10
Pic. 11: Certificate of Analysis for the UNGUATOR® jar of 50 ml
disinfection prior usage
could put the certified asepsis at risk. We would recommend storing
the UNGUATOR® Jars in its plastic packaging after opening for protection against possible
dust contamination.
The UNGUATOR® Jar sizes 300 to 1000 ml are particularly well suited as storage and transfer
vessels for semisolids and other preparations. Since the contents dispensed using the
movable jar bottom are always close to the lid, The UNGUATOR® Jar solves the problem
of the unsightly contents in traditional porcelain vessels used previously. Evaporation,
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® Pumpball System.
Analysenzertifikat / Certificate of Analysis Dat. 01.03.2012
UNGUATOR® Kruke / Jar
EINWEGEFÄSS VOR GEBRAUCH NICHT SPÜLEN
DISPOSABLE / DO NOT RINSE BEFORE USAGE
NENN- / FÜLL- / NOMINAL- / FILLING -VOL.: 50/70 ml
PZN: 0471975 * INHALT / PACKING UNIT:10 ST / pcs
ART. / PROD.-NR.: 808 CHARGE: 1234/56P78
Geprüft nach ZL-Verp.-Vorschrift: DK II/94
Examined acc. to central lab. pack. regul.: DK II/94
Lichtdurchlässigkeit / Opaqueness :OK
Partikelgehalt / Particle Concentration :OK
Farbbeständigkeit / Color Fastness : OK
Dichtigkeit / Seal Integrity :OK
Mikrobiologie / Microbiology :OK
gez/signed: Grieser (head of quality assurance)
GAKO® * www.unguator.com
The body of the UNGUATOR® Jar sizes 300 to 1000 ml can be cleaned in a dishwasher as
long as it has not left the pharmacy. Asepsis 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 body.
The UNGUATOR® Jar is subject to periodic inspections in accordance to the German ZL
packing regulation DK II/94.All plastic materials, which come into contact with food are
made with the legal requirements of the EU plastic regulation N° 10/2011 and N° 1935/2004
as of January 2013.
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) is retained after receiving visual inspection. This certificate
is affixed to the plastic packaging of the UNGUATOR® Jars. It may be removed from the
plastic packaging as needed and added to the records.
