FagronLab PRO, Руководство пользователя

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FagronLab™ PRO – User Manual | 21
Weighed portion of the formulation
5. Compounding guidelines for the technology
Preparing the FagronLab™ mixing unit
The FagronLab™ mixing unit consists of a FagronLab™ jar, a FagronLab™ stirrer and the components of the formulation to be
mixed.
First, the jar cap (small red screw cap) of the jar and then the jar lid (large red, white or coloured screw cap) must be unscrewed
from the jar.
Second, the stirrer is inserted into the jar housing and used to slide the jar bottom straight down. The jar lid is then slid onto the
stirrer standing in the jar housing and pressed down firmly using both thumbs. Ensure that the sealing lip of the jar lid opening is
not damaged by the bayonet noses, because the ointment may otherwise rise up the stirring shaft during the mixing process.
Third, the stirrer is carefully removed from the jar and the jar lid will be moved all the way in the direction of the blade. Both parts,
i. e. the stirrer and the jar lid are put down or possibly tare on the scale together with the jar.
After weighing out the formulation components into the jar, the lid including the stirrer has to be screwed on. Afterwards move
the lid with a slight twist, about a half centimeter, to open it a tad. By pushing the bottom up with the thumb or for large jars, with
help from an applicator, the spindle or AirDynamic the air will escape between the jar lid and the jar housing. This process is called
air diminution .
Air diminution will prevent ointment exudation at the sealing zones of the jar through reduction of any overpressure that may
have developed. The mixing result is also optimized since there is no trapped air.
Then the mixing unit should be closed by tightly screwing the jar lid down.
Generally, oily, greasy, aqueous and pulverized components can be weighed out into the jar all at the same time. However, it
is advantageous to consider certain general procedures to optimize the mixing results. Generally, know-how gained from the
traditional preparation of ointments is very helpful when using the mixing device. As already mentioned at the beginning of the
operating manual, true to the motto:
learning by doing
The mixing programs are general procedures used to produce the routine standard formulations in pharmaceutical preparation of
compounds.
In the following, these standard formulations will be defined and the recommended procedure on weighing described. This will
produce a code of practice for orientation. This does not exclude other possible methods for optimization.
For mixtures with high liquid content, ensure that the ointment foundation on the jar bottom is first carefully placed around the
sealing lip. This enhances the leak tightness of the jar. For jars of 200 ml and up an active substance proportion of less than 5 %, the
active ingredient can be filled alternating with the foundation ointment over two or more levels to speed up vertical intermixture.
Solid components should be inserted on the side of the jar and covered with foundation. This will prevent the solid materials to
adhere onto the stirrer.
FagronLab™ PRO