Gako PM140 User manual

gako PM140
User Manual
www.gako.de

Contents
1. All-in-One Solution: gako PM140 ....................................................................................
1.1. Mechanism of Action ....................................................................................................
1.2. Application and Uses ....................................................................................................
1.3. Key Features .........................................................................................................................
2. Technical Parameters ..............................................................................................................
3. Accessories ........................................................................................................................................
4. Functions and Use .........................................................................................................................
4.1. Installation ................................................................................................................................
4.2. Operation .................................................................................................................................
5. Safety Shutdown ............................................................................................................................
6. Maintenance ......................................................................................................................................
6.1. Cleaning .....................................................................................................................................
6.2. Operational Error ................................................................................................................
6.3. Technical Error .....................................................................................................................
7. Transportation and Storage ...................................................................................................
8. Warranty ................................................................................................................................................
ANNEX I. Declaration of Conformity ......................................................................................
ANNEX II. IQ/OQ ..................................................................................................................................
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4
Figure 2. The working mechanism of gako PM140.
Figure 1. gako PM140 device.
For pharmacists who are looking for a simple, fast,
and aordable solution for mixing, deaeration, and
melting, the gako PM140 is a revolutionary device
that combines those multiple functionalities to
standardize the compounding process, ensuring
safety, quality, and eicacy for compounded prepa-
rations while saving time and money for the pharma-
cy (Figure 1).
Moreover, it can be used on its own or in a combined
worklow with other compounding equipment, such
as the gako unguator* or other devices or molds re-
quired for the preparation of semi-solids or molded
and melted solids.
1.1. Mechanism of Action
Due to its ingenious mechanism, the preparation in-
side the PM jar (mixing jar) simultaneously spins and
rotates around an axis in opposite planetary motion
while keeping all the components at an angle of 40°.
This promotes a centrifugal force caused by the ro-
tational movement making particles in the mixture
move toward the edges of the PM jar. As a result, the
mixing process can be conducted in an enclosed
environment without blades (Figure 2), reducing the
number of items to be cleaned afterwards and ena-
bling the pharmacist to mix and deaerate formulas
within a simple one-step process (a process in less
than 60 seconds). This centrifugal motion is accom-
panied by uniform and gradual heat release, facilitat-
ing the melting of substances such as suppository
bases, gelatin bases, or gelling agents in the prepa-
ration (a process that requires around 15 minutes de-
pending on the base).
For optimal results, we are continuously developing
suitable accessories including jars and dispensers
for the gako PM140 (see section 3. Accessories). The
PM jars and dispensers provide a closed environ-
ment to reduce microbial contamination and elimi-
nate spilling and spreading problems. They can be
used in negative pressure cabinets to prevent haz-
ardous drug exposure. The disposable ones that are
also used as primary packages, help avoiding mate-
rial loss that would otherwise occur during the trans-
fer step from the preparation cup into the package.
* The gako unguator is a product line of fully automatic, semi-automatic, and manual versions devices, designed for mixing and the homogenization of
semi-solid preparations (gels, creams, ointments, and suppositories) using blades.
1. An All-in-One Solution: gako PM140

5
Creams
Ointments
Vaginal Inserts
Gels
Suppositories
Gelatin
bases
Gums
Mixing
Melting
Deaeration
Figure 3. Mixing process using the gako PM140.
Before After Before After
Figure 4. Deaeration process
using the gako PM140.
Figure 5. Melting process using
the gako PM140.
1.2. Application and Use
Mixing
The gako PM140 is a user-friendly and practical de-
vice that allows the preparation of formulas in less
than a minute, in a closed mixing jar, with no need
for mixing blades (Figure 3). The studies conducted
by our laboratories show the content uniformity in
all portions of the formulations produced. The stand-
ardized mixing allows for greater stability of emul-
sions, therefore eliminating formulation issues such
as creaming, sedimentation, locculation, and coa-
lescence. An adequate homogenization also ensures
correct rheological properties, such as the formula-
tion’s viscosity and low.
Deaeration
The gako PM140 deaerates emulsions and gels in
just 45 seconds, ensuring the removal of macrobub-
bles from those formulations (Figure 4).
Melting
The gako PM140 can melt gelatin, suppository, and
vaginal inserts bases in one simple step: the base
can be placed together with the APIs and other nec-
essary ingredients in the PM jar (Figure 5).

