ERWEKA GmbH · Ottostr. 20-22 · 63150 Heusenstamm · Germany · Tel: +49 (0) 6104 6903-0Directors: Werner G. Müller, Claudia Müller, Manfred Koller · District court Offenbach HRB 2382Fax: +49 (0) 6104 6903-40 · E-mail: info@erweka.com · www.erweka.com

Instruction Manual

Disintegration TesterZT 221-324

CopyrightThe material in this document is the intellectual property of ERWEKA. Any copy or reproduction of this document or its parts without the written permission of and reference to ERWEKA is prohibited and will be prosecuted according to the law. All trademarks are the property of their respective owners.

Copyright© 2017 by ERWEKA

Document version 1.3Date: 2016-05-24Firmware version: from 1.24Document No.: 21841File name: ZT 221-324 Manual_21841_En_V1.3Language: EnglishPage number: 32

Version table

DateDocumentversion* Change

2014-03-03 1.0 Firmware version was increased.2015-07-15 1.1 management; corporate identity2016-03-07 1.2 new document No. (old No.: 591-309-0001)2016-05-24 1.3 new format (11/15)

* When the document version X.Y is increased, X means a technical change and Y – a document change only.

Instruction ManualDisintegration TesterZT 221-324

4 ZT 221-324

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Table of Contents

1 – Introduction 51.1 – About this instruction manual 51.2 – Service 51.3 – Safety instructions and symbols 61.4 – Protection of the environment 6

2 – Safety 72.1 – Safety information 72.2 – Intended use 7

3 – Overview 83.1 – Description 83.2 – Device types 83.3 – Type label 83.4 – Construction 93.5 – Operation elements and connections 103.5.1 – Keypad 103.5.2 – Connections 113.5.3 – Baskets 113.6 – Technical data 12

4 – Installation 134.1 – Storage and transport conditions 134.2 – Unpacking and checking 134.3 – Installation 134.3.1 – Positioning 134.3.2 – Acclimatization 134.3.3 – Required installation environment 134.4 – Assembly and first switching on 14

5 – Configuration 165.1 – Date/time 175.2 – Alarm 175.3 – LEDs 175.4 – Test stop 185.5 – Lifting speed 185.6 – Printout mode 195.7 – Printer type 195.8 – Data export mode 195.9 – Printer settings 20

6 – Temperature Settings 206.1 – Nominal temperature 206.2 – Maximal temperature 206.3 – Minimal temperature 216.4 – Temperature offset 216.5 – Bath heating 21

7 – Calibration 227.1 – Instructions for calibration 227.2 – Calibrating temperature sensors 22

8 – Performing Tests 248.1 – Performing a disintegration test 248.2 – Pausing / aborting a test 25

9 – Maintenance 269.1 – Cleaning 269.2 – Inspection and maintenance 27

9.3 – Spare parts 27

Attachment 28Terminology list 29

ZT 221-324 – Introduction 5

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1 – Introduction

Thank you for purchasing the ERWEKA disintegration tester of ZT 22x-32x series!

1.1 – About this instruction manual

This instruction manual supports you in work with your ERWEKA device. It describes the device, its operation and gives you useful tips on its handling. Furthermore, read descriptions of installation and setting as well as detailed step-by-step work operations in the present manual. Pictures facilitate the understanding of processes described here.

The instruction manual is a part of the product. Read this manual completely and make sure you understand its content. Keep this manual in a safe place so that it will be available for any questions at a later date. This is important for warranty of permanent and accurate operation of the corresponding device.

For the operation of ZT 32x an external temperature sensor (PT 100) must be used additionally.

For the disintegration tester operation this instruction manual is valid only in connection with the manuals of additionally used components!

The editorial team of ERWEKA appreciates your feedback regarding the present manual. Just send an e-mail to quality@erweka.com with your topic and “technical documentation” as a subject. Your reply contributes to our high quality level.

1.2 – Service

Contact ERWEKA at service@erweka.com to order spare parts, in case of technical questions or possible repairs. Please supply the following information:

• Type of the device (on the type label)• Serial number of the device (on the type label)• Short description of the case

6 ZT 221-324 – Introduction

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1.3 – Safety instructions and symbols

WARNING indicates a possible hazardous situation which, if not avoided, could result in death or serious injury.

CAUTION indicates a possible hazardous situation which, if not avoided, could result in moderate or minor injury.

HAZARD due to electric shock! Indicates a possible hazardous situation which, if not avoided, can lead to injuries due to electric shock.

This symbol indicates a possible hazardous situation which, if not avoided, can lead to equipment damage.

This symbol emphasizes the information to ensure a smooth work process.

This symbol provides you with additional useful information.

