Sotax - Tablet Friability - FT2

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DKSH Japan K.K. Technology

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DKSH Japan K.K.
3-4-19 Mita, Minato-ku
108-8360 Tokyo
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Tablet Friability FT2 Brochure - Sotax - Protected
(PDF, 248 KB)

FT2

FT2

Performing and documenting friability & abrasion tests has never been faster. From SingleButton™ navigation to intergrated balance interface, single and dual drum options for increased capacity, as well as automatic calculation of percent friability for your report, and a fully menu-guided qualification procedure – the FT2 offers easy and flexible testing in your lab.

Key Features

Automatically record weight readings before / after test from an external analytical balance
Front-loading drums with automatic discharge function on completion of a test run
Calculation of percent friability / weight loss and printing of test protocols
Password protection to prevent unauthorized access to instrument settings
Flexible operation in timer, counter or speed mode and programmable rotational speed
Menu-guided qualification procedure with printed report
Integrated 10° tilting mechanism as per USP <1216>
Easy menu navigation with SingleButton™ operation

Friability Testing

Friability describes the mass reduction of a solid dosage form such as compressed, uncoated tablets occurring when subjected to mechanical strain during handling such as tumbling, vibration, or rubbing in a blister packaging. According to USP <1216> and Ph. Eur. 2.9.7, a maximum mean weight loss of not more than one percent (1%) is considered acceptable for most products. Effervescent tablets and chewable tablets may have different specifications for friability. Measurement of tablet friability supplements other physical strength measurements such as abrasion tests and tablet hardness measuring (breaking force determination)

Technical Specifications

Number of drums	1 - 2
Rotation speed	20 – 100 rpm, programmable
Rotation accuracy	± 1 rpm
Interfaces	Ethernet / RS-232 parallel
Power supply	100 – 240 V / 50 – 60 Hz
Weight (without packaging)	8 kg (17.7 lbs)
W x D x H (mm)	305 x 280 x 475
CE Conformity	The FT2 fully complies with all CE and EMC equipment guidelines relative to mechanical and electrical safety and electromagnetic compatibility.

Highlights

User-friendly operation

The FT2 excels with simple and user-friendly operation: fast SingleButton™ operation allow for quick navigation through the user menu. Efficient tablet loading is another feature of the friability tester: At test start, the drum automatically rotates to its loading position – an opening in the anti-static drum allows samples to be conveniently inserted without having to remove the drum. At the end of the test, tablets are automatically discharged into a tray.

Full flexibility

The FT2 features two different modes to perform tests: time mode or revolution / rotation count mode. The rotational speed can be programmed (20 – 50 rpm) and the maintenance-free drive ensures gentle starting and stopping of the drum. The anti-static drums are designed to fully engage with the drive to prevent any slippage. The capacity of the front-load FT2 friability tester can be extended by using two drums instead of just one drum.

USP <1216> and more

A 10° tilt of the drum is provided by an extension in the instrument base. This tilt is used to prevent irregular tumbling, causing non-reproducible results. The FT2 fulfills all requirements of USP <1216>, EP 2.9.7 and other Pharmacopoeias. It is available with friability drums as well as abrasion drums (Rus. Pharm.).

GMP / GLP-compliant

Weight readings before and after each test run can be either entered manually or collected automatically from a connected analytical balance. Reports can be printed via Ethernet LAN and include test parameters, time and date, and serial number of the instrument along with entry fields for user name and product details. For electronic data collection, q-doc® data management software is available.

SOTAX leads the way in the development and manufacture of high-quality pharmaceutical testing equipment and associated services. Our equipment is used worldwide in the development and production processes of our customers and the pharmaceutical and science industries. SOTAX develops, produces and markets system solutions for pharmaceutical testing and does so in close cooperation with pharmaceutical and scientific partners.