FagronLab BASIC User manual

FagronLab™ BASIC
Automatic mixing/homogenization/emulsification system
User Manual

FagronLab™ BASIC – User Manual | 3
Quick - Start
How to register your FagronLab™ BASIC device
•Hold the FagronLab™ 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
•Apply slight pressure from the top onto the lift arm. Fix the jar with a slight turn counterclockwise (about a quarter turn)
into the lift arm
•Move the mixing unit in the lift arm by hand all the way up and push the compounding button
•Touch panel with:
- Minus button (left)
- Compounding button (middle)
- Plus button (right)
•Start display shows jar size, mixing time and mixing speed
•After pushing the compounding button for two seconds
"Start" appears on the display and the jar can be
mounted
FagronLab™ BASIC
Display handling
Lift arm with integrated quick-lock coupling
•Go to www.fagronlab.com/re
•Enter the 12 digit serial number
•Enter the four digit unlock PIN on your device

FagronLab™ BASIC – User Manual | 4
Dear FagronLab™ user, dear Compounder
FagronLab™ BASIC
thank you for choosing the 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.fagronlab.com
www.fagron.com
For additional support, operation handling and all other questions regarding
the technology
please feel free to contact your local Fagron company or dealer.
Enjoy the successful production of quality assured compounding.
Your
FagronLab™ Compounding Support Team

Table of contents
1. Installation information................................................................................................................................................................................. 6
2. initial operation....................................................................................................................................................................................................... 6
3. The Unguator technology - Competence from the start ............................................................................................ 8
FagronLab™ mixing devices ................................................................................................................................................................................ 8
FagronLab™ assortment ..................................................................................................................................................................................... 10
4. Display handling.................................................................................................................................................................................................... 17
Initial operation....................................................................................................................................................................................................... 17
Compounding with the FagronLab™ BASIC................................................................................................................................................ 19
Aborting the mixing process.............................................................................................................................................................................. 21
5. Compounding guidelines for the technology........................................................................................................................ 21
Preparing the FagronLab™ mixing unit......................................................................................................................................................... 21
Weighed portion of the formulation.............................................................................................................................................................. 21
The mixing process ............................................................................................................................................................................................... 22
Mixing parameters................................................................................................................................................................................................ 24
Requirements for components of a formulation..................................................................................................................................... 28
After the mixing process is complete............................................................................................................................................................ 29
6. General notes on the FagronLab™ mixing system .......................................................................................................... 30
Identification number ID.................................................................................................................................................................................... 30
Error codes ................................................................................................................................................................................................................ 32
Operation errors..................................................................................................................................................................................................... 32
Cleaning the FagronLab™ BASIC...................................................................................................................................................................... 34
7. Service and warranty....................................................................................................................................................................................... 34
Notes on malfunctions........................................................................................................................................................................................ 34
Notes on safety....................................................................................................................................................................................................... 35
Technical data of the FagronLab™ BASIC..................................................................................................................................................... 35
8. Manufacturing and Customer Service.......................................................................................................................................... 36
Installation qualification IQ............................................................................................................................................................................... 37
Operation qualification OQ............................................................................................................................................................................... 39

FagronLab™ BASIC – User Manual | 6
1. Installation information
2. Initial operation
FagronLab™ BASIC
The FagronLab™ BASIC weighs 22 lbs (10 kg).
Select a suitable location for the FagronLab™ BASIC.
•Solid, horizontal surface
•Away from direct airflow 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 components are included in your
shipment:
•FagronLab™ BASIC mixing device
•Standard mixing Blades 1 - 4
•Power cable
•Disposable Blade starter kit I
•Operating instructions
Please contact your local FagronLab™ support team or dealer 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
FagronLab™ BASIC.
The warranty lapses if the original packing materials are not used for return deliveries.
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 FagronLab™ BASIC. 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 FagronLab™ BASIC. Now the device is ready for operation.

