Farmakologiset mittalaitteet
Tabletin kovuuden mittalaitteet
TBH 125 tabletin koveuuden mittalaite
The TBH 125 is the ERWEKA basic device for testing tablet hardness (dual-mode: “constant speed” and “constant force”), offering accuracy, robust design as well as easy and quick handling. The unit is operated via a symbol keypad which allows effortless entering of the samples number required for testing.
Up to three physical parameters (hardness, diameter/length and thickness) can be tested. The test results (including date/time) are shown on two bright LED displays and can be printed out via the standard USB printer interface. The TBH 125 can be calibrated either statically with weight stones or dynamically with AutoCal 2.0 (3-point-calibration; menu guided). In addition, the unit generates a calibration print-out outlining individual calibration data and further information (service date and time, serial number).
The integrated menu allows easy, precise setting of the measuring mode including breaking speed/force increase rate, time/date, sensitivity of the hardness measurement and breaks between the tests to remove dust and debris.
TBH 325 tabletin koveuuden mittalaite
The TBH 325 is the ERWEKA hardness- or combination tester with integrated product memory for up to 50 products. Its robust design can be easily used in production environments. Via the numeric membrane keypad with alpha-numeric sub-function the nominal hardness in combination with three tolerances can be stored for up to 50 products and afterwards recalled for testing.
Alpha-numeric information such as product name and remarks can be entered into the device by using the alpha-numeric subfunction of the keypad, comparable with writing a message on a mobile phone. In addition, the TBH 325 allows to type in batch/lot numbers numerically or even alpha-numerically before the test run starts. The recorded information and test results can be documented via different options: data can be printed out via a connected printer or transferred to a computer over the LAN interface. Since the samples are manually inserted into the test station, all kind and shapes of tablets can be tested. Broken samples can be removed from the test station into an acrylic glass disposal container.
The TBH 325 measures the hardness of samples in a range of 10–500 Newton with two selectable measuring modes: “Constant Speed” or “Constant Force”. The measuring sensitivity (3–40 N) as well as the test speed (0.05–3 mm/sec. or 10–200 N/sec.) can be adjusted. Results are displayed and printed in either Newton (N), Kilopond (KP) or Strong Cobb (SC).
Easy calibration – Simple setup
Calibration of the hardness test station is completely menu driven and may be carried out by either weight stones or the electronic ERWEKA AutoCal 2.0 System. If performing by weight stones, the TBH 325 offers a two-point adjustment of which one point is fixed (0 kg) and the second one may be freely selected of the unit’s measurement range.
To assure accurate results of the complete measurement range, ERWEKA recommends setting the second calibration point in the middle of the unit’s measurement range, i. e. at 30 kg. On completion of adjustment the accuracy/linearity of the measurement range may be calibrated and documented (by up to three points within the measurement range).
Multiple interfaces – Get connected
Via a SD memory card or USB memory stick the laid down product data can be either secured or easily transferred to any other TBH 325/425. The ERWEKA MC.NET software controls the TBH from a PC. In addition, the USB printer interface can be connected to receive a hard-copy documentation with data such as unit serial number, date/time of calibration, date/time of test run as well as individual results and statistics. Alternatively, the TBH 325 can be integrated into a computer network via the Ethernet LAN interface to receive the documentation print-out at virtually any network printer.
The Ethernet LAN interface allows connecting a computer with the optional ERWEKA MC.NET software. In combination with this option the TBH 325 series is 100 % 21 CFR 11 compliant and can be controlled via a PC.
The TBH 325 series is available for measurement of:
- Hardness – TBH 325
- Hardness and diameter TBH 325 D
- Hardness/diameter/thickness TBH 325 TD
- Hardness/diameter/thickness/weight TBH 325 WTD
TBH 425 tabletin koveuuden mittalaite
The ERWEKA TBH 425 is a tablet hardness and combination tester for half-automatic measuring of up to 10 samples. The samples are inserted in a star-shaped feeder and then automatically transported to the test station. Depending on the device model, automatic measurement can be taken for tablet hardness and thickness (optional), diameter or length (for oblongs) of round or odd-shaped samples.
