operating manual - topitec · the move from manual grinding with mortar and pestle to...

OPERATING MANUAL

2AUTOMATIC 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 KG56204 Hillscheid, Germanywww.wepa-dieapothekenmarke.de

3

CO

Py

RIG

hT

/ T

Ab

LE O

f C

ON

TE

NT

s

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


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 videothat shows you how easy it is to operate the TOPITEC® AUTOMATIC and how the devicecan 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 +49 (0)2624 107-145 Phone +49 (0)2624 107-146 www.topitec.deYourTOPITEC® Competence Centre

5

INT

RO

dU

CT

ION

/ s

ER

vIC

E

CUsTOMER sERvICE ANd sPARE PARTs

The TOPITEC® Competence Centre is there to assist you.

News and tipsThe latest information and many useful tips in connection with the production of drugs withthe 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 formulationsand applications that might arise in the use of your TOPITEC® mixing system.

Phone +49 (0)2624 107-145 or +49 (0)2624 107-146 [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 +49 (0)2624 107-201 or +49 (0)2624 107-208 [email protected] www.topitec.de

Technical support for TOPITEC® dokuManagerIf you have any queries regarding the TOPITEC® documentation software, call our helpline to talk to a member of our IT support staff.

Phone +49 (0)2624 107-555 [email protected] www.topitec.de

TrainingWe assist professional associations in devising training courses to ensure that pharmacists and other specialists are kept informed of the latest developments in the field.


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

sA

fE

Ty

IN

sT

RU

CT

ION

s /

TE

Ch

NIC

AL

dA

TA /

MA

NU

fAC

TU

RE

R w

AR

RA

NT

y

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 notcover 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.


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

sTA

Nd

AR

d E

qU

IPM

EN

T /

CO

MM

Iss

ION

ING

COMMIssIONING

Remove all packaging and protective material, position the TOPITEC® AUTOMATICon 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.


Power switch (at rear)

Selecting system parameters

Selecting / confirming menu option

Stop button (emer-gency-stop button)

Move slide

Starting / terminatingprocess

Tool shaft adapter

Jar clamping device with locking handles

Receptacle for TOPITEC® jars 50 - 200 g (detachable)

Receptacle for TOPITEC® single-patient jarsor stock preparation jars

CONTROL ELEMENTs

Printer/PC interfaceRS 232 (at rear)

11

CO

NT

RO

L E

LEM

EN

Ts

/O

PE

RA

TIN

G M

Od

Es

/ b

UT

TON

fU

NC

TIO

Ns

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 buttonis 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• M: to 200g• M: froM 300G• CoMMinution• Powder-Mixing

+/-Press to select mode

setPress 1x: "Min” flashes

setPress 1x: "M: to 200g" flashes

+/–Set "min." with

setPress 1x: "rpm" flashes

+/–Set "rpm" with

setPress 1x to confirm entry

I/0Press 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 productionof single preparation

+/–

set

set

set

set

+/–

+/–

+/–

I/0


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

initial position:Mixing container clamped in slide

Default settings: M: to 200g, 0:00 min., 000 rpm

Single-step preparation





Lift and hold safety bracket, while pressing and holding button until slide with mounted jar fully lowered.

setPress 1x: "Prep. no." (e.g. 1/1) flashes

stopPress 1x: Default settings

setup for once-off preparation M: to 200g

setPress 1x: "min.” flashes



+/–Set "rpm" with

setPress 1x to confirm entry


+/–


Program starts ("rpm" flashes and canbe changed by pressing )



Lift and hold safety bracket, while pressing and holding the button until slide with mounted jar is fully lowered.

