rinse Sampling" Limits

Criterion
MACO (mg/batch) Limit/Vol. of rinse Analytical Limit
Dose L1 = ((SF*I)*K)/J L2 = (L1*1000*RS)/(L*V*1000) L3 = L2*RF
10 ppm L4 = 10*N L5 = L4*1000*RS/(L*V*1000) L6 = L5*RF
Toxicological L7 = (((LD50*(W/2000))*RAF)*K)/J L8 = (L7*1000*RS)/(L*V*1000) L9 = L8*RF
Visual Limit L10 = (VRL*L)/1000 L11 = VRL*RS/(V*1000) L12 = L11*RF