FagronLab™ BASIC – User Manual | 7
FagronLab™ BASIC
1
1
3
3
2
5
4
2
No Description
1 Minus button
2 Compounding button
3 Plus button
4 Display
5 Manual lift arm with quick lock coupling
Pic.: FagronLab™ BASIC front
Pic.: FagronLab™ BASIC rear
No Description
1 Power button/emergency button
2 RS232 port
3 Socket outlet

FagronLab™ BASIC – User Manual | 8
FagronLab™ BASIC
3. The Unguator technology - Competence from the start
The FagronLab™ product line is based on the Unguator Technology originally patented by Gako Konietzko GmbH,
Germany. The core of the technology is to comply with requirements of prescription ointments it consists of the patented
arrangement of the Mixing Blade and the jar that serves as both, a hygienic mixing jar and a hygienic dispensing jar.
The principle of the preparation method using technology in the closed FagronLab™ 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 complicated at first. Using the
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 first time, it is possible to not only standardize
ointments, but validate them, too.
The current FagronLab™ mixing devices - FagronLab™ BASIC, FagronLab™ EMP and FagronLab™ PRO - are useful and
advanced improvements.
The FagronLab™ mixing devices feature a high safety standard. They were audited for safety by TÜV Rheinland, Germany.
The devices are manufactured by Gako International GmbH, Schesslitz - Germany. With increased product quality, product
uniformity and reproduction of ointments prepared individually and in batches were vastly improved.
FagronLab™ mixing devices
Method of
ointment
preparation
Pharmaceutical
quality Uniformity of ointment Lift arm
Mixing
parameters
(rpm, mixing
time)
Mortar and Pestle ●●○○ ●○○○ - Individually
FagronLab™ BASIC ●●●○ ●●●○ Manual guided
lift
Individually
programmable
FagronLab™ EMP ●●●○ ●●●○ Automatic Individually
programmable
FagronLab™ PRO ●●●● ●●●● Automatic Fully automatic
Tab: Quality improvements with increasing automation

FagronLab™ BASIC – User Manual | 9
FagronLab™ BASIC
FagronLab™ BASIC
•The FagronLab™ 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 FagronLab™ BASIC
•The FagronLab™ EMP ensures a GMP suitable
preparation of semi-solid compounds up to 500 ml
•The integrated quick-lock coupling allows for faster
attachment 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 FagronLab™ EMP
•The FagronLab™ PRO the complete solution for the
pharmacy
•The FagronLab™ PRO will not only support GMP
compounding of semi-solid preparations up to 2000 ml.
It also will be useful for additional compounding needs in
the pharmacy
•Another beneficial feature will make stirring in medicine
bottles possible
•Integrated standard mixing programs (suspension,
emulsion, gel, etc.) with default mixing parameters
makes the production 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
•In addition, is the FagronLab™ 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 FagronLab™ PRO is equipped with several ports and
ready for potential interconnection with electronic scales,
printers (label, paper), keyboard and networking
FagronLab™ EMP
FagronLab™ PRO
Pic.: FagronLab™ PRO
Pic.: FagronLab™ BASIC/EMP

FagronLab™ BASIC – User Manual | 10
FagronLab™ BASIC
FagronLab™ assortment
FagronLab™ stirrer
Assignment of the FagronLab™ stirrer
Flowing recess of the FagronLab™ SMB
Warming
Cleaning the FagronLab™ stirrer
As well as the FagronLab™ devices, the FagronLab™ assortment underlies further and new developments. All FagronLab™
accessories are compatible with all current and former available FagronLab™ mixing devices.
The FagronLab™ stirrer are the FagronLab™ Standard Mixing Blade (SMB) and the FagronLab™ Disposable Blade (Disp. Blade).
The stirrers 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 influences.
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 FagronLab™ 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.
The flow-adapted shape of the SMB generally cleans itself during the rotating penetration of the ointment. Depending
on ointment’s ingredients’, compatibility of weighted formulation and also if the jar is considerably under filled (e. g. large
volumes of powder), unmixed ingredients may adhere to the SMB in recesses of flow. These remnants should be transferred
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 process. When using the Disp. Blade,
however there are no recesses of flow and no remedial work is generally required.
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 accelerates the penetration of potential powder pockets. Even the
emulsifying ability of fats and oils benefits by warming.
A temperature of 54°C/129°F was the maximum taken after 6 minutes of mixing a highly 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
field. Ointments of low viscosity only heat slightly. Volatile substances such as ethereal oils or alcohol do not evaporate from
the closed mixing unit.
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 dishwasher.
The FagronLab™ devices as well as the FagronLab™ line of products should never be treated with sharp-edged objects or
abrasive cleaning agents.