Automatic: Default settings


TOPITEC® AUTOMATIC qUICK sTART

set

set

set

+/–

+/–

+/–

I/0

set

I/0

set

stop

13

ME

NU

NA

vIG

AT

ION

define single-step or two-step preparations (max. 3 programming steps) M: to 200g

+Press 1x: "Prep. no." flashes

+/–Select "Prep. no." (e.g. 1) with


setPress 1x: "min.” flashes



+/–Set "rpm" with

setPress 1x: "pause" flashes

+/–

set

Set "pause" with : "min.” flashes OR

press to skip "pause": "min.” flashes

Two-step preparations Three-step preparations







stopPress 1x: default settings



+/–Set "rpm" with






+/–Set "rpm" with







stopPress 1x: default settings



+/–Set "rpm" with


+/–

set



set

set

set

+/–

+/–

+/–

set

set

+/–

+/–

set

set

+/–

+/–

set

set

+/–

+/–

set

set

I/0 I/0

set

stop stop

+/–

set


Mixing Mode /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

Mix

ing

Mo

de

/ P

re

Par

at

ion

se

t-u

P (

on

Ce

-of

f)

Mixing Mode /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.


wORKING wITh CUsTOMIsEd sETTINGs

The machine's settings for mixing can of course be modified by adjusting the valuesfor "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

wO

RK

ING

wIT

h C

Us

TOM

IsE

d s

ET

TIN

Gs

/s

Eq

UE

NC

E O

f s

TOR

Ed

PR

EPA

RA

TIO

Ns

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.

–

+


Mixing Mode /REPROdUCIbLE PREPARATION sET-UP

setting up single-step preparations

A template for a table in which you can record the definedpreparations 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

Mix

ing

Mo

de

/R

EP

RO

dU

CIb

LE P

RE

PAR

AT

ION

sE

T-U

P


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

+

+

+



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

21

Mix

ing

Mo

de

/ r

eP

ro

du

Cib

le P

re

Par

at

ion

sE

T-U

P (

MU

LTIP

LE-s

TE

P)

/ PA

Us

E f

UN

CT

ION

PAUsE fUNCTION

1. For multiple-step preparations, you have the option to define pause times (max. 30 minutes per step). This enables you to include a cooling phase in the process. The pause time is automatically added by the TOPITEC® system to the overall production time and shown on the display during production. To prevent inhomogeneous results, the TOPITEC® system automatically stirs the product 3 times every 2 minutes at low speed (300 rpm) during the pause.

1.


ChANGING vALUEs IN sAvEdPREPARATIONs

1. Press to call up the respective preparation. (Example: "prep. no." 10; 1st step NEW: 1:20 minutes at 2000 rpm). "Prep. no." flashes.

2. Press 2x. The time entered for the 1st step is displayed. Press to change the time to 1:20 minutes. Press again. "rpm" flashes.

Press to change the value to 2000 rpm.

Repeatedly press until "prep. no." is displayed again (flashing).

The preparation parameters are now changed and saved in the TOPITEC® AUTOMATIC.Press to return to the TOPITEC® system default settings.

1.

2.

set

+

set

+

+

set

stop

23

Ch

AN

GIN

G v

ALU

Es

IN

sA

vE

d P

RE

PAR

AT

ION

s /

dE

LET

ING

sA

vE

d P

RE

PAR

AT

ION

s

dELETING sAvEd PREPARATION

1. Press to call up the respective preparation. (Example: "prep. no." 10). "Prep. no." flashes.

2. Press 2x. The time entered for the 1st step is displayed Press the button to set the time to 0:00 and then press again. "Prep. no." flashes.

All other steps and settings of "prep. no. 10" are now deleted and the respectivememory slot can now be used for a new preparation. Press to returnto the TOPITEC® system default settings.

1.

2.

+

set

set

stop

–


CONNECTION Of PERIPhERALs

Connecting documentation printer

For the documentation of your preparations and production runs, we recommend connectinga SARTORIUS data printer (model YDP 03-OCE) to your TOPITEC® AUTOMATIC system.

1. First check whether the printer is correctly configured for connec-tion and printing. The baud rate must be set to 9600. For detailed instructions, please refer to the user manual of the printer.

2. Connecting the printer Connect the printer power cable to the socket. The printer is auto-matically switched on. The display shows the time and the activated numerator (NUM). Deactivate the numerator by pressing the [N/N] button.

3. The serial port for PC connection (RS 232) is located at the rear of the TOPITEC® AUTOMATIC. Connect the serial cable (prod. no. 25 25663) to the serial port at the rear of the printer (labelled DATA).

