• Product Name: TBF1000 Tablet Hardness Tester
• Order number: tlyon000119
• Brand Name: Copley UK

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Tablet Hardness Tester - TBF 1000

The TBF 1000 tablet hardness tester combines the economy of a simple and easy-to-use tester with the performance and accuracy of data acquisition controlled by a microprocessor.

Its design complies with the specifications specified in (EP) Ph.Eur. 2.9.8 Anti tablet fragmentation and (USP) USPhappy<1217>tablet fragmentation force. The most important thing in the design specifications is you, which users consider to be an essential feature of an "ideal" hardness tester.

The device is exquisitely designed to be used within the range of tablet press booths. The TBF 1000 measures only 283 millimeters wide x 235 millimeters deep x 160 millimeters high (including built-in printer and optional keyboard), weighs 8.5 kilograms, and is the smallest footprint of any hardness tester on the market.

TBF 1000 only uses the three touch keys located on the front panel for setting, testing, and providing printed results, namely<New<<Size>< Test>and<Stats>- There is nothing simpler than this.
At the same time, you requested many advanced and complex features - therefore, we offer a small QWERTY keyboard located at the bottom of the instrument.

The 4-line screen menu guides you through the measurement process:

• Attach a balance and/or thickness gauge, TBF 1000 will collect weight and thickness data.
• After the test is completed, TBF 1000 will automatically print the results and perform statistical analysis, including time, date, minimum value, maximum value, mean and standard deviation, as well as batch number and size.

Output data to external PC or printer - On the back of the device, in addition to the balance and thickness gauge interfaces, we also provide two ports, one is RS232 and one is USB.

operating principle

The measurement principle is based on validated electronic weighing sensor technology, combined with mechanical drive and electronic signal processing.

• In practice, tablet samples are placed on a platform between two precision grounded platforms (jaws), one connected to a weighing sensor and the other connected to a motor providing mechanical drive.
• During the testing process, the motorized jaw drive presses the tablet forward onto the fixed jaw until it breaks. So the electric jaw retracted and measured the resistance change (fracture force) of the strain gauge used on the weighing sensor.
• The pressure of tablets can be applied in two ways. Most modern testers, including TBF 1000, operate on the principle of constant velocity (i.e. jaw movement speed). Other units, mainly early models, monitor the rate of applying compressive force, i.e. constant load. Regardless of the method used, in order to ensure comparability of results, uniformity and loading rate must be kept constant.

TBF 1000 Typical Print Output

Generally speaking, the lower the speed or load, the more consistent the results. For example, the United States Pharmacopeia recommends a constant table movement of less than 3 millimeters per second. Undoubtedly, TBF 1000 offers a speed range of 0.06 to 0.5 millimeters per second, with a default setting of 0.1 millimeters per second, all of which exceed the pharmacopoeia requirements by a considerable margin.

The measurement range of standard TBF 1000 is 0-520 Newtons (/-0.1N). Other ranges, such as 50N and 1000N, can be provided upon request

The device will accept tablets with a diameter of up to 36 millimeters. The results can be expressed in kilogram force (kgf), kilopounds (kp), newtons (N), or pounds (pounds).

The throughput of TBF 1000. Depending on the hardness and diameter of the test tablet, 5-8 tablets per minute.

operation

• Set up a new sample for testing

Press the<New Size>key - Electric Jaw Retract, allowing the operator to insert a new tablet between the jaws, then move forward again and gently press the tablet onto the fixed jaw.

The electronic components of the weighing sensor detect this contact and then instruct the electric jaw to retract to a testing position approximately 5mm wider than the diameter of the tablet computer. The diameter of the new tablets is printed together on the built-in printer.
The unit is now preparing for testing.

• Conduct testing

Place a tablet on the testing platform, lower the cover, and then press<Test>twice. The moving jaws will quickly move forward (2 millimeters per second) until they reach approximately one position. 0.2 millimeters away from the tablet, then change to test speed (default is 0.1 millimeters per second).