1.4 – Protection of the environment

Note that residues of the test products must be properly disposed of in accordance with the applicable environmental regulations. According to the valid EC directives all the electrical parts (electrical waste) must be disposed of appropriately.

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2 – Safety

2.1 – Safety information

To guarantee the health and safety, read the following safety instructions before using the device.

WARNINGWear personal protective outfit and glasses, if necessary!

HAZARD due to electric shock! Electric devices are to be plugged into safety sockets only! Use the delivered network cable! The voltage of the existing current supply is to be compared to the indications on the type label! Before installation works always switch the corresponding device off and disconnect it from the rear panel.

ERWEKA devices should be operated by qualified and trained personnel only!

Pay attention to the on-site safety instructions for work in the laboratory and with the laboratory equipment!

2.2 – Intended use

The ERWEKA disintegration tester ZT 22x-32x should be used only for disintegration tests of tablets, dragees, oblongs and other dosage forms in the installation environment defined by ERWEKA.

ERWEKA devices should not be used for processing:

• products that are easily flammable or explosive• products that develop vapours which may create flammable or explosive mixtures in combination with air• products that release harmful or poisonous substances

The device should be operated and maintained only as it is foreseen and due to the instructions presented in this manual.

8 ZT 221-324 – Overview

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3 – Overview

3.1 – Description

The ERWEKA disintegration testers ZT 22x and ZT 32x are manufactured in compliance with the requirements of the valid pharmacopoeia (USP, EP und JP) for determination of disintegration time of tablets, dragees, oblongs and other dosage forms.

The devices are controlled by means of a foil keypad with LED display in the upper part that offers maximal safety and visibility.

The flow-through heating guarantees the constant distribution of heated water. An external PT 100 temperature sensor (in ZT 32x) serves for check of the temperature in the water bath.

The ZT 22x devices are available with 1, 2, 3 or 4 test stations. All test stations are driven together. These devices are equipped with a manual lifter as a standard.

The ZT 32x devices are also available with 1, 2, 3 or 4 test stations. Each test station can be driven individually. The devices are equipped with a manual lifter as a standard. Optionally all test stations can be equipped with an automatic lifter. In this case the test baskets are automatically lifted from the test vessels at the end of the runtime. The downward and upward speed of the test basket can be set.

The RS 232 interface allows the control of the ZT 32x disintegration tester via PC and ZT.NET software.

Moreover, the devices can be optionally ordered with a serial printer interface for connection of a printer.

3.2 – Device types

ZT 221 ZT 222 ZT 223 ZT 224

Number of test stations / vessels / baskets

1 2 3 4

Support arms 1 (one-seated) 1 (two-seated) 1 (three-seated) 1 (four-seated)

ZT 321 ZT 322 ZT 323 ZT 324

Number of test stations / vessels / baskets

1 2 3 4

Support arms 1 2 3 4

3.3 – Type label

The type label is placed on the rear panel of the device and contains following data:

Typ: Device typeSerial No: Serial numberPN: Normal output in Watt [W] or Volt Amper [VA]IN: Nominal current in Amper [A]U: Voltage in Volt [V]F: Frequency in Hertz [Hz]

ZT 221-324 – Overview 9

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3.4 – Construction

1) Beaker glass (vessel)2) PT 100 (ZT 32x series only)3) LED display and keypad (1st test station)4) LED display and keypad (2nd test station)5) Support arm6) Basket (see 3.5.3 – Baskets)7) Water bath

The external temperature sensor (PT 100) is not described in this manual. Read the information on the PT 100 in the corresponding instruction manual.

Pict. ZT 322 disintegration tester with external PT 100

7

6

5

4

1

3

2

10 ZT 221-324 – Overview

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3.5 – Operation elements and connections

3.5.1 – Keypad

The control panel of the ZT 220 devices contains a keypad and 2 displays. The control panel of the ZT 321 contains also a keypad and 2 displays. All further devices of the ZT 32x series contain an additional control panel with a keypad and a display for each further suppport arm (ZT 322 - ZT 324) respectively.

Keypad

Key symbol Description/FunctionThe Down arrow key; to scroll menus, submenus or values down

The Quick Down arrow key; to scroll menus, submenus or values down quickly

The Start key; to start a test and enter a selected menu

The Stop key; to pause or stop a test and exit a menu

The Up arrow key; to scroll menus, submenus or values up

The Quick Up arrow key; to scroll menus, submenus or values up quickly

Display

According to their type the devices have a diferent number of displays. Left display, right display and for ZT 322 - ZT 324 a further display per additional support arm.

The display on your disintegration tester can differ from the above shown form. The upper picture is only an example on which all LED-displays are flashed.

