Disintegration Tester ZT

Transcription

1 Instruction Manual Disintegration Tester ZT ERWEKA GmbH Ottostr Heusenstamm Germany Tel: +49 (0) Directors: Werner G. Müller, Claudia Müller, Manfred Koller District court Offenbach HRB 2382 Fax: +49 (0)

2 Document version 1.3 Date: Firmware version: from 1.24 Document No.: File name: ZT Manual_21841_En_V1.3 Language: English Page number: 32 Version table Date Document version* Change Firmware version was increased management; corporate identity new document No. (old No.: ) new format (11/15) * When the document version X.Y is increased, X means a technical change and Y a document change only. Copyright The 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

3 Instruction Manual Disintegration Tester ZT

4 4 ZT Table of Contents 1 Introduction About this instruction manual Service Safety instructions and symbols Protection of the environment Spare parts 27 Attachment 28 Terminology list 29 2 Safety Safety information Intended use 7 3 Overview Description Device types Type label Construction Operation elements and connections Keypad Connections Baskets Technical data 12 4 Installation Storage and transport conditions Unpacking and checking Installation Positioning Acclimatization Required installation environment Assembly and first switching on 14 5 Configuration Date/time Alarm LEDs Test stop Lifting speed Printout mode Printer type Data export mode Printer settings 20 6 Temperature Settings Nominal temperature Maximal temperature Minimal temperature Temperature offset Bath heating 21 7 Calibration Instructions for calibration Calibrating temperature sensors 22 8 Performing Tests Performing a disintegration test Pausing / aborting a test 25 9 Maintenance Cleaning Inspection and maintenance 27

5 ZT Introduction 5 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 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 6 ZT Introduction 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.

7 ZT Safety 7 2 Safety 2.1 Safety information To guarantee the health and safety, read the following safety instructions before using the device. WARNING Wear 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 8 ZT Overview 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 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 Support arms Type label The type label is placed on the rear panel of the device and contains following data: Typ: Device type Serial No: Serial number P N : Normal output in Watt [W] or Volt Amper [VA] I N : Nominal current in Amper [A] U: Voltage in Volt [V] F: Frequency in Hertz [Hz]

9 ZT Overview Construction Pict. ZT 322 disintegration tester with external PT 100 1) Beaker glass (vessel) 2) PT 100 (ZT 32x series only) 3) LED display and keypad (1 st test station) 4) LED display and keypad (2 nd test station) 5) Support arm 6) Basket (see 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.

10 10 ZT Overview 3.5 Operation elements and connections 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 ZT 324) respectively. Keypad Key symbol Description/Function The 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 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.

11 ZT Overview Connections Switch and connections are located upside on the device rear panel (see following picture) ) On/Off switch 2) RS 232 interface (optional) 3) Connection for temperature sensor PT 100 (only ZT 32x) 4) Network connection 5) USB A e.g. for extra printer (optional) 6) Fuses 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 Multiplexer 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 / / 24

12 12 ZT Overview 3.6 Technical data ZT 22x Series ZT 32x Series Dimensions: Height [mm] 660 Width [mm] Depth [mm] 400 Weight: [kg] Compliance: USP / EP / JP Power supply: 115 / 230 VAC; 50 / 60 Hz Power consumption: max 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 PT 100 or PT 100 Temperature range: 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.NET Acoustic 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

13 ZT Installation 13 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 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 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 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 Required installation environment Ambient temperature in operation: Storage and transport temperature: Relative humidity: +10 C up to +30 C + 5 C up to +40 C 25-80% no condensation

14 14 ZT Installation 4.4 Assembly and first switching on The following procedure describes how to assemble the device and prepare it for the operation. 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. Picture ) Connection nozzle 2) Connection nozzle 3) Inlet pipe 4) Outlet pipe 5) 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. Make sure that the inlet pipe is directed upwards and the outlet pipe downwards. 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.

15 ZT Installation Ensure that the connection tubes of the heating system are filled with water. The filling is finished once the air is leaked completely out of the heating system. 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. 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! 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 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).

16 16 ZT Configuration 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 TIME (date/time) SND (alarm) LEDS (brightness) STOP (test stop) UPSD (upward speed) DNSD (downward speed) P.MOD (printing mode) P.TYP (printer type) E.MOD (export mode) SETT (nominal temperature) MAXT (maximal temperature) MINT (minimal temperature) OFST (temperature offset) HEAT (heater on/off) CLBR (calibration) Function Setting of the date and time. Switching the alarm signal on the test end on/off. Setting of the LED display brightness. Test end after achieving the definite time or full product disintegration. ZT 32x - setting of the speed for lifting the support arm. ZT 32x - setting of the speed for lowering the support arm. Setting of the printing mode. Setting of the printer type. Settings for the data export. Setting of the nominal temperature. Setting of the maximal temperature. Setting of the minimal temperature. Setting of the temperature offset. Switching the water bath heating on/off. 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 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.)

17 ZT Configuration Date/time In the TIME menu set the current date and time on your device. 5.2 Alarm In the SND menu enable or disable the acoustic alarm signaling about the completion of a test run. The TIME menu is available only if a printer is connected to the device. The acoustic alarm is turned on by default. To set the date and time: 1. Using the arrow keys scroll the Configuration menu items until the TIME menu appears. To enable/disable the alarm: 1. Using the arrow keys scroll the Configuration menu items until the SND menu appears. 2. Press Start. TIME is shown in the hh:mm format (hours and minutes) on the display. 2. Press Start. SND with the currently set status (ON or OFF) is shown 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. 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. 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. To adjust the LED brightness: 1. Using the arrow keys scroll the Configuration menu items until the LEDS menu appears. 8. Using the arrow keys set the required date. 9. Press Start to save your entry. 2. Press Start. LEDS and the currently set brightness is shown on the display.

