gako unguator B/R User manual
Operang Instrucons and Producon Recomendaons
B/R
Dear UNGUATOR® user,
thank you for choosing the UNGUATOR® Mixing Technology,
a quality system
for advanced prescripon compounding.
Please read the operaons manual carefully.
For addional informaon about the use
and operaon of the
UNGUATOR® Mixing Technology,
please feel free to contact us at
contact@unguator.com
Table of content
1. Installaon informaon 1
2. Inial operaon 3
3. UNGUATOR® Technology 3
3.1 UNGUATOR® mixing machines 3
3.1.1 UNGUATOR® B/R 4
3.1.2 UNGUATOR® e/s 4
3.1.3 UNGUATOR® 2100 5
3.1.4 UNGUATOR® Q 5
3.2 UNGUATOR® Assortment 6
3.2.1 UNGUATOR® Mixing Blade (MB) 6
3.2.2 UNGUATOR® Jar 9
3.2.3 UNGUATOR® Varionozzles 12
3.2.4 UNGUATOR® Applicators 12
3.2.5 UNGUATOR® Spindle 13
3.2.6 UNGUATOR® Coupling 14
3.2.7 Air Dynamic® Pumpball System 14
4. General guidelines for the UNGUATOR® Technology 15
4.1 Preparing the UNGUATOR® Mixing System 15
4.2 Weighedporonoftheformulaon 15
4.3 Preparing the mixing process 16
4.4 The mixing process using the UNGUATOR® B/R 17
4.4.1 Emulsion 18
4.4.2 Emulsion + 18
4.4.3 Normal 19
4.4.4 Suspension <2% 19
4.4.5 Suspension >2% 20
4.4.6 Gel 20
4.4.7 Suppositories 21
4.4.8 Powder 21
4.5 Requirementsfortheingredientsofaprescripon 21
4.6 Aerthemixingprocessiscomplete 22
5. General notes for the UNGUATOR® Mixing System 24
5.1 PatentProtecon 24
5.2 Potenalsourcesofnonconformances 24
5.3 Qualityassuranceoftheointments 25
6. Service and warranty 25
6.1 Notesonmalfuncons 25
6.2 Manufacturer’sServiceandwarranty 26
6.3 Notes on maintenance 26
6.4 Notesonsafety 27
6.5 TechnicaldataoftheUNGUATOR®B/R 28
6.6 Quality and material 28
7. Manufacture’s cercate 30
8. References 29
9. Bibliography 31
10. Distribuon, manufacturing and customer service 32
Index of tables
Tab.1.Qualityimprovementwithincreasingautomaon 4
Tab.2.Minimumvaluesformixingmeatspeedlevel9inmin:sec 17
Tab.3.Minimumvaluesformixingmeatspeedlevel5inmin:sec 18
Index of pictures
Pic.1UNGUATOR®B/Rdescripon 2
Pic. 2 UNGUATOR® B/R 4
Pic. 3 UNGUATOR® e/s 4
Pic. 4 UNGUATOR® 2100 5
Pic. 5 UNGUATOR® Q 5
Pic. 6 UNGUATOR® Standard mixing blade (SMB) 6
Pic. 7 UNGUATOR® disposable blade 7
Pic. 8 Handling the UNGUATOR® disp. blade 7
Pic.9AssignmentoftheUNGUATOR®SMBwithdierentlengthofsha 8
Pic. 10 UNGUATOR® Jars 9
Pic.11CercateofanalysisfortheUNGUATOR®Jar50ml 10
Pic.12DispensingwithregularUNGUATOR®varionozzle 11
Pic.13DispensingwithUNGUATOR®1mmvarionozzlesorUNGUATOR®
applicator short 11
Pic. 14 Dispensing with UNGUATOR® 2mm Varionozzles or UNGUATOR®
applicator long 11
Pic.15DispensingwithUNGUATOR®varionozzles4mm 11
Pic.16UNGUATOR®varionozzles,1,2,4mm. 12
Pic. 17 UNGUATOR® Applicator short 12
Pic. 18 UNGUATOR® Applicator long 12
Pic. 19 UNGUATOR® Spindle 13
Pic. 20 How to operate the UNGUATOR® Spindle 13
Pic. 21 UNGUATOR® Coupling 14
Pic. 22 UNGUATOR® AirDynamic® Pumpballsystem 14
1
1. Installaon informaon
Select a suitable locaon for the UNGUATOR® B/R
CAUTION! The UNGUATOR® B/R weighs almost 15 lbs (6,8 kg). It is recommended to have
an assistant while carrying and moving the equipment to the nal desnaon.
