WEPA TopiTec Automatic User manual

OPERATING MANUAL

2
AUTOMATIC Operating Manual | 01-2013
COPYRIGHT
The copyright for this operating manual is owned by WEPA Apothekenbedarf GmbH & Co KG.
This manual must not be reproduced, in whatever form and by whatever means, without the prior
written permission of WEPA Apothekenbedarf GmbH & Co KG.WEPA Apothekenbedarf GmbH & Co KG
shall not be liable for damage caused in connection with the use of this manual.
6th edition: January 2013 © Copyright 2010
WEPA Apothekenbedarf GmbH & Co KG
56204 Hillscheid, Germany
www.wepa-dieapothekenmarke.de

3
COPYRIGHT / TABLE OF CONTENTS
TABLE OF CONTENTS
Introduction 4
Customer service and spare parts 5
Safety instructions 6
Technical data 7
Standard equipment 8
Commissioning / start-up 9
Control elements 10
TOPITEC®AUTOMATIC button functions 11
Safety instructions 12-13
Mode: Mixing / preparation set-up 14-23
Connection of peripherals 24-25
Pricing 26-27
TOPITEC®jars + accessories 28-32
Cleaning and care instructions 33
Practical tips – instant remedy 34-36
Maintenance 37
Preparation list / template 38-39

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AUTOMATIC Operating Manual | 01-2013
INTRODUCTION
The production of preparations by pharmacists for the treatment of dermatological disorders is
bound to remain an important element of drug treatment. In this context, the preparation of medi-
cine for external application that can be extremely complex plays an important role.
The move from manual grinding with mortar and pestle to semi-automated and automated produc-
tion methods offers many advantages as regards the quality and the safety of the pharmaceutical
product. With the innovative TOPITEC®AUTOMATIC, you now have the option to perform many dif-
ferent comminution and mixing processes and save relevant parameters so that they can be called
up at any time for another batch.
Whether you use the TOPITEC®jar to mix ingredients for a single batch or work with the larger
stock preparation container available as an optional accessory – the TOPITEC®AUTOMATIC records
and stores the device settings, if you wish to do so. For this purpose, the device comes with 99
memory places.
Visit www.topitec.de/Wepa Wissensmanagement/TOPITEC®/Mediathek for a short video
that shows you how easy it is to operate the TOPITEC®AUTOMATIC and how the device
can be used for production in closed systems.
With the optional TOPITEC®DokuManager software, you even have the option to connect the
multi-talented mixing device to your PC, bringing together drug formulations and quality assurance.
All patient-specific prescriptions, preparations and stock preparations can thus be documented in a
single system.
Please contact us for more information: Phone [phone]
Phone [phone]
www.topitec.de
Your
TOPITEC®
Competence Centre

5
INTRODUCTION / SERVICE
CUSTOMER SERVICE AND SPARE PARTS
The TOPITEC®Competence Centre is there to assist you.
News and tips
The latest information and many useful tips in connection with the production of drugs with
the TOPITEC®AUTOMATIC mixing system are published on your website at www.topitec.de.
Please have a look and share your experience with the device!
Galenic queries concerning TOPITEC®equipment
Our qualified pharmaceutical specialists advise you on all matters regarding formulations
and applications that might arise in the use of your TOPITEC®mixing system.
Phone [phone] or [phone] [email protected] www.topitec.de
Technical support for TOPITEC®equipment
For technical support, contact our team of experts by telephone.
In Germany, we operate a technical call-out service.
Phone [phone] or [phone] [email protected] www.topitec.de
Technical support for TOPITEC®DokuManager
If you have any queries regarding the TOPITEC®documentation software,
call our helpline to talk to a member of our IT support staff.
Phone [phone] [email protected] www.topitec.de
Training
We assist professional associations in devising training courses to ensure that
pharmacists and other specialists are kept informed of the latest developments in the field.

