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Semisolids Manufacturing Consideration: 1) Flow Diagram

This document provides a monitoring output acceptance sampling plan for content uniformity testing of a product batch, requiring testing of 10 units total with 3-4 units each from the beginning, middle, and end of the filling cycle. The average result of the 10 tests must meet the release limit for assay, and the relative standard deviation must be less than or equal to 4.2%. A second section provides a flow diagram for semisolids manufacturing involving combining water and oil-soluble ingredients in separate vessels and heating to critical temperature before homogenizing the mixture and filling and packaging the finished product.

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Jai Murugesh
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446 views2 pages

Semisolids Manufacturing Consideration: 1) Flow Diagram

This document provides a monitoring output acceptance sampling plan for content uniformity testing of a product batch, requiring testing of 10 units total with 3-4 units each from the beginning, middle, and end of the filling cycle. The average result of the 10 tests must meet the release limit for assay, and the relative standard deviation must be less than or equal to 4.2%. A second section provides a flow diagram for semisolids manufacturing involving combining water and oil-soluble ingredients in separate vessels and heating to critical temperature before homogenizing the mixture and filling and packaging the finished product.

Uploaded by

Jai Murugesh
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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Monitoring Output Acceptance Sampling Plan

Criteria
(n = 10)

3 – 4 units from
Content UPL & LPL within 90 beginning,
Uniformity – 110% LA
middle and end
of filling cycle;
RSD ≤ 4.2%
total = 10 units
● The average result of 10 individual results must meet the
release limit for assay.

● The usual sample size for testing ranges between 0.5 and
1.5 g per sample assay.

Semisolids manufacturing consideration


1) Flow diagram
Combine water Combine oil soluble
soluble ingredient ingredient in main
Transfer water
in auxiliary kettle. kettle. Heat to critical
phase by pump
Heat to critical temperature. Counter
temperature sweep agitation

Homogenize or pass
Filling and Transfer finished thru colloid mill while
packaging product by pump warm.
operation into drum or tank Cool slowly with
counter sweep agitator
The Ointment Manufacturing Plants are ideal tools for the
production of Ointment, Cream, Lotions, Tooth Paste &
other emulsions & homogenizations.

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