ZT 221-324 – Overview 11

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3.5.2 – Connections

Switch and connections are located upside on the device rear panel (see following picture).

1) On/Off switch2) RS 232 interface (optional)3) Connection for temperature sensor PT 100 (only ZT 32x)4) Network connection5) USB A e.g. for extra printer (optional)6) Fuses

3.5.3 – Baskets

Baskets of type A and B

There are baskets of A and B types. They differ in number and size of vials. Type A is equipped with 6 vials and type B – with 3 bigger vials.

Basket designs

Baskets can be standard and magnetic (mBaskets). The mBaskets have sensors in the basket bottom for detecting the tablet disintegration and can be used with the ZT 32x devices only. With the help of the ConBox multiplexer and ZT.NET software mBaskets are connected to the corresponding slots of the ConBox multiplexer. The ConBox Multip-lexer is connected to the PC with USB cable and to the ZT 32x with RS 232 cable. Standard baskets do not have any sensors and do not need any multiplexer because they are connected to the support arms directly.

The “Quick-Clean” baskets are equipped with springs to take off the vials for cleaning. This facilitates the cleaning.

Discs

The number of the delivered discs is different according to device type.

ZT x21 ZT x22 ZT x23 ZT x24

Number of discs (for basket of B / A type) 3 / 6 6 / 12 9 / 18 12 / 24

1

4

2

5

3

6

12 ZT 221-324 – Overview

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3.6 – Technical data

ZT 22x Series ZT 32x Series

221-222 223-224 321-322 323-324

Dimensions:Height [mm] 660Width [mm] 430 750 430 750Depth [mm] 400Weight:[kg] 17 -19 21 - 27 23 - 33 47.5 - 51.5Compliance:

USP / EP / JP

Power supply:115 / 230 VAC; 50 / 60 Hz

Power consumption:max. 1500 Watt

Safety fuses:15 A / 3.15 A

Safety protection:IP 21 according to IEC 529

Height of stroke:55 ± 2 mm

Speed:30 ± 1 stroke/min

Basket:type A and B

Temperature control:optional glass thermometer

or PT 100PT 100

Temperature range:30 - 50°C

Heating:flow-through heater

Water bath:transparent PET moulded

Operation:LED display with foil keypad

Run time:variable adjustable up to 99 h, 59 min, 59 s ±1 s

Lift in/out:manual optional automatic

Start time:manually by sensor switch optional automatic lift

Automatic detection of disintegration time:– optional type A / B mBasket,

ZT.NETAcoustic signal:

available

Interfaces:– RS 232

Housing material:laquered metal

Printer:optional USB adapter

Basket cleaning and media preheating station:for ZT 321 and ZT 323 only

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4 – Installation

4.1 – Storage and transport conditions

The device should not be exposed to punches and vibrations.

Temperature and humidity should not be lower or higher than the values defined by ERWEKA (see 4.3.3 – Required installation environment).

4.2 – Unpacking and checking

Upon receiving the delivery, check that no physical damage has occurred to the packaging and device during the transportation.

If available, check the tilt indicator label for undue turning of the packaging. In case of 60° inclination the colored quartz sand flows into the display field and is visible there.

If undue transporting or any damage is evident, take a photo of this and send it to our ERWEKA Service immediately.

4.3 – Installation

4.3.1 – Positioning

Position the device on a horizontal, plane, stable surface, e.g. on a laboratory table, and pay attention so that not to displace it during the operation.

For operation and access, when positioning the device, pay attention to the sufficient distance to the walls, cabinets or other fixed components of the facility.

Besides sticking to the requirements for installation environment defined by ERWEKA avoid the following:

• Heat (heating, insolation)• Direct draught through open windows, doors or air conditioning and ventilating systems• Shaking• Dampness

4.3.2 – Acclimatization

When a cold device is taken into the warm environment, this can lead to the condensation. Therefore, acclimatize the switched off device during approximately 2 hours at the room temperature.

4.3.3 – Required installation environment

Ambient temperature in operation: +10°C up to +30°CStorage and transport temperature: + 5°C up to +40°CRelative humidity: 25-80% no condensation

14 ZT 221-324 – Installation

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4.4 – Assembly and first switching on

The following procedure describes how to assemble the device and prepare it for the operation.

Picture

1) Connection nozzle2) Connection nozzle3) Inlet pipe4) Outlet pipe5) Bottle

Procedure

1. Remove the water bath and its cover.

2. Remove the sealing plugs.

3. Place the water bath to its initial position.

4. Place the water pipes (inlet and outlet) into the corresponding connection nozzles.

5. Fill the water bath with demineralized water up to the graduation mark on the bath. Check the water bath, heating system and connection tubes for leaks.

