Physicals Guide Our broad range of physical testers Our physical testers program ERWEKA offers a broad range of physical testers. Tablet hardness testers We offer a wide range of tablet TBH 125 .................................. 4 hardness testers - from the TBH 325 .................................. 4 manual TBH 125 up to the fully TBH 425 .................................. 5 automated testers EasyCheck AutoCal 2.0 ............................. 5 and MultiCheck 6. EasyCheck .............................. 6 MultiCheck 6 ........................... 8 Disintegration testers To analyse disintegration time, ZT light Series ....................... 10 we offer manual and automated ZT 320 Series ........................ 11 disintegration testers. ZT 720 Series ........................ 12 Tapped density testers The SVM and its accompanying SVM ....................................... 13 noisebox are the perfect soluti- on for tapped density testing. Friability/Abrasion testers The TAR is our friability and TAR ........................................ 14 abrasion tester. 2 Vacuum leak testers The VDT/S is our vacuum leak VDT/S .................................... 15 tester. Granulate flow testers For testing of flow characteri- GTL ........................................ 16 stics of granules and powders. GT & GTB .............................. 16 Suppository testers We offer a variety of suppository ST 35 ..................................... 17 testers for testing of suppository SBT 2 ..................................... 17 disintegration, hardness, melting SSP ........................................ 18 point and penetration testing. PM 30 .................................... 18 Contact Do you have further questions? Contact .................................. 19 We are here to answer them for you. 3 Physicals Guide Our physical testers program Manual tablet hardness testers TBH 125 Dual-mode tester with robust design and basic functions The ERWEKA TBH 125 tablet hard- ness tester is the ERWEKA entry- level tablet hardness and combi- nation tester. The device is perfectly suited for quick and manual testing of up to 99 samples. Depending on the device model, automatic measurement can be taken for tablet hardness and thickness (optional), diameter (for round 100% Setting of test USP / EP / JP speed (0.5 - 3.00 tablets) or length (for oblongs). The compliant mm/sec.) integrated electronic measurement cell ensures highest accuracy for precise measurement results. Adjustment of Collection force increase container for Due to the USB printer interface (10 - 200 N/sec.) broken samples the results can be printed directly. TBH 325 Manual tester with product memory The ERWEKA TBH 325, part of manual hardness and combination tester product range, features an integrated product memory for up to 50 products. The TBH 325 provides various documentation and evaluation possibilities. Depending on the device model, automatic mea- surement can be taken for tablet 100% Adjustable breaks USP / EP / JP between the hardness and thickness (optional), compliant test runs diameter (for round tablets) or length (for oblongs) and weight (optional). Up to 100 tablets can Adjustment of force increase LAN / USB be precisely tested in one run. (10 - 200 N/sec.) interface 4 Semi-automated tablet hardness tester TBH 425 The ERWEKA TBH 425 is a semi-au- Via a numeric keypad with alpha- 100% tomatic tablet hardness and com- numeric subfunction the nominal USP / EP / JP bination tester for measuring of hardness values in combination compliant up to ten samples. The samples with three individual tolerances are automatically transported to can be entered for up to 50 pro-Star feeder the test station by a star-shaped ducts and afterwards recalled magazine rotary magazine. Depending on for testing. the device model, automatic measurement can be taken for In addition, the unit generates Setting of test speed tablet hardness and thickness a calibration print-out outlining (0.5 - 3.00 mm/sec.) (optional), diameter (for round individual calibration data and tablets) or length (for oblongs). further information (service date In combination with the optional and time, serial number). Adjustment of balance the weight can also be force increase determined. (10 - 200 N/sec.) In addition, the rotary magazine enables full visual inspection of the test processes at all times. Up to 100 tablets can be precisely tested in one run and the acquired data can be documented and evaluated in a variety of ways. Therefore the TBH 425 can be connected to a printer via the USB printer interface or directly integrated into a computer network via the Ethernet LAN interface. Calibration instrument for hardness testers AutoCal 2.0 The certified AutoCal 2.0 system to the USB port and ensures the is an electrical device for calibra-adjustment/calibration either in ting the integrated tablet hardness conjunction with the MC.NET measuring system. Not requi- software or the calibration funcring