Ensure that there is enough space to operate the UNGUATOR® B/R. This must include
sucient space around the UNGUATOR® B/R to provide good venlaon.
Select a suitable environment:
• Solid, horizontal surface
• Away from direct air ow from air condioning systems, heaters, open windows or fans.
• Keep the temperature between 15°- 30° C (59°- 86°F) and maximum humidity of 80%.
• Clean, dry and dust-free.
Remove all components from the cardboard box. Check to ensure that the following
components are included in your shipment:
• UNGUATOR® B/R mixing device
• Power cable
• Operang instrucons
Please contact your responsible UNGUATOR® dealer and/or supplier immediately in case
that components are missing or arrived damaged. Aerwards, we will not accept any
claims regarding missing or defect items, they will be for your account!
Please hold on to the original cardboard box and packing material in case you have to send
the UNGUATOR® device in for service.
Fig. 1: UNGUATOR® B/R descripon
UNGUATOR B/R
2
Speed controller
Drive head
Power cord
2. Inial operaon
You will nd the power switch “O/I” located at the rear of the UNGUATOR® B/R on its
base. This is also the emergency switch. Please check that the UNGUATOR® B/R power
switch is set to o. Connect the power cord to the socket outlet. You may now switch
the UNGUATOR® B/R on using the power switch. The device is now ready for operaon.
3. UNGUATOR® Technology
The UNGUATOR® Technology reduces the mechanical preparaon of formulaon ointments
to the least common denominator. The core of UNGUATOR® Technology consists of
the patented arrangement of the UNGUATOR® Mixing Blade adapted to the
requirements of prescripon ointments and the UNGUATOR® Jar that serves as both
a hygienic mixing jar and a hygienic dispensing jar.
The principle of the preparaon method using UNGUATOR® Technology in the closed
UNGUATOR® Mixing System is quick and easy to learn, true to the moo:
learning by doing
A lile experience will make it easy to prepare ointments though they may seem
rather complicated at rst. Using the UNGUATOR® Technology enables the pharmacy
to beer prepare prescripon ointments in a shorter period of me compared to
the convenonal methods that were used prior to the invenon (1994). For the
rst me, it is possible to not only standardize ointments, but validate them too.
3.1 UNGUATOR® mixing machines
The current UNGUATOR® mixing machines - the UNGUATOR® B/R, the UNGUATOR® e/s,
the UNGUATOR® 2100 and the UNGUATOR Q - are useful and advanced improvements on
the rst UNGUATOR® from 1994. They are designed for a working capacity of approx. 500
work hours wich corresponds to approximately 15,000 to 20,000 preparaons.
The UNGUATOR® mixing machines feature a high safety standard and were tested by
TÜV-Rheinland, Germany for safety. The devices are manufactured under license and
maintained by dened service partners.
Product quality, product uniformity and reproducibility of ointments prepared individually
and in batches were improved with the increasing automaon of the UNGUATOR® units
starng with the individual model B/R- through the e/s-, Q- and 2100 models.
3
4
Method of
ointment
preparaon
Pharmaceucal
QUality
Uniformity of oint-
ment
Liing arm Mixing parameters
Bowl and pestle ++ +(-) manual
UNGUATOR® B/R +++ ++ manual manually
adjustable
UNGUATOR® e/s +++ +++ automac individually
programmable
UNGUATOR® Q ++++ ++++ automac fully automac
UNGUATOR® 2100 ++++ ++++ automac fully automac
3.1.1 UNGUATOR® B/R
The UNGUATOR® B/R is the basic machine with controlled
mixing motor and manual jar guidance.
3.1.2 UNGUATOR® e/s
The UNGUATOR® e/s machine was developed for ecient individual and batch preparaons.