6
1.3. Key Features
Single-Step Process
The gako PM140 combines mixing, melting, and deaer-
ation processes in a single step. Therefore, it simpliies
the compounding of pharmaceutical preparations and
saves time while ensuring high-quality formulations. As
demonstrated in studies conducted by our scientiic ex-
pert team, the temperature rise is limited to 45°C, mak-
ing it suitable for most heat-sensitive ingredients.
Time-Saving
The high mixing speed of gako PM140 is ixed to 2800
rpm, allowing the preparation of formulations in less than
60 seconds.
Dosage Accuracy
In volume-dependent doses, as in HRT creams, a reliable
mixing process that deaerates the formulation improves
API distribution and ensures dosage accuracy for each
application.
Material-Loss Prevention
In traditional mixing processes, material loss occurs dur-
ing the transfer to the inal package after mixing. Even if
the exact amounts are calculated and weighed, the com-
pounded preparation is never completely transferred
from the mortar into the package, especially when work-
ing with semi-solid dosage forms. To prevent material
loss, the gako PM140 is designed to mix the formulation
in a disposable PM jar, also used as a inal package to be
delivered to the patient.
Conservation of Resources
The gako PM140 contributes to water conservation, as it
does not require subsequent washing and rinsing steps
of spare parts such as blades and mixing rods.
Low-Maintenance
The gako PM140 is distinguished by quality materials
that allow for a low-maintenance and durable service,
improving cost-eiciency. Due to its compact and func-
tional design, the device can be easily integrated into lab
furniture or used on the workbench. It also eliminates
issues when compounding colored ingredients, such as
coloring the blades or wearing them out by changing
color and avoiding cross-contamination in a hormone
preparation through the edges.
Compounding Hazardous Drugs
The term “hazardous drug” (HD) was irst described by
the American Society of Health-System Pharmacists
(ASHP) in 1990 and has also been used by Occupational
Safety and Health Administration (OSHA) for compounds
that display the following characteristics: genotoxicity;
carcinogenicity; teratogenicity or loss of fertility; and
severe toxic manifestations at low doses in experiments
with animals or treated patients. An API is considered
hazardous if it features one or more of these characteris-
tics, and new APIs with structure and toxicity proiles that
mimic those of hazardous APIs are also classiied as HDs.
According to the United States Pharmacopoeia (USP),
pharmacists can be potentially exposed to HDs while
compounding when:
• Weighing or mixing components;
• Crushing or splitting tablets or opening capsules;
• Pouring oral or topical liquids from one container
to another;
• Constituting or reconstituting powdered or
lyophilized HDs;
• Withdrawing or diluting injectable HDs from
parenteral containers;
• Expelling air or HDs from syringes;
• Contacting HD residues present on Personal Protective
Equipment (PPE) or other garments;
• Deactivating, decontaminating, cleaning, and
disinfecting areas contaminated with or suspected
to be contaminated with HDs;
• Maintenance activities for potentially
contaminated equipment and devices.
The gako PM140 decreases the risk of exposure to HDs
as it works in a closed environment provided by the PM
jars. Additionally, the PM jars can be placed in negative
pressure cabinets, which increases safety for the com-
pounding of HDs.
Volume-Adjustable Jar
For the preparation of smaller batches than 100 mL, the
gako PM jar 100mL HV enables the reduction of the jar
volume by pushing the bottom upwards after the op-
eration. This eliminates the requirement of acquiring
multiple jar sizes and additional jar holders/adaptors to
accommodate them with the device. Additionally, it min-
imizes air contact by removing excess space, resulting in
improved quality.