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AUTOMATIC Operating Manual | 01-2013
SAFETY INSTRUCTIONS
Carefully read all chapters in this operating manual. Non-compliance
with our instructions might have serious consequences, including breach
of best practice or statutory regulations. If the device is operated improperly,
its safety devices might fail.
Keep the system and the accessories out of the reach of persons
who are not trained in its operation.
Protect the TOPITEC®AUTOMATIC system against splash water and
never immerse it in water.
Before opening the device, for example to replace a fuse,
set the power switch to "0" and disconnect the power plug.
After a power failure, the device automatically returns to the default settings
and the interrupted processes must be restarted.
Operate the TOPITEC®AUTOMATIC system only with a properly
mounted and secured mixing or grinding vessel.
During processing, do not reach into the slide guide or the rotating parts.
Keep long hair, limbs and clothing away from the slide. If hair,
limbs or clothing is caught in the slide, immediately press
the "STOP" button on the TOPITEC®AUTOMATIC display.
Keep the area below the slide guide free. If the slide is blocked,
remove the obstacle so that it can continue its movement.
For the use of detergents, observe the relevant manufacturer instructions.
Do not mix solvents, flammable or explosive substances.
Use only approved accessories. Do not connect any devices
that are not approved by the manufacturer.
All repairs, etc. must be performed by qualified and
authorised WEPA customer service technicians.

7
SAFETY INSTRUCTIONS / TECHNICAL DATA /
MANUFACTURER WARRANTY
TECHNICAL DATA
Display (WxH) 15.9 x 18 cm
Speed range from 300 to 4.000 rpm
Time settings from 0:10 to 99:50 minutes
Device dimensions (WxHxD) 240 x 680 x 240 mm
Weight 16.5 kg
Power connection 230 V / 50 Hz
Power consumption max. 400 W
Protection class IP 20
Permissible ambient temperature +15°C to +35°C
Permissible storage temperature +5°C to +50°C
Permissible air humidity 10% to 80%, non-condensing
Noise emission max. 62 dB(A) from min. to max. speed
TÜV approval by TÜV Rheinland Product Safety GmbH
Subject to technical changes without prior notice!
MANUFACTURER WARRANTY
TOPITEC®mixing devices come with a 5-year manufacturer warranty. The warranty shall not
cover damage caused by improper use or incorrect operation of the device. Proper use includes
strict adherence to the safety and care instructions in this manual. Damage caused by improper
packaging when shipping the device shall not be covered by the manufacturer's warranty.

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AUTOMATIC Operating Manual | 01-2013
STANDARD EQUIPMENT
TOPITEC®AUTOMATIC II. generation
available in the following colours
Order no. 25620 - Housing colour blue
Order no. 25621 - Housing colour white
Power cable, order no. 80850
10 A slow-acting spare fuses
2 fuses order no. 80426
Dust cover, order no. 25635
TOPITEC®jar holder (size 1)
for TOPITEC®jar sizes 20 g and 30 g, order no. 26631
TOPITEC®jar holder (size 2)
for TOPITEC®jar sizes 50 g to 200 g, order no. 26632
TOPITEC®clamping ring (metal)
for TOPITEC®single-patient jars preparation containers and powder mixing systems,
order no. 26633
Standard kit of TOPITEC®jars
1 SU (20 jars) TOPITEC®50 g jars, order no. 35252
1 SU (15 jars) TOPITEC®100 g jars, order no. 35253
1 SU (50 disks) mixing disks for TOPITEC®50-200 g jars, order no. 25691
Standard kit of TOPITEC®single-patient jars, order no. 25688
1 mixing tool for large containers
2 mixing lids for large containers
6 sealing rings for mixing lid
Tool shaft for mixing disks,
TiN coated, order no. 25680
Tool shaft cleaning vessel
with POM insert and exchangeable brush
(not including detergent), order no. 25675
Receipt booklet
including TOPITEC®jar user instructions, order no. 38053

9
STANDARD EQUIPMENT / COMMISSIONING
COMMISSIONING
Remove all packaging and protective material, position the TOPITEC®AUTOMATIC
on the worktop and switch it on.
The TOPITEC®AUTOMATIC must be placed on a level and firm surface.
When choosing the location of installation, observe the information below.
The power cable socket of the TOPITEC®AUTOMATIC is located at the rear of the device.
Compare the mains voltage with the rated voltage of the system (220/230 V).
The mains plug should always be easily accessible.
Before connecting the plug to the mains socket,
ensure that the power switch is set to "0" (OFF).
Switch on the TOPITEC®AUTOMATIC
by setting the power switch to "I".
The information to the left is displayed.
The device is now ready for operation.