6. Turn the inlet pipe upwards and fill in the heating system with water from the delivered bottle.

Damage to heater and pump in case of insufficient filling of the water bath before operation! Ensure that the water is flowing into and out of the inlet pipe before the disintegration tester is connected to the mains supply.

7. Turn the inlet pipe to its downward directed position.

The device can be damaged and therefore become useless. Follow the instructions of the assembly thoroughly and carefully.Do not switch the device on without water in the heating system.Do not connect the device before or during the assembly to the current supply.

1

2

3

4

5

Make sure that the inlet pipe is directed upwards and the outlet pipe downwards.

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8. Ensure that the connection tubes of the heating system are filled with water.

9. Put the support plate into the water bath.

10. Fill the test vessels with medium and insert them into the orifices in the water bath cover.

11. Attach the baskets to the support arms. If you are using mBaskets connect them to the appropriate slots of the ConBox multiplexer.

12. Ensure that the mains switch on the device rear panel is in the OFF position.

ERWEKA accepts no liability in case of wrong connection!Defective devices should be opened by the manufacturer or authorized staff only!

13. Plug the device into a safety socket. Use the delivered network cable.

14. To switch the disintegration tester on, set the mains switch on the rear panel to I (ON). As soon as the disintegration tester is switched on its firmware version is being shown during 2 seconds.

15. Check the functioning of the heating system, attach the water bath cover and check the device with pipes for leakages.

16. For devices of the ZT 32x series: Connect the PT 100 [1] with the device and insert it through the corresponding orifice in the water bath cover (see following picture).

1) PT 100 temperature sensor

17. If the device is controlled by the software, connect the device with the corresponding network cable to the computer. The serial interface is located on the device rear panel.

18. If you use a printer, connect it to the printer interface on the device rear panel and switch it on.

We recommend configuring the device according to your needs before performing the tests. (See following chapter.)To switch the device off, set the mains switch to 0 (OFF).

The filling is finished once the air is leaked completely out of the heating system.

HAZARD due to electric shock! Electric devices are to be plugged into safety sockets only!The voltage of the existing current supply is to be compared to the indications on the type label!

1

16 ZT 221-324 – Configuration

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5 – Configuration

Upon completion of the installation of your device apply the device configuration settings.

1. Switch the disintegration tester off.

2. Press and hold the Start + Stop keys for 2-3 seconds and switch the device on simultaneously.

3. Release the specified key combination when the CLBR menu, which appears by default, is shown.

The CLBR (Calibration) menu is an item of the Configuration menu. MENU on the left display shows that you are in the uppermost level of the Configuration menu. All menu items are listed below:

Menu item FunctionTIME (date/time) Setting of the date and time.SND (alarm) Switching the alarm signal on the test end on/off.LEDS (brightness) Setting of the LED display brightness.STOP (test stop) Test end after achieving the definite time or full product disintegration.UPSD (upward speed) ZT 32x - setting of the speed for lifting the support arm.DNSD (downward speed) ZT 32x - setting of the speed for lowering the support arm.P.MOD (printing mode) Setting of the printing mode.P.TYP (printer type) Setting of the printer type.E.MOD (export mode) Settings for the data export.SETT (nominal temperature) Setting of the nominal temperature.MAXT (maximal temperature) Setting of the maximal temperature.MINT (minimal temperature) Setting of the minimal temperature.OFST (temperature offset) Setting of the temperature offset.HEAT (heater on/off) Switching the water bath heating on/off.CLBR (calibration) Performing the calibration.

Navigation in the Configuration menu

Using the arrow keys you can scroll the items of the Configuration menu.

Press the Start key to open the menu items and to apply changes entered previously.

Press the Stop key to enter the next menu item without changes.

To exit the configuration mode and enter the test mode, press Stop in any of the menus when you are on the MENU level of the Configuration menu.

For the ZT 322 - 324 devices the configuration occurs on the control panel of the first test station. For all other test stations the LED settings only can be applied. (See section 5.3 – LEDs.)

ZT 221-324 – Configuration 17

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5.1 – Date/time

In the TIME menu set the current date and time on your device.

To set the date and time:

1. Using the arrow keys scroll the Configuration menu items until the TIME menu appears.

2. Press Start. TIME is shown in the “hh:mm” format (hours and minutes) on the display.

3. Using the arrow keys set the required time.

4. Press Start to set the time. The screen changes. DATE

5. is shown in the “dd:mm” format (day and month) on the display.

6. Using the arrow keys set the required date.

7. Press Start for confirmation. The screen changes. YEAR is shown in the “20yy” format (the last two values can be changed) on the display.