FagronLab™ BASIC – User Manual | 11
FagronLab™ BASIC
FagronLab™ Standard Mixing Blade (SMB)
FagronLab™ Disposable Blade (Disp. Blade)
FagronLab™ jar
The FagronLab™ SMB’s are adjusted to the size of each individual FagronLab™ 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 formulations. We
recommend especially for suspension ointments and pre-grinding the use of the
standard mixing blade.
The FagronLab™ Disp. Blade is suitable for all FagronLab™ 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 material 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 final 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-grinding is recommended
the use of SMB.
The FagronLab™ 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 FagronLab™ 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 contamination surface, the jar
guarantees the minimization of negative quality interference demanded by section 13, ApBetrO (Pharmacy Operation
Regulations); including those caused by germs on fingers when dispensing the ointment. Therefore, the user can remove
very hygienically the ointment from the jar.
Pic.: FagronLab™ Standard Mixing
Blade
Pic.: FagronLab™ Disposable Blade
Pic.: FagronLab™ Disposable Blade Shaft

FagronLab™ BASIC – User Manual | 12
FagronLab™ BASIC
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.
All jars come sealed in plastic packaging. Cleaning or disinfection prior usage could put the certified 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.
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 destroyed after repeated mixing. The corresponding jar lids or jar
bottoms can be ordered as spare parts in sets of five and used for the economical reuse of the body.
Pic.: FagronLab™ jars
Pic.: AirDynamic/spindle
Jars are available in following sizes: 15-20/33 ml, 30/42 ml, 50/70 ml, 100/140 ml,
200/280 ml, 300/390 ml, 500/600 ml, 1000/1250 ml and 2000/2600 ml (rated
volume/filling 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.
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 oxidation 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.