7
Model gako PM140
Width (mm) 205
Height (mm) 295
Depth (mm) 265
Weight (kg) 17.3
Table-Top Model Yes
Electrical requirements 100 VAC - 230 VAC, 50 / 60 Hz
Power Consumption (W) 250
Feed Line 3 x 1.5 mm
2
On-Time %15
Fuse Protection 2 x 4 AT
Revolutions 2800 rpm
Time-range Seconds 10, 20, 30, 40, 50, 60, 90
Minutes 2, 3, 4, 5, 10, 15
2. Technical Parameters
3. Accessories
The gako PM jar 100ml HV is a sterile and disposable
jar composed of polypropylene, and it is speciically de-
signed to be used in the deaeration and mixing processes
of gels, creams, and ointments. Although its capacity is
up to 100 ml, the internal nominal volume is 140 ml. This
extra volume is necessary to allow the particles to move
through the process, and promote its features. This PM
jar presents a movable bottom. After the preparation,
the remaining volume can be eliminated by pushing the
bottom upwards, reducing air contact. It is also com-
patible with gako unguator devices, enabling it to be
used with low-soluble APIs and to prepare suspension
formulas. It, therefore, eliminates the need to transfer
the compound from the unguator jar to the gako PM
jar 100ml HV. Since the PM jars are made of a dispos-
able material, they can also be used as a primary pack-
age to deliver to the patient, reducing the tools to be
cleaned, saving time, and avoiding material loss during
the transfer phase.
The gako PM jar 125ml HV+LV is a disposable jar with a
ixed bottom, designed to be used mainly for the melt-
ing of the suppository preparation, and mixing more
luid formulas – but it can also be used for other prepa-
rations like creams, ointments, and gels. The capacity
of this PM jar is 125 ml with a 180 ml nominal volume.
When the device is operated in room temperature, the
content can reach up to 45 °C. In case the prescription
requires higher temperature, the external heat can be
applied to the gako PM jar 125ml HV+LV, up to 85 °C by
using a hot water bath.

8
4. Functions and Use
4.1 Installation
Table 1. Comparing gako PM jars.
* STERILE|EO: Sterilized with ethylene oxide.
1.
Remove the safety screws from
the bottom, turn the device back
to its rubber feet, open the cover
and remove the cardboard tube.
2.
Connect the device to the local power
supply using the provided connection
cable.
3.
Turn the device on using the power
switch at the back of the device.
I ON OOFF
Accessory gako PM jar 100ml HV gako PM jar 125ml HV+LV
Internal Nominal Volume 140 ml 180 ml
Maximum capacity for Mixing 100 ml 125 ml
Bottom Movable Stable
Sterility STERILE|EO* STERILE|EO*
Applications Deaeration
Mixing
Deaeration
Mixing
Melting
unguator Suitability Suitable Not suitable
Mixing Period Up to 1 minute Up to 15 minutes for melting
Up to 1 minute for mixing and deaeration
Suitable Dosage Forms •Ointment •Cream •Gel •Ointment •Cream •Gel
•Lotion •Suppository •Insert
Usability as Dispensing
Primary Packaging Applicable Applicable

9
4.2. Operation
1.
After turning the device on, and
when the lid is closed, the LED light
is lashing.
2.
Open the lid to insert the PM jar.
3.
Select the time (min/sec).
4.
Put the PM jar holder on the table.
5.
Insert the PM jar in the PM jar holder.
6.
Turn the PM jar slightly clockwise to
ensure it is placed inside the PM jar
holder completely.
7.
Place the PM jar with the PM jar holder
into the well. Make sure the PM jar lid is
completely closed, the shape is
complementary with the well and
the PM jar is pushed all the way down.
8.
Close the lid.
9.
Press START. The device automatically
stops after the mixing process is
completed.

