gako unguator EMP User manual


160419_EMP_QuickStart_en
Quick - Start
How to register your gako unguator EMP device
• Go to unguator.com/reg
• Enter the 12 digit serial number
• Enter the four digit unlock PIN on your device
--> review chapter 3
Display handling
• Touch panel with minus button (left)
gako button (middle)
plus button (right)
• start display shows jar size, mixing time and mixing speed
• After pushing the gako button for two seconds the lift arm
moves automatically into the mounting postition
--> review chapter 3
Lift arm with integrated quick-lock coupling
• Hold the gako logo on top of the jar to the front; insert the mixing shaft directly from the
front into the lift arm
• Insert the mixing unit from below
• Fix the jar with a slight turn counterclockwise (about a quarter turn) into the lift arm and
push the gako button
--> review chapter 4

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Dear gako unguator user,
thank you for choosing the Unguator Technology. You purchased
a quality system for advanced pharmaceutical compounding.
Please read the following operation manual carefully.
For more information and compounding recommendation consult
our homepage
www.unguator.com
For additional support, operation handling and all other questions regarding
the Unguator Technology
please feel free to contact us by
E-Mail: [e-mail]
Enjoy the successful production of quality assured compounding ointments.
Your
gako competence center

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Table of content
Installation Information / Initial Operation
The Unguator Technology - Competence from the start
gako unguator Mixing Devices
gako unguator Assortment
Display Handling
Initial Operation
Compounding with the gako unguator BASIC
Aborting the mixing process
Compounding guidelines for the Unguator Technology
Preparing the gako unguator Mixing Unit
Weighed Portion of the Formulation
The Mixing Process
Mixing Parameters
Requirements for Components of a Formulation
After the Mixing Process is Complete
General Notes on the gako unguator Mixing System
Patent Protection
Identication Number ID
Error codes
Operation Errors
Cleaning the gako unguator BASIC
Service and Warranty
Notes on Malfunctions
Manufacturer’s Service and Warranty in Germany
Notes on Safety
Technical Data of the gako unguator BASIC
Distribution, Manufacturing an Customer Service
Warranty Certicate
Documents
Manufacturer´s Certicate
Installation Qualication IQ
Operation Qualication OQ

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Index of Pictures
Installation Information / Initial Operation
gako unguator EMP front
gako unguator EMP rear
The Unguator Technology - Competence from the start
gako unguator BASIC / EMP
gako unguator PRO
gako unguator Standard Mixing Blade
gako unguator Disposable Blade
gako unguator Disposable Blade Shaft
gako unguator Jars
AirDynamic / Spindle
Certicate of analysis gako unguator jar
jar label gako unguator jar
gako unguator Varionozzles
gako unguator Applicator short
gako unguator Applicator long
Operation instruction Spindle
gako unguator Spindle
gako unguator Coupling
gako unguator AirDynamic
gako unguator ExactDose
Display Handling
Display gako unguator EMP
Display device type
Display current preparations
Display Registration
Display PIN
Display Wrong PIN
Display IQ-Mode
Display contact
Display start screen
Display OQ-Mode
Display maintenance
Display initializing
Display start?
Display free spin?

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Compounding guidelines for the Unguator Technology
quick-lock Coupling
praparation free spin
General Notes on the gako unguator Mixing System
Display ID
quick-lock Coupling
Index of Tables
The Unguator Technology - Competence from the start
quality improvements with increasing automation
Compounding guidelines for the Unguator Technology
value chart rotation speed
mixing parameter pre-grinding
mixing parameter Suspension < 2 %
mixing parameter Suspension > 2 %
mixing parameter Emulsion
mixing parameter Emulsion +
mixing parameter Gel
mixing parameter Soft in Soft
mixing parameter Specialties
General Notes on the gako unguator Mixing System
number / jar size correlation
letter / time correlation
number / rpm correlation
error codes
Operation Errors / Stirrer
Operation Errors / Jar
Operation Errors / Common Errors
Service and Warranty
Technical Data of the gako unguator EMP

