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"sudan red" worked in a semi-solid base. You can spread out the finished mixture on a glass
plate or a microscope slide and check the solids distribution and the grain particle size.
For a short-term statement about the solids distribution in the formula basis, you can test
in different levels of the UNGUATOR® Jars and examine these as described.
7.3 Potential sources of nonconformances
•
The UNGUATOR® jar bottom was not pressed fully down to the stop position prior
to weighing out or filling. First and foremost, it is not imperative to accommodate
specifically light constituents in an UNGUATOR® Jar of equal weight although the filling
volume is 40 % more than the rated volume. Please use the next largest UNGUATOR®
jar for the mixing.
•
The air was not removed before the mixing preocess of semisolid preparations from
the UNGUATOR® jar. Then the mixing blade centrifuges the ointment against the
UNGUATOR® Jar wall, forming an air column inside in which the UNGUATOR® MB
cannot clean itself and unmixed constituents may adhere to the UNGUATOR® MB.
•
The UNGUATOR® jar bottom has not been moved up. The penetrating UNGUATOR®
MB will generate an overpressure at high rate of speed that cannot be compensated
when the movable bottom yields. Thus the overpressure may cause mixed material,
mainly liquid constituents, to squeeze out of the seals on the threaded UNGUATOR®
jar lid, between UNGUATOR® Jar bottom and UNGUATOR® Jar body and along the
shaft of the UNGUATOR® MB [1].
•
The sealing lip on the UNGUATOR® jar bottom does not retain liquids during the
emulsifying process. Before starting the mixing process, particularly for large amounts
of liquids, the region round the sealing lip of the UNGUATOR® Jar bottom should be
carefully brushed with foundation so as to improve its sealing quality.
•
The sealing lip of the UNGUATOR® jar lid has been damaged by the shaft tappets of the
UNGUATOR® MB upon perforating the lid. This will cause ointment to creep up the shaft.
•
The UNGUATOR® Jar Lid is not tightened correctly and not held during the manually
guided stroke. This may cause the UNGUATOR® jar lid to unscrewed during the mixing
process, resulting in a large mess.
•
The user failed to remove air again or to mount a UNGUATOR® Varionozzle or
UNGUATOR® Applicator before dispensing. This will cause the user to first push the air
out of the opening and the ointment will follow in a gush [1].
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