10
10.
After the operation is completed,
open the lid to remove the PM jar.
11.
Place the PM jar holder on the table.
12.
By holding the PM jar holder, take the
PM jar out of it while turning slightly
clockwise and pulling out.
5. Safety Shutdown
• The safety shutdown protects individuals from injury and the device from damage.
• Any attempt against the opening of the lid during mixing procedures leads to an immediate safety
shutdown, which may lead to mechanical damage to the device and requires customer service support.
• Mixing procedures are immediately interrupted and stopped when pressing START.
6. Maintenance
6.1. Cleaning
• Clean the surface with a soft fabric or cloth soaked
with warm water and a non-abrasive
household cleaning agent.
• Afterward, wipe the surface with another soft fabric
or cloth soaked with warm water and clear it.
• In the end, rapidly wipe the entire surface with a dry
cotton cloth or towel.
• Heavy scaling may be cleaned with a standard liquid
cleanser.
• Do not use scratching sponges or abrasive cleaning
agents such as nitro or synthetic resin thinner.
• Since it may cause irreparable damage, ensure
no luids enter the device.
• Use mild surface disinfectants.
• Do not use thermal disinfection.
6.2. Operational Error
Error Troubleshooting Solution
Insuicient mixture quality Short mixing time Adjust mixing-time
The expiry date of the mixture passed Observe expiry date
Uncombined powder after mixing Humid powder Store the powder according to the
manufacturer's instruction
Processing and segregation
time too short Mixing time set too long Shorten mixing time
Powder residues in PM jar holder The PM jar is not closed properly Close PM jar properly
The PM jar cannot be lifted easily from
the PM jar holder Powder residues in the PM jar holder Clean PM jar holder, observe proper closing of PM jar

11
Error Troubleshooting Solution
The device is not running,
no LED light
Defective fuse Check the fuse and replace it
if necessary
ON/OFF switch in o-state Activate the ON/OFF switch
Flashing LED
The lid has not been opened
after switching on the device (with a
closed lid)
The lid circuit is not yet activated. Open
and close the lid
The lid has not been opened before
the further mixing process Open and close the lid
The device cover does not close
properly after pressing the start
button
Close the lid, press the start button
Flash Mode: ON 300ms / OFF 300ms, 1.6 Hz
Rapidly Flashing LED Device activated for more than
recommended on-time Let the device cool down
Overheating Let the device cool down
Flash Mode: ON 100ms / OFF 100ms, 5 Hz
1 x Flashing LED Defective locking Let a service technician
check the lock
Missing locking signal Let a service technician
check the lock
Flash Mode: ON 2000ms / OFF 300ms / ON 2000 ms
2 x Flashing LED
Defective incremental decoder Request service technician
Flash Mode: ON 2000ms / OFF 300ms / ON 300 ms / OFF 300ms / ON 2000ms
3 x Flashing LED
The defective motor control unit Replace motor and control (service
technician)
Flash Mode: ON 2000ms / OFF 300ms / ON 300 ms / OFF 300ms /
ON 300 ms / OFF 300ms / ON 2000ms
6.3. Technical Error
Errors are indicated by a lashing LED light on the start button. They could be reset by pressing the start button or
restarting the device. If the error continues, the LED light will lash again. The device does only work after eliminating
the error.

12
This device is under warranty and free from defects in materials under regular use and service for 12 months from
the invoice date (excluding consumable accessories). The warranty is extended only to the original purchaser. The
warranty is not valid on a device damaged by improper installation, connections, misuse, accident, or abnormal op-
erating conditions. If the warranty has expired, manufacturer will still be responsible for repair with relative charges.
For claims under warranty, please get in touch with your local supplier.
7. Transportation and Storage
8. Warranty
The gako PM140 weighs approximately 17.3 kg and should only be stored on lat, leveled surfaces capable of sup-
porting the device's weight. The device is attached to the base plate with safety screws for protection during trans-
portation, and the cardboard tube is inserted into the PM jar holder. Transporting the device should avoid collisions.
NOTE: Do not store the device in wet or extremely damp locations.