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Installation Information
The gako unguator EMP weighs 24 lbs (11 kg).
Select a suitable location for the gako unguator EMP.
• Solid, horizontal surface
• Away from direct airow from air conditioning systems, heaters, open windows or fans
• No direct sunlight, keep the temperature steady 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 compo-
nents are included in your shipment:
• gako unguator EMP mixing device
• Standard mixing Blades 1 - 4
• Power cable
• Disposable Blade starter kit I
• Operating instructions
Please contact the gako support team by E-mail [e-mail] in case components
are missing or arrived damaged.
To ensure proper return without additional costs please, hold on to the original cardboard
box and packing material of the gako unguator EMP.
The warranty lapses if the original packing materials are not used for return deliveries.
Initial Operation
If the device is exposed to cold weather conditions, please allow the device to acclimatize
for approx. 30 minutes, this will prevent humidity and condensation from interfering with the
device’s proper operation.
The socket outlet is located on the rear of the gako unguator EMP. First connect the power cord
to the socket outlet and then plug the power cord into the power outlet.
The power button is also the emergency button. It is located on the rear of the device.
Use the power button to turn on the gako unguator EMP. Now the device is ready for operation.

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Display
Plus Button
gako Button
Minus Button
automatic lift arm with
quick-lock coupling
RS232 port
pic.: gako unguator EMP front
pic.: gako unguator EMP rear
socket outlet
power button / emergency button

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The Unguator Technology - Competence
from the start
The core of the gako unguator Technology is to comply with the requirements of prescription
ointments it consists of the patented arrangement of the gako unguator. Mixing Blade and the
gako unguator Jar that serves as both, a hygienic mixing jar and a hygienic dispensing jar.
The principle of the preparation method using gako unguator Technology in the closed gako
unguator Mixing System is quick and easy to learn, true to the motto:
learning by doing
A little experience will make it easy to prepare ointments though it may seem rather compli-
cated at rst. Using the gako unguator Technology enables the pharmacy to better prepare
prescription ointments in a shorter period of time, compared to the conventional methods that
were used prior to the invention (1994). For the rst time, it is possible to not only standardize
ointments, but validate them, too. Mixing parameters and examples of formulation are found
at www.unguator.com.
gako unguator Mixing Devices
The current gako unguator Mixing Devices - gako unguator BASIC, gako unguator EMP and
gako unguator PRO - are useful and advanced improvements over the rst gako unguator
Device, launched in 1994.
The gako unguator Mixing Devices feature a high safety standard.They were audited for safety
by TÜV Rheinland, Germany. The devices are manufactured under license and maintained by
Gako International GmbH, Scheßlitz.
With increased automation; of the gako unguator units from B/R, e/s, 2100 and QMS to BASIC,
EMP and PRO; product quality, product uniformity and reproduction of ointments prepared
individually and in batches were vastly improved.
Method of Ointment
Preparation
Pharmaceutical
Quality
Uniformity of
Ointment Lift arm Mixing Parameters (rpm, mixing time)
Mortar and Pestle ++ + - individually
gako unguator BASIC +++ +++ manual guided
lift
individually
programmable
gako unguator EMP +++ +++ automatic individually
programmable
gako unguator PRO ++++ ++++ automatic fully automatic
tab.: quality improvements with increasing automation

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gako unguator BASIC
The gako unguator BASIC ensures a GMP suitable preparation of semi-solid compounds up to
500 ml.
The lift by hand is much easier through the guided lift arm
with integrated quick-lock coupling.
Jar size, mixing time and ten mixing speeds can be set on the
gako unguator BASIC.
gako unguator EMP
The gako unguator EMP ensures a GMP suitable preparation
of semi-solid compounds up to 500 ml.
The integrated quick-lock coupling allows for faster attach-
ment of the mixing unit into the lift mount.
The lift arm works automatically so the mixing time can be
used for e. g. documentation.
Jar size, mixing time and ten mixing speeds can be set with
the gako unguator EMP.
gako unguator PRO
The gako unguator PRO the complete solution for the phar-
macy.
The gako unguator PRO will not only support GMP compoun-
ding of semi-solid preparations up to 2000 ml. It also will be
useful for additional compounding needs in the pharmacy.
Another benecial feature will make stirring in medicine
bottles possible (available End of 2016).
Integrated standard mixing programs (suspension, emulsion,
gel, etc.) with default mixing parameters makes the produc-
tion of semi-solid compounds a lot easier. It is possible to
rescale an already created mixing program to a dierent jar
size to ensure the constant quality of the compound. This
feature is time saving because
there is no need to recalculating the parameters for an
existing mixture. The optimized mechanics and electronics
ensure a quiet operation.
pic.: gako unguator PRO
pic.: gako unguator BASIC / EMP

