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MACO Calculation

This document provides instructions for calculating the Maximum Allowable Carry Over (MACO) for chemical residues in cleaning validation. It includes a template for entering cleaning parameters like surface area, solvent quantities, and minimum/maximum doses of active ingredients. The template then calculates the MACO per batch, MACO per swab sample, and MACO per rinse sample of individual equipment based on the entered parameters and safety factor.

Uploaded by

Nishit Suva
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2K views2 pages

MACO Calculation

This document provides instructions for calculating the Maximum Allowable Carry Over (MACO) for chemical residues in cleaning validation. It includes a template for entering cleaning parameters like surface area, solvent quantities, and minimum/maximum doses of active ingredients. The template then calculates the MACO per batch, MACO per swab sample, and MACO per rinse sample of individual equipment based on the entered parameters and safety factor.

Uploaded by

Nishit Suva
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as XLS, PDF, TXT or read online on Scribd
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MACO (Maximum Allowable Carry Over) Calculation for Chemical Residue in Cleaning Validation

Instructions for Entering the Data

1. Enter the required details in YELLOW coloured cells.


2. Results will be derived in GREEN coloured cells.
3. MACO per Swab sample is common for all equipment where as MACO per Rinse sample is specific to particular equipment.

Enter The details as required below

Description Data Value Description Data Value

Safety Factor 1000 Surface Area of Individual Equipment 69000


cm2
Solvent Quantity used for Rinsing
Minimum daily dose of Active of Product A 150 µg Individual Equipment 500 ml

Maximum daily dose of Product B 1500 µg


Minimum Batch Size of Product B 150000000 µg

Total Shared Surface Area of Equipment Train 262700


cm2
Swab Sample Area cm2
Solvent Desorption Quantity for Swab Sample ml

MACO per Batch (in µg) [Minimum daily dose of Active of [Minimum Batch Size of Product B
= [Safety Factor] x x
Product A (µg)] (µg)]

[Maximum daily dose of Product B (µg)]

= 1000 x 150 x 150000000

1500

= 15000000000 µg

MACO per Swab Sample (in ppm or µg/ml)


= MACO per Batch (in µg) x Swab Sample Area (cm2)

Solvent Desorption Quantity for x Total Shared Surface Area of


Swab Sample (ml) Equipment Train (cm2)

= 15000000000 x 0
0 x 262700

= #DIV/0! ppm

MACO per Rinse Sample of Particular Equipment (in ppm or µg/ml) Surface Area of Individual Equipment
= MACO per Batch (in µg) x
(cm2)

Solvent Quantity used for Rinsing x Total Shared Surface Area of


Individual Equipment (ml) Equipment Train (cm2)

= 15000000000 x 69000
500 x 262700

= 7879710.69661211 ppm
150000000000

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