8. Using the arrow keys set the required date.

9. Press Start to save your entry.

The TIME menu is available only if a printer is connected to the device.

5.2 – Alarm

In the SND menu enable or disable the acoustic alarm signaling about the completion of a test run.

To enable/disable the alarm:

1. Using the arrow keys scroll the Configuration menu items until the SND menu appears.

2. Press Start. SND with the currently set status (ON or OFF) is shown on the display.

3. Using the arrow keys change the status as required.

4. Press Start to save your entry.

5.3 – LEDs

In the LEDS adjust the brightness of the LED display of each test station.

To adjust the LED brightness:

1. Using the arrow keys scroll the Configuration menu items until the LEDS menu appears.

2. Press Start. LEDS and the currently set brightness is shown on the display.

The acoustic alarm is turned on by default.

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5.5 – Lifting speed

In the UPSD and DNSD menus specify the basket lifting speed (for ZT 32x with automatic support arm).

The lifting speed defines how quickly the basket is dropped into the vessel at the beginning and raised at the end of the test.

To set the upward speed:

1. Using the arrow keys scroll the Configuration menu items until the UPSD menu appears.

2. Press Start. UPSD with the current set value is shown on the display.

The upward speed is set to 35 mm/s by default.

3. Using the arrow keys change the value as required.

4. Press Start to save your entry.

Take into account that the lifting speed can influence the medium in the vessel so that it can be spilled. In this case set this speed to the lowest value.

The lifting speed (upward and downward) can be adjusted for each test station individually. The UPSD and DNSD menus are available for disintegration testers of the ZT 32x series with automatic support arm only.

The brightness can be adjusted from 0 to 5.

For the other test stations the LEDS menu looks as follows.

3. Using the arrow keys change the brightness as required.

4. Press Start to save your entry.

5.4 – Test stop

In the STOP menu you can set whether to stop the tests immediately after achievement of the preset time or after complete product disintegration.

To switch the test stop after the preset time on/off:

1. Using the arrow keys scroll the Configuration menu items until the STOP menu appears.

2. Press Start. STOP with the currently set status (ON or OFF) is shown on the display.

The function of the test stop after the preset time is switched on by default.

3. Using the arrow keys change the status as required.

4. Press Start to save your entry.

The brightness of the LED display is set to 2 by default.

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To set the downward speed:

1. Using the arrow keys scroll the Configuration menu items until the DNSD menu appears.

2. Press Start. DNSD with the currently set value is shown on the display.

The downward speed is set to 30 mm/s by default.

3. Using the arrow keys change the value as required.

4. Press Start to save your entry.

5.6 – Printout mode

In the P.MOD menu set the automatic printout mode, printout after question or no printout for the reports.

To set the printout mode:

1. Using the arrow keys scroll the Configuration menu items until the P.MOD menu appears.

2. Press Start. P.MOD and the currently set printout mode is shown on the display.

You can select between AUTO (automatic printout), ASK (printout after question) and OFF (no printout).

3. Using the arrow keys change the printout mode as required.

4. Press Start to save your entry.

5.7 – Printer type

In P.TYP menu select the printer type (normal or portable) to be used for the report printout.

To select the printer type:

1. Using the arrow keys scroll the Configuration menu items until the P.TYP menu appears.

2. Press Start. P.TYP with the currently set value (NORM for normal printer or PORT for portable printer) is shown on the display.

3. Using the arrow keys select your printer type.

4. Press Start to save your entry.

5.8 – Data export mode

In the E.MOD menu select the automatic data export mode, data export after question or no data export.

To select the data export mode:

1. Using the arrow keys scroll the Configuration menu items until the E.MOD menu appears.

2. Press Start. P.MOD and the currently set data export mode is shown on the display.

You can select between AUTO (automatic export), ASK (export after question) and OFF (no export).

3. Using the arrow keys change the data export mode as required.

4. Press Start to save your entry.

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6 – Temperature Settings

Configure the temperature settings before test start. Use the corresponding items of the Configuration menu (see 5 – Configuration). The procedure is described below.

6.1 – Nominal temperature

In the SETT menu set the nominal temperature. By default the temperature is set to 37.0 °C. The preset temperature is shown in the right part of the display as soon as the device is switched on.

To set the nominal temperature:

1. Using the arrow keys scroll the Configuration menu items until the SETT menu appears.

2. Press Start. PRST with the currently set value is shown on the display.

3. Using the arrow keys set the nominal temperature.

The adjustment range is (in 0.1°C steps) from 30.0°C to 40.0°C by default or to 50.0°C optionally.

4. Press Start to save your entry.

6.2 – Maximal temperature

In the MAXT menu set the maximal temperature.