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In addition, is the gako unguator PRO preloaded with a database of several mixing parameters
for semi-solid NRF formulations. This will optimize the manufacturing of NRF and NRF similar
formulations and increase the compound quality.
The gako unguator Pro is equipped with several ports and together with the optional gako
software ready for potential interconnection with electronic scales, printers (label, paper),
keyboard and networking.
gako unguator Assortment
As well as the gako unguator Devices, the gako unguator Assortment underlies further and
new developments. All gako unguator accessories are compatible with all current and former
available gako unguator Mixing Devices.
gako unguator Stirrer
The gako unguator Stirrer are the gako unguator Standard Mixing Blade (SMB) and the gako
unguator Disposable Blade (Disp. Blade). The stirrer are steadily guided up and down inside the
jar. Their unique design results in a tight contact between the mixing blade and the inside wall
of the jar, which serves, primarily, for distributing the substances during the mixing process.
The lubrication eect of the ointment and the foundation generally protects the jars and the
stirrer against abrasion. Discolorations of the mixing blade are mostly irreversible and therefore
harmless. All SMB and Disp. Blade shafts are dishwasher safe.
The SMB and mixing shaft of the disposable blades are coated with titanium nitride, which
makes them more resistant towards chemical and physical inuences.
• Assignment of the gako unguator stirrer
Ensure to use the correct stirrer for the corresponding jar. Selecting the wrong shaft may
cause failure messages with the automated devices. Also ensure that the right shaft is used
when working with the Disp. Blade. Both available shafts are marked for use with sizes
15-100 ml or 200 ml in the gako unguator Jar. They have to be combined with the correct
Disp. Blade. While the same Disp. Blade is used for the 100 ml and 200 ml jar sizes, it still
needs a dierent shaft for each. See also the operation instructions that come with the
disposable blade shafts.
• Flowing recess of the gako unguator SMB
The ow-adapted shape of the SMB generally cleans itself during the rotating penetration
of the ointment. Depending on ointment’s ingredients’, compatibility of weighted formula-
tion and also if the jar is considerably under lled (e. g. large volumes of powder), unmixed
ingredients may adhere to the SMB in recesses of ow. These remnants should be transfer-
red into the jar using a spatula when about half of the mixing time is complete.
The air should be diminished again, by pushing the bottom of the jar up, following this pro-

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cess. When using the Disp. Blade, however there are no recesses of ow and no remedial
work is generally required.
• Warming
The warmth that develops from the friction between the stirrer and the inside wall of the
jar is generally desired. Decreased viscosity increases the wettability of powders and ac-
celerates the penetration of potential powder pockets. Even the emulsifying ability of fats
and oils benets by warming.
A temperature of 54°C/129°F was the maximum taken after 6 minutes of mixing a high-
ly pasty preparation made of vaseline and zinc oxide aa at full speed. This temperature
increase is generally safe for the substances used in the pharmaceutical eld. Ointments of
low viscosity only heat slightly. Volatile substances such as ethereal oils or alcohol do not
evaporate from the closed Mixing Unit.
• Cleaning the gako unguator Stirrer
The stirrer is normally cleaned with a paper towel and, if necessary, held under hot water
faucet and then dried with a paper towel. The stirrers can also be cleaned in the dish-
washer.
The gako unguator devices as well as the gako unguator line of products should never be
treated with sharp-edged objects or abrasive cleaning agents.
• gako unguator Standard Mixing Blade (SMB)
The gako unguator SMB’s are adjusted to the size of each indivi-
dual gako unguator Jar.
For jar size 100 ml and 200 ml use the same SMB, also the 300
ml and 500 ml jars share a SMB.
Before each use make sure the SMB used has the correct
length, and the blades are clean prior using them (e.g. cleaning
with isopropanol 70%).
The SMB is suitable for the production of all kinds of formula-
tions. We recommend especially for suspension ointments and
pre-grinding the use of the standard mixing blade. pic.: gako unguator Standard
Mixing Blade

