Cleaning Validation Calculation

Validation Department
Page 1 of 2
Cleaning validation calculation
 Product information:
Product name Atorvastatin

ADE value 80 µg/day
Smallest recommended daily dose 10 mg/day
Equipment train Train 11
Next product Voriconazole 200 mg
Max daily dose of the next product 700 mg/day
Min batch size for next product 8 Kg
Swab area 25 cm²
Solvent dilution volume 5 ml
Rinse amount 200 ml
Rinsed area 1332.7 cm²
 Total Surface Area:
S.No. Equipment Name Equipment Surface Area (cm²)

1.
Scoop 1332.7
2.
Mesh 15700
3.
Sifter 36090
4.
Tapasya High speed Mixer 61670
5.
Tapasya Fluid Bed Dryer 144920
6.
Solution Tank 30 L 25978.05
7.
Cad Mill 13320.00
8.
Oscillating Granulator 13258
9.
Blending 31700
10. Fete Tablet Press 17967
11. Fete Metal detector*2 4929.3
12. Fete De Duster*2 12842.041
13. Sejong Coating 86548.23
14. Solution Tank 30797.11
15. Blister 1 19873.6
Total Surface Area : cm²
516926.031
Validation Department
Page 2 of 2
Cleaning validation calculation
 Limit calculations:
Criterion Calculation
Swab Limit: Rinse Limit:
𝐴𝐷𝐸 ∗ 𝑀𝑖𝑛 𝑏𝑎𝑡𝑐ℎ 𝑠𝑖𝑧𝑒 𝑓𝑜𝑟 ∗ 𝑆𝑤𝑎𝑏 𝑎𝑟𝑒𝑎 𝐴𝐷𝐸 ∗ 𝑀𝑖𝑛 𝑏𝑎𝑡𝑐ℎ 𝑠𝑖𝑧𝑒 𝑓𝑜𝑟 ∗ 𝑅𝑖𝑛𝑠𝑒𝑑 𝑎𝑟𝑒𝑎
𝑛𝑒𝑥𝑡 𝑝𝑟𝑜𝑑𝑢𝑐𝑡 𝑛𝑒𝑥𝑡 𝑝𝑟𝑜𝑑𝑢𝑐𝑡
= =
𝑀𝑎𝑥 𝐷𝑎𝑖𝑙𝑦 𝑑𝑜𝑠𝑒 𝑓𝑜𝑟 ∗ 𝑇𝑜𝑡𝑎𝑙 𝑠𝑢𝑟𝑓𝑎𝑐𝑒 ∗ 𝑆𝑜𝑙𝑣𝑒𝑛𝑡 𝑑𝑖𝑙𝑢𝑡𝑖𝑜𝑛 𝑣𝑜𝑙𝑢𝑚𝑒 𝑀𝑎𝑥 𝐷𝑎𝑖𝑙𝑦 𝑑𝑜𝑠𝑒 𝑓𝑜𝑟 ∗ 𝑇𝑜𝑡𝑎𝑙 𝑠𝑢𝑟𝑓𝑎𝑐𝑒 ∗ 𝑅𝑖𝑛𝑠𝑒 𝑎𝑚𝑜𝑢𝑛𝑡
Toxicology 𝑛𝑒𝑥𝑡 𝑝𝑟𝑜𝑑𝑢𝑐𝑡 𝑎𝑟𝑒𝑎 𝑛𝑒𝑥𝑡 𝑝𝑟𝑜𝑑𝑢𝑐𝑡 𝑎𝑟𝑒𝑎
limits
(ADE) = ( 80 µg x 8000000 mg x 25 cm² ) / = ( 80 µg x 8000000 mg x 1332.7 cm² ) /
( 700 mg x 516926.031 cm² x 5 ml ) ( 700 mg x 516926.031 cm² x 200 ml )