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AUTOMATIC Operating Manual | 01-2013
Power switch
(at rear)
Selecting
system parameters
Selecting / confirming
menu option
Stop button (emer-
gency-stop button)
Move slide
Starting / terminating
process
Tool shaft adapter
Jar clamping device
with locking handles
Receptacle for TOPITEC®jars
50 - 200 g (detachable)
Receptacle for
TOPITEC®single-patient jars
or stock preparation jars
CONTROL ELEMENTS
Printer/PC interface
RS 232 (at rear)

11
CONTROL ELEMENTS /
OPERATING MODES / BUTTON FUNCTIONS
Button functions
Set values for "min.", "rpm"; select mode, or "Prep. no."
Press 1x to move slide based on default settings
(M: to 200g, 0:00 min, 000 rpm)
Select menu option (mode/min./rpm/pause/prep. no.) and confirm
Actuate when prompted by system: "Release tool shaft" and "Move slide".
Do not forget to release the tool shaft! Lift the safety bracket!
When the container is engaged, the next cycle is started when this button
is pressed. Alternatively, the process is terminated prematurely.
Only press this button if there is an error or malfunction!
(After switching off the TOPITEC®AUTOMATIC system
it must be restarted, see TOPITEC®manual, section
"Troubleshooting"). Exception: Change from
save mode to default mode.
Stop
+/–
–
Set
I/0
OPERATING MODES / BUTTON FUNCTIONS
 
 300G


+/-
Press to select mode
Set
Press 1x: "Min” flashes
Set
Press 1x: "M: to 200g" flashes
+/–
Set "min." with
Set
Press 1x: "rpm" flashes
+/–
Set "rpm" with
Set
Press 1x to confirm entry
I/0
Press 1x to start process
+/–
Slide moves up & tool shaft engages.
Program is started ("rpm" flashes; if necessary,
adjust rpm with ).
Program time countdown begins.
"Program terminated"
"Release tool shaft"
"Move slide"
Lift and hold safety bracket.
Press and hold button until slide with
mounted jar fully lowered.
Automatic: default settings
Mode selection for once-off production
of single preparation
+/–
Set
Set
Set
Set
+/–
+/–
+/–
I/0

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AUTOMATIC Operating Manual | 01-2013
Button functions
Set values for "min.", "rpm"; select mode, or "Prep. no."
Press 1x to move slide based on default settings
(M: to 200g, 0:00 min., 000 rpm)
Select menu option (mode/min./rpm/pause/prep. no.) and confirm
Actuate when prompted by system: "Release tool shaft" and "Move slide".
Do not forget to release the tool shaft! Lift the safety bracket!
When the container is engaged, the next cycle is started.
Alternatively, the process is terminated prematurely.
Only press this button if there is an error or malfunction!
(After switching off the TOPITEC®AUTOMATIC system
it must be restarted, see TOPITEC®manual, section
"Troubleshooting") Exception: Change from
save mode to default mode.
Stop
+/–
+/–
Set
I/0

Mixing container clamped in slide
Default settings: M: to 200g, 0:00 min., 000 rpm
Single-step preparation
I/0
Press 1x to start process
Slide moves up & tool shaft engages.
Program time countdown begins.
"Program terminated"
"Release tool shaft"
"Move slide"
Lift and hold safety bracket, while pressing
and holding button until slide with mounted jar
fully lowered.
Set
Press 1x: "Prep. no." (e.g. 1/1) flashes
Stop
Press 1x: Default settings
Setup for once-off preparation

Set
Press 1x: "min.” flashes
+/–
Set "min." with
Set
Press 1x: "rpm" flashes
+/–
Set "rpm" with
Set
Press 1x to confirm entry
I/0
Press 1x to start process
+/–
Slide moves up & tool shaft engages.
Program starts ("rpm" flashes and can
be changed by pressing )
Program time countdown begins.
"Program terminated"
"Release tool shaft"
"Move slide"
Lift and hold safety bracket, while pressing
and holding the button until slide with mounted
jar is fully lowered.
Automatic: Default settings
Set
Press 1x: "M: to 200g" flashes
TOPITEC®AUTOMATIC QUICK START
Set
Set
Set
+/–
+/–
+/–
I/0
Set
I/0
Set
Stop