FagronLab™ BASIC – User Manual | 13
FagronLab™ BASIC
The jar is subject to periodic inspections in accordance to the guidelines of the Bundesapothekerkammer "Examination and
Storage of primary packaging material". A certificate of analysis is issued after batch-defined examinations. After a visual
receiving inspection the manufacturer‘s test certificate (certificate of analysis) is retained for the documentation of primary
packing materials as stipulated.This certificate is axed to the plastic packaging of the jar. If required, it can be removed and
added to the stipulated documentation.
A detailed certificate is available for download at www.fagronlab.com/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.
Pic.: Certificate of analysis FagronLab™ jar
Pic.: Jar label FagronLab™ jar
Analysenzertifikat
Certificate of analysis
VPE/pu: 10
Ch-B/Lot.No: 5AAAAAAAARYD
Art.-Nr./PCN: AT1000000267
PZN: 11602883 BLOZ: 1234567
PPN: 1111602883
Prüfdatum/date of control: 1/1/2016
VPE/pu: 10
Ch-B/Lot.No: 5AAAAAAAARYD
Art.-Nr./PCN: AT1000000267
PZN: 11602883 BLOZ: 1234567
PPN: 1111602883
Prüfdatum/date of control: 1/1/2016
Detailliertes Analysenzertifikat/detailed certificate of analysis: fagronlab.com/coa
Geprüft nach Arzneibuch (entspricht) / tested according to pharmacopoeia (complies)
manufactured for Fagron Group by Gako International GmbH, D-96110 Scheßlitz
which is certified according DIN EN ISO 9001:2015
Gezeichnet/signed: Glöckner (Leiter Qualitätswesen/Head of Quality)
Made in Germany
Detailliertes Analysenzertifikat/detailed certificate of analysis:
fagronlab.com/coa
en: Only material and color components which correspond to
the
German Consumer Goods Ordinance (BedGgstVO),
the
regulation
(EC) No. 1935/2004 and the FDA
regulations
(21CFR177.1520,
4/2012) are used for this product.
Quality
control
is performed in accordance with the
Pharmacopoeias
DAB,
Ph. Eur., USP and JP. Detailed certificate of
analysis
available:
fagronlab.com/coa This product can be
used
without cleaning.
pl:
Wszystkie surowce i barwniki odpowiadają
niemieckiemu
rozporządzeniu
dotyczącym konsumentów i
towarów
(BedGgstVO),
europejskiemu rozporządzeniu (WE)
nr.
1935/2004
oraz regulacjami FDA (21CFR177.1520,
4/2012).
Kontrola
jakości odbywa się zgodnie z Farmakopei DAB,
Ph.
Eur.,
USP i JP. Szczegółowe informacje:
fagronlab.com/coa
Produkt
ten może być stosowany bezpośrednio
bez
oczyszczenia.
pt:
Este produto utiliza apenas componentes com materiais
e
cores
de acordo com o regulamento de bens de
consumo
alemão
(BedGgstVO), o Regulamento (CE) N.o 1935/2004
e
os
regulamentos da FDA (21CFR177.1520, 4/2012).
O
controlo
de qualidade é realizado em conformidade com
as
Farmacopeias
DAB, Ph. Eur., USP e JP. Certificado de
análise
detalhado,
disponível em fagronlab.com/coa Este
produto
pode ser utilizado de imediato sem limpeza prévia.
fr: Ce produit utilise exclusivement des composants (matériaux
et
couleurs) qui suivent la réglementation en vigueur
en
Allemagne
(BedGgstVO), en Europe (règlement (CE)
No
1935/2004
et aux États-Unis (21CFR177.1520, 4/2012).
Le
contrôle
de la qualité est effectué en conformité avec
les
Pharmacopées
DAB, Ph. Eur., USP et JP. Certificat
d'analyse
détaillée
disponible:
www.unguator.com/coa.
fagronlab.com/coa
Ce produit peut être utilisé
sans
nettoyage préalable.
sl:
Za izdelke se uporabljajo samo materiali in
barvne
komponente,
ki ustrezajo nemškemu odloku o
potrošniškem
blagu
(BedGgstVO), uredbi (ES) št. 1935/2004 in
predpisih
organa
FDA (21CFR177.1520, 4/2012). Nadzor kakovosti
se
izvaja
v skladu s farmakopejami DAB, Ph. Eur., USP in
JP.
Podrobno
potrdilo o analizi je na voljo:
unguator.com/coa
fagronlab.com/coa
Izdelek se lahko uporablja
neposredno
brez predhodnega čiščenja
es:
En este producto se utilizan exclusivamente
componentes
(materiales
y colores) de acuerdo con la Ordenanza
Alemana
de
Bienes de Consumo (BedGgstVO), el Reglamento (CE)
No
1935/2004
y la directriz de la FDA (21CFR177.1520,
4/2012).
El
control de calidad se realiza de acuerdo con
las
farmacopeas
DAB, Ph. Eur., USP y JP. El certificado
de
análisis
detallado está disponible en: fagronlab.com/coa
Este
producto se puede utilizar directamente sin limpieza
de:
Für dieses Produkt werden nur Material-
und
Farbkomponenten
verwendet, die der BedGgstVO, der
Verordnung
(EG) Nr. 1935/2004 und der FDA-Richtlinie
(21CFR177.1520,
4/2012) entsprechen. Die
Qualitätskontrolle
wird gemäß den Arzneibüchern DAB,
Ph.
Eur., USP und JP durchgeführt. Dieses Produkt kann
ohne Reinigung direkt verwendet werden.
cs:
Pro výrobu tohoto produktu byly použity pouze
materiály
a barvy, které odpovídají německým vyhláškám o
spotřebním
zboží (BedGgstVO), nařízení (ES) č1935/2004
a
předpisům FDA (21CFR177.1520, 4/2012). Kontrola
kvality
je prováděna podle lékopisů DAB, Ph. Eur., USP a
JP.
Podrobné certifikáty o analýze je dotupné na:
fagronlab.com/coa
Tento produkt může být použit bez
dalšího mytí.
sk:
Pre výrobu tohto produktu boli použité iba materiály a
farby,
ktoré zodpovedajú nemeckým vyhláškam o
spotrebnom
tovare (BedGgstVO), nariadenia (ES) č
1935/2004
a predpisom FDA (21CFR177.1520, 4/2012).
Kontrola
kvality je vykonávaná podľa liekopisov DAB, Ph.
Eur.,
USP a JP. Podrobné certifikáty o analýze je dotupné
na:
fagronlab.com/coa Tento produkt môže byť použitý
bez ďalšieho umývania.
manufactured for Fagron Group by
Gako International GmbH, D-96110 Scheßlitz
which is certified according
DIN EN ISO 9001:2015
Gezeichnet/signed: Glöckner
(Leiter Qualitätswesen/Head of Quality)
4 251208 8000604 251208 800060
Made in Germany
! 100
! 100
! 100
Ch-B/Lot.No: 5AAAAAAAARGD
PCN: AT1000000267
1/1/2016 - 1/1/2018
PZN: 11602883 BLOZ: 1234567
fagronlab.com/coa
manufactured for Fagron Group by
Gako International GmbH, D-96110 Scheßlitz
which is certified according
DIN EN ISO 9001:2015
Made in Germany

