Gako Unguator e/s, Operating Instructions Manual

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General notes on the UNGUATOR
®
Mixing System
4 General Notes on the UNGUATOR
®
Mixing System
In its quality guideline for the production of semisolid preparations, the German
Chamber of Pharmacists has recommended a closed system and delivery in dispensing
containers with small dispensing opening since the year 2000.
4.1 References
The advantages of the UNGUATOR ® Mixing System vs. traditional production methods
with a mortar and pestle have been described in the literature several times:
• GMP-compatible ointment formulation possible in pharmacies [2], [4].
• Ointment formulation can be standardized [4], [8].
• Better homogeneity [2], [4], [9].
• Improved microbiology [3], [8].
• Risk of contamination strongly reduced during production: Hygienic production
in a closed system, no transfer into a separate dispensing jar [2], [3], [4], [8].
• Hygienic product extraction, low risk of contamination through the user [2],
[3], [4], [8].
• Improved product quality in improved packaging guaranteed extended product
durability [3], [4].
4.2 Notes on the Mixing Process
This subchapter serves to clarify frequently asked questions and clear up possible
misunderstandings. Adhering to the following tips will help eliminate possible error
sources quickly and efficiently.
4.2.1 Assignment of the UNGUATOR
®
MB
Please take care to use the correct UNGUATOR
®
MBs for the corresponding
UNGUATOR
®
Jar (cf. Fig. 4-1). Mix-up may trigger fault messages with UNGUATOR
®
devices with a semiautomatic stroke feature.
Please take care to ensure that the right shaft is used with the UNGUATOR
®
Disp.
Blade. Both shafts available are marked for use with sizes 15–100 ml or 200 ml in the
UNGUATOR
®
Jar. They have to be combined with the correct UNGUATOR
®
Disp. Blade,