The automated stroke enables the user to leave the UNGUATOR® e/s during the mixing
process to serve a customer for instance or to prepare the next formulaon at the same
me.
The precisely set sensor for the automac oscillaon arm will
always ascertain at each upward or downward stroke the exact
posion of the UNGUATOR® Jar boom or lid. This guarantees
that the UNGUATOR® Jar is always accessible to the UNGUATOR®
Mixing Blade despite the inevitable vercal moon during the
mixing process. If the stroke length of the rst stroke was taken
as a constant value, then the acve ingredient weighed out in the
lower region of the UNGUATOR® Jar might not be included in the
mixing process by the UNGUATOR® Mixing Blade, geng „lost“
at the boom. The liing technique of the UNGUATOR® Mixing
System prevents this from happening, so that the result of the
mixing process is not just a homogeneous ointment, but also one
with the desired rao of acve ingredients.
Tab.1: Quality improvement with increasing automaon
Pic. 2: UNGUATOR® B/R
Pic. 3: UNGUATOR® e/s
5
3.1.3 UNGUATOR® 2100
The UNGUATOR® 2100 shows all the advantages of its
predecessors and can therefore automacally control the
mixing parameters for each UNGUATOR® Jar size and dierent
types of ointments. The user may program individual mixing
parameters with a maximum of 180 addional programs that
can be stored. The UNGUATOR® 2100 can be connected to a
PC via an USB interface.
An integrated microprocessor measures the actual revoluons
of the UNGUATOR® Mixing Blade carried out by the UNGUATOR®
2100. This guarantees that the selected mixing program will
always be idencal, even for paste-like preparaons which usually might demand more
power from the mixing motor. This makes it easy to develop new ointments, cosmecs,
etc. using the UNGUATOR® 2100, since only the composion changes and not the mixing
program. As a result, ointments can now nally be reliably reproduced even in smaller
quanes.
The adjustable stroke speed, or the speed of the upward or downward moon of the
automated oscillaon arm, is another unique feature of the UNGUATOR® 2100. This allows
the UNGUATOR® Mixing Blade to rotate at lower speed while the UNGUATOR® Jar quickly
travels up and down, or vice versa. This new funcon is parcularly useful using a low
rotang speed of the UNGUATOR® Mixing Blade since it allows the UNGUATOR® Mixing
Blade to mix an ointment homogeneously with a slow stroke.
3.1.4 UNGUATOR® Q
The UNGUATOR Q is the result of connuous improvement of
the UNGUATOR® e/s from the year 2003.
It combines both the mixing funcons of the UNGUATOR® e/s
and the operang concept of the UNGUATOR® 2100. The basic
funconality of the e/s - System, with the seng parameters of
the mixing rotaon speed and me are retained. A signicant
innovaon of the UNGUATOR® Q is the possibility of scaling
one mixing program already created automacally to another
jar size. This enables a constant quality of the formulaons
and as a consequence, has a tremendous me saving result,
since recalculaon can be very me consuming and complex.
Pic. 4: UNGUATOR® 2100
Pic. 5: UNGUATOR® Q
3.2 UNGUATOR® Assortment
Appart from the UNGUATOR® Standard Mixing Blade (SMB), the UNGUATOR® Disposable
Blade (Disp. Blade) and the UNGUATOR® Jars, the UNGUATOR® Assortment provides
addional and useful components. These include dosing aids such as the UNGUATOR®
Varionozzles and UNGUATOR® Applicators, removal or transfer aids such as the
UNGUATOR® Spindle, the UNGUATOR® Coupling and the patented AirDynamic® Pumpball
System. All UNGUATOR® products are compable with all UNGUATOR® Mixing devices.
3.2.1 UNGUATOR® Mixing blade (MB)
The UNGUATOR® Standard Mixing Blade and the UNGUATOR® Disposable Blade are
designated as UNGUATOR® MBs. The UNGUATOR® MBs are steadily guided up and down
inside the UNGUATOR® Jar. Their special design results in a ght contact between the
mixing blade and the inside wall of the UNGUATOR® Jar, which serves, primarily, for
comminung the substances during the mixing process. Addionally forced mixing in
the whole mixing unit is achieved through the shape and vibraon of substances while
preparing the ointment.
