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.