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chapter 2 - page 5
• gako unguator Disposable Blade (Disp. Blade)
The gako unguator Disp. Blade is suitable for all gako unguator
Devices. The one time use mixing blade is connected to the
disp. blade shaft by pushing it down and twisting the blade
counterclockwise, it can be disconnected after the mixing
process with a clockwise turn.
The material contact in the ointment is three times higher
due to the three times amount of blades when using the Disp.
Blade compared to the SMB at the same mixing speed. The
counter rotating twist of the mixing blades causes intensive
material vibration, therefore a better distribution in the ma-
terial to be mixed and achieves good product quality faster
than using the SMB. However, we recommend using the same
mixing time as for the SMB.
In the obligated process of nal quality control the mixing blade can
be removed and discarded or left inside the jar. Cleaning is limited to
the Disp. Blade shaft. We also recommend using the Disp. Blade for
substances that may discolor the regular blade.
This type of stirrer also comes with dierent shaft lengths. Every shaft
is imprinted on its thinner end with the associated range of jar sizes,
15-100 ml and 200 ml.
Disp. Blades are specially suitable for compounding emulsion, gels
and “soft in soft” formulations. For suspension ointments and pre-grin-
ding is recommended the use of SMB.
gako unguator Jar
The gako unguator Jar is both, a mixing and a dispensing jar, and is therefore designed as a
disposable jar. The jar guarantees evaporation free and contamination free preparation in an
air reduced mixing space.
The gako unguator Jar Lid closes the jar tightly to prevent evaporation and therefore loss of
active ingredients. Used as a dispensing jar, the jar corresponds to the guidelines for quality
assurance from the German Chamber of Pharmacists (“Apothekerkammer”).
With its small dispensing opening, comparable to a tube and without an environmental contami-
nation surface, the jar guarantees the minimization of negative quality interference demanded
by section 13, ApBetrO (Pharmacy Operation Regulations); including those caused by germs
on ngers when dispensing the ointment. Therefore, the user can remove very hygienically the
ointment from the jar.
pic.: gako unguator Disposable Blade
pic.: gako unguator
Disposable Blade Shaft

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Additionally, it is possible to open the jar by unscrewing the lid and removing compound
remainders.
The jar is resistant to hot-water baths and microwaves with temperatures maximum of
85°C/185°F. Higher temperatures may alter the tightness of the jar and the sliding ability of the
jar bottom might be negatively impacted.
The jar material could become brittle at temperatures below 0 °C/32 °F.
Jars are available in the following sizes: 15-20/33 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 of the jar housing is white and the lid red.
The 300 ml, 500 ml, 1000 ml und 2000 ml jar come only with
white lids. In addition, the 20 ml to 200 ml jars are available in
the pastel colors pink, light yellow, light blue and turquoise.
Furthermore, jar from 20 to 200 ml can be ordered with jar lids
in the special colors green, blue and white.
Customized jar colors are also possible if demanded.
All jars come sealed in plastic packaging. Cleaning or disinfection prior usage could put the
certied low microbiological contamination at risk. We would recommend storing the jar in its
plastic packaging after opening for protection against possible dust contamination.
A large applicator is standardly delivered with a 200 ml jar as pushing aid.
The jar sizes 300 to 2000 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, jars
solve the problem of the unsightly contents in traditional porcelain vessels
used previously. Evaporation, formation of crust, contamination and oxida-
tion processes can thereby be avoided to a great extent. Furthermore, the
contents of the jar can be moved close to the lid after dispensing using the
spindle or the AirDynamic.
As long as the housing of a 300 ml to 2000 ml jar is meant to remain in the
pharmacy it can be cleaned in a dishwasher.
Low microbiological contamination has to be ensured before reuse though. The movable
bottom of the jar is not suitable for the dishwasher and the sealing lip of the jar lid may be dest-
royed after repeated mixing. The corresponding jar lids or jar bottoms can be ordered as spare
parts in sets of ve and used for the economical reuse of the body.
pic.: gako unguator Jars
pic.: AirDynamic /
Spindle