18 18 ZT Configuration 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 The brightness of the LED display is set to 2 by default. 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: 5.5 Lifting speed In the UPSD and DNSD menus specify the basket lifting speed (for ZT 32x with automatic support arm). To set the upward speed: 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 lifting speed defines how quickly the basket is dropped into the vessel at the beginning and raised at the end of the test. 1. Using the arrow keys scroll the Configuration menu items until the UPSD menu appears. 1. Using the arrow keys scroll the Configuration menu items until the STOP menu appears. 2. Press Start. UPSD with the current set value is shown on the display. 2. Press Start. STOP with the currently set status (ON or OFF) is shown on the display. The upward speed is set to 35 mm/s by default. The function of the test stop after the preset time is switched on by default. 3. Using the arrow keys change the value as required. 4. Press Start to save your entry. 3. Using the arrow keys change the status as required. 4. Press Start to save your entry.

19 ZT Configuration 19 To set the downward speed: 1. Using the arrow keys scroll the Configuration menu items until the DNSD menu appears. 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: 2. Press Start. DNSD with the currently set value is shown on the display. 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. 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. 3. Using the arrow keys select your printer type. 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. 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 printout mode is shown on the display. 2. Press Start. P.MOD and the currently set data export 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. 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.

20 20 ZT Temperature Settings 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 automatically. ERWEKA supports the OKI B431 and HP M401A printer models that can be connected to the disintegration testers ZT 22x-32x. 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: If your device is connected to a printer, the TIME menu is available. 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.

21 ZT Temperature Settings 21 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. 2. Press Start. OFST with the currently set value is shown on the display. 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 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. 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. 3. Using the arrow keys set the minimal temperature. By default the minimal temperature is set to 30 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. 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. 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.

22 22 ZT Calibration 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. A calibrated external reference thermometer must be applied for the calibration. 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.

23 ZT Calibration 23 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 24 ZT Performing Tests 8 Performing Tests Before performing a test ensure that the disintegration tester is calibrated. For more information see chapter 7 Calibration. 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. In case the displayed nominal temperature does not meet your test requirements, you can change it. Read more in section 6.1 Nominal temperature. 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. 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. 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.

25 ZT Performing Tests 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. 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. 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.

26 26 ZT Maintenance 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. 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. 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. Vessels without centering rings can be cleaned in a dish washer. 4. Empty the water bath. Clean it with cleansing agents for acrylic glass and afterwards rinse thoroughly with water. 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. 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. 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. If needed, e.g. in case of serious dirtying, use a damp cloth and blot the cleaned surface dry.

27 ZT Maintenance Inspection and maintenance Ensure that the device is regularly inspected and each time is clean. To ensure a long lifetime of your units and systems, we recommend a regular maintenance performed by our specialized staff. 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. Non-performance of the instructions given above can lead to damages! 9.3 Spare parts Electronic and mechanical replacements are to be made by the ERWEKA personnel or approved by ERWEKA! 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.

28 28 ZT Attachment Attachment This chapter contains a protocol example printed out from the device:

29 ZT Attachment 29 Terminology list Notion / Abbreviation Pict. ASTM Basket BP i.e. DAB Disintegration test Display Disintegration test EP FDA GMP Internal temperature sensor IQ JP Adjustment Calibration LC LED Medium Method OQ PT 100 Report Disc SOP Stack USP Vessel Vial e.g. Picture Explanation Abbreviation for American Society for Testing Materials Defined sample container (metal basket) British Pharmacopoeia Lat. id est - it means German Pharmacopoeia (Deutsches Arzneibuch) Test of tablet disintegration in definite media under definite conditions LC or LED display Disintegration test, test of tablet disintegration in certain media under specified conditions European Pharmacopoeia U.S. Food and Drug Administration Good Manufacturing Practice, quality standard in pharmaceutical industry Temperature measurement sensor integrated in heater Installation Qualification Japanese Pharmacopoeia 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) 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) Liquid Crystal Light-emitting diode Fluid environment in the test vessel A set of defined conditions, methods and techniques for testing a product Operational Qualification A temperature measurement sensor, here used as external temperature sensor, e.g. for measuring water bath or medium temperature Report, protocol Disintegration disc for a sample in a glass tube Standard Operating Procedure, instructions for carrying out specific operations Device internal buffer, stored actions allow the process to continue after interruption U.S. Pharmacopeial Convention Test container, beaker Small test container in basket for example (exempli gratia)

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31 Certificate 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 declaration 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 Electromagnetic Compatibility, (EMC) Directive 2014 / 30 / EU Electrical equipment for measurement, control and laboratory use; EN Wir, die ERWEKA GmbH, erklären in alleiniger Verantwortung, dass das Produkt, auf das sich diese Erklärung bezieht, mit folgenden EU-Richtlinien und harmonisierten Normen übereinstimmt: Niederspannungsrichtlinie 2014 / 35 / EU Sicherheitsbestimmungen für elektrische Mess-, Steuer-, Regel- und Laborgeräte; EN Elektromagnetische Verträglichkeit, EMV-Richtlinie 2014 / 30 / EU Mess-, Steuer-, Regel- und Laborgeräte, EN Heusenstamm, Manfred Koller -CTO- ERWEKA GmbH Ottostr Heusenstamm Germany Tel: Fax: info@erweka.com Managing Director & CEO: Werner G. Müller, Claudia Müller, Manfred Koller District court Offenbach HRB 2382

32 ERWEKA GmbH Ottostr Heusenstamm Germany Tel: +49 (0) Directors: Werner G. Müller, Claudia Müller, Manfred Koller District court Offenbach HRB 2382 Fax: +49 (0)