To set the maximal temperature:

1. Using the arrow keys scroll the Configuration menu items until the MAXT menu appears.

2. Press Start. MAXT with the currently set value is shown on the display.

5.9 – Printer settings

There is the possibility to connect a printer to the device. The printer is connected to the device through an optional interface. For more information contact ERWEKA sales manager.

A device with printer interface and properly connected printer prints the test reports for each test station auto-matically.

ERWEKA supports the OKI B431 and HP M401A printer models that can be connected to the disintegration testers ZT 22x-32x.

If your device is connected to a printer, the TIME menu is available.

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By default the maximal temperature is set to 40°C.

3. Using the arrow keys set the maximal temperature.

4. Press Start to save your entry.

6.3 – Minimal temperature

In the MINT menu set the minimal temperature.

To set the minimal temperature:

1. Using the arrow keys scroll the Configuration menu items until the MINT menu appears.

2. Press Start. MINT with the currently set value is shown on the display.

3. Using the arrow keys set the minimal temperature.

4. Press Start to save your entry.

6.4 – Temperature offset

In the OFST menu specify the temperature offset for your future tests.

Temperature offset is the value that indicates the temperature range allowed during the test run. For example, if the temperature offset value is 0.3°C and the temperature set previously is 37°C, the water bath will be heated to 37.3°C.

To set the temperature offset:

1. Using the arrow keys scroll the Configuration menu items until the OFST menu appears.

By default the minimal temperature is set to 30°C.

2. Press Start. OFST with the currently set value is shown on the display.

3. Using the arrow keys set the temperature offset. The adjustment range of the temperature offset is from 0.0°C to 0.9°C.

4. Press Start to save your entry.

6.5 – Bath heating

In the HEAT menu turn the water bath heating on/off. If the heating is turned off, the water bath will not be warmed up to the nominal temperature.

To turn the bath heating on/off:

1. Using the arrow keys scroll the Configuration menu items until the HEAT menu appears.

2. Press Start. HEAT with the currently set status (ON or OFF) is shown on the display.

3. Using the arrow keys turn the bath heating on/off.

4. Press Start to save your entry.

If the water bath is overheated, the external temperature sensor might be damaged. To check this, switch it off. Then switch the device off and on again. In case the water bath is not overheated anymore, the external temperature sensor is damaged and should be replaced.

22 ZT 221-324 – Calibration

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7 – Calibration

7.1 – Instructions for calibration

Before performing disintegration tests both the internal (heater) and external (PT 100 temperature sensor) thermometers of the device must be calibrated to ensure their correct functionality with regard to required accuracy. For this purpose measurement values of the device are compared with measurement values of a reference thermometer.

For the calibration process you must warm the water bath. This process will take some time and depends on the specified nominal temperature.

For the ZT 22x-32x disintegration testers a one-point calibration is performed.

7.2 – Calibrating temperature sensors

In the CLBR menu calibrate the temperature sensor (internal and optionally external). CLBR is a menu item of the Configuration menu (see 5 – Configuration). The calibration procedure is described below.

To calibrate the temperature sensor:

1. Switch the device off.

2. Fill the water bath up to the graduation mark.

3. Put the hand temperature sensor (if available) into the bath.

4. Put the calibrated reference thermometer into the bath.

5. Simultaneously press and hold the Start + Stop keys for 2-3 seconds and switch the device on to enter the configuration mode. The Calibration menu appears as item of the Configuration menu by default.

6. Press Start.

Devices without PT 100

CLBR and the specified nominal temperature are shown on the display.

7. Press Start to continue the calibration.

A calibrated external reference thermometer must be applied for the calibration.

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Devices with PT 100

SNSR and the currently selected temperature sensor (INT - internal or EXT - external) are shown on the display.

7. Using the arrow keys select the temperature sensor to be calibrated and press Start once to save your selection and again to continue the calibration.

The heater is switched on. The display shows the remaining time of the heating on the left and the current bath temperature on the right.

The symbol indicates that the water bath is being warmed up. This symbol appears only on the disintegration tester without externally connected PT 100, i.e. ZT 22x.

8. Wait until the temperature in the water bath is stabilized. The real temperature is displayed.

9. Read the value from the reference thermometer and enter it using the arrow keys.

10. Press Start to save the calibration.

If the calibration was successful, the display shows OK.

In case some error occurred during the calibration the display shows Err.

A faulty calibration is unvalid. The device must be calibrated again. Refer to the ERWEKA Service if the error repeats.

11. Press Start to finish the calibration.

24 ZT 221-324 – Performing Tests

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8 – Performing Tests

8.1 – Performing a disintegration test

1. Switch the disintegration tester on. The main display appears.

The time of the last test is shown in the left part of the display, the specified nominal temperature – in the right part.