[e-mail] | unguator.com
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chapter 2 - page 7
The jar is subject to periodic inspections in accordance to the guidelines of the Bundesapothe-
kerkammer “Examination and Storage of primary packaging material”. A certicate of analysis is
issued after batch-dened examinations. After a visual receiving inspection the manufacturer‘s
test certicate (certicate of analysis) is retained for the documentation of primary packing
materials as stipulated.This certicate is axed to the plastic packaging of the jar. If required,
it can be removed and added to the stipulated documentation.
A detailed certicate is available for download at www.unguator/coa.
A label is attached to each jar, which provides jar size, serial number (S/N), product number
(PCN), date of packing, date of expiration and PPN.
We recommend for a complete documentation to attach the jar label of the used jar onto the
manufacturing record.
• Notes on Dispensing ointment
Each customer should be given specic instructions with an empty jar at how to use the
jars. The use of the spindle should be explained for large jar, size 300 and 500 ml. Low
viscosity ointments should be equipped with an applicator or a varionozzle to reduce the
dispensed volume. Medium viscosity ointments can be easily extracted through the regular
opening of the jar. Very pasty ointments (e.g. pasta zinc) may not necessarily be pressed
through the regular opening, even by using a spindle.
pic.: certicate of analysis gako unguator Jar
pic.: jar label gako unguator jar


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In this case, the ointment can also be removed, similar to handling conventional jars with a
regular lid, by removing the lid and with the help of a spatula. If the jar lid has been remo-
ved, the ointment should be pushed up close to the lid after each dispensing process. In
larger jars by using the spindle or the AirDynamic.
The diameter of the dispensing nozzle allows simple dosing of the quantity of ointment
to be applied using approximate values. The regular dispensing nozzle in the screw lid of
each gako unguator Jar has a diameter of 8 mm. The varionozzles or applicators reduce
the diameter to 4, 2 or 1 mm. To ensure an exact dosage of highly active compounds, it is
recommended to use the ExactDose Adapter. It is possible to extract an exact amount of
0.5 ml.
gako unguator Varionozzles
The gako unguator Varionozzles with inner diameters of 1, 2 or 4
mm can be pressed into the regular nozzle of any gako unguator
Jar. They reduce the opening size, making it possible to safely
dose even low viscosity formulations. The viscosity of the nished
product normally species the diameter of the varionozzles. The
softly rounded surface allows ointment to be pleasantly spread
directly onto 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)
gako unguator Applicators
The gako unguator Applicators reduce the extracted quantity of low-viscosity formulations
and are particularly helpful in cases where the ointment must be
precisely applied.
• gako unguator Applicator short
The gako unguator Applicator short with a diameter of 1mm is
obligatory for nose and ear ointments.
pic.: gako unguator Varionozzles
pic.: gako unguator Applicator short

[e-mail] | unguator.com
160323_EMP2en
chapter 2 - page 9
• gako unguator Applicator long
The gako unguator Applicator long with a diameter of 2 mm al-
lows formulations to be introduced into large orices of the body
or probes.
In addition, the applicator long also comes inside each gako un-
guator 200 ml Jar to help pushing up the bottom of this jar size
in full.
gako unguator Spindle
The gako unguator Spindle serves as a dispensing system for gako unguator jar sizes 300 ml or
500 ml. Extract the spindle from the jar. Push carefully the bottom of the jar with a disinfected
SMB (if not available, with a disinfected spatula) all the way down.
Air can be diminished by placing the jar with slightly open lid loosely
onto a spindle and pushing the bottom upwards.
Before giving the jar to the customer, the safety adapter needs to be
removed and the spindle must be screwed in the jar counter clock-
wise from the bottom until it locks into place. The spindle must be
turned clockwise to extract the ointment. One turn dispenses approx.
20 ml of the contents of the jar.
Caution! If the movable bottom is accidentally perforated or the spindle is permanently locked
in the bottom of the jar, the jar may only serve as dispensing or storage vessel and can no longer
be used for the mixing process.
gako unguator Coupling
The gako unguator Coupling connects two gako unguator Jars by their screw
threads of their dispensing openings and is very useful when preparing oint-
ments in larger batches. Transferring a formulation from a larger jar into a
smaller jar using the coupling will ensure hygiene from the mixing process to
the end user.
The 200 ml jar becomes a convenient transfer device to smaller jars when
their jar bottoms are carefully pressed towards the work surface using an
applicator, long screwed on a 30 ml jar.
pic.: gako unguator Spindle
pic.: gako unguator
Coupling
pic.: gako unguator Applicator long