FagronLab™ BASIC – User Manual | 14
FagronLab™ BASIC
Notes on dispensing ointment
FagronLab™ applicators
FagronLab™ applicator short
Each customer should be given specific 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.
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 removed, 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 FagronLab™ 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.
The FagronLab™ applicators reduce the extracted quantity of low-viscosity formulations and are particularly helpful in cases
where the ointment must be precisely applied.
The FagronLab™ applicator short with a diameter of 1 mm is obligatory for nose
and ear ointments.
FagronLab™ varionozzles
The FagronLab™ varionozzles with inner diameters of 1, 2 or 4 mm can be pressed
into the regular nozzle of any FagronLab™ jar. They reduce the opening size,
making it possible to safely dose even low viscosity formulations. The viscosity
of the finished product normally specifies 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)
Pic.: FagronLab™ varionozzles
Pic.: FagronLab™ applicator short

FagronLab™ BASIC – User Manual | 15
FagronLab™ BASIC
FagronLab™ applicator long
FagronLab™ coupling
The FagronLab™ applicator long with a diameter of 2 mm allows formulations to
be introduced into large orifices of the body or probes.
In addition, the applicator long also comes inside each FagronLab™ 200 ml jar to
help pushing up the bottom of this jar size in full.
The FagronLab™ coupling connects two FagronLab™ jars by their screw threads
of their dispensing openings and is very useful when preparing ointments 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.
The jar coupling is available as FagronLab™ jar coupling 15 - 1000 ml and
also as FagronLab™ jar coupling 2000 ml.
Pic.: FagronLab™ applicator long
Pic.: FagronLab™ coupling
Pic.: FagronLab™ spindle
FagronLab™ spindle
The FagronLab™ spindle serves as a dispensing system for FagronLab™ 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 clockwise 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.
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 formulation is still warm and less viscous.

FagronLab™ BASIC – User Manual | 16
FagronLab™ BASIC
FagronLab™ AirDynamic
FagronLab™ ExactDose adapter
The FagronLab™ AirDynamic optimizes batch preparation within the closed
system:
•Contamination-free transfer
•Contamination-free storage
It is designed for FagronLab™ jar sizes from 300 to 2000 ml for hygienic
transfer of the compound. The jar is attached to the base plate of the
AirDynamic with the central hole at the bottom of the jar housing. By closing
the easy-lock system on the side of the base plate, the jar is attached
airtight.
The FagronLab™ 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 finished.
Insert the red set screw with a little pressure into the transparent part of the
ExactDose Adapter.
The coloured ball inside the ExactDose Adapter lays on its lowest position when
the red set screw is horizontally positioned.
Pic.: FagronLabAirDynamic
Pic.: FagronLab™ ExactDose
By pressing the pump ball, with its valve screw closed, air is pumped into the lower chamber of the jar. The thus generated
pressure pushes the movable bottom up.
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 has 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 environment, depending on the formulation viscosity.
With pushing the jar bottom upwards the ExactDose chamber will be filled 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 filled again with compound for the next dosage extraction.

FagronLab™ BASIC – User Manual | 17
•On initial operation the reference for the online
registration at www.fagronlab.com/re will be displayed
•The touch panel is on the front of the FagronLab™
BASIC, with a minus button (left), the compounding
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
"FagronLab™ BASIC"
•Followed by the current number of preparations. After
a few seconds it forwards automatically to the next
screen.
•Enter the 12 digit serial number online at
www.fagronlab.com/re to register the new device. Then
a four digit PIN number will be provided to activate the
FagronLab™ BASIC
•Enter the four digit PIN on the display of the FagronLab™
BASIC
4. Display handling
FagronLab™ BASIC
Initial operation
Pic.: Display FagronLab™ BASIC
Pic.: Display device type
Pic.: Display current preparation
Pic.: Display registration
Pic.: Display PIN
Registration