2. Press Start and wait until the water bath achieves the nominal temperature. The remaining time of the heating phase is shown in the left, the current bath temperature – in the right. Wait until the nominal temperature value is displayed stably.

3. Using the arrow keys set the required test runtime.

The runtime in the left is displayed in hours and minutes (hh:mm) by default. If you want to specify the runtime in seconds, press Stop. There will be S (seconds) and the specified value, e.g. 20, in the left part of the display.

You can also set the test runtime to 00:00 (i.e. null hours, nul minutes and null seconds). This means that the runtime is unlimited and the test will continue until you lift the basket out of the medium or press Stop twice.

Before performing a test ensure that the disintegration tester is calibrated. For more information see chapter 7 – Calibration.

In case the displayed nominal temperature does not meet your test requirements, you can change it. Read more in section 6.1 – Nominal temperature.

You may press Stop to skip the heating phase. When you press Stop, the current bath temperature is shown and the display starts blinking. The blinking indicates that the value set previously has not been reached. You may now press Start to return to the heating phase or press Stop again to continue working.

ZT 221-324 – Performing Tests 25

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4. Lift in the basket into the medium. The motor switches on and the time counting starts. The test has been started.

The elapsed test runtime is shown in the left part of the display, the current temperature – in the right part.

30 seconds before the test runtime is reached the device starts beeping (1 beep every 2 seconds).

When the test runtime is expired, the disintegration tester starts beeping faster (1 beep every ½ second) indicating that you should lift the basket out of the medium.

You can switch the beeping off by pressing Stop. The time counting is continued until you press Stop again or lift the basket out of the medium.

As soon as the basket is lifted out the beeping switches off and the time counting stops. If there are no tests running on the other test stations, the motor also switches off.

5. Now press Stop to finish the test.

When the test runtime is out, but you are not satisfied with the achieved result, you may continue the test. To do so, lift in the basket into the medium or (in case of automatic) press Start. The beeping switches off, if enabled. The motor switches on and the test continues. The runtime for such a test is unlimited. The test is continued until you stop it by lifting the basket out or pressing Stop.

Tests on other test stations of the device (depending on the device type) are performed analogically to the first station. The display of each following test station shows only the runtime of the last test or the elapsed time (according to status). The test runtime can be specified for each test station individually. Current and nominal water bath temperatures can be seen on the display of the first test station.

8.2 – Pausing / aborting a test

You can pause a test at any time. To do so, lift the basket out of the medium. The time counting pauses. To resume the test, lift in the basket into the medium again. The time counting and test resume.

You can also pause a running test by pressing Stop. In this case the time counting is stopped, but the basket still remains in the medium. To resume the test, press Start.

To abort a running test, press Stop twice or lift the basket out of the medium and press Stop.

If the test runtime is set to more than one hour, in the left part of the display hours and minutes are shown. If the test runtime is set to less than one hour, minutes and seconds are shown there.

26 ZT 221-324 – Maintenance

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9 – Maintenance

9.1 – Cleaning

To guarantee the failure-free operation, it is recommended to clean the device regularly. The device is to be cleaned after each test and at least once a month. Spilt liquid must be removed immediately. Read the following instructions thoroughly before you begin with the cleaning.

Instructions for cleaning:

1. Disconnect the mains supply and, if available, printer.

2. Detach the baskets from the support arms. Clean the baskets at temperature below 80 °C and in ultrasonic way.

3. Take out and empty the vessels.

4. Empty the water bath. Clean it with cleansing agents for acrylic glass and afterwards rinse thoroughly with water.

Acrylic glass can be scratched during the dry cleaning with the present dust particles. That’s why wipe acrylic glass always with a damp cloth. The best way is to have special microfiber clothes at hand that you can damp with the lukewarm water.

5. Wipe the device with a soft and slightly damped cloth.

If needed, e.g. in case of serious dirtying, use a damp cloth and blot the cleaned surface dry.

HAZARD of electric shock when cleaning the electric devices!Disconnect the mains supply for cleaning the electric devices! Switch the device off and unplug it for cleaning! Clean the electrical devices without liquids.

Note that residues of the test products must be properly disposed of in accordance with the applicable environmental regulations.

Vessels without centering rings can be cleaned in a dish washer.

The water bath is made of high-grade acrylic glass and therefore is sensitive to the aggressive cleansing agents. Do not use organic solvents (e.g. ethanol or methanol) because this causes damage. Use only a special cleansing agent for acrylic glass.

Do not use an excessively damped cloth but slightly damped one. Do not add any chemical cleansing agents to the cleaning water. For lacquered housing parts use no cleansing agents which attack this material.