An alignment routine and a support-groove in the hardness test station (optional) help to align odd shaped samples while breaking. Via the numeric membrane keypad with alpha-numeric sub function the nominal hardness, in combination with three individual plus/minus tolerances (T3 = pass/fail criteria), and other remarks may be entered and stored for up to 50 different products and recalled for future testing. Information such as product names and batch numbers can be typed in easily as well. The stored product data can be transmitted via SD card or USB stick to other devices of the TBH 325/425 family.
The calibration of the hardness test station is menu guided and may be performed with either weight stones or the electronic ERWEKA AutoCal 2.0 System. Via a USB printer interface a printer can be connected to print out documentation. The serial LAN/USB interface allows to connect a computer with the optional MC.NET software for external control. In combination with this option, the TBH 425 series is 100 % 21 CFR 11 compliant.
Different versions available
- Hardness – TBH 425
- Hardness and diameter – TBH 425 D
- Hardness/diameter/thickness – TBH 425 TD
- Hardness/diameter/thickness/weight – TBH 425 WTD
The ERWEKA TBH 425 D is based on the TBH 425, but in addition offers diameter/length measurement and documentation options of the samples. With this functions it can be ensured that the samples are placed in the correct alignment for the hardness testing process. The semi-automated TBH 425 TD provides in addition to the standard TBH 425 an automatic measurement of sample’s diameter/length and thickness by a motor driven and calibratable electronic linear potentiometer.
The unit can either fulfill a three parameter hard-copy print-out by a connected printer (optional) or can transfer the data to a PC with the optional MC.NET software. The ERWEKA TBH 425 WTD, which is based on the TBH 425 TD, is additionally equipped with an external Sartorius or Mettler analytical balance with windshield (20 mg to 64 g; accuracy ± 0.1 mg; Sartorius balance with in-built calibration weight) for connection with the unit. Before testing the other parameters, the sample is manually placed onto the balance, the weight is determined and the results are transferred to the unit’s electronics.
EasyCheck automaattinen tabletin kovuuden mittalaite
EasyCheck is the new entry-level tablet combination tester that tests for up to 5 parameters. The compact system is 100 % compliant with all common pharmacopeias, and excels, above all, through 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, and the intuitive touch display allows storage of up to 100 products/methods. The EasyCheck offers a test memory for up to 1 million test results directly on the unit, a 21 CFR Part 11 compliant audit trail light feature and a data export function to CSV- and XML-format.
EasyCheck is your entry-level device for easy, fully automatic and highly precise testing for up to 5 parameters!
Intuitive operation – broad feature set
In the development of the EasyCheck touch display we focused on those features which users find most important: Easy and uncomplicated creation, starting and documenting of test methods. The highly intuitive touch display enables the unit‘s complex functions to be operated and controlled with maximum ease of operation. Measurements can be launched and displayed quickly and easily. For convenient data input (e.g. in order to create new products) the unit now also offers support for USB keyboards – which significantly facilitates data management directly from the device itself.
Storage of test results!
By default, the unit stores 100 products/methods and has a product memory that can hold up to 1 million test results – enabling results from earlier tests to be re-called whenever required.
In addition, extensive integrated calibration functions and the Audit Trail Light feature (logging What, Who, When) ensures that you have access to precise test results and extensive documentation of all working steps at all time – highest user convenience combined with powerful functionality.
MultiCheck 6 automaattinen tabletin kovuuden mittalaite
The new MultiCheck 6 offers ease of operation, maximum efficiency and enhanced operator convenience. This fully automatic combination tester is packed with innovative technology: The intuitive touch display with integrated MC.NET software functionality, the capsule weight measurement system and the patented Oblong Navigator® are only some of the innovative new features. In addition, the new MultiCheck 6 provides an unsurpassed low noise level and cleanest operation in its class.