any measurement weights, tion integrated into the firmware. AutoCal 2.0 is simply connected 5 Physicals Guide TBH 125 | TBH 325 | TBH 425 Ful y automated tablet hardness tester EasyCheck Fully automatic hardness testing as easy as never before EasyCheck is the new entry-level tablet combination tester that tests 100% for up to 5 parameters. The compact system is 100 % compliant USP / EP / JP with all common pharmacopoeias, and excels, above all, through compliant innovative design features and a clear focus on essentials: Its integrated load cell automatically weighs samples, the Oblong Slider automatically brings evenly shaped oblongs into perfect alignment Oblong Slider and the intuitive touch display al ows storage of up to 100 products/ methods. EasyCheck offers a test memory for up to 1 million test results directly on the unit – enabling results from earlier tests to be Integrated weight re-called whenever required. measurement In addition, extensive integrated calibration functions and the Audit Trail Light feature (logging What, Who, When) ensures that you have Test memory, access to precise test results and extensive documentation of all Audit Trail Light & working steps - highest user convenience combined with powerful data export functionality. Optionally the Easy Check offers a data export function to CSV and XML format. Star feeder magazine EasyCheck is your entry-level device for easy, fully automatic and highly precise testing for up to 5 parameters! EasyCheck EasyCheck Basic Pro Main application Round tablets, Round tablets evenly shaped oblongs 4 parameters 5 parameters Measurement values Weight, thickness, Weight, thickness, diameter/ diameter, hardness length, width, hardness Touch display Oblong Slider ® Memory for up to 1 million test results optional optional Audit Trail Light (21 CFR Part 11 compliant) optional optional Data export in CSV and XML format optional optional 6 7 Physicals Guide EasyCheck 8 Ful y automated tablet hardness tester MultiCheck 6 The MultiCheck 6 offers ease of operation, maximum efficiency and 100% enhanced operator convenience. This fully automatic combination USP / EP / JP tester is packed with innovative technology: The intuitive touch compliant display with integrated MC.NET software functionality, the capsule weight measurement system and the patented Oblong Navigator® Oblong are only some of the innovative new features. In addition, the new Navigator ® MultiCheck 6 provides an unsurpassed low noise level and cleanest operation in its class. integrated weight Extensive integrated calibration functions and the Audit Trail Light measurement feature (logging What, Who, When) ensures access to precise test results and extensive documentation of all working steps – highest user convenience combined with powerful functionality. Proven features have been retained: MultiCheck 6 can be equipped with the Touch display 12 batch magazine and test up to five tablet parameters, fully automated and 100 % compliant with all pharmacopoeias around the world: A true all-rounder. MultiCheck 6 MultiCheck 6 Standard Allrounder Round tablets, dragées, evenly Main application Round tablets, dragées, shaped oblongs, odd-shaped evenly shaped oblongs oblongs 4 parameters 5 parameters Measurement values Weight, thickness, diameter, Weight, thickness, diameter, hardness width, hardness Touch display Separation drum Capsule measurement Alignment threshold (fixed) Alignment threshold (electronic, adjustable) Slot for oblongs not required Positioning arm for oblongs Oblong Navigator ® 9 Physicals Guide MultiCheck 6 Compact disintegration testing – ZT 120 light series The ERWEKA ZT 120 light series is the perfect entry-level disintegra-100 % USP / EP / JP tion tester with one or two single-motor driven USP/EP/JP compliant compliant test station. The compact unit of our light series is equipped with an integrated flow-through heater and a moulded one-piece PET water bath (no leaking / breaking, easy to clean) with cover. 1 or 2 test stations The ZT 120 light series can be easily operated via a membrane keypad. Defined test run parameters such as run time and water bath temperature are entered with symbol keys and the actual values are Easy control via a large then shown on large and bright LED displays. The run-time counter LED display automatically starts as soon as the basket rack assembly is lowered into the test media. Compact entry-level device NEW 10 Asynchronous disintegration tester – ZT 320 series The test stations of our ZT 320 series are driven individually. Each 100% USP / EP / JP test station is controlled by its own keypad. After programming the compliant required test run-time, the basket rack assembly with its loaded samples is automatically lowered into the media. On completion of the preset run-time or when the stop button is pressed, the basket 1 to 4 rack is raised from the media to prevent further disintegration of the test stations samples (optional). Individually driven