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COPLEY HARDNESS TESTER TBF 1000
  • ADVANCED FEATURES
  • The TBF 1000 has been specifically designed such that all basic day-today operations can be performed using the four touch sensitive keys located on the front panel. Other obvious features like the safety guard system which prohibits operation unless closed, the tablet debris collection tray, the integral 30 column printer and keyboard drawer are, of course, included as standard.
  • This outward simplicity disguises the many special sophisticated and advanced features available to the user via the setup menu which may be accessed through the optional keyboard. This feature is passcode protected to prevent unauthorised changes to operational settings. In the original design brief for the TBF 1000, considerable emphasis was placed on providing the user with the ability to configure the unit to their own specific needs.
  • This emphasis is reflected in the setup menu. In addition to basic settings such as time and date, units (kgf, kp, N or lb), test speed (4, 6, 10, 16 or 30 mm/min), PC interface (RS232 or USB) and LCD backlight functions, the user can also configure the way in which the unit actually operates: the print format, the way in which the unit interfaces with other peripherals and the calibration of the instrument. Operational settings include the ability to change the way in which batches are counted and incremented, whether a test is instigated via the key or simply closing the safety guard and the fracture detect percentage, a particularly useful feature for soft crumbly or extra hard tablets.
  • During a test, the load cell constantly monitors the increasing force applied to the tablet. The breaking point of the tablet is said to have been reached when the force falls to a set % (the fracture detect percentage) of the maximum (peak) load reached during that particular test. The default setting for this percentage is 70% - it can however be adjusted if circumstances dictate between 30 and 90%.
  • Print format settings include options available to enable or disable start-up messages, the print-out of individual tablet results and diameter print-out, together with the provision to enter product names and operator identities (requires optional keyboard).
  • Peripheral and calibration settings allow the user to connect the hardness tester to a balance and/or a micrometer for measuring thickness and to calibrate the instrument, respectively.
  • SYSTEM SUITABILITY
  • The TBF 1000 incorporates an automatic load check routine that runs automatically every time the unit is switched on.
  • This routine imposes a simulated load of known proportions. The simulated load and the difference between this and the value stored at the last full calibration are displayed on the LCD.
  • A difference of > 0.1 kg, for example, would suggest a potential problem and the need for recalibration (see below).
  • CALIBRATION
  • All tablet hardness testers should be calibrated on a periodic basis, for example, monthly or quarterly
  • Calibration on the TBF 1000 can be carried out in-house and takes only a few minutes using the calibration rig provided for this purpose. It is based on a static calibration technique using calibrated weights traceable to national standards.
  • The user is guided through the passcode protected calibration process by a series of prompts from the in-built software accessible from the setup menu.
  • A full report is printed out at the end of the calibration process.
  • An individual calibration number is generated on each occasion the unit is calibrated and reiterated on subsequent test printouts - this ensures that any test printout is traceable to a specific calibration certificate.
  • IQ/OQ/PQ QUALIFICATION DOCUMENTATION
  • Analytical Instrument Qualification is no doubt an essential element of your quality control procedures. The following documentation is available in helping you to meet these obligations:
  • Certificate of Compliance to USP/Ph.Eur.: Included with each unit. Written statement that the product, by design, complies with the current pharmacopoeial specifications.
  • IQ/OQ/PQ Qualification Documentation: (option) Comprehensive documentation to guide the user through the installation, operating and performance checks of the equipment, in its operating environment, using specified test protocols. It provides a comprehensive record of the suitability of the equipment to perform its specified task, to be completed and archived.
  • WEIGHT AND THICKNESS MEASUREMENT
  • The versatility of the TBF 1000 does not end with the measurement of hardness - simply add a balance and/or a Mitutoyo micrometer for measuring thickness and you have a complete system for measuring the hardness, weight and thickness of tablets and similar objects with the same capabilities as many of the more sophisticated systems that are commercially available.
  • A list of compatible balances (by make and model) may be found in the setup menu - please consult our technical staff for further details. Weight and thickness measurements are conducted in a similar manner to that of hardness (see section on OPERATION on Page 30).
  • If, for example, both weight and thickness are enabled, then at the start of the test the LCD display will show Weight - the operator should then place the tablet on the balance, wait for the weight to stabilise and then press . The weight of the tablet will now be displayed and the LCD will show Thickness to request a thickness measurement. Remove the tablet from the balance pan, place it in the micrometer and press . Repeat the exercise for hardness.
  • At the end of the individual tests, the results relating to all three parameters are printed out on the printer.