The lubricang eect of the ointment and substances generally protects the UNGUATOR®
Jars and the UNGUATOR® MB against abrasion. Discoloraons of the mixing blade are
mostly irreversible and therefore harmless. All UNGUATOR® MBs are dishwasher safe.
UNGUATOR® Standard mixing blade (SMB)
UNGUATOR® SMBs are adjusted to the size of each
individual UNGUATOR® Jar. While the UNGUATOR®
SMBs for 100 and 200 ml and for the 300 and 500 ml
jars have the same mixing blade diameter, their sha
length diers. This must be taken into consideraon,
parculary when using the UNGUATOR® e/s and the
UNGUATOR® 2100, since the use of the wrong lenght
may cause problems with the automated stroke.
Always make sure the UNGUATOR® MB used is the right lenght, and that it is clean prior
use. (e.g. with isopropanol 70%).
The UNGUATOR® SMB is suitable for the producon of all recipes. For suspension
ointments and glass cleaning operaons, we recommend the use of the UNGUATOR®
Disp. Blade.
6
Pic. 6: UNGUATOR® SMB
7
UNGUATOR® Disposable blade (Disp. blade)
The UNGUATOR® Disp. Blade is suitable for all UNGUATOR® devices. The mixing blade of
UNGUATOR® Disp. Blade is connected to the UNGUATOR® Disp. Blade sha by twisng
the blade counterclockwise and can be disconnected aer the mixing process with a
clockwise turn.
The material contact in the ointment is three mes as high as when using the Disp. Blade
compared to the UNGUATOR® SMB at the same mixing speed. The counter rotang twist
of the mixing blades causes intensive material vibraon in the material to be mixed and
achieves good product quality faster than using the UNGUATOR® SMB. We do however
recommend using the same mixing me as for the UNGUATOR® SMB.
In the process of nal quality control
the mixing blade can be picked up and
discarded with the small end of the
sha, or le inside the jar. Cleaning
is limited to the UNGUATOR® Disp.
Blade sha. We recommend using the
UNGUATOR® Disp. Blade for substances
that may discolor the regular blade. This
type of UNGUATOR® MB also comes
with dierent sha lengths. The range
of UNGUATOR® Jar sizes that can be
used for the applicaon is marked for
orientaon on the weak end of the sha.
(15-100 ml and 200 ml respecvely)
Assignment of the UNGUATOR® MB
Please make sure to use the correct UNGUATOR® MBs for the corresponding UNGUATOR®
Jar (Fig. 6). Mixing up may cause failure messages.
Please also ensure that the right sha is used with the
UNGUATOR® Disp. Blade. Both available shas are marked for
use with sizes 15–100 ml or 200 ml UNGUATOR® Jar. They have
to be combined with the correct UNGUATOR® Disp. Blade, and
while the same UNGUATOR® Disp. Blade is used for the 100 and
200 ml UNGUATOR® Jar sizes, it sll needs a dierent sha for
each jar size. Please also mind the operang instrucons that
come with the shas.
Fig. 7: UNGUATOR® Disposable Blade (HD)
Pic. 8: Handling the
UNGUATOR® Disp. Blade
8
Flowing recesses of the UNGUATOR® SMB
The ow-adapted shape of the UNGUATOR® SMB generally cleans itself during the rotang
penetraon of the ointment. Unmixed ingredients may adhere to recesses of ow of the
UNGUATOR® SMB depending on the ointment’s ingredient’s compability sequence of
weighted sample but also if the UNGUATOR® Jar is considerably underlled (e.g. large
volumes of powder). These remnants should be transferred into the UNGUATOR® Jar using
a spatula when about half of the mixing me is complete. The air should be decreased
again following this process. When using the UNGUATOR ® Disp. Blade, however, there are
no recesses and no remedial work is required.
