gako unguator B/R User manual

Operang Instrucons and Producon Recomendaons
B/R

Dear UNGUATOR® user,
thank you for choosing the UNGUATOR® Mixing Technology,
a quality system
for advanced prescripon compounding.
Please read the operaons manual carefully.
For addional informaon about the use
and operaon of the
UNGUATOR® Mixing Technology,
please feel free to contact us at
[e-mail]

Table of content
1. Installaon informaon 1
2. Inial operaon 3
3. UNGUATOR® Technology 3
3.1 UNGUATOR® mixing machines 3
3.1.1 UNGUATOR® B/R 4
3.1.2 UNGUATOR® e/s 4
3.1.3 UNGUATOR® 2100 5
3.1.4 UNGUATOR® Q 5
3.2 UNGUATOR® Assortment 6
3.2.1 UNGUATOR® Mixing Blade (MB) 6
3.2.2 UNGUATOR® Jar 9
3.2.3 UNGUATOR® Varionozzles 12
3.2.4 UNGUATOR® Applicators 12
3.2.5 UNGUATOR® Spindle 13
3.2.6 UNGUATOR® Coupling 14
3.2.7 Air Dynamic® Pumpball System 14
4. General guidelines for the UNGUATOR® Technology 15
4.1 Preparing the UNGUATOR® Mixing System 15
4.2 Weighedporonoftheformulaon    15
4.3 Preparing the mixing process 16
4.4 The mixing process using the UNGUATOR® B/R 17
4.4.1 Emulsion 18
4.4.2 Emulsion + 18
4.4.3 Normal 19
4.4.4 Suspension <2% 19
4.4.5 Suspension >2% 20
4.4.6 Gel 20
4.4.7 Suppositories 21
4.4.8 Powder 21
4.5 Requirementsfortheingredientsofaprescripon   21
4.6 Aerthemixingprocessiscomplete    22
5. General notes for the UNGUATOR® Mixing System 24
5.1 PatentProtecon      24
5.2 Potenalsourcesofnonconformances    24
5.3 Qualityassuranceoftheointments    25
6. Service and warranty 25
6.1 Notesonmalfuncons      25
6.2 Manufacturer’sServiceandwarranty    26
6.3 Notes on maintenance 26
6.4 Notesonsafety       27

6.5 TechnicaldataoftheUNGUATOR®B/R    28
6.6 Quality and material 28
7. Manufacture’s cercate 30
8. References 29
9. Bibliography 31
10. Distribuon, manufacturing and customer service 32
Index of tables
Tab.1.Qualityimprovementwithincreasingautomaon   4
Tab.2.Minimumvaluesformixingmeatspeedlevel9inmin:sec  17
Tab.3.Minimumvaluesformixingmeatspeedlevel5inmin:sec  18
Index of pictures
Pic.1UNGUATOR®B/Rdescripon     2
Pic. 2 UNGUATOR® B/R 4
Pic. 3 UNGUATOR® e/s 4
Pic. 4 UNGUATOR® 2100 5
Pic. 5 UNGUATOR® Q 5
Pic. 6 UNGUATOR® Standard mixing blade (SMB) 6
Pic. 7 UNGUATOR® disposable blade 7
Pic. 8 Handling the UNGUATOR® disp. blade 7
Pic.9AssignmentoftheUNGUATOR®SMBwithdierentlengthofsha 8
Pic. 10 UNGUATOR® Jars 9
Pic.11CercateofanalysisfortheUNGUATOR®Jar50ml   10
Pic.12DispensingwithregularUNGUATOR®varionozzle   11
Pic.13DispensingwithUNGUATOR®1mmvarionozzlesorUNGUATOR®
applicator short 11
Pic. 14 Dispensing with UNGUATOR® 2mm Varionozzles or UNGUATOR®
applicator long 11
Pic.15DispensingwithUNGUATOR®varionozzles4mm   11
Pic.16UNGUATOR®varionozzles,1,2,4mm.    12
Pic. 17 UNGUATOR® Applicator short 12
Pic. 18 UNGUATOR® Applicator long 12
Pic. 19 UNGUATOR® Spindle 13
Pic. 20 How to operate the UNGUATOR® Spindle 13
Pic. 21 UNGUATOR® Coupling 14
Pic. 22 UNGUATOR® AirDynamic® Pumpballsystem 14

