Determination of Acceptance Criteria for Cleaning Validation (CV) Studies

Add Company Name/Logo Here

ORAL PRODUCTS
Equipment Details

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

SB-MIX-02
Equipment ID
Equipment FunctionPowder Mixing

Cleaning Validation Details

Cleaning SOP
Validation Protocol

ABC-Cleaning of V-Mixer-Rev01
ABC-CV-Cleaning validation protocol for V-Mixer-Rev00

Manual
Cleaning Type
Validation Incharge Ovais

Details for calculation of Acceptance Criteria

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

Mefenamic Acid
Active (Product A)
Product B2
Product E Tablets
16.000 Units/day
J
5000.000 cm
L
25.000 cm
U
70.000 Kg
W
0.00100
RAF
5.000 g/cm
VRL
V

Cleaning Validation Acceptance Criteria

Criterion
MACO (mg/batch)Limit/surface area Analytical Limit
Dose
750.000 mg/batch 150.000 g/cm
262.500 g/mL
10 ppm
150.000 mg/batch
30.000 g/cm
52.500 g/mL
Visual Limit
25.000 mg/batch
5.000 g/cm
8.750 g/mL
Toxicological
388.500 mg/batch
77.700 g/cm
135.975 g/mL
Acceptance Limit 25.000 mg/batch
5.000 g/cm
8.750 g/mL
Compilation

Compiled by
Checked by
Date Compiled

Ovais
Mr Manager
October 15, 2009

50.000 L

INSTRUCT
INSTRUCTI
Selectthe
theac
a
Select
chart)from
fromt
chart)

Cleaning Validation Acceptance Criteria

MACO (mg/batch)
8 0 0 .0 0 0
7 0 0 .0 0 0

mg/batch

Sampling Method
Product A
Product B1

6 0 0 .0 0 0
5 0 0 .0 0 0
4 0 0 .0 0 0
3 0 0 .0 0 0
2 0 0 .0 0 0
1 0 0 .0 0 0
0 .0 0 0
Dose

10ppm

INSTRUCTI
INSTRUCTIO
Fillin
inall
allthe
the n
Fill
(readthe
thecom
com
(read

Visual

Tox.

1 0 0 .0 0 0
0 .0 0 0
Dose

10ppm

Visual

Tox.