Heang
The heat that develops from the fricon between the UNGUATOR® MB and the inside
wall of the UNGUATOR® Jar is required. Decreased viscosity increases the weability
of powders and accelerates the penetraon of potenal powder pockets. Even the
emulsifying readiness of fats and oils is beneted by heat. A temperature of 54 °C/129
°F was the maximum taken aer 6 minutes of mixing a highly pasty preparaon made of
vaseline and zinc oxide aa at full speed. This temperature increase is generally safe for the
substances used in the pharmaceucal eld. Ointments of low viscosity only heat slightly
[2]. Volale substances such as ethereal oils or alcohol do not evaporate from the closed
UNGUATOR® Mixing System.
Pic. 9: Assignment of the UNGUATOR® SMB with dierent length of shas
9
Cleaning the UNGUATOR® MB
The UNGUATOR® MB is normally cleaned with a paper towel and, if necessary, held under a
hot water jet and then dried with dispensing pulp. UNGUATOR® MBs can also be cleaned in
a convenonal dishwasher.
All the UNGUATOR® devices as well as UNGUATOR® line of products must not be treated
with sharp-edged objects or abrasive cleaning agents.
3.2.2 UNGUATOR® Jar
The UNGUATOR® Jar is both the mixing and dispensing jar and is therefore designed as
an expendable or disposable jar. The UNGUATOR® Jar guarantees evaporaon and
contaminaon-free preparaon in an air-reduced mixing space. The UNGUATOR® Jar Lid
closes the UNGUATOR® Jar to ensure no loss of acve ingredients.
Used as a dispensing jar, the UNGUATOR® Jar corresponds to the guidelines for quality
assurance from the German Chamber of Pharmacists (Apothekenkammer) [11]. With its small
dispensing opening, comparable to a tube and without an environmental contaminaon
surface, the UNGUATOR® Jar guarantees the minimizaon of negave quality interference
demanded by secon 13, ApBetrO (Pharmacist Operang regulaons); including those
caused by germs on the ngers when dispensing the ointment. Consequently, the user can
extract the ointment from the UNGUATOR® Jar very hygienically.
The UNGUATOR® Jar is resistant to hot-water baths and microwaves with temperatures
below 85 °C/185 °F. Higher temperatures may alter the ghtness of the UNGUATOR® Jar
and the displaceability of the boom (“push-up” process might be negavely impacted).
The UNGUATOR® material becomes brile at temperatures below 0 °C/32 °F. UNGUATOR®
Jars are available in the following sizes: 15/28 ml, 20/33 ml, 30/42 ml, 50/70 ml, 100/140
ml, 200/280 ml, 300/390 ml, 500/600 ml and 1000/1250 ml (rated volume/lling volume).
The standard color for the UNGUATOR® Jar body is white with
red lid. The 300 ml, 500 ml and 1000 ml UNGUATOR® Jars come
with white lids. In addion, jar sizes 20 ml to 200 ml are also
available in pastel colors pink, light yellow, light blue and turquoise.
Furthermore, UNGUATOR® Jars from 20 to 200 ml are available
with special color lids, green, blue and white. Upon special demand
and dened quanty, UNGUATOR® Jars from 20 to 200ml may also
be ordered in customized colors.
All UNGUATOR® Jars come sealed in plasc packaging. Cleaning o Pic. 10: UNGUIATOR® Jar
10
Pic. 11: Cercate of Analysis for the UNGUATOR® jar of 50 ml
disinfecon prior usage could put the cered asepsis at risk. We would recommend storing
the UNGUATOR® Jars in its plasc packaging aer opening for protecon against possible
dust contaminaon.
The UNGUATOR® Jar sizes 300 to 1000 ml are parcularly well suited as storage and transfer
vessels for semisolids and other preparaons. Since the contents dispensed using the
movable jar boom are always close to the lid, The UNGUATOR® Jar solves the problem
of the unsightly contents in tradional porcelain vessels used previously. Evaporaon,
formaon of crust, contaminaon and oxidaon processes can thereby be avoided to a great
extent. Furthermore, the contents of the UNGUATOR® Jar can be moved close to the lid aer
spatula dispensing using the UNGUATOR® Spindle or the AirDynamic® Pumpball System.
