ERWEKA 8 ELNOVA ZT30 ZT40 ZT50 ZT60 ZT70 _!! disintegration testers ZT 20. If* h» L i J. Handelsgesellschaft mbh ERWEKA

Transcription

1 ERWEKA L i J If* h» _!! disintegration testers ZT 20 ZT30 ZT40 ZT50 ZT60 ZT70 ELOVA Handelsgesellschaft mbh Berlin Moskau Paul-Zobel-StraBe 8 k Telefon D Berlin Telefax Telefon +49(0) Kaunas Telefax +49(0) Tel./Fax ERWEKA 8

2 Table of Contents Page 2 'i story PageS ZT20 Page 4 PageS Page Page Page Page 14 'lical Details sires Page 15 ZT ZT

3 A history of experience tanufacture res that the. - ;. - -; s of jtion foi ; '' И- ":.'' ' : ; J; \ - ''.

4 The ERWEKA Disintegration Tester ZT20 Series is available with between one and four test stations, namely the ZT 21, ZT 22, ZT 23, or the ZT 24 respectively. In this series, the test basket(s) must be removed from the test medium manually. A locking device to hold the basket steady during loading and inspection is provided as standard. With the multiple stage testers, the test stations operate simultaneously. The instrument features a central motor drive unit which is fitted with a vertical shaft and cam disc to provide a stroke of 55 mm (± 1 mm). The drive is generated by a motor operating at a fixed speed of 30 (± 1) strokes per minute. The basket rack assembly or assemblies are located on a single hanger assembly mounted on the drive shaft. ote: This series comes without test vessels and heating: it is the responsibility of the purchaser to provide his own beakers, water bath and immersion thermostat. ZT20 Disintegration Tester Type ZT 21 with one test station (without beaker, water bath and immersion thermostat). : :: = USP, ЕР, ВР, DAB Disintegration Basket Rack Assembly (to accept six tablets). Dimensions (mm): H W D ZT ZT ZT ZT

5 ZT40 The ERWEKA Disintegration Tester ZT 40 Series provides the basic system for determination of the disintegration time according to USR ER DAB and BP requirements. It is ideally suited for the medium size laboratory where, nevertheless budgetary considerations are important. Similar in construction to the ZT 20 Series, the ZT 40 Series comprises of a central housing which serves to support the motor drive unit, basket rack assembly, beaker, removable perspex tank and immersion thermostat. Depending on the number of test stations chosen, the ZT 40 Series has the capacity of testing up to one, two, three or four different tablet samples simultaneously. Disintegration Tester Type ZT 43 (with three simultaneously driven test stations). As in the ZT 20 series, motive power is provided by a single drive-unit thus each of the test stations operate simultaneously. Similarly, the basket rack assembly or assemblies must be removed manually from the beaker and then locked into the loading/inspection position. The test run is started by lowering the basket(s) into the test media. In the case of the ZT 42, ZT 43 and ZT 44, the baskets are mounted in a single line of 2, 3 or 4. As in all the ZT Series, the temperature of the warming solution is controlled by means of a proportionally regulated circulation thermostat having a temperature range of C (with an accuracy of ± 0.5 C) and a power consumption of 1500 watts at 230 V (1000 watts at 115V). The temperature in the water bath may be monitored by means of a glass thermometer provided with the instrument for this purpose. Disintegration Tester Type ZT 42 (with two simultaneously driven test stations). Dimensions (mm): H ZT ZT ZT ZT W D

6 The ZT 50 Series Disintegration Tester Type ZT 54 (with four simultaneously driven test stations and provision to programme in the duration of the test). Disintegration Discs in accordance with the specifications as laid down in USP, ЕР, ВР and DAB.

7 vision to The ERWEKA Disintegration Tester ZT 50 Series is available with one (ZT 51), two (ZT 52), three (ZT 53) and four (ZT 54) test stations. The multiple station Testers operate simultaneously. LCD-display and keypad for programming in the test run time. n. nj-u л и* f i" iи _h LmisJ L_ s 1 00 The plexiglass water bath is equipped with a removable cover for easy cleaning. The temperature of the warming solution is controlled by means of a proportionally regulated circulation thermostat to an accuracy of ± 0.5 C. The temperature of the warming solution may be monitored by the immersion thermometer provided for this purpose. Calibrated thermometers are available on request. The USP Disintegration basket rack assembly or assemblies (with a capacity of 6 tablets each) can be removed manually from the glass beaker and locked in place with a special locking device. This enables the operator to insert the test samples into the basket rack assembly prior to each test run and before lowering the basket into the test media. Alternatively, an automatic version is available on request, whereupon, on completion of the test, the basket rack assembly or assemblies are automatically removed from the test media. The touch sensitive keypad allows for the selection of test run times of between 1 second and 9 hours 59 minutes 59 seconds. An LCD-display indicates the test run time. During the test, the remaining test run time can also be displayed. If required, an audible alarm can be pre-set to signal the completion of a test run. A RESET option is available allowing the total test run time for the previous test to be recalled if required. All electronic components are mounted in the head of the instrument to protect them against damaging water spray or test media. Dimensions (mm): H ZT ZT ZT ZT W D