= 8.84 µg/ml = 11.78 µg/ml
𝑆𝑚𝑎𝑙𝑙𝑒𝑠𝑡 𝑟𝑒𝑐𝑜𝑚𝑚𝑒𝑛𝑑𝑒𝑑 ∗ 𝑀𝑖𝑛 𝑏𝑎𝑡𝑐ℎ 𝑠𝑖𝑧𝑒 𝑓𝑜𝑟 ∗ 𝑆𝑤𝑎𝑏 𝑎𝑟𝑒𝑎 𝑆𝑚𝑎𝑙𝑙𝑒𝑠𝑡 𝑟𝑒𝑐𝑜𝑚𝑚𝑒𝑛𝑑𝑒𝑑 ∗ 𝑀𝑖𝑛 𝑏𝑎𝑡𝑐ℎ 𝑠𝑖𝑧𝑒 𝑓𝑜𝑟 ∗ 𝑅𝑖𝑛𝑠𝑒𝑑 𝑎𝑟𝑒𝑎
𝑑𝑎𝑖𝑙𝑦 𝑑𝑜𝑠𝑒 𝑜𝑓 𝑎𝑐𝑡𝑖𝑣𝑒 𝑛𝑒𝑥𝑡 𝑝𝑟𝑜𝑑𝑢𝑐𝑡 𝑑𝑎𝑖𝑙𝑦 𝑑𝑜𝑠𝑒 𝑜𝑓 𝑎𝑐𝑡𝑖𝑣𝑒 𝑛𝑒𝑥𝑡 𝑝𝑟𝑜𝑑𝑢𝑐𝑡
= =
𝑆𝑎𝑓𝑒𝑡𝑦 ∗ 𝑀𝑎𝑥 𝐷𝑎𝑖𝑙𝑦 𝑑𝑜𝑠𝑒 ∗ 𝑇𝑜𝑡𝑎𝑙 𝑆𝑢𝑟𝑓𝑎𝑐𝑒 ∗ 𝑆𝑜𝑙𝑣𝑒𝑛𝑡 𝑑𝑖𝑙𝑢𝑡𝑖𝑜𝑛 𝑆𝑎𝑓𝑒𝑡𝑦 ∗ 𝑀𝑎𝑥 𝐷𝑎𝑖𝑙𝑦 𝑑𝑜𝑠𝑒 ∗ 𝑇𝑜𝑡𝑎𝑙 𝑆𝑢𝑟𝑓𝑎𝑐𝑒 ∗ 𝑅𝑖𝑛𝑠𝑒 𝑎𝑚𝑜𝑢𝑛𝑡
𝑓𝑎𝑐𝑡𝑜𝑟 𝑓𝑜𝑟 𝑛𝑒𝑥𝑡 𝑝𝑟𝑜𝑑𝑢𝑐𝑡 𝐴𝑟𝑒𝑎 𝑣𝑜𝑙𝑢𝑚𝑒 𝑓𝑎𝑐𝑡𝑜𝑟 𝑓𝑜𝑟 𝑛𝑒𝑥𝑡 𝑝𝑟𝑜𝑑𝑢𝑐𝑡 𝐴𝑟𝑒𝑎
0.001
dose
= ( 10 mg x 8000000000 µg x 25 cm² ) / = ( 10 mg x 8000000000 µg x 1332.7 cm² ) /
( 1000 x 700 mg x 516926.031 cm² x 5 ml ) ( 1000 x 700 mg x 516926.031 cm² x 200 ml )
= 1.10 µg/ml = 1.47 µg/ml
10 ∗ 10−6 ∗ 𝑀𝑖𝑛 𝑏𝑎𝑡𝑐ℎ 𝑠𝑖𝑧𝑒 𝑓𝑜𝑟 𝑛𝑒𝑥𝑡 𝑝𝑟𝑜𝑑𝑢𝑐𝑡 ∗ 𝑆𝑤𝑎𝑏 𝑎𝑟𝑒𝑎 10 ∗ 10−6 ∗ 𝑀𝑖𝑛 𝑏𝑎𝑡𝑐ℎ 𝑠𝑖𝑧𝑒 𝑓𝑜𝑟 𝑛𝑒𝑥𝑡 𝑝𝑟𝑜𝑑𝑢𝑐𝑡 ∗ 𝑅𝑖𝑛𝑠𝑒𝑑 𝑎𝑟𝑒𝑎
= =
𝑇𝑜𝑡𝑎𝑙 𝑠𝑢𝑟𝑓𝑎𝑐𝑒 𝑎𝑟𝑒𝑎 ∗ 𝑆𝑜𝑙𝑣𝑒𝑛𝑡 𝑑𝑖𝑙𝑢𝑡𝑖𝑜𝑛 𝑣𝑜𝑙𝑢𝑚𝑒 𝑇𝑜𝑡𝑎𝑙 𝑠𝑢𝑟𝑓𝑎𝑐𝑒 𝑎𝑟𝑒𝑎 ∗ 𝑅𝑖𝑛𝑠𝑒 𝑎𝑚𝑜𝑢𝑛𝑡
10 ppm
= ( 0.00001 x 8000000000 µg x 25 cm² ) / = ( 0.00001 x 8000000000 µg x 1332.7 cm² ) /
( 516926.031 cm² x 5 ml ) ( 516926.031 cm² x 200 ml )
= 0.77 µg/ml = 1.03 µg/ml
The most Swab Limit (PPM): 0.77 µg/ml Rinse Limit (PPM): 1.03 µg/ml
stringent
limit

Cleaning Validation Calculation

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Validation Department

Product name Atorvastatin

 Total Surface Area:

S.No. Equipment Name Equipment Surface Area (cm²)

= 8.84 µg/ml = 11.78 µg/ml

Swab Limit: Rinse Limit:

= 1.10 µg/ml = 1.47 µg/ml

Swab Limit: Rinse Limit:

= 0.77 µg/ml = 1.03 µg/ml

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