Analysenzerkat / Cercate 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
Geprü nach ZL-Verp.-Vorschri: DK II/94
Examined acc. to central lab. pack. regul.: DK II/94
Lichtdurchlässigkeit / Opaqueness :OK
Parkelgehalt / Parcle Concentraon :OK
Farbbeständigkeit / Color Fastness : OK
Dichgkeit / 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 le the pharmacy. Asepsis has to be ensured before reuse though. The
movable boom of the UNGUATOR® Jar is not suitable for the dishwasher and the sealing
lip of the UNGUATOR® Jar Lid may be destroyed aer repeated mixing. The corresponding
UNGUATOR® Jar Lids or jar booms can be ordered in sets of ve and used for the economical
reuse of the body.
The UNGUATOR® Jar is subject to periodic inspecons in accordance to the German ZL
packing regulaon DK II/94.All plasc materials, which come into contact with food are
made with the legal requirements of the EU plasc regulaon N° 10/2011 and N° 1935/2004
as of January 2013.
A cercate of analysis is issued aer batch-dened examinaons. The documentaon
of primary packaging materials at the pharmacy spulates that the manufacturer’s test
cercate (cercate of analysis) is retained aer receiving visual inspecon. This cercate
is axed to the plasc packaging of the UNGUATOR® Jars. It may be removed from the
plasc packaging as needed and added to the records.
11
Notes on dispensing ointment
Each customer should be given specic instrucons at how to apply the UNGUATOR®
Jars when handing to the individual client. The use of the UNGUATOR® Spindle should be
explained for large UNGUATOR® Jars. Low viscosity ointments should be equipped with an
UNGUATOR® Applicator or an UNGUATOR® Varionozzle to reduce the dispensed volume.
Medium viscosity ointments can easily be extracted through the regular opening of the
UNGUATOR® Jar. Very pasty ointments (e.g. pasta zinc) may not necessarely be pressed
through the regular opening, even by using a spindle.
In this case, once the UNGUATOR® Jar lid has been removed, the ointment can be extracted
with the help of a spatula, similar to handling convenonal jars with a regular lid. If the
UNGUATOR® Jar Lid has been removed, the ointment should be pushed up close to the lid
aer each dispensing process, using the UNGUATOR® Spindle or the AirDynamic® System.
The diameter of the dispensing nozzle allows simple dosing of the quanty of ointment
to be applied using approximate values. The regular dispensing nozzle in the screw lid of
each UNGUATOR® Jar has a diameter of 8mm. The varionozzles or applicators reduce the
diameter to 4, 2 or 1 mm. The approximate values represented in the following diagrams
may also be helpful to weight out concentrated acve substances or regular trituraon
from the UNGUATOR® Jar.
Pic. 12: Dispensing with regular
UNGUATOR® Jar Nozzle
Pic. 13: Dispensing with UNGUATOR® 1mm
varionozzles or UNGUATOR® applicator short
Pic. 14: Dispensing with UNGUATOR® 2mm
ovarionozzle or UNGUATOR® applicator long
Pic. 15: Dispensing with UNGUATOR®
varionozzles 4mm
Lenght of ointment rope in cm
Lenght of ointment rope in cm
Lenght of ointment rope in cm
Lenght of ointment rope in cm
Quantity of ointment in ml
Quantity of ointment in ml
Quantity of ointment in ml
Quantity of ointment in ml
12
3.2.3 UNGUATOR® Varionozzles
The UNGUATOR® Varionozzles with inner diameters of 1,
2 or 4 mm can be pressed into the regular nozzle of any
UNGUATOR® jar. They reduce the opening size, making
it possible to safely dose even low formulaons. The
viscosity of the nished product normally species the
diameter of the UNGUATOR® Varionozzles. The soly
rounded surface allows ointment to be pleasantly
spread directly on your skin.
The coloring was selected corresponding to the wavelength of light:
• 4 mm: red (long-wavelength light)
• 2 mm: yellow
• 1 mm: blue (short-wavelength light)
3.2.4 UNGUATOR® Applicators
The UNGUATOR® Applicators reduce the extracted quanty of low-viscosity formulaons
and are parcularly helpful in cases where the ointment must be precisely applied.
UNGUATOR® Applicator short
The UNGUATOR® Applicator short with a diameter of 1mm is
obligatory for nose and ear ointments. The UNGUATOR® Applicator
short comes with a cap to close the applicator
UNGUATOR® Applicator long
The UNGUATOR® Applicator long with a diameter of 2 mm allows
formulaons to be introduced into large orices of the body or probes.