13
Annex I. Declaration of Conformity
DDeeccllaarraattiioonn ooff CCoonnffoorrmmiittyy
Gako Deutschland GmbH
Is certified according
DIN EN ISO 9001:2015 &
DIN EN ISO 50001:2018
Product: Laboratory mixing device
Product type: FagronLab™ PM140
Manufacturer: Gako Deutschland GmbH
Am Steinernen Kreuz 24
96110 Scheßlitz/Germany
The manufacturer declares the conformity of the designated product with the following European guideline:
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The conformity of the designated product has been proven by the complete compliance of the following
directions:
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:
:
2
2
0
0
2
2
2
2
-
-
1
1
1
1
D
D
I
I
N
N
E
E
N
N
6
6
1
1
0
0
0
0
0
0
-
-
4
4
-
-
2
2
:
:
2
2
0
0
0
0
9
9
-
-
1
1
2
2
D
D
I
I
N
N
E
E
N
N
6
6
1
1
0
0
0
0
0
0
-
-
4
4
-
-
4
4
:
:
2
2
0
0
1
1
3
3
-
-
0
0
4
4
D
D
I
I
N
N
E
E
N
N
6
6
1
1
0
0
0
0
0
0
-
-
4
4
-
-
5
5
:
:
2
2
0
0
1
1
9
9
-
-
0
0
3
3
D
D
I
I
N
N
E
E
N
N
6
6
1
1
0
0
0
0
0
0
-
-
4
4
-
-
8
8
:
:
2
2
0
0
1
1
0
0
-
-
1
1
1
1
D
D
I
I
N
N
E
E
N
N
I
I
E
E
C
C
6
6
1
1
0
0
0
0
0
0
-
-
4
4
-
-
1
1
1
1
:
:
2
2
0
0
1
1
9
9
-
-
0
0
8
8
D
D
I
I
N
N
E
E
N
N
5
5
5
5
0
0
1
1
1
1
:
:
2
2
0
0
2
2
2
2
-
-
1
1
5
5
For the intended use the designated product meets the requirements from
European, US, British and Japanese Pharmacopeia and
ROHS ((EU) 2015/863 and 2011/65/EU) regulations.
The product has been examined regarding the compliance of the direction/standards mentioned above.
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a
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n
n
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d
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H
H
96110 Scheßlitz / Germany
Dipl.-Wirtsch.-Ing. Matthias Konietzko, MBA
01.11.2022

14
Annex II. IQ/OQ
Functional Test of the gako PM140
Assessment
Conclusion
OK Not OK
Check the device label for readability.
Check device location for stability and suitability.
Check the device location for drafts, direct sunlight, extreme humidity, or temperature
luctuations.
Check the device location for cleanliness, dryness, and freedom from dust.
Check the accessibility to the power plug and power switch.
Check the power supply for suitability and country-speciic nominal voltage and frequency.
Handling by unauthorized persons is excluded.
Operation instructions in the user manual are available.
Turn the device upside down and remove the safety screws from the bottom.
Turn the device back to its rubber feet and open the lid.
Remove the cardboard tube from the device and close the lid.
Connect the device to the local power supply using the provided connection cable.
Switch the power button on the back side of the device to “I”.
Check if the red light keeps lashing after turning it on.
Prepare a PM jar adding a transparent gel and close the lid of the jar to test deaeration (both
gako PM jar 100ml HV and gako PM jar 125ml HV+LV can be used).
Place the PM jar holder on the table, insert the PM jar into the PM jar holder, and turn the jar
slightly clockwise. It is normal to be tight.
Is the PM jar inserted in the PM jar holder?
Place the PM jar with the PM jar holder into the well. Make sure the PM jar lid is completely
closed, the shape is complementary with the well and the jar is pushed down.
Is the PM jar fully inserted into the well?
Close the lid of the device and set the time to 30 seconds from the button.
Does the button move properly?
Press “START”.
Does the device start operation?
Is the operation time the same as the set time?
Does the device stop operating automatically?
Open the lid of gako PM140 and remove the PM jar with the PM jar holder.
Put the PM jar holder on the table.
Turn the PM jar slightly clockwise and take it out (it is normal to be tight).