160323_EMP2en
chapter 2 - page 10
In addition to the coupling, required for transferring from a 300 ml or 500 ml jar into a smaller
jar, both the spindle and the AirDynamic may also be used. Dispensing and transferring a
formulation via the regular jar nozzle from a 1000 ml and 2000 ml jar is practically only possible
using the AirDynamic.
We recommend transferring the formulation after mixing as soon as possible, since the formu-
lation is still warm and less viscous.
gako unguator AirDynamic
The gako unguator AirDynamic optimizes batch preparation
within the closed system:
• Contamination-free transfer
• Contamination-free storage
The AirDynamic has been designed to apply with jars from
size 300 ml to 2000 ml to extract compounds. An adapter
connected to a pump ball is axed to the center hole on the
body’s bottom of the jar with an air-tight connection.
By pumping air into the lower chamber of the jar using the pump ball, the pressure thus gene-
rated moves the bottom upward. Thanks to the AirDynamic, even thick pastes can be dispensed
via the small dispensing opening in the screw cap or transferred to small jars using the coupling.
The material outlet velocity depends on viscosity which may be reduced through warming.
The air pressure that had developed in the lower chamber of the jar can be relieved by opening
the valve screw.
This is mandatory after the transfer process using the coupling before the smaller jar is
removed. Otherwise this may result in considerable contamination of the immediate environ-
ment, depending on the formulation viscosity.
gako unguator ExactDose Adapter
The gako unguator ExactDose Adapter allows the exact dosage of 0.5
ml paste, gel, cream or ointment for topical or transdermal therapy.
The adapter will be screwed onto the jar after the mixing process is
nished. Insert the red set screw with a little pressure into the trans-
parent part of the ExactDose Adapter.
The coloured ball inside the ExactDose Adapter lays on its lowest posi-
tion when the red set screw is horizontally positioned.
pic.: gako unguator AirDynamic
Abb.: gako unguator Exact-
Dose


160323_EMP2en
chapter 2 - page 11
With pushing the jar bottom upwards the ExactDose chamber will be lled with the exact
amount of compound and the coloured ball will be pushed up to its highest position.
With a 180 degree turn of the set screw the coloured ball will be in the lowest position again,
the compound will be extracted by pushing the jar bottom upwards and the chamber will be
lled again with compound for the next dosage extraction.


160415_EMP3en
chapter 3 - page 1
Display Handling
Initial Operation
The touch panel is on the front of the gako EMP, with a minus button (left), the gako button
(middle) and a plus button (right).
After starting up the device with the power switch, located on the back, the display shows the
device type “gako unguator EMP”.
Followed by the current number of preparations. After a few seconds it forwards automatically
to the next screen.
pic.: Display gako unguator EMP
pic.: Display device type
pic.: Display current preparation


160415_EMP3en
chapter 3 - page 2
On initial operation the reference for the online registration at unguator.com/reg will be
displayed.
Registration
Enter the 12 digit serial number online at unguator.com/reg to register the new device. Then a
four digit PIN number will be provided to activate the gako unguator EMP.
Enter the four digit PIN on the display of the gako unguator EMP.
The displayed numbers change with the plus and minus button. By pushing on the gako button,
it jumps to the next position. If a number is incorrect entered, it is possible to navigate to the
input position again.
By pressing the gako button for three seconds the four digit PIN is conrmed.
If the PIN was not entered correctly the display will show “Wrong PIN”.
After pushing the gako button the PIN can be entered again.
pic.: Display Registration
pic.: Display PIN
pic.: Display Wrong PIN