13
MENU NAVIGATION
Define single-step or two-step preparations

+
Press 1x: "Prep. no." flashes
+/–
Select "Prep. no." (e.g. 1) with
Set
Press 1x: "M: to 200g" flashes
Set
Press 1x: "min.” flashes
+/–
Set "min." with
Set
Press 1x: "rpm" flashes
+/–
Set "rpm" with
Set
Press 1x: "pause" flashes
+/–
Set
Set "pause" with : "min.” flashes OR
press to skip "pause": "min.” flashes
Two-step preparations Three-step preparations
I/0
Press 1x to start process
Slide moves up & tool shaft engages.
Program time countdown begins.
"Program terminated"
"Release tool shaft"
"Move slide"
Lift and hold safety bracket, while pressing
and holding the button until slide with mounted
jar is fully lowered.
Set
Press 1x: "Prep. no." (e.g. 1/3) flashes
Stop
Press 1x: default settings
+/–
Set "min." with
Set
Press 1x: "rpm" flashes
+/–
Set "rpm" with
Set
Press 1x: "pause" flashes
Set "pause" with : "min.” flashes OR
press to skip "pause": "min.” flashes
+/–
Set "min." with
Set
Press 1x: "rpm" flashes
+/–
Set "rpm" with
I/0
Press 1x to start process
Slide moves up & tool shaft engages.
Program time countdown begins.
"Program terminated"
"Release tool shaft"
"Move slide"
Lift and hold safety bracket, while pressing
and holding the button until slide with mounted
jar is fully lowered.
Set
Press 1x: "Prep. no." (e.g. 1/2) flashes
Stop
Press 1x: default settings
+/–
Set "min." with
Set
Press 1x: "rpm" flashes
+/–
Set "rpm" with
Set
Press 1x: "pause" flashes
+/–
Set
Set "pause" with : "min.” flashes OR
press to skip "pause": "min.” flashes
Set
Set
Set
+/–
+/–
+/–
Set
Set
+/–
+/–
Set
Set
+/–
+/–
Set
Set
+/–
+/–
Set
Set
I/0 I/0
Set
Stop Stop
+/–
Set

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AUTOMATIC Operating Manual | 01-2013

PREPARATION SETUP (ONCE-OFF)
1. If you wish to process a formulation that you do not require at
any later stage, you have the option to adjust the default set-
tings according to your requirements without the need to save
these settings. To do this, press 2x. "min." flashes on the
display, indicating that you can now adjust the time. To do this,
press the buttons as required.
Press the button. "rpm" flashes on the display, indicating
that you can now adjust the speed.
To start production, press the button.
2. The slide moves to its end position, and the message to the left
is shown on the display:
The TOPITEC®AUTOMATIC system inserts the tool shaft into the
drive shaft sleeve and locks it in position. After a short run-up
time of the motor, production starts with the user-defined set-
tings. The speed and time remaining until the end of the mixing
process is shown on the display. The TOPITEC®AUTOMATIC
display also shows a number (1 to 99) referred to as the pro-
duction number. It is generated automatically and shown during
the entire production time in the top right corner of the display
(here: 11).
This number does not have any effect on the actual production
process and is only relevant in systems where the TOPITEC®
AUTOMATIC is operated in conjunction with TOPITEC®Doku-
Manager.
3. "rpm" flashes on the display, indicating that you can
adjust the speed throughout the mixing process by means
of the / buttons.
1.
2.
3.
+/–
–+
Set
Set
I/0

15


PREPARATION SETUP (ONCE-OFF)
4a. After completion of the mixing process,
message "Process terminated" is displayed.
4b. After approx. 10 seconds, an acoustic signal is generated,
and the display changes to "Release tool shaft".
5. Using one hand, lift the safety bracket to the stop,
pulling the lock ring of the shaft sleeve upwards.
With the second hand, press the button. The slide
returns to its initial position. Release the two locking
handles at the sides and pull the locking device upwards.
The aponorm®jar with metering bottom (TOPITEC®jar)
can now be removed from the device!
4a.
4b.
5.