4. Connect the serial cable to the port of the TOPITEC® AUTOMATIC. Ensure that all adapters are properly inserted in the ports. The printer can be connected before the TOPITEC® AUTOMATIC is started or during production.

1.

3.

4.

25

CO

NN

EC

TIO

N O

f P

ER

IPh

ER

ALs

CONNECTION Of PERIPhERALs

Connection to PC

1. For the networked documentation of the production data, and for the control of the TOPITEC® AUTOMATIC in conjunction with the TOPITEC® DokuManager, you can connect your TOPITEC® AUTOMATIC system to a PC or laptop. More detailed information regarding this future-proof solution is available from the TOPITEC® Competence Centre at [email protected].

2. Connection to PC Establish the connection to the PC system before switching on the TOPITEC® AUTOMATIC.

3. The serial port for PC connection (RS 232) is located at the rear of the TOPITEC® AUTOMATIC.

4. Connect the data cable (RS 232 USB cable, order no. 80359) to the port. Establish a connection to the PC/laptop. Ensure that all plugs are properly connected to the ports. Enter the relevant settings in the TOPITEC® DokuManager program by calling up menu option "SYSTEM SETUP" ("INTERFACES" tab). For detailed instructions, please refer to the application HELP (TOPITEC® DokuManager).

3.


aponorm® tamper-evident jars (TOPITEC® tamper-evident jars) & accessories

Order no. Colour/design Content PZN (1 unit) sU (quant.)

33150 red/white 20 g / 28 ml 7317326 2033151 red/white 30 g / 42 ml 7317332 2033152 red/white 50 g / 70 ml 7317349 2033153 red/white 100 g / 140 ml 7317355 1533155 red/white 200 g / 250 ml 7317361 12

96090 Ointment spatula 100 mm _ 2096092 Ointment spatula 100 mm _ 1596091 Ointment spatula 150 mm _ 12

35425 orange/cosmetics 20 g / 28 ml 2726379 2035426 orange/cosmetics 30 g / 42 ml 2726385 2035427 orange/cosmetics 50 g / 70 ml 2726391 2035428 orange/cosmetics 100 g / 140 ml 2726422 1535429 orange/cosmetics 150 g / 200 ml 2726439 1035430 orange/cosmetics 200 g / 250 ml 2726445 10

PRICING

The latest edition of the "Hilfstaxe für Apotheken" that applies in Germany contains the agreed prices for the aponorm® jars with metering bottom (TOPITEC® jars). For your convenience, the listed packing units (aponorm® jars with metering bottom (TOPITEC® jars), aponorm® tamper-evident jars (TOPITEC® tamper-evident jars), aponorm® single-patient jars (TOPITEC® single-patient jars) and other TOPITEC® accessories are compiled in the table below:

35230 blue/blue 20 g / 28 ml 2684385 2035231 blue/blue 30 g / 42 ml 2684391 2035232 blue/blue 50 g / 70 ml 2684416 2035233 blue/blue 100 g / 140 ml 2684422 1535235 blue/blue 150 g / 200 ml 0764683 1035234 blue/blue 200 g / 250 ml 2684439 10

aponorm® jars with metering bottom (TOPITEC® jars)Order no. Colour/design Content PZN (1 unit) sU (quant.)

35250 red/white 20 g / 28 ml 0775126 2035251 red/white 30 g / 42 ml 0775161 2035252 red/white 50 g / 70 ml 0775190 2035253 red/white 100 g / 140 ml 0775221 1535255 red/white 150 g / 200 ml 2381704 1035254 red/white 200 g / 250 ml 0775244 10

For jars and ointment

spatulas with your own

pharmacy print, please see

our packaging catalogue!

27

PR

ICIN

G

aponorm® jars for stock preparation (TOPITEC® jars for stock preparation)

Order no. Colour/design Content PZN (1 unit) sU (quant.)

35263 red/white 1,000 g / 1,260 ml 3451051 4

TOPITEC® accessories Order no. Item Content/length PZN (1 unit) sU (quant.)