The LCD display shows the increase in load when the moving claw reaches the tablet, as well as the tablet count, time, and date.
Automatic detection of pill breakage - Once detected, the result will be printed on the printer, and moving the jaw will retract to the testing position, ready for the next sample.
(a) Pressing the<Test>button or (b) lowering the protective device can initiate the testing of the next sample in two ways.

The tablet testing position is arranged for horizontal loading and includes a removable tray for handling any tablet fragments.

• Batch End - Statistical Analysis

European Pharmacopoeia. USP recommends testing 10 and at least 6 samples separately.
At the end of the test, to start the print output and re count the tablet count, press<Statistics>. Now we can test another batch of pills.

Advanced features

The design of TBF 1000 has been specifically designed to perform all basic daily operations, such as security guard system, prohibited operation unless turned off, tablet fragment collection tray, integrated 30 column printer, and keyboard drawer, which are included in the standard.

This concise appearance masks many of the special, complex, and advanced features available to users through a settings menu that can be accessed through an optional keyboard. This feature is password protected to prevent unauthorized changes to operational settings.

In the original design brief of TBF 1000, significant emphasis was placed on providing users with the ability to configure units to meet their specific needs. This emphasis is reflected in the settings menu. In addition to basic settings such as time and date, unit (kgf, kp, N or lb), testing speed (4, 6, 10, 16 or 30mm/min), PC interface (RS232 or USB) and LCD backlight function, users can also configure the actual operation mode of the unit: printing format, interface mode between the unit and other peripheral devices, and instrument calibration.

The operation settings include the ability to change batch counting and increment methods, whether testing through the<Test>key or simply turning off safety protection devices and fracture detection percentages, which is particularly useful for fragile or superhard hardware. During the testing process, the weighing sensor will continuously monitor the increased force applied to the tablet. It is said that when the force drops to the set percentage (fracture detection percentage) of the maximum (peak) load reached during the specific testing period, the fracture point of the tablet has been reached. The default setting for this percentage is 70% - but if the situation determines, it can be adjusted between 30% and 90%.

The print format settings include enabling or disabling startup messages, printing individual digital board results and diameter prints, as well as regulations for entering product names and operator identities (requiring optional keyboards).

Peripheral devices and calibration settings allow users to connect the hardness tester to a balance and/or micrometer to measure thickness and calibrate the instrument separately.

System Applicability

TBF 1000 includes an automatic load check program that runs automatically every time it is turned on. This routine imposes a simulated load with a known proportion. The LCD screen displays the simulated load and the difference between it and the value stored during the last full calibration. For example, a difference of>0.1 kilograms will imply potential issues and the need for recalibration (see below).

calibration

All tablet hardness testers should be calibrated regularly, such as monthly or quarterly. The calibration of TBF 1000 can be performed "internally" and can be done in just a few minutes using the calibration device provided for this purpose. It is based on "static" calibration technology, using calibration weights traceable to national standards.

IQ/OQ/PQ documents

The identification of analytical instruments is undoubtedly an important component of quality control procedures. The following documents can help you fulfill these obligations:

• Compliant with USP/Ph.Eur certificate:

Included in each unit. A written statement stating that the product is designed to comply with current pharmacopoeia standards.

• IQ/OQ/PQ files: (optional)

Comprehensive documentation to guide users in using specified testing protocols for device installation, operation, and performance checks in their operating environment. It provides a complete record of the device's suitability to perform specified tasks for completion and archiving.

Weight and thickness measurement

The versatility of TBF 1000 does not end with hardness measurement - simply add a balance and/or Mitutoyo micrometer to measure thickness, and you have a complete system to measure the hardness, weight, and thickness of tablets and similar objects, just like many more complex systems available on the market.
You can find a list of compatible scales (by brand and model) in these menus.

Weight and thickness measurements are conducted in a manner similar to hardness.

For example, if weight and thickness are enabled, the LCD display will show weight at the beginning of the test - the operator should place the tablet on the balance and wait for the weight to stabilize before pressing<test>. Now the weight of the tablet will be displayed, and the LCD will show the thickness to request thickness measurement. Remove the tablet from the balance plate, place it in a micrometer, and press<test>. Repeat the exercise to obtain hardness.

At the end of the individual test, print out the results related to all three parameters.