1
1. Installaon informaon
Select a suitable locaon for the UNGUATOR® B/R
CAUTION! The UNGUATOR® B/R weighs almost 15 lbs (6,8 kg). It is recommended to have
an assistant while carrying and moving the equipment to the nal desnaon.
Ensure that there is enough space to operate the UNGUATOR® B/R. This must include
sucient space around the UNGUATOR® B/R to provide good venlaon.
Select a suitable environment:
• Solid, horizontal surface
• Away from direct air ow from air condioning systems, heaters, open windows or fans.
• Keep the temperature between 15°- 30° C (59°- 86°F) and maximum humidity of 80%.
• Clean, dry and dust-free.
Remove all components from the cardboard box. Check to ensure that the following
components are included in your shipment:
• UNGUATOR® B/R mixing device
• Power cable
• Operang instrucons
Please contact your responsible UNGUATOR® dealer and/or supplier immediately in case
that components are missing or arrived damaged. Aerwards, we will not accept any
claims regarding missing or defect items, they will be for your account!
Please hold on to the original cardboard box and packing material in case you have to send
the UNGUATOR® device in for service.

Fig. 1: UNGUATOR® B/R descripon
UNGUATOR B/R
2
Speed controller
Drive head
Power cord

2. Inial operaon
You will nd the power switch “O/I” located at the rear of the UNGUATOR® B/R on its
base. This is also the emergency switch. Please check that the UNGUATOR® B/R power
switch is set to o. Connect the power cord to the socket outlet. You may now switch
the UNGUATOR® B/R on using the power switch. The device is now ready for operaon.
3. UNGUATOR® Technology
The UNGUATOR® Technology reduces the mechanical preparaon of formulaon ointments
to the least common denominator. The core of UNGUATOR® Technology consists of
the patented arrangement of the UNGUATOR® Mixing Blade adapted to the
requirements of prescripon ointments and the UNGUATOR® Jar that serves as both
a hygienic mixing jar and a hygienic dispensing jar.
The principle of the preparaon method using UNGUATOR® Technology in the closed
UNGUATOR® Mixing System is quick and easy to learn, true to the moo:
learning by doing
A lile experience will make it easy to prepare ointments though they may seem
rather complicated at rst. Using the UNGUATOR® Technology enables the pharmacy
to beer prepare prescripon ointments in a shorter period of me compared to
the convenonal methods that were used prior to the invenon (1994). For the
rst me, it is possible to not only standardize ointments, but validate them too.
3.1 UNGUATOR® mixing machines
The current UNGUATOR® mixing machines - the UNGUATOR® B/R, the UNGUATOR® e/s,
the UNGUATOR® 2100 and the UNGUATOR Q - are useful and advanced improvements on
the rst UNGUATOR® from 1994. They are designed for a working capacity of approx. 500
work hours wich corresponds to approximately 15,000 to 20,000 preparaons.
The UNGUATOR® mixing machines feature a high safety standard and were tested by
TÜV-Rheinland, Germany for safety. The devices are manufactured under license and
maintained by dened service partners.
Product quality, product uniformity and reproducibility of ointments prepared individually
and in batches were improved with the increasing automaon of the UNGUATOR® units
starng with the individual model B/R- through the e/s-, Q- and 2100 models.
3

4
Method of
ointment
preparaon
Pharmaceucal
QUality
Uniformity of oint-
ment
Liing arm Mixing parameters
Bowl and pestle ++ +(-) manual
UNGUATOR® B/R +++ ++ manual manually
adjustable
UNGUATOR® e/s +++ +++ automac individually
programmable
UNGUATOR® Q ++++ ++++ automac fully automac
UNGUATOR® 2100 ++++ ++++ automac fully automac
3.1.1 UNGUATOR® B/R
The UNGUATOR® B/R is the basic machine with controlled
mixing motor and manual jar guidance.
3.1.2 UNGUATOR® e/s
The UNGUATOR® e/s machine was developed for ecient individual and batch preparaons.
The automated stroke enables the user to leave the UNGUATOR® e/s during the mixing
process to serve a customer for instance or to prepare the next formulaon at the same
me.
The precisely set sensor for the automac oscillaon arm will
always ascertain at each upward or downward stroke the exact
posion of the UNGUATOR® Jar boom or lid. This guarantees
that the UNGUATOR® Jar is always accessible to the UNGUATOR®
Mixing Blade despite the inevitable vercal moon during the
mixing process. If the stroke length of the rst stroke was taken
as a constant value, then the acve ingredient weighed out in the
lower region of the UNGUATOR® Jar might not be included in the
mixing process by the UNGUATOR® Mixing Blade, geng „lost“
at the boom. The liing technique of the UNGUATOR® Mixing
System prevents this from happening, so that the result of the
mixing process is not just a homogeneous ointment, but also one
with the desired rao of acve ingredients.
Tab.1: Quality improvement with increasing automaon
Pic. 2: UNGUATOR® B/R
Pic. 3: UNGUATOR® e/s

