quipment Name: Example
Location:
Compiled By:
Determination of Acceptance Criteria for
Cleaning Validation (CV) Studies
Add Company Name/Logo Here
ORAL PRODUCTS
Date
Sampling Method Swab Sampling
INSTRUCTIONS:
INSTRUCTIONS:
Fill in
inthe
the Coral
Coralinput
inputfields
fieldsas
asmentioned
mentioned(read
(readthe
the
Fill
comments
if
needed)
comments if needed)
Parameter
Product A
AI
Product B1
Description
Product selected for cleaning validation study (worst ca
Active ingredient in Product A
Product B2
Product with smallest batch size
iprofloxacin HcL Tablet
Active principle present in the cleaning agent
lkylBenzene Sulphonate
Smallest strength of Product A manufactured
500.000 mg/day
Maximum number of dosage units of Product B1 taken/day
16.000 Units/day
Number of dosage units per batch of final mixture of Product B
240000.000 Units
CA
I
J
K
LD50-AI
LD50-Detergent
W
L
N
U
SF
* Give justification
Value Units
Product No. 5
Mefenamic Acid
Product with largest MDD (Maximum Daily Dose) value
Product No. 1
Lethal Dose 50 for active ingredient in Product A
740.000 mg/kg
Lethal Dose 50 for the detergent
Average human body weight
Equipment surface area in common between Product A & B
240.000 mg/kg
70.000 kg
5000.000 cm
Batch size of Product B2
15.000 kg
25.000 cm/Swab
0.001
Swab area
Safety Factor *
for using safety factor other than 0.001 in the CV Protocol
Lim it (m g/25cm )
Summary: MACO for both AI & CA to subsequently manufactured product
40.000
MACO
35.000
Criterion
Active Ingredient
Cleaning Agent
30.000
25.000
Dose
37.500 mg/25 cm
20.000
Toxicological
1.943 mg/25 cm
0.630 mg/25 cm
15.000
0.750 mg/25 cm
0.750 mg/25 cm
10 ppm
10.000
1.000 mg/25 cm
1.200 mg/25 cm
Visual Limit
5.000
Active
Cleaning Agent
0.000
Dose
Cr iter ion
Tox.
10 ppm
Visual
Tox.
Cr iter ion
Formulas used for calculation:
A) Dose criterion (0.001)
10 ppm
Visual
This spreadsheet
spreadsheet may
may not
not be
be resold
resold or
or distributed.
distributed. Please
Please request
request
This
author ([email protected]
([email protected] for
for any
any changes
changes required
required to
to be
be
author
made).
made).
mg of active ingredient in product A permitted per 25 sq cm swab area =
(I/J) X (K/L) X U
Where
I = (SF * Smallest strength of product A manufactured)/day expressed as mg/day & based on the number of mg of active ingredi
J = Maximum number of dosage units of Product B1 taken/day
K = Number of dosage units per batch of final mixture of Product B 1
L = Equipment surface area in common between Product A & B1/B2 expressed as cm
U = Swab area (25 cm/swab)
B) Toxicological Criterion
mg of active ingredient in product A permitted per 25 sq cm swab area =
NOEL x K x U
SF x J x L
Where
NOEL = LD50 X (W/E)
NOEL = No observed Effect Level =
LD50 = Lethal Dose 50 in mg/kg animal for active ingredient in product A
E = Empirical Constant = 2000
S = Safety Factor = 0.01 - 0.001 (for Oral Products)
J = Maximum number of dosage units of Product B1 taken/day
K = Number of dosage units per batch of final mixture of Product B 1
L = Equipment surface area in common between Product A & B1/B2 expressed as cm
U = Swab area (25 cm/swab)
C) 10 ppm Criterion
mg of active ingredient in product A permitted per 25 sq cm swab area =
R X (N/L) X U
Where
R = 10 mg active ingredient in product A/kg Product B2
N = Number of kgs per batch of final mixture of Product B2
L = Equipment surface area in common between Product A & B1/B2 expressed as cm
U = Swab area (25 cm/swab)
ogo Here
he
e
s/day
Swab
Cleaning Agent
Visual
Visual
request
request
ed
to be
be
d to
mg of active ingredient
quipment Name: Example
Location:
Compiled By:
Determination of Acceptance Criteria for
Cleaning Validation (CV) Studies
Add Company Name/Logo Here
ORAL PRODUCTS
Date
Sampling Method Rinse Sampling
Parameter
Product A
AI
Product B1
Description
Product selected for cleaning validation study (worst ca
Active ingredient in Product A
Product B2
Product with smallest batch size
iprofloxacin HcL Tablet
Active principle present in the cleaning agent
lkylBenzene Sulphonate
Smallest strength of Product A manufactured
400.000 mg/day
Maximum number of dosage units of Product B1 taken/day
8.000 Units/day
Number of dosage units per batch of final mixture of Product B
300000.000 Units
J
K
LD50-AI
LD50-Detergent
W
L
R
Product with largest MDD (Maximum Daily Dose) value
Product No. 1
Lethal Dose 50 for active ingredient in Product A
2300.000 mg/kg
Lethal Dose 50 for the detergent
Average human body weight
Equipment surface area in common between Product A & B
437.000 mg/kg
35.000 kg
31627.944 cm
1000.000 cm
Surface area of the rinsed surface
Batch size of Product B2
N
V
Rinse Volume
SF
Safety Factor *
* Give justification for using safety factor other than 0.001 in the CV Protocol
97.500 kg
50.000 L
0.001
L i m i t (m g /2 5 c m )
Detergent
I
Value Units
Product No. 5
Mefenamic Acid
Summary: MACO for both AI & CA to subsequently manufactured product
MACO
Criterion
Active Ingredient
Cleaning Agent
Dose
9.485 mg/L
10.000
Toxicological
0.954 mg/L
0.181 mg/L
8.000
0.617 mg/L
6.000
0.617 mg/L
10 ppm
4.000
1.000 mg/L
1.200 mg/L
Visual Limit
Active
Cleaning Agent
2.000
0.000
Dose
Cr i ter i on
Tox.
10 ppm
Visual
0.000
Dose
Cr i ter i on
Tox.
10 ppm
Visual