Moreover, the UNGUATOR® Applicator long also comes inside each
UNGUATOR® 200 ml. Jar to help pushing up the boom of this jar size
in full. The UNGUATOR® Applicator long is generally available both
with and without cap.
Pic. 16: UNGUATOR® Varionozzles
1, 2, 4 mm
Pic. 18: Applicator
UNGUATOR® long
Fig. 17: Applicator
UNGUATOR® short
13
3.2.5 UNGUATOR® Spindle
The UNGUATOR® Spindle serves as a dispensing system for UNGUATOR® jar sizes 300
ml or 500 ml UNGUATOR® Jars that come with UNGUATOR® Spindles. The spindle has
to be removed by rotang it clockwise prior the mixing process. The boom can be slid
up and down when the UNGUATOR® Spindle is screwed slightly (1/2 to max. 1 turn)
counterclockwise without perforang the movable boom (a slight resistance can be felt
before the boom is perforated).
Air can be decreased by placing the UNGUATOR® Jar onto the table and using both hands
pushing the jar against the table.
Before giving the UNGUATOR® Jar to the customer, the UNGUATOR® Spindle must be
screwed in the UNGUATOR® Jar counter clockwise from the boom ll it locks into place.
The UNGUATOR® Spindle must be turned clockwise to extract the ointment. To remove
the ointment the UNGUATOR® Spindle must be twisted to the right. One turn dispenses
approx. 20 ml of the contents of the UNGUATOR® Jar.
Cauon! If the movable boom is accidentally perforated or the spindle is permanently
locked in the boom of the jar, the UNGUATOR® Jar may only serve as dispensing or storage
vessel and can no longer be used for the mixing process.
Pic. 19: How to operate the UNGUATOR® Spindle Pic. 20: UNGUATOR® Spindle
14
3.2.6 UNGUATOR® Coupling
The UNGUATOR® Coupling connects two UNGUATOR® Jars by the
threads of their dispensing openings and is very useful when preparing
ointments in larger batches. Transferring a formulaon from a larger
UNGUATOR® Jar into a smaller UNGUATOR® Jar using the UNGUATOR®
Coupling will ensure hygiene from the mixing process to the end user.
The 200 ml UNGUATOR® Jar becomes a convenient transfer device
to smaller UNGUATOR® Jars when their UNGUATOR® Jar booms are
carefully pressed towards the work surface using an UNGUATOR®
Applicator (long) screwed on a 30 ml UNGUATOR® Jar.
In addion to the UNGUATOR® Coupling, required for transferring from a 300 ml or 500 ml
UNGUATOR ® Jar into a smaller UNGUATOR® Jar, both the UNGUATOR® spindle and the
AirDynamic® Pumpball System may also be used. Dispensing and transferring a formulaon
via the regular UNGUATOR® Jar nozzle from a 1000 ml UNGUATOR® Jar is praccally only
possible using the AirDynamic® Pumpball System.
We recommend transferring the formulaon aer mixing as soon as possible, since the
formulaon is sll warm and less viscous.
3.2.7 Air Dynamic® Pumpball System
The AirDynamic® Pumball System opmizes batch
preparaon within the closed system:
• Contaminaon-free transfer
• Contaminaon-free storage
The AirDynamic® Pumball System has been designed to
apply with UNGUATOR® Jars from size 300 ml to 1000 ml
to extract mixtures. An adapter connected to a pumpball
is axed to the center hole on the body’s boom of the
UNGUATOR® Jar with an air-ght connecon.
Pic. 21: UNGUATOR®
Coupling
Fig. 22: UNGUATOR® AirDynamic®
Pumpball system
15
By pumping air into the lower chamber of the UNGUATOR® Jar using the pumball, the
pressure thus generated moves the boom upward. Thanks to the AirDynamic® Pumball
System, even thick pastes can be dispensed via the small dispensing opening in the screw
cap or transferred to small UNGUATOR® Jars using the
4. General Guidelines for the UNGUATOR® Technology
4.1 Preparing the UNGUATOR® Mixing System
The UNGUATOR® Mixing System consists of an UNGUATOR® Jar, an UNGUATOR® MB and
the components of the formulaon to be mixed.