5
3.1.3 UNGUATOR® 2100
The UNGUATOR® 2100 shows all the advantages of its
predecessors and can therefore automacally control the
mixing parameters for each UNGUATOR® Jar size and dierent
types of ointments. The user may program individual mixing
parameters with a maximum of 180 addional programs that
can be stored. The UNGUATOR® 2100 can be connected to a
PC via an USB interface.
An integrated microprocessor measures the actual revoluons
of the UNGUATOR® Mixing Blade carried out by the UNGUATOR®
2100. This guarantees that the selected mixing program will
always be idencal, even for paste-like preparaons which usually might demand more
power from the mixing motor. This makes it easy to develop new ointments, cosmecs,
etc. using the UNGUATOR® 2100, since only the composion changes and not the mixing
program. As a result, ointments can now nally be reliably reproduced even in smaller
quanes.
The adjustable stroke speed, or the speed of the upward or downward moon of the
automated oscillaon arm, is another unique feature of the UNGUATOR® 2100. This allows
the UNGUATOR® Mixing Blade to rotate at lower speed while the UNGUATOR® Jar quickly
travels up and down, or vice versa. This new funcon is parcularly useful using a low
rotang speed of the UNGUATOR® Mixing Blade since it allows the UNGUATOR® Mixing
Blade to mix an ointment homogeneously with a slow stroke.
3.1.4 UNGUATOR® Q
The UNGUATOR Q is the result of connuous improvement of
the UNGUATOR® e/s from the year 2003.
It combines both the mixing funcons of the UNGUATOR® e/s
and the operang concept of the UNGUATOR® 2100. The basic
funconality of the e/s - System, with the seng parameters of
the mixing rotaon speed and me are retained. A signicant
innovaon of the UNGUATOR® Q is the possibility of scaling
one mixing program already created automacally to another
jar size. This enables a constant quality of the formulaons
and as a consequence, has a tremendous me saving result,
since recalculaon can be very me consuming and complex.
Pic. 4: UNGUATOR® 2100
Pic. 5: UNGUATOR® Q

3.2 UNGUATOR® Assortment
Appart from the UNGUATOR® Standard Mixing Blade (SMB), the UNGUATOR® Disposable
Blade (Disp. Blade) and the UNGUATOR® Jars, the UNGUATOR® Assortment provides
addional and useful components. These include dosing aids such as the UNGUATOR®
Varionozzles and UNGUATOR® Applicators, removal or transfer aids such as the
UNGUATOR® Spindle, the UNGUATOR® Coupling and the patented AirDynamic® Pumpball
System. All UNGUATOR® products are compable with all UNGUATOR® Mixing devices.
3.2.1 UNGUATOR® Mixing blade (MB)
The UNGUATOR® Standard Mixing Blade and the UNGUATOR® Disposable Blade are
designated as UNGUATOR® MBs. The UNGUATOR® MBs are steadily guided up and down
inside the UNGUATOR® Jar. Their special design results in a ght contact between the
mixing blade and the inside wall of the UNGUATOR® Jar, which serves, primarily, for
comminung the substances during the mixing process. Addionally forced mixing in
the whole mixing unit is achieved through the shape and vibraon of substances while
preparing the ointment.
The lubricang eect of the ointment and substances generally protects the UNGUATOR®
Jars and the UNGUATOR® MB against abrasion. Discoloraons of the mixing blade are
mostly irreversible and therefore harmless. All UNGUATOR® MBs are dishwasher safe.
UNGUATOR® Standard mixing blade (SMB)
UNGUATOR® SMBs are adjusted to the size of each
individual UNGUATOR® Jar. While the UNGUATOR®
SMBs for 100 and 200 ml and for the 300 and 500 ml
jars have the same mixing blade diameter, their sha
length diers. This must be taken into consideraon,
parculary when using the UNGUATOR® e/s and the
UNGUATOR® 2100, since the use of the wrong lenght
may cause problems with the automated stroke.
Always make sure the UNGUATOR® MB used is the right lenght, and that it is clean prior
use. (e.g. with isopropanol 70%).
The UNGUATOR® SMB is suitable for the producon of all recipes. For suspension
ointments and glass cleaning operaons, we recommend the use of the UNGUATOR®
Disp. Blade.
6
Pic. 6: UNGUATOR® SMB