FagronLab™ BASIC – User Manual | 18
FagronLab™ BASIC
•The displayed numbers change with the plus and minus
button. By pushing on the compounding button , it jumps
to the next position. If a number is entered incorrectly, it is
possible to navigate to the input position again
•By pressing the compounding button for three seconds the
four digit PIN is confirmed
•If the PIN was not entered correctly the display will show "Wrong PIN"
•After pushing the compounding button the PIN can be entered
again
Pic.: Display wrong PIN
Pic.: Display IQ - Mode
Pic.: Display contact
•We recommend to perform a function test before using the device for the first time "Installation Qualification (IQ)"
•Move the lift arm in its lowest position. To insert the mixing unit into the quick-lock coupling (review chapter 4 "quick-lock
coupling"), it is recommended to use slight pressure from the top of the lift arm
•Press the compounding button for two seconds, the display will show "IQ-Mode Start?"
•Move the mixing unit up by hand and with pushing the compounding button the mixing process starts. The jar is moved by
hand up and down in its available range, the complete compound needs to be interpenetrated from lid to bottom
•Every mixing speed level runs five seconds, to test intern if the actual speed of rotation equals the level of the given speed of rotation
•As soon as the FagronLab™ display shows the free spin program
•Move the jar into its lowest possible position. After the process is finished, the mixing shaft automatically unlocks and the mixing
unit in the lift arm can be moved to its lowest position for extracting
•By pushing the compounding button the start screen appears
•Fill a 50 ml FagronLab™ jar with following testing compound:
- Iron oxide (or a dierent colourful test substance) 0,01
- Semi-solid foundation ad 50,00
•Insert the SMB into the test jar and close it
•If the mixing speed level test determines discrepancies, the
display shows "please contact [e-mail]". Please
contact the technical service per email with the serial
number of the FagronLab™ BASIC
•By pushing the compounding button the start screen
appears
Installation qualification (IQ)/Operation qualification (OQ)
IQ - Mode
Not OK

FagronLab™ BASIC – User Manual | 19
FagronLab™ BASIC
•Push the minus button for two seconds and the start screen will automatically appear
Skip the IQ - Mode
Pic.: Display OQ-Mode
Pic.: Display maintenance
•After 1000 preparations upon start the request
to perform a functional test appears - Operation
Qualification (OQ)
•We recommend to perform the functional test always
after 1000 preparations to prove and record the proper
functioning of the FagronLab™ device. This is the only
way to ensure the expected mixing results are not
aected by malfunctions caused by constantly usage
•After 1500 preparations we recommend a maintenance
performed by our technical service
After 1000 preparations
After 1500 preparations
of the FagronLab™ device. If a repeated OQ test is not wanted, it is possible to jump to the start display by pushing the
minus button for two seconds
•If desired, the OQ functional test can be performed at any time by pushing the "+" and "-" button simultaneously for two
seconds
Compounding with the FagronLab™ BASIC
•The touch panel is on the front of the FagronLab™ BASIC,
with a minus button (left), the compounding button (middle)
and a plus button (right)
Pic.: Display FagronLab™ BASIC
Pic.: Start screen
•The device transfers to the start screen
OK

FagronLab™ BASIC – User Manual | 20
FagronLab™ BASIC
•Followed by the current number of preparations
•After a few seconds, it forwards to the next screen
•The start display shows the jar size, mixing time and the
mixing speed in levels
•Both, the mixing parameters and the jar size, can be changed individually through pressing the plus and minus touch button. To
switch between the operation settings push the compounding button . The changeable setting which will be modified with the
plus and minus button flashes
•The time changes in five seconds steps by pressing the plus/minus button. If the plus/minus button is longer pressed down, the
time setting changes will accelerate
•Depending which jar size will be used the recommended standard mixing speed level and the minimum mixing time will also
automatically be changed. Due to high rotation the levels 8 and 9 are not suitable for manufacturing in the jar sizes 300 ml and
500 ml, therefore, they are disabled for these quantities
•The lift arm is in its lowest position. To insert the mixing unit into the quick-lock coupling (review chapter 4 "quick-lock coupling"),
it is recommended to use slight pressure from the top of the lift arm
•Press the compounding button for two seconds, the display shows "Start?". Move the mixing unit up by hand and with pushing
the compounding button the mixing process starts. The jar is moved by hand up and down in its available range, the complete
compound needs to be interpenetrated from lid to bottom
Pic.: Display current preparations
Pic.: Start screen
Pic.: Display initializing Pic.: Display start?
•After starting up the device with the power switch, located
on the back, the display shows the device type "FagronLab™
BASIC"
Pic.: Display device type