Gako Unguator e/s User manual

Content

1 UNGUATOR

Mixing System ..........................................................................7

1.1 UNGUATOR

Technology ................................................................................7

1.2 UNGUATOR

Mixing Machines ..................................................................... 10

1.2.1 UNGUATOR

B/R .......................................................................................... 11

1.2.2 UNGUATOR

e/s ...........................................................................................11

1.2.3 UNGUATOR

2100 ........................................................................................11

1.3.1 UNGUATOR

Mixing Blade (MB) ..................................................................11

1.3.2 UNGUATOR

Jar ...........................................................................................13

1.3.3 UNGUATOR

Varionozzles ........................................................................... 15

1.3.4 UNGUATOR

Applicators ..............................................................................15

1.3.5 UNGUATOR

Spindle ....................................................................................16

1.3.6 UNGUATOR

Coupling .................................................................................. 17

1.3.7 AirDynamic

System .....................................................................................18

1.4 Quality verification .........................................................................................18

2 General guidelines for the UNGUATOR

Mixing System .............................19

2.1 Preparing the UNGUATOR

Mixing System .................................................19

2.2 Weighing in the formulation constituents ......................................................19

2.2.1 Emulsion ........................................................................................................20

2.2.2 Emulsion + .....................................................................................................20

2.2.3 Normal ........................................................................................................... 21

2.2.4 Suspension < 2% ..........................................................................................21

2.2.5 Suspension > 2% ..........................................................................................22

2.2.6 Gel .................................................................................................................22

2.2.7 Suppositories.................................................................................................23

2.2.8 Powder ...........................................................................................................23

2.2.9 General notes ................................................................................................23

2.3 Preparing the mixing process .......................................................................25

2.4 The mixing process ....................................................................................... 25

2.5 After the mixing process is complete ............................................................25

3 The mixing process using the UNGUATOR

e/s...........................................27

3.1 Operation mode “AUTO“ ............................................................................... 28

3.2 Operation mode “HAND“ ...............................................................................29

3.3 General notes on operation ..........................................................................30

4 General notes on the UNGUATOR

Mixing System .....................................33

4.1 References ....................................................................................................33

4.2 Notes on the mixing process .........................................................................33

4.2.1 Assignment of the UNGUATOR

MB ............................................................ 33

4.2.2 Niches of flow on the UNGUATOR

Standard Mixing Blade (SMB) ............. 34

4Content

4.2.3 Heating ..........................................................................................................35

4.2.4 Cleaning the UNGUATOR

MB ..................................................................... 35

4.2.5 Possible error sources to be avoided ............................................................35

4.3 Notes on dispensing ointment.......................................................................36

4.4 Quality assurance of the ointments ..............................................................38

5 Service and warranty ....................................................................................39

5.1 Notes on malfunctions ...................................................................................39

5.2 Manufacturer’s service and warranty in Germany ........................................39

6 Bibliography ...................................................................................................41

7 Notes on safety ............................................................................................. 42

8 Technical data of the UNGUATOR

e/s.........................................................43

9 Manufacturer’s Certificate .............................................................................44

10 Distribution, manufacturing and customer service .......................................45

11 WARRANTY CERTIFICATE ..........................................................................46

12 Document template .......................................................................................48

Indes of tables and figures

Index of tables and figures

Tab. 1-1: Quality improvement with increasing automation ...................................... 8

Fig. 1-1 UNGUATOR

B/R ....................................................................................... 9

Fig. 1-2: UNGUATOR

e/s ......................................................................................... 9

Fig. 1-3: UNGUATOR

2100 ................................................................................... 10

Fig. 1-4: UNGUATOR

SMB .................................................................................... 11

Fig. 1-5: UNGUATOR

Disp. Blade ......................................................................... 12

Fig. 1-6: Handling the UNGUATOR

Disp. Blade.................................................... 12

Fig. 1-7: UNGUATOR

Jars ..................................................................................... 13

Fig. 1-8: Certificate of analysis for the 100 ml UNGUATOR

Jar ........................... 14

Fig. 1-9: UNGUATOR

Varionozzles ....................................................................... 15

Fig. 1-10: UNGUATOR

Applicator short and long ................................................. 15

Fig. 1-11: Note on operation 1 for the UNGUATOR

Spindle ................................... 16

Fig. 1-12: Note on operation 2 for the UNGUATOR

Spindle ................................... 16

Fig. 1-13: UNGUATOR

Spindle ............................................................................... 16

Fig. 1-14: Transfer using a 200 ml UNGUATOR

Jar................................................ 17

Fig. 1-15: UNGUATOR

Coupling ............................................................................. 17

Fig. 1-16: AirDynamic

System ................................................................................. 18