First, the UNGUATOR® jar cap (small white screw cap) of the UNGUATOR® Jar and then
the UNGUATOR® Jar lid (large red or white screw cap) must be unscrewed from the
UNGUATOR® Jar.
Second, the UNGUATOR® MB is inserted into the UNGUATOR® Jar housing, sliding the
UNGUATOR® Jar down. The UNGUATOR® Jar lid is then slid onto the UNGUATOR® MB
standing in the UNGUATOR® Jar housing and pressed down rmly using both thumbs.
Ensure that the sealing lip of the UNGUATOR® Jar lid opening is not damaged by the
bayonet noses because the ointment may otherwise rise on the UNGUATOR® MB sha
during the mixing process.
Third, the UNGUATOR® MB is carefully removed from the UNGUATOR® Jar and the
UNGUATOR® Jar lid will be moved all the way in the direcon of the Blade. Both parts, i.
e. the UNGUATOR® MB and the UNGUATOR® Jar lid are put down or possibly tarde on the
balance together with the UNGUATOR® Jar.
4.2 Weighed poron of the formulaon
Generally, oily, greasy, aqueous and pulverized ingredients can be weighed out into the
UNGUATOR® Jar all at the same me. It is however advantageous to consider certain
general procedures to opmize the mixing results. Generally, know-how gained from the
tradional preparaon of ointments is very helpful when using the UNGUATOR® Mixing
System. As already menoned at the beginning of the operang instrucons, true to the
moo:
learning by doing
16
Listed below are the seven dierent general procedures used to produce the roune
standard formulaons in pharmaceucal preparaon of ointments: EMULSION, EMULSION
+, NORMAL, SUSPENSION<2%, SUSPENSION>2% as well as GEL and SUPPOSITORIES. Due
to the rapid heat generaon, powder mixtures should be processed only at very low speed.
In the following, these standard formulaons will be dened and the recommended
procedure on weighing described. This will produce a code of pracce for orientaon. This
does not exclude other possible methods for opmizaon.
For mixtures with high liquid content, ensure that the ointment base on the UNGUATOR®
Jar Boom is rst carefully placed around the sealing lip. This enhances the leak ghtness
of the UNGUATOR® Jar when it is lled. For UNGUATOR® Jars of 200 ml and up an acve
ingredient proporon of less than 5 %, of the acve ingredient can be lled alternang
with the foundaon ointment over two or more levels to speed up vercal intermixture.
4.3 Preparing the mixing process
Together with the UNGUATOR® Jar Lid, the UNGUATOR® MB should be loosely screwed
onto the UNGUATOR® Jar body aer the components of the formulaon have been
weighed out. By pushing up the UNGUATOR® Jar boom with your thumb or, for large
UNGUATOR® Jars, with the help of the UNGUATOR® Spindle or the AirDynamic® Pumpball
System, the air will escape between the UNGUATOR® Jar Lid and the UNGUATOR® Jar body.
Then the UNGUATOR® Mixing System should be ghtly screwed down. This process is
called air diminuaon.
Air diminuon will prevent ointment exudaon at the sealing zones of the UNGUATOR®
Jar through reducon of any overpressure that may have developed. The mixing result
is also opmized since there is no trapped air. We recommend, mainly in the case of
intermingling large quanes of powder, that air diminuaon be repeated aer 15 seconds
of the mixing process.
When pregrinding by pasng the solids with ointment base in the UNGUATOR® Jar,
we recommend posioning the movable UNGUATOR® Jar Boom as far downward as
possible. This will guarantee that the large surface area of the inside wall of the
UNGUATOR® Jar also including the lid and boom can be used for dispersion between
the fricon surfaces of the UNGUATOR® MB and the inside surface area of the
UNGUATOR® Jar body. Consequently, no air diminuaon need be carried out prior
pegrinding.
At this point of the mixing process, device-specic sengs will need to be implemented
and the UNGUATOR® Mixing System connected to the UNGUATOR®.
This manual suits for next models
3
Table of contents