basket racks 11 Physicals Guide ZT 121 light | ZT 320 Series | Asynchronous disintegration tester – ZT 320 series Automated disintegration tester with touch display ZT 720 Series The ERWEKA ZT 720 series automatically determines the disintegra-100% USP / EP / JP tion time of samples by using a unique system of magnets and sen-compliant sors. It also tests whether or not a sample completely disintegrates. The ZT 720 is available with one (ZT 721) or two (ZT 722) individually driven test stations and is equipped with an integrated flow-through Touch display heater. Its temperature sensor PT 100 allows constant control of the water bath temperature. The ZT 720 series is controlled through an innovative 7” touch screen and is capable of storing and retrieving up to 100 products/methods with results and parameters. Automated detection of disintegration Select the basket type for your individual need: Basket type A comes with 6 test tubes for standard tablets, basket type B contains 3 test tubes for bigger tablets (according to USP/EP standards). Memory of 1 million test results and 100 products Effortless cleaning is easily possible due to the removable acrylic water bath, equipped with an outlet valve. The USB and LAN interfaces ensure simple and easy data export in XML and CSV format. LAN/USB data export 12 Tapped density tester SVM Tapped density testing according to USP methods 1 and 2 The ERWEKA SVM series has been designed to measure tapped 100% USP volume and tapped density of powders, granules and similar pro-compliant ducts. It is available for holding one or two glass cylinders and works according USP method 1 (300 strokes/min; stroke height 14 mm) or USP method 2 (250 strokes/min; stroke height 3 mm), which is equal Easy to use to Pharm.Eur. and DIN ISO EN 787/11 requirements. As a special version, the SVM 223 offers two test methods simulta-neously: one test station operates according to USP method 1 and LED display the second test station according to USP method 2. Compliant glass cylinders are available in 100 ml, 250 ml and 500 ml versions for the test stations. The Tapped density testing according to USP 1 SVM 122 (one test station) and the SVM 222 (two test or / and USP 2 stations) meet USP 2 and EP standard requirements with respect to strokes/min. and height of stroke. A special version for higher volumes and weights is available on request. SVM Noise box for 25 db(a) noise reduction available* *measured from a standard distance of 0.65 m 13 Physicals Guide ZT 720 series | SVM Friability / Abrasion tester TAR USP/EP/JP compliant friability/abrasion tester Friability or The TAR series is a USP/EP/JP compliant ERWEKA unit for testing abrasion drums friability and/or abrasion of tablets. Programming is easily performed selectable by the symbol style keypad. The rotation speed can be programmed between 20 and 100 rpm and test run duration can be set in either time or total number of revolutions. Variable RPM During the test run, the actual rotation speed and the remaining test run time are shown at bright LED displays. For larger samples, the complete unit can be set to the USP/EP required 10° position by a Built-in timer standard switching leg. To increase the ease of handling on the TAR series, the friability drums do not have to be removed and opened for loading and emptying. USB interface Instead they can be effortlessly filled and emptied through a special opening. On completion of a test run, the samples are automatically removed into a container located under the drums. The USB interface allows you either to download the test parameters (time, actual/nominal speed) to a PC or receive a hardcopy print-out if a printer is connected. 14 Vacuum leak tester for blisters and other packaging forms VDT / S The VDT/S is a vacuum leak tester for blisters and other packaging 100% USP forms. The maximum vacuum (absolute pressure range up to 100 compliant mbar) and the vacuum hold time before release can be easily set via the symbol keypad. The actual vacuum is continuously displayed on the LED display. Test run parameters such as actual/set vacuum Easy to use value and hold time can be simply documented via a USB interface or a connected printer. Leak testing LED display For checking the density the ERWEKA VDT/S performs a methylene blue dye test, which is divided into several phases. During the pressure maintenance phase the blisters are exposed to a vacuum, USB interface which is generated in the vacuum container. Afterwards the container is ventilated. In the subsequent penetration process the blister is resting in the methylene blue solution, so that the solution can suck into any imperfectly sealed packaging. The integrated vacuum pump can be recalibrated using the optional validation kit which includes a vacuummeter, type DVR. 15 Physicals Guide TAR | VDT / S Granulate flow tester GTL The GTL is the basic ERWEKA unit for testing flow characteristics of powders and granulates, to ensure that accurate