Fig. 3-1: Control panel ofthe UNGUATOR

e/s....................................................... 27

Tab. 3-1: Value table of the speed steps ................................................................. 28

Tab. 3-2: Minimum values for mixing time at speed step 9 in min:sec .................... 30

Tab. 3-3: Minimum values for mixing time at speed step 5 in min:sec .................... 31

Tab. 3-4: Minimum values for mixing time at speed step 1 in min:sec .................... 31

Tab. 3-5: UNGUATOR

e/s error messages ............................................................ 32

Fig. 4-1: Assignment of the UNGUATOR

SMB with different

lengths of shaft ......................................................................................... 34

Fig. 4-2: Opening of the UNGUATOR

Jar Lid........................................................ 37

Fig. 4-3: Opening of the UNGUATOR

Varionozzle 4 mm ..................................... 37

Fig. 4-4: Opening of the UNGUATOR

Varionozzle 2 mm

or of the UNGUATOR

Applicator long .................................................... 37

Fig. 4-5: Opening of the UNGUATOR

Varionozzle 1 mm

or of the UNGUATOR

Applicator short .................................................. 37

6UNGUATOR®Mixing System

Please look over the operating instructions carefully

, in particular the notes on

safety, before operating the UNGUATOR

e/s. After a certain period of use, it may

make sense to study the operating instructions more closely for selected information.

Installation notes:

Select a suitable location for the UNGUATOR

e/s. CAUTION! The UNGUATOR

e/s

weighs almost 21 lbs.

Ensure that there is enough space to operate the UNGUATOR

e/s.This must include

sufficient space around the UNGUATOR

e/s to provide good ventilation.

Select a suitable environment:

•

Solid, level surface

•

Away from direct air flow from air conditioning systems, heaters, open windows

or fans

•

Removed from direct insolation, extreme humidity or temperature fluctuations

•

Clean, dry and dust-free

Remove all components from the cardboard box. Check to ensure that the following

components were included in shipment:

•

UNGUATOR

e/s

•

Operating instructions

Please contact customer service at SMS Elap GmbH & Co. KG. in the event that

components are missing or damaged. Contact information is at the end of these

operating instructions. Keep the cardboard box and the packing material in case you

have to send the UNGUATOR

e/s in for service.

You will find the power switch „O/I“ at the rear of the UNGUATOR

e/s on its base.

This is also the emergency switch. Please check now that the UNGUATOR

e/s power

switch is set to off. Connect the power cord to the socket outlet. You may now switch

the UNGUATOR

e/s on using the power switch. It is now ready for operation and

should show the default settings 2 minutes mixing time and speed step „5“ on the

display.

UNGUATOR®Mixing System

UNGUATOR®-Rührsystem

1 UNGUATOR®Mixing System

The UNGUATOR

Mixing System consists of UNGUATOR

Technology, the

UNGUATOR

mixing machines and further UNGUATOR

line products.

The UNGUATOR

Mixing System, and UNGUATOR

Technology and the AirDynamic

System integrated therein are inventions of the pharmacist Albrecht Konietzko from

Bamberg in Germany. UNGUATOR

Technology and the AirDynamic

System are

patented in selected countries. UNGUATOR

and AirDynamic

are protected

trademarks and exclusively refer to devices and line products from GAKO

Konietzko GmbH or under license of GAKO International GmbH.

The UNGUATOR

Mixing System from GAKO Konietzko GmbH is the original.

The UNGUATOR

Mixing System with its versatile and comprehensive line products

captivates with its simplicity. Everything the pharmacist needs for the production of

pharmaceutical ointments and cosmetics is covered by the UNGUATOR

Mixing Sy-

stem.To continue to ensure that this is remains so, GAKO Konietzko GmbH consistently

strives to both maintain and improve the quality of the UNGUATOR

Mixing System.

To achieve this aim we continue to search for efficient improvements in addition to

periodic quality controls. This objective is actively supported by application of vast

know-how of the inventor of the UNGUATOR

Mixing System, pharmacist Albrecht

Konietzko.

1.1 UNGUATOR®Technology

UNGUATOR

Technology reduces the mechanical preparation of formulation 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 prescription ointments and the UNGUATOR

Jar that serves as both

a hygienic mixing jar and a hygienic dispensing jar.

The principle of the preparation method using UNGUATOR

Technology in the closed

UNGUATOR

Mixing System is quick and easy to learn. Despite the almost countless

number of possible combinations of ingredients used in a pharmacy, there is no need

here to offer or list instructions for preparation. The motto here is:

learning by doing.

8UNGUATOR®Mixing System

A little experience will make it easy to prepare ointments though they may seem rather

complicated at first.