25690 Mixing disks 20 g and 30 g 0775304 5025691 Mixing disks 50 g to 200 g 0775310 5035270 Ointment cannula 1.5 mm 0775327 3035271 Reducer element 2.5 mm 0775333 3035275 Metering tips – 0775362 200These accessories and their prices can be entered into your formulation pricing program. For details, please contact your software supplier.

ACCEssORIEsThe table below contains information you might require for the pricing ofTOPITEC® accessories or for your stock management:

aponorm® single-patient jars (TOPITEC® single-patient jars)Order no. Colour/design Content PZN (1 unit) sU (quant.)

35260 red/white 300 g / 408 ml 0775379 10 35261 red/white 500 g / 690 ml 0775416 10

PRICING

Metering tips for aponorm® jars with metering bottom (TOPITEC® jars) made in PP, red, SU 200 Order no. 35275; PZN 0775362

Ointment cannula for aponorm® jars with metering bottom (TOPITEC® jars) for targeted application, e.g. in body cavities, made in PP, white, SU 30 Order no. 35270; PZN 0775327

Ointment cannula for aponorm® jars with metering bottom (TOPITEC® jars) for accurate dosing of low-viscous formulations, top Ø 2.5 mm, made in PP, white, SU 30 Order no. 35271; PZN 0775333


TOPITEC® jARs + ACCEssORIEs

Receipt booklet, including user information for aponorm® jars with metering bottom (TOPITEC® jars) Order no. 38053

aponorm® single-patient jars (TOPITEC® single-patient jars) made in polypropylene (a product of the aponorm® packaging range), with batch certificate, SU 10 300 g / 408 ml single-patient jar, order no. 35260; PZN 0775379 500 g / 690 ml single-patient jar, order no. 35261; PZN 0775416

Mixing tool for aponorm® single-patient jars (TOPITEC® single-patient jars) SU 1, order no. 25695 The mixing tool is made in stainless steel. Its shaft is protected by an extra resistant TiN alloy coat. The mixing element (Ø x H = 103.5 x 4.0 mm) is equipped with a wear-proof plastic coat.

Mixing lid for aponorm® single-patient jars (TOPITEC® single-patient jars) The mixing lid is made in white POM. It features a centre guide hole for the tool and is equipped with two recessed silicone O-ring seals. Order no. 25683 (white)

Replacement seals for mixing lid SU 6, order no. 25683 The silicone seals (Ø x H = 8.1 x 1.6 mm) must always be placed in pairs in the central opening of the mixing lid.

29

AC

CE

ss

OR

IEs

TOPITEC® jARs + ACCEssORIEs

aponorm® jar for stock preparation (TOPITEC® jar for stock preparation) for the production and storage of semi-solid formulations produced in TOPITEC® AUTOMATIC II and TOPITEC® TOUCH systems Size 1000 g, capacity 1,260 ml, dimensions 128 x 123 mm (H x outer Ø ), jar made in PE, white, with red polypropylene screw lid and anti-tamper ring, bearing aponorm ® logo. Order no. 35263

Mixing tool for aponorm® jars for stock preparation (TOPITEC® jar for stock preparation) SU 1, order no. 25702 The mixing tool is made in stainless steel. Its shaft is protected by an extra resistant TiN alloy coat. The mixing element (Ø x H = 113.5 x 4.0 mm) is equipped with a wear-proof plastic coat.

Mixing lid for aponorm® jar for stock preparation (TOPITEC® jar for stock preparation) The mixing lid is made in white POM. It features a centre guide hole for the tool and is equipped with two recessed silicone O-ring seals. Order no. 25705 (white)

Replacement seals for mixing lid SU 6, order no. 25683 The silicone seals (Ø x H = 8.1 x 1.6 mm) must always be placed in pairs in the central opening of the mixing lid.