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9.2 – Inspection and maintenance

Ensure that the device is regularly inspected and each time is clean.

In longer standstills:

If the device is not used for a long time, follow the instructions below:

• Switch off and unplug the device.• Dismount additional components.• Empty and clean containers.• Clean the device thoroughly.• Store the device, its components and manual under conditions defined for the installation environment.

9.3 – Spare parts

Only original spare parts or components released by ERWEKA should be used. Only repairs or changes on the device performed by the ERWEKA technicians or approved explicitly by ERWEKA are to be made.

To ensure a long lifetime of your units and systems, we recommend a regular maintenance performed by our specialized staff.

Non-performance of the instructions given above can lead to damages!

Electronic and mechanical replacements are to be made by the ERWEKA personnel or approved by ERWEKA!

28 ZT 221-324 – Attachment

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Attachment

This chapter contains a protocol example printed out from the device:

ZT 221-324 – Attachment 29

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Terminology list

Notion / Abbreviation ExplanationPict. Picture

ASTM Abbreviation for American Society for Testing Materials

Basket Defined sample container (metal basket)

BP British Pharmacopoeia

i.e. Lat. id est - it means

DAB German Pharmacopoeia (Deutsches Arzneibuch)

Disintegration test Test of tablet disintegration in definite media under definite conditions

Display LC or LED display

Disintegration test Disintegration test, test of tablet disintegration in certain media under specified conditions

EP European Pharmacopoeia

FDA U.S. Food and Drug Administration

GMP Good Manufacturing Practice, quality standard in pharmaceutical industry

Internal temperature sensor Temperature measurement sensor integrated in heater

IQ Installation Qualification

JP Japanese Pharmacopoeia

Adjustment Configuration or alignment of the measurement device to eliminate systematic deviations as much as it is required for the foreseen application (in the text the corresponding menu name is applied as notion for convenience)

Calibration Verification through comparison with reference or traceable standard that a definite device produces an appropriate range of measurement results within specific limits (in the text the corresponding menu name is applied as notion for convenience)

LC Liquid Crystal

LED Light-emitting diode

Medium Fluid environment in the test vessel

Method A set of defined conditions, methods and techniques for testing a product

OQ Operational Qualification

PT 100 A temperature measurement sensor, here used as external temperature sensor, e.g. for measuring water bath or medium temperature

Report Report, protocol

Disc Disintegration disc for a sample in a glass tube

SOP Standard Operating Procedure, instructions for carrying out specific operations

Stack Device internal buffer, stored actions allow the process to continue after interruption

USP U.S. Pharmacopeial Convention

Vessel Test container, beaker

Vial Small test container in basket

e.g. for example (exempli gratia)

Certifi cate of Compliance for Konformitätserklärung für

Disintegration Tester,Type ZT 22x - 32x

We, ERWEKA GmbH, declare under our sole responsibility that the product to which this declara-tion relates is in conformity with the following EU-Directives and harmonized standards:

■ Low Voltage Directive (LVD) 2014 / 35 / EU

■ Safety requirements for electrical equipment for measurement, control and laboratory use; EN 61010-1

■ Electromagnetic Compatibility, (EMC) Directive 2014 / 30 / EU

■ Electrical equipment for measurement, control and laboratory use; EN 61326-1

Wir, die ERWEKA GmbH, erklären in alleiniger Verantwortung, dass das Produkt, auf das sich die-se Erklärung bezieht, mit folgenden EU-Richtlinien und harmonisierten Normen übereinstimmt:

■ Niederspannungsrichtlinie 2014 / 35 / EU

■ Sicherheitsbestimmungen für elektrische Mess-, Steuer-, Regel- und Laborgeräte; EN 61010-1

■ Elektromagnetische Verträglichkeit, EMV-Richtlinie 2014 / 30 / EU

■ Mess-, Steuer-, Regel- und Laborgeräte, EN 61326-1

ERWEKA GmbH · Ottostr. 20-22 · 63150 Heusenstamm · Germany · Tel: +49 6104 6903-0Fax: +49 6104 6903-40 · E-mail: info@erweka.com · www.erweka.comManaging Director & CEO: Werner G. Müller, Claudia Müller, Manfred Koller · District court Offenbach HRB 2382

Manfred Koller -CTO-

Heusenstamm, 07.03.2016

ERWEKA GmbH · Ottostr. 20-22 · 63150 Heusenstamm · Germany · Tel: +49 (0) 6104 6903-0Directors: Werner G. Müller, Claudia Müller, Manfred Koller · District court Offenbach HRB 2382Fax: +49 (0) 6104 6903-40 · E-mail: info@erweka.com · www.erweka.com