Using UNGUATOR

Technology enables the pharmacy to better prepare prescription

ointments in a shorter period of time compared to the preparation methods that were

common until 1994. For the first time, it is possible to not only standardize ointments,

but validate them too.

1.2 UNGUATOR®Mixing Machines

The current UNGUATOR

mixing machines - the UNGUATOR

B/R, the UNGU-

ATOR

e/s and the UNGUATOR

2100 - are useful and advanced improvements on

the first UNGUATOR

from 1994. They are designed for a working capacity of approx.

500 work hours which corresponds to approximately 15,000 to 20,000 prescriptions.

The UNGUATOR

mixing machines feature a high safety standard and were tested by

TÜV-Rhineland for their safety. They are manufactured under license and maintained

by SMS Elap GmbH & Co. KG in Zella Mehlis (Germany).

Product quality, product uniformity and reproducibility of ointments prepared individually

and in batches were improved with the increasing automation of the UNGUATOR

units starting with the B/R through the e/s to the 2100.

Notes on production Pharmaceutical Homogeneity Stroke Mixing parameters

quality of ointment guidance (speed, mixing time)

Mortar and pestle ++ + (–) (individual)

UNGUATOR

B/R +++ ++ individual individually adjustable

UNGUATOR

e/s +++ +++ automatisch individually programmable

UNGUATOR

2100 ++++ ++++ automatic fully automatic

Tab. 1-1: Quality improvement with increasing automation

UNGUATOR®Mixing System

1.2.1 UNGUATOR®B/R

The UNGUATOR

B/R is the basic machine with a

controlled mixing motor and manual jar guidance.

1.2.2 UNGUATOR®e/s

The UNGUATOR

e/s lift-off machine was developed

for efficient individual and batch preparation. 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

preparation.

The precisely set sensor for the automatic oscillation

arm will always ascertain at each upward or downward

stroke the exact position of the UNGUATOR

Jar

bottom or lid. This guarantees that the UNGU-

ATOR

Jar is always accessible to the UNGUATOR

Mixing Blade despite the inevitable displacement

motion during the mixing process. If the stroke length

of the first stroke was taken as a constant value, then

the active ingredient weighed in into the lower region

of the UNGUATOR

Jar might not be included in the

mixing process by the UNGUATOR

Mixing Blade,

getting “lost” at the bottom.The lifting 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 ratio of active ingredients.

1.2.3 UNGUATOR®2100

The UNGUATOR

2100 has all advantages of its predecessors and can therefore

automatically control the mixing parameters for each UNGUATOR

Jar size and diffe-

rent types of ointments. The user may program his or her own mixing programs into

the device and a maximum of 180 additional programs can be stored.

Fig. 1-2: UNGUATOR®e/s

Fig. 1-1: UNGUATOR®B/R

10 UNGUATOR®Mixing System

The UNGUATOR

2100 can be connected to and

controlled by a PC via a USB interface. This makes

programming even easier, making the number of

programs that can be stored practically unlimited.

An integrated microprocessor measures the actual

revolutions of the UNGUATOR

Mixing Blade carried

out by the UNGUATOR

2100. This guarantees that

the mixing program called up will always be identical,

also for paste preparations which demand more

power from the mixing motor. This makes it easy to

develop new ointments, cosmetics, etc. using the

UNGUATOR

2100 since only the composition

changes and not the mixing program. As a result,

ointments can now finally be reliably reproduced in

smaller quantities.

The adjustable stroke speed, or the speed of the upward or downward motion of the

automated oscillation arm, is another unique feature of the UNGUATOR

2100. This

allows the UNGUATOR

Mixing Blade to rotate at lower speed while UNGUATOR

Jar

quickly travels up and down, or vice versa. This new function is particularly useful

using a low rotating speed of the UNGUATOR

Mixing Blade since it allows the

UNGUATOR

Mixing Blade to mix an ointment homogeneously by slow stroke.

1.3 UNGUATOR®Assortment

In addition to the UNGUATOR

Standard Mixing Blade (SMB), the UNGUATOR

Disposable Blade (Disp. Blade) and the UNGUATOR

Jar, all essential for preparing

ointments using the UNGUATOR

Mixing System, the UNGUATOR

assortment

includes other additional and very 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

System. All UNGUATOR

products are compatible with each other.

1.3.1 UNGUATOR®Mixing Blade (MB)

The UNGUATOR

Standard Mixing Blade and the UNGUATOR

Disposable Blade are

designated as the UNGUATOR

MBs. The UNGUATOR

MBs are steadily guided up

and down inside the UNGUATOR

Jar. Their special design results in tight contact

Fig. 1-3: UNGUATOR®2100

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