TOPITEC® ACCEssORIEs

Tool shaft with titanium-nitride (TiN) alloy coating, in storage box Order no. 25680

Tool shaft cleaning vessel with POM insert and exchangeable brush (Aronal brush, not including cleaning liquid) Order no. 25675

Replacement brush Aronal brush, SU 3 Order no. 25676 (PZN 4945370)

TOPITEC® jar holder (size 1) for TOPITEC® 20 g and 30 g jars Order no. 26631

TOPITEC® jar holder (size 2) for TOPITEC® 50 g and 200 g jars Order no. 26632

31

AC

CE

ss

OR

IEs


TOPITEC® TOUCh clamping ring for preparation containers and power mixing system. Order no. 26633

Preparation container (complete) Consisting of a production container made in white POM and a white POM filling plunger with mounted stainless steel M9 threaded adapter; sterilisable, with storage box (order no. 85500) and user instructions (order no. 80897) Size 50 g (70 ml): Order no. 25707 Size 100 g (140 ml): Order no. 25696

Replacement lift bases made in white PE, SU=10 Order no. 25688

Production container made in white POM, sterilisable size 50 g (70 ml) Order no. 25708 size 100 g (140 ml) Order no. 25697

filling plunger made in white POM, with mounted stainless steel M9 threaded adapter for the attachment of filling tubes or threaded tube heads For 50 g container Order no. 25710 For 100 g container Order no. 25698



stock preparation system Consisting of stainless steel container, capacity to brim 1000 ml, for the filling of various aponorm® packing units from a stock preparation container Mixing tool, metal metering press and cleaning brush Order no. 25650

Powder mixing system for the production of powder and granule mixtures, and tea blends, up to 500 g. Consisting of PP mixing containers (100 g, 500 g and 1000 g), clamping rings made in anodised aluminium, drive block with two metal balls Order no. 25720

TOPITEC® dokuManager software for the documentation and management of all pharmacy preparations, the printing of logs, product labels, etc. and the connection of TOPITEC® AUTOMATIC II precision scales For operating systems: WINDOWS XP, WINDOWS VISTA and WINDOWS 7. Order no. 25661

33

AC

CE

ss

OR

IEs

/ C

LEA

NIN

G A

Nd

CA

RE

IN

sT

RU

CT

ION

s

CLEANING ANd CARE INsTRUCTIONs

The TOPITEC® AUTOMATIC has been designed specifically for use in pharmaciesand is manufactured at our own production plants. Our technical expertise andexperience enable us to offer you reliable high-tech equipment.

To ensure trouble-free operation over its service life, strictlyadhere to our instructions for cleaning, maintenance and operation.

Protect the device against mechanical impact!Do not drop the device or any of its accessories. When moving the device on the work top,ensure that no electronic or mechanical components are damaged.

Protect against dust!Install and store the system and its accessories in adust-free environment, as fine particles could damage moving parts!

Protect the device against high temperature!Do not install or store the system or its accessories in a room where they are exposedto high temperatures. High temperature could damage electronic components,or lead to the deformation or melting of certain plastic parts.

Protect against extreme temperature changes!Do not install or store the system or its accessories in a room where they are exposed to very low temperatures. As, during operation, the electronic devices are heated to operating temperature, there is a risk of condensation inside the housing, which could damage electronic components.

Cleaning of housing and baseDo not use pointed implements or aggressive detergents. Clean the housing and the base witha damp, soft cloth and a mild soapy solution. Alternatively, use an alcohol/water mixture.

Before cleaning the device, disconnect the power plug from the socket!

Cleaning of TOPITEC® AUTOMATIC tool shaftAlways clean the tool shaft immediately after use with a cellulose cloth. Subsequentlysoak it in approx. 30 ml of alcohol/water solution in the supplied shaft cleaning vessel.Recommended product: MELISEPTOL® to dissolve any deposits. Never clean theTOPITEC® AUTOMATIC tool shaft with washing-up liquid or in the dishwasher! The POMinsert of the tool shaft cleaning vessel can however be cleaned in the dishwasher.


PRACTICAL TIPs - INsTANT REMEdy!

when the sTOP button is pressed,message "Stop: program abort" is displayed on the display. Press the button, and switch off the TOPITEC® AUTOMATIC system at the power switch. Eliminate the cause of the problem.

switch on the systemThe display shows two alternating messages: "Release tool shaft" and "Move slide".After having released the shaft locked and moved the slide by hand, the TOPITEC®

system is again in its initial position and ready for operation. The display shows thedefault settings (M: to 200g; 0:00 ,in; 000 rpm).

