Scribd
Upload
53 views2 pages

Cleaning Validation Calculation

Uploaded by

Conquer Conquer
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
53 views2 pages

Cleaning Validation Calculation

Uploaded by

Conquer Conquer
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 2

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

Swab Limit: Rinse Limit:

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

Swab Limit: Rinse Limit:

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

You might also like

pFad - Phonifier reborn

Pfad - The Proxy pFad of © 2024 Garber Painting. All rights reserved.

Note: This service is not intended for secure transactions such as banking, social media, email, or purchasing. Use at your own risk. We assume no liability whatsoever for broken pages.


Alternative Proxies:

Alternative Proxy

pFad Proxy

pFad v3 Proxy

pFad v4 Proxy