8 Disintegration Testers of the ZT 30 Series are available with one (ZT 31), two (ZT 32), three (ZT 33) and four (ZT 34) test stations. ZT30 In contrast with the ERWEKA Disintegration Tester Series ZT 20, ZT 40 and ZT 50, the ZT 30 Series allows for independent testing on the two, three and four-stage units. In these units, each test station is driven by an independent motor controlled by separate electronic timers thus allowing each test station to be operated independently from the others. Each individual test station has a motor drive unit fitted with a vertical shaft with a stroke of 55 mrn (± 1 mm). The drive of each unit is generated by a motor operating at a fixed speed of 30 strokes per minute (± 1 stroke per minute). Each test station has its own touchsensitive keypad to enable the setting of individual test run times of between 1 second and 9 hours 59 minutes 59 seconds. Once set, the operator only has to press the appropriate START key to commence testing on the individual test station. u f» "и 00 ФФФ Each test station is also provided with an individual LCD-display indicating the remaining test run time during a test run. An alarm can be pre-set to sound at the end of a test. In the case of the ZT 30 Series, on completion of the test run, the basket rack assembly is automatically removed from the test media. The Disintegration Basket Rack Assembly can be removed by a quick release coupling within seconds. A RESET option is available allowing the total test run time for the previous test to be recalled if required. Disintegration Tester Type ZT 31 (with automatic removal of the basket from the test media on completion of the test). All electronic components are mounted in the head of the instrument to protect them against damaging water spray or test media.

9 ilyfrirt-; Aftfi ' I The plexiglass water bath is equipped with a removable cover to facilitate easy cleaning. The temperature of the warming solution is controlled by means of a proportionally regulated circulation thermostat having an accuracy of ± 0.5 C. Rigid arm support with drive and lifter motor. The temperature of the warming solution may be monitored by the immersion thermometer provided for this purpose. Calibrated thermometers are available on request. Dimensions (mm): ZT31 ZT32 ZT33 ZT34 H W D

10 The ERWEKA Disintegration Tester Series ZT 60 provides for the fully automatic disintegration testing of tablets, oblongs and coated tablets. The series is available with one test station (ZT 61), two test stations (ZT 62), three test stations (ZT 63) and four test stations (ZT 64). ZT60 This series provides the option of operating test stations either simultaneously or independently. The specially designed electronic measuring head comes complete with a modified basket rack assembly and six guided discs with photo sensitive detectors which monitor when the individual samples have disintegrated by determining the time when each individual guided disc touches the sieve mesh, that is to say, when the tablet has disintegrated through the sieve mesh. ft В С О _Е.F G H 1 J К I 0 fd О Р Q _,..Oj;:' Each electronic measuring head is fitted with six calibration adjustment knobs relating to each of the six separate tubes of the basket rack assembly. These are used for zeroing, or, in the case of dosage forms which generate tablet debris on disintegration, allow for the offsetting of the zero point. In the case of the latter, a special plate is positioned under the disintegration disc and the tester is then zeroed by this distance. Individual red lights (LED's) are illuminated when the disintegration discs touch the sieve mesh of the basket rack assembly. The disintegration time of each individual tablet is indicated on an LCD-display on the control panel as and when it occurs. As standard, the tester is supplied with modified timing facilities for use with sustained release products. In this instance, following the expiration of a preset time, the tester stops and the baskets are raised to allow the medium to be changed to a different ph-value. The test can then be restarted. Electronic measuring head with six guided discs. 10

11 A range of Testers for the determination and reporting of the disintegration time of tablets and simiiar forms. Sample print-out of test results and statistics in Stand-Alone operation when connected to a suitable printer. The Disintegration Tester ZT 60 Series are all provided with an alpha-numeric touch-sensitive keypad and special function keys to allow the operator to enter test identification parameters. A digital LCD-display with 320 digits (8 x 40) provides a visual check of the data entry and the ensuing display of programme parameters and test results. A password protected product memory allows the entry of up to 60 different product data files. These files contain the essential information on the product name, number, form, temperature of the water bath and minimum, nominal and maximum disintegration times of the product concerned and can be entered or recalled at will. Before starting a test run, the operator opens the product list contained in the sub menu "TEST", selects the appropriate product name and enters in the batch and machine number. The actual temperature in the water bath is measured by a calibratible PT 100 temperature sensor. This temperature is indicated on the LCD-display and recorded on the print-out of the test protocol. MfllMEU ZT6 Product memory Res и. Its Я d j u. s t I ns P e e t ion display о n f i 3 u г a t i о n С a 1 i b г a t i о n U s e r s e 1 e о t i..,i i t h t + Enter 320 digit, illuminated LCD-display and disintegration time control LED's. As an optional extra, a thermostat with a serial interface is available. In this case, the temperature required is entered via the programme menu of the tester (temperature accuracy ± 0.2 C). Test results, statistics and the temperature of the water bath are indicated on the digital display and transferred to an external printer via the parallel interface provided for this purpose. The language menu is pre-selectable in either English, French, German or Spanish. Both RS 232 and RS 485 serial interfaces are provided for connection to external data processing systems. Optional Immersion Thermostat with serial interface, Type ET 1500i. A Windows based software programme "ERWEKA ZT-WI" is available on request. This allows for unlimited entry of product data, storage of test results, comparison of batches and presentation of test results and statistics in the form of a histogram. Dimensions (mm): H ZT ZT ZT ZT W D 11