Proven features have been retained: MultiCheck 6 can test up to five tablet parameters, fully automated and 100 % compliant with all pharmacopoeias around the world: A true all-rounder.
The new MultiCheck 6 touch display – Convenient operation – broad feature set
During the development of the MultiCheck 6 touch display we focused on the features which users will find most useful: Easy and fast creation of methods, launching of tests and documentation of test results. The intuitive touch display enables easy operation of offered functions. Thanks to the integrated MC.NET software functions, measurements can be launched and results displayed directly on the unit.
Storage of test results!
By default, the unit stores 100 products/methods and has a product memory that can hold up to 1 million test results – enabling results from earlier tests to be re-called whenever required. In addition, extensive integrated calibration functions and the Audit Trail Light feature (logging What, Who, When) ensures that you have access to precise test results and extensive documentation of all working steps at all time – highest user convenience combined with powerful functionality.
AutoCal 2.0 tabletin kovuuden mittalaitteen kalibrointityökalu
The ERWEKA AutoCal 2.0 System is a calibration tool for automated calibration of the hardness test station, without the need for weights, an external PC and software.
Calibration has never been easier. The AutoCal 2.0 USB stick is plugged into the USB interface of the TBH x25 (previous series without USB interface require an adapter) and the connected certified load cell is inserted into the hardness test station.
The complete system (adjustment and calibration) is now performed via the keypad and the display of the hardness tester. The unit will automatically conduct adjustments and calibration can be controlled on linearity by checking of up to three points within the measuring range. In addition, a documentary report can be generated via the standard printer interface.
Tabletin kovuuden mittausohjelmisto
The MC.NET software is our innovative solution for external control of the ERWEKA hardness and combination testers. The software controlls all from the compact TBH 325 and TBH 425 up to the fully automated EasyCheck and MultiCheck 5/5.1/6. With the power of MC.NET, data from multiple devices can be stored inside a single, network MS SQL database and easily accessed by multiple installations of MC.NET in the same network. Thanks to its advanced Audit Trail features, the data integrity is ensured.
With the help of MC.NET, the user can easily qualify devices, create and use methods and analyze test results – all with full 21 CFR part 11 conformity and extensive Audit Trail.
All features within MC.NET are optimized on one thing: saving time while maintaining full documentation.
Central data mangement
With MC.NET, the user manages all data used for and by the hardness tester, in either a local or a central MS SQL database.
Products, methods, users and testresults can be shared across several devices by the central database, removing the need to maintain the same data repeatedly.
MC.NET hardness diagramm – Quality control on the highest level.
The optional hardness diagramm shows the force-path progress of the tablet hardness, enabling easy visual confirmation of the tablet hardness measurement.
The graphical results of the hardness diagramm assist with derivation of a method aswell as with selection of test parameters. The function also serves as quality control feature, because expected results can be easily compared to the actual diagramm.
After completion of the tests, up to 20 hardness diagramms can be compared to each other. The zoom function and different colors of the selected diagramms makes rating of the results as easy as never before.
The hardness diagramms can be saved and printed. Single data points can be exported as XML file.
Electronic signature
The electronic signature feature allows the user to fully digitalize the process of audit and release of test results, right inside the software. This removes the need for manual signing a printed document.
The report can be digitally created, audited and released by entering the users login data. With the vastly configurable user rights, the software ensures that only authorized users can run the specific steps of the process.
After each step, MC.NET creates a report with a unique protocol number. Simultaneously, all results are stored in the database and can be easily viewed at all times.
MC.NET Audit Trail with full data integrity – Tracking all changes
The audit trail inside MC.NET is conform to regulatory rules (e.g. 21 CFR Part 11) and tracks all activities of the software, logging change, user, time and (optional) reason (What, who, when, why). For quick completion of the audit trail dialog, reasons can be either predefined and then selected or entered freely.
With the Audit Trail Viewer, users can quickyly and conviently search and filter all changes to the system, never loosing overview of the system.