Select the desired mode (mixing, grinding, powder-mixing)or select the respective "Prep. no". using the or button.You can now continue working with the TOPITEC® AUTOMATIC system.

Extreme speed fluctuationsThe factory-set tolerance of the electronic speed control is minimal. If you experience significant speed fluctuations, which tend to be audible, this is most likely due to power fluctuations in the mains. If such fluctuations occur repeatedly, please contact our technical support team.

Locking device is released during productionRepeat opening and closing of the two locking handles of the clamping device mightlead to a reduction of the clamping force. In this case, the locking device might beginto move up during production.

To prevent the clamped mixing container from becoming dislodged, tighten the clampingscrews below the handles with an Allen key (size 3) by turning them clockwise.

stop

–+

35

PR

AC

TIC

AL

TIP

s -

IN

sTA

NT

RE

ME

dy

!


The display texts guide you step by step through the process.

disPlaY texts: reMedY:

“safety bracket tripped!” Reposition the safety bracket and follow the instructions on the display.

“No correction value available!” Contact technical customer support team!

“Reference run failed!” Check whether there are any obstacles on the plate under the slide guide. Check whether the switch or cable is defective. Please contact our technical support team!

“Container not correctly mounted!” Check the container/jar position in the system.

“input error: Value missing!” Check settings and amend, if necessary. Restart production process.

“Total time exceeded!” Check settings and amend, if necessary. Restart production process.

“Memory error. Program abort!” Switch off the system and contact technical support team!

“Limit switch error. Program abort!” Switch off and restart the system. Should this error occur, please contact technical support team!



defective motor fuse

situation a: Slide lift disabled – LCD and tool shaft ON Cause: Failure of stepped motor fuse: 1.0 A situation b: Slide lift enabled – LCD ON tool shaft not rotating

Cause: Failure of main motor fuse: 5.0 A (slow)

in both cases, proceed as follows:

• Switch off the TOPITEC® AUTOMATIC (power switch to "0").• Disconnect the main plug.• Using a suitable tool, unscrew the fuse holder

from the rear panel (observe arrow).• Remove the defective fuse from the holder and replace it

with a fuse of the same rating (included in basic kit).• Ensure that the fuse is inserted correctly. Screw the holder

into the rear panel (against arrow).• Connect the power cable to the power mains and

switch on the TOPITEC® AUTOMATIC.

Depending on operating status before the failure, the process is resumed or must be restarted.

37

PR

AC

TIC

AL

TIP

s -

IN

sTA

NT

RE

ME

dy

! /

MA

INT

EN

AN

CE

MAINTENANCE

The TOPITEC® AUTOMATIC is of a sturdy design made for continuous operation. The systemis virtually MAINTENANCE-FREE and requires only minimum inspection and care.

Customers who have entered into a maintenance contract with WEPA will be contacted by our technical support team to arrange for regular on-site inspections of the TOPITEC® AUTOMATIC. Our service technicians are of course also available to assist you in the event of problems or ifyou have any technical queries.

YourTechnical Support Team

WEPA Apothekenbedarf GmbH & Co KG56204 Hillscheid, Germanywww.wepa-dieapothekenmarke.de

Phone +49 (0)2624 107-201Fax +49 (0)2624 107-101


PREPARATION LIsT / TEMPLATE

Prep. no. Mode/ step 1 step 2 step 3 Created/set up Preparation min. rpm pause min. rpm pause min. rpm (date) (initials)

39

PR

EPA

RA

TIO

N L

IsT

/ T

EM

PLA

TE

Prep. no. Mode/ step 1 step 2 step 3 Created/set up Preparation min. rpm pause min. rpm pause min. rpm (date) (initials)

UsE ZL-APPROvEd PACKAGING

UNITs TO EMPhAsIsE

ThE qUALITy Of yOUR PROdUCTs!

WEPA Apothekenbedarf GmbH & Co KG, 56204 Hillscheid, GermanyPhone +49 (0)2624 107-361, fax +49 (0)800 5252500 (order hotline)[email protected], www.wepa-dieapothekenmarke.de

operating manual - topitec · the move from manual grinding with mortar and pestle to...

Documents