12 The ERWEKA Disintegration Testers Series ZT 70 have been designed for the automatic determination and documentation of the disintegration time of tablets, oblongs, coated tablets according to the specifications as laid down in the USP, ER DAB and BR ZT70 The Series is available in four versions dependent on the number of test stations employed, namely from one to four (ZT 71, ZT 72, ZT 73 and ZT 74 respectively). The construction of the ZT 70 Series is identical to that of the ZT 60 with the exception of the method for determining the disintegration time. In case of the ZT 70, the disintegration time is determined by means of a magnet and inductive sensor. The method employs a specially modified disc which has an annular magnet in its centre. In all other respects, even weight, the disc is identical to that as specified in USP, ER DAB and BP such that its adherence to those Pharmacopoeia is not compromised. The modified basket rack assembly is fitted with a series of six inductive sensors located underneath the disintegration basket sieve mesh which detect the magnets embedded in the guided discs as they touch the sieve mesh indicating the disintegration time and hence the end of the test. These events are indicated by a series of six red LED's (representative of each tablet) mounted on the control panel of the tester. The sensitivity of the inductive sensors can be adjusted in increments of 0.1 mm between a distance of 0.0 and 0.5 mm in order to effectively off-set the zero point to allow for those forms containing tablet debris (film or coated tablets). The Windows based ERWEKA Disintegration software for PC operation, storage of test results and Dimensions (mm): statistical evaluation. H ZT ZT ZT ZT W D 12

13 с determination of disintegration with the specification s Disintegration Basket Rack Assembly with quick release coupling. Disintegration Basket Rack Assembly with sensors and Disintegration discs with contacts (in accordance with the specifications as laid down in USP, EP, BP and DAB). 13

14 ZT20 ZT40 ZT50 ZT30 ZT60 ZT70 Complies with USP XXIII, DAB 1996, ER DAB Validation required for USP Determination of the Disintegration Time Manual (Visual observation) Automatic Test Stations One to four test stations Test Stations operate simultaneously Individual control over each test station Basket rack assembly for 6 test samples Disintegration Discs comply with USP P Removal of the Test Basket from the media Manual with locking device Automatic О Display One LCD-display One LCD-display for each test station 320 Digit LCD-display (illuminated) Touch-Sensitive Keypad One One for each test station In-built alpha-numeric keyboard Water Bath and Heating Plexiglass Water Bath Immersion Thermostat Immersion Thermostat with Serial Interface Thermometer Calibratible PT 100 Temperature Sensor Glass Testing Vessel/s 0 О Operation Option to enter the test time In-built programme menu comprising: Product menu for up to 60 individual product data sets (product name, product number, remarks); language menu (English, French, German, Spanish), Batch o., Operator, etc. Interface Parallel Printer Interface RS 232 and RS 485 Serial Interface Documentation Documentation of test conditions, results and statistics* Software ERWEKA Windows based Software Package "ZT-WI" for unlimited entry of product data, storage of test results, comparison of batches and display o f histograms О О : es : ot available O: Option, at additional cost P: Possible *: when a standard printer is connected to the parallel printer port ie., Epson LX or similar ote: The Disintegration Testers illustrated in this catalogue may be fitted with special accessoires available only as an optional extra. Please consult our technical staff for full details. Technical details are subject to change. June

15 Our Customer Service Department Our service comes with no compromises. We know that break-downs engender high costs and that quick service is essential in the case of emergency. Our Service organisation is staffed by a team of highly skilled and experienced engineers. Servicing can be provided onsite on request ie; at your factory. Maintenance and calibration contracts are available for virtually all our products. For spare parts, please contact our Spare Parts Department. Phone o. +49/6104/ , Fax o. +49/6104/ Our Quality Assurance Department serves to permanently monitor the quality of our products. ERWEKA is to ISO 9001 у TUV B% 15

16 ERWEKA Quality through experience ERWEKA GmbH OttostraBe Heusenstamm Germany Phone: 06104/ Fax: 06104/ ERWEKAVK aol.com ERWEKA USA Inc. 56 Quirk Road Milford, CT USA Phone: (203) Fax: (203) ERWEKAUSA aol.com homepage: ERWEKA Poland Sp. zo.o. ul. Odolahska 7/ Warszawa Poland Phone: Fax: Mobil: