Gako Unguator e/s, Operating Instructions Manual

Page: 14 / 52

14
UNGUATOR
®
Mixing System
the problem of the unsightly contents in traditional porcelain vessels use previously.
Evaporation, the formation of crust, contamination and oxidation processes can thereby
be avoided to a great extent. Furthermore, the contents of the UNGUATOR
® Jar can
be moved close to the lid after spatula dispensing using the UNGUATOR ® Spindle or
the AirDynamic ® System.
The housing of the UNGUATOR
®
Jar sizes 300 to 1000 ml can be cleaned in a
dishwasher as long as it has not left the pharmacy. Sterility has to be ensured before
reuse though. The movable bottom of the UNGUATOR
®
Jar is not suitable for the
dishwasher and the sealing lip of the UNGUATOR
®
Jar Lid may be destroyed after
repeated mixing. The corresponding UNGUATOR
®
Jar Lids or jar bottoms can be
ordered in sets of five and used for the economical reuse of the housings.
The UNGUATOR
®
Jar is subject to periodic inspection in accordance with ZL packing
regulation DK II/94. A certificate of analysis is issued after batch-defined examinations.
The documentation of primary packaging materials at the pharmacy stipulates that
the manufacturer’s test certificate (certificate of analysis) after visual receiving inspection
be retained. This certificate is affixed to the plastic wrapping in which the UNGU-
ATOR
® Jars are packed. It may be removed from the plastic wrapping as needed and
added to the records.
1.3.3 UNGUATOR ® Varionozzles
The UNGUATOR
®
Varionozzles with inner diameters of 1, 2 or 4 mm can be pressed
into the dispensing opening of the UNGUATOR
®
jar lid. They reduce the opening size,
making it possible to safely dose even low-viscous formulations. The viscosity of the
finished product normally specifies the diameter of the UNGUATOR
® Varionozzles.
Fig. 1-8: Certificate of analysis for the 100 ml UNGUATOR
®
Jar
Certificate of Analysis
DISPOSABLE / DO NOT RINSE BEFORE USAGE
CH.No.*: 7202/05P00 NOMINAL-/ FILLING VOL.: 100/140 ml
PRODUCT No.: 340 SHIPPING UNIT: 500 units
PZN**: 0702570 : 10 units
Examined acc. to the central lab. packing regulations
Translucency
Date May 6, 2007
UNGUATOR - JAR
®
PACKING UNIT
signed: Grieser (head of quality assurance)
G-A-K-O Konietzko GmbH * 96049 Bamberg
: DK II/94
: confirmed
Particle Concentration :
Color Fastness :
confirmed
confirmed
Dichtigkeit : confirmed
Microbiology : confirmed
* ** Internal Registration No. Pharmaceutical Ref. No.