dosing is maintained. It supports the determination of the flow time of a pre-weight sample (DAB 10) and the determination of the flow time of a pre-defined sample volume. The GTL is handled by numeric membrane keys and the results are displayed by the illuminated LC display. As standard, the unit is delivered with a stainless steel hopper (200 ml) and three stainless steel outlet nozzles (10/15/25 mm) which can be exchanged by a quick coupling. Additional stainless steel hoppers (100/480 ml) and outlet nozzles (6/8/11.3 mm) are available as options. Granulate flow testing GT & GTB On the GT a special balance is integrated into the unit to determine the flow time of a sample weight or pre-specified sample volume as well as the sample weight that falls within a specified flow time. For easy comparison a graph according to List and Müller (mass/time) is calculated and displayed and/or printed. Granulate flow testing 16 Manual powder and granulate density testing SMG 53 466 & SMG 697 The manual ERWEKA SMG 697 and SMG 53466 are the units for the Granulate reproducible determination of apparent bulk density, which can be flow testing used with all free flowing powders or granulates. According to DIN ISO 697 and DIN 53 466, the apparent bulk density is determined by measuring the mass of powder in a receiver of known dimension after filling from a funnel of a specified shape under specified conditions. Included in the delivery are the apparatus SMG 697 or SMG 53466, operating instructions and a calibration certificate. 17 Physicals Guide GTL | GT & GTB | SMG 53 466 & SMG 697 Suppository melting point tester SSP The ERWEKA SSP measures the melting point of suppository samples. It consists of a graduated tube with an integrated test chamber made of glass. The sample to be tested is placed in the spiral shaped glass test basket inside the test chamber, which is surrounded by a water jacket. The water inside the jacket can be simply heated by the optional circulation heater EST 2 and the melting point is determined by a stop watch. Suppository melting point testing Suppository penetration tester PM 30 The ERWEKA PM 30 measures the softening time of suppositories. Suppositories must disintegrate, dissolve or melt at body temperature in order to release their active ingredients to the body. ERWEKA offers a version for USP method A and method B. The PM 30 penetration tester (compliant to EP, Apparatus A) and the PM 3 (acc. to EP, App. B) have been designed to carry out reproducible measure-ments regarding the softening time of suppositories at predetermined temperatures. The construction of the tester makes visual observation of the melting characteristics extremely simple. In total, the unit comprises of three test stations. Suppository penetration testing 18 Suppository disintegration tester ST 35 The ERWEKA suppository disintegration tester ST 35 comes with three turning test stations, each located inside a four liter glass vessel with an optional magnetic stirrer. Additionally, the unit contains a ther-mostatically heated water bath, in which the test stations are placed. The test stations are automatically turned 180° in adjustable intervals. The ST 35 features an integrated flow-through heating system (accuracy ± 0.2° C) and an internal temperature sensor for temperature display. Test time and nominal bath temperature are easily entered via the membrane keys. Current test time as well as actual water temperature are shown on a LED display. On request, an alarm may be selected to sound upon completion of the preset test time. Due to the width of the ST 35, the test stations can be easily separated to facilitate the cleaning process. Suppository disintegration testing Suppository hardness tester SBT 2 The suppository hardness tester (type SBT 2) consists of an electrically heated chamber with an integrated sample holder and a number of interchangeable plastic inserts to accept various sized suppositories. Once up to the desired temperature, the hardness is checked by weights (included in the standard delivery range) which are gradually placed on the device until the suppository collapses under the load of the added weights. The results are expressed in terms of total weight required to bring about the collapse of the suppository. Suppository hardness testing by weight 19 Physicals Guide SSP | PM 30 | ST 35 | SBT 2 Contact Are you curious and want to find out more? Head over to our website and download our product brochures, watch videos of our equipment in action or find the ERWEKA dealer of your country. E-Mail: sales@erweka.com Tel.: +49 6103 92426-200 Fax: +49 6103 92426-999 support@erweka.com www.erweka.com spareparts@erweka.com www.facebook.com/erweka.gmbh ERWEKA GmbH Pittlerstr. 45 E-Mail: sales@erweka.com 63225 Langen Telefon: +49 6103 92426-200 Technical specifications of products described are stated without warranty and subject to change at Germany Fax: +49 6103 92426-999 any time without further notice. v.2.3.9.19