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Problem in MACO Calculation of Micro dosage form

iqbalsikder@iqbalsikder
8 Posts
#1 · October 29, 2024, 9:44 am
I'm getting Higher MACO. This is a shared facility for MDI production. Calculating MACO by using  PDE/ADE value .
For example: Value of PDE/ADE is 0.2 mcg/day. The minimum batch size (next) of this facility is 17.01 kg (170100000000 mcg) & the maximum daily dose (next) of the products is 1200 mcg.
 
MACO formula for share facility:
 
    PDE x minimum B/S
= ----------------------------------
        Max. Daily Dose
 
The result of MACO is 2996666.667 mcg.

mcg.

which is to much higher
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Chief Pharmacist@pharmato
89 Posts
#2 · October 29, 2024, 10:19 am

You can verify the calculatuon here:  Cleaning Validation Acceptance Criteria Calculation

 

If you are getting same, it is OK.

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Last edited on October 29, 2024, 11:26 pm by Chief Pharmacist
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iqbalsikder