15
Date Signature
Assessment
Conclusion
OK Not OK
Is the air entrapped in the gel removed?
Prepare a PM jar adding a cream base and a liquid API, then close the lid of the jar
to test mixing (both gako PM jar 100ml HV and gako PM jar 125ml HV+LV
can be used).
Place the PM jar into the PM jar holder and insert it by following the steps above.
Is the PM jar fully inserted into the well?
Close the lid of the device, set the time to 45 seconds from the button and press
“STA RT ”.
Does the device start operation?
Is the operation time the same as the set time?
Does the device stop operating automatically?
Open the lid of gako PM140 and remove the PM jar with the PM jar holder.
Take the PM jar out from the PM jar holder and check the preparation.
Does it look homogeneous?
Prepare a gako PM jar 125ml HV+LV adding a suppository base and an API, then close the lid of
the PM jar to test mixing.
Place the PM jar into the PM jar holder and insert it by following the steps above.
Set the time to 15 minutes from the button and press “START”.
Does the device start operation?
Is the operation time the same as the set time?
Does the device stop operating automatically?
Open the lid of gako PM140 and remove the gako PM jar 125ml HV+LV
with the PM jar holder.
Take the PM jar out from the PM jar holder and check the preparation.
Does the suppository base melt?
Does the preparation look homogeneous?
Date Signature

Gako Deutschland GmbH
Am Steinernen Kreuz 24
96110 Scheßlitz
Germany
P: [phone]
F: [phone]
www.gako.de
References
1. Treadway AK, Craddock D, Le R. Practices of pharmacies that compound
extemporaneous formulations. American Journal of Health-System Pharmacy.
2007;64(13):1403-1409. doi:10.2146/ajhp060251
2. Lloyd Allen. The Art, Science, and Technology of Pharmaceutical Compound-
ing. 6th ed. American Pharmaceutical Association; 2020.
3. USP - United States Pharmacopeia. <1163> Quality Assurance in Pharmaceuti-
cal Compounding.; 2022.
4. USP - United States Pharmacopeia. <795> Pharmaceutical Compounding -
Nonsterile Preparations.; 2022.
5. Ferreira A de O, Brandão MAF, Polonini HC. Guia Prático Da Farmácia Magistral.
5th ed. Editar; 2018.
6. Rob Standridge. Mixing In a Compounding Pharmacy in the 21st Century. In-
ternational Journal of Pharmaceutical Compouding. 2015;19(6):479-484.
7. N.E. Hotrum. Emulsion Droplet Spreading at Air/Water Interfaces. Wageningen
University; 2004.
8. Leong TSH, Wooster TJ, Kentish SE, Ashokkumar M. Minimising oil droplet
size using ultrasonic emulsiication. Ultrason Sonochem. 2009;16(6):721-727.
doi:https://doi.org/10.1016/j.ultsonch.2009.02.008
9. A.N. Martin, G.S. Banker. Rheology. In: H.S. Bean, A.H. Beckett, J.E. Carless,
eds. Advances in Pharmaceutical Sciences. Academic Press; 1964.
10. L.A. Power, J.W. Coyne. ASHP guidelines on handling hazardous drugs. Ameri-
can Journal of Health-System Pharmacy. 2018;75(24):1996-2031.
11. USP - United States Pharmacopeia. <800> Hazardous Drugs - Handling in
Healthcare Settings.; 2022.