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AUTOMATIC Operating Manual | 01-2013
WORKING WITH CUSTOMISED SETTINGS
The machine's settings for mixing can of course be modified by adjusting the values
for "min." and "rpm". In the example below, the following parameter values are entered:
M: to 200g; 1:30 min.;1500 rpm.
1. Display with default settings
Press 2x.
2. Press to set the time to 1:30 minutes.
3. Press 2x.
Press to change the speed (rpm)
4. To start the process, press button.
1.
2.
3.
4.
–
+
Set
I/0
Set

17
WORKING WITH CUSTOMISED SETTINGS /
SEQUENCE OF STORED PREPARATIONS
SEQUENCE OF STORED PREPARATIONS
Switch on the system... > M: to 200g
0:00 min. 000 rpm
Press to select... > prep. no. 1 to prep. no. 99
Press to ... > move slide
Setting up single-step preparations
If you wish to produce the same preparation more than once,
you can save the respective system settings in one of the 99
available memory slots so that they can later be called up at
the push of a button. After switching on the system,
the default settings are displayed.
–
+

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AUTOMATIC Operating Manual | 01-2013

REPRODUCIBLE PREPARATION SET-UP
Setting up single-step preparations
A template for a table in which you can record the defined
preparations and related memory slots is included on pages 40/41.
1. If you wish to produce the same preparation more than once,
you can save the respective system settings in one of the 99 avail-
able memory slots so that they can later be called up at the push
of a button. After switching on the system, the default settings are
displayed.
2. To call up a memory slot, press (here: 1x).
"prep. no" flashes on the display.
3. Press :
"M: to 200g" (mode) flashes. Press again:
"M: to 200g" is continuously shown. "min." flashes.
4. Using the button, enter the desired time in minutes and sec-
onds. If you have inadvertently selected a value that is too high,
press the button to correct it. Press 1x.
You can now adjust the speed.
5. Using the button, enter the desired speed.
6. Conform by pressing 3x. The preparation number is shown
on the display:
7. All entered values are saved under the respective prep. no. (here: 1). If you wish to process
another batch with these settings, simply call up "prep. no 1". To start production, press
the button. Alternatively, you can set other preparations in the system or press
to return to the TOPITEC®AUTOMATIC default settings.
2.
4.
5.
6.
3.
1.
+
+
+
I/0
–
Set
Set
Set
Set
Stop

19

REPRODUCIBLE PREPARATION SET-UP

REPRODUCIBLE PREPARATION SET-UP
Setting up multiple-step preparations
Each preparation can be divided into three separate steps with individual time (min.),
speed (rpm) and pause settings.
Example:
"prep. no. 10“ step 1: 0:30 minutes at 500 rpm, pause time 1:00 minute
step 2: 2:00 minutes at 1500 rpm, pause time 2:30 minutes
step 3: 1:30 minutes at 2500 rpm
1. Press to select "prep. no. 10".
2. Press 2x: "min." flashes.
3. Using the button to enter the time in minutes
(here: 0:30). Press the button again: "rpm" flashes.
Using the button to enter the speed
(here: 500). Confirm with .
"pause" flashes.
4. Using the button, enter the pause time
(here: 1:00 and confirm with .
"min." flashes.
1.
2.
3.
4.
+
Set
Set
Set
Set
+
+
+

20
AUTOMATIC Operating Manual | 01-2013

REPRODUCIBLE PREPARATION SET-UP
5. You are now ready to enter the settings for the step 2
of the preparation. Repeat the above steps
(here, 2:00 min.; 1500 rpm; 2:30 pause
"pause" flashes.
6. Confirm with the button. You are now ready to enter
the settings for step 3 of the preparation.
"min." flashes.
7. Using the and button, enter the relevant values for time and speed
(here: 1:30 min.; 2500 rpm). Confirm the rpm entry with . In our example
the preparation is saved in the TOPITEC®AUTOMATIC system under "prep. no. 10".
You can now start production by pressing (TOPITEC®jar in place?), set up other
preparations in the system or press to return to the TOPITEC®default settings.
Preparations can consist of one, two or three steps.To configure a preparation with two steps,
follow the instructions above and confirm your entries by pressing twice after entry of the
second "rpm" value.
5.
6.
Set
Set
Set
Set
+
I/0
Stop