PTF 10E and PTF 10ER

PTF 10E/ER single drum friability tester

PTF 10E and PTF 10ER

Tablet Friability Test Instrument

The PTF 10E and PTF 10ER single-drum, fixed or variable speed tablet friability test Instruments are manufactured in compliance to the USP <1216>, EP <2.9.7> and other Pharmacopoeias. Both versions are available as single or dual drum instruments.

PTF 10E/ER single-drum Tablet Friability Test Instrument

PTF 10E/ER single-drum Tablet Friability Test Instrument

General Information

One of the testing criteria of mechanical strength of tablets and cores is friability and abrasion testing. During the process of coating, transportation and packing the tablet will lose some amount of weight. To measure the weight loss, the samples are counted and weighed. Then the friability test is performed following the individual monographs of the relevant Pharmacopoeia. The tablets are tumbled at each turn of the drum of the friability testing instrument by a curved projection that extends from the middle of the drum to the outer wall.

10° Feature

Once the friability test is finished, the samples have to be de-dusted and weighed again. The weight difference before and after the test is determined as friability; this usually should not exceed 1%. Tablets of a weight >650mg or with a bigger diameter or odd shaped samples are tested while the instrument is raised on one side using collapsible feet to an angle of 10%.

Additional Abrasion Drums

The standard supply scope includes the friability (also known as “Roche”) drums, but abrasion drums are available as options. The standard friability drum causes the samples to roll and fall during the test while the abrasion drum continuously puts the sample under stress by contact with lamellas.

Different Speed Settings

A silent DC geared motor rotates the drums at a fixed speed of 25 rpm (PTF E) or variable speed (PTF ER). The actual drum is made from Plexiglas (Perspex) and is separated into two parts, the drum body and a removable cover, which opens to fill, discharge and clean the drum from the inside when required. The instrument itself is made from high quality stainless steel which fully meets the current GLP requirements. An anti-static coated friability drum is available as an option.

Principle of Operation

The PTF E instruments operate at a fixed speed setting of 25 drum rotations per minute and are available with either one drum (PTF 10E) or two drum (PTF 20E). The PTF ER instruments feature a variable speed setting between 20 and 70 rpm and are also available with either one drum (PTF 10ER) or two drums (PTF 20ER).

Clean the samples from any dust prior to the test. Weigh the samples and introduce them into any drum of the instrument. Program the test information, such as speed, time etc. and start the run. When the test is finished the drum revolution stops and the samples have to be discharged. De-dust the samples using a brush and weigh them again. The maximum mean weight loss from 3 consequent tests should not exceed 1%.

Tablets inside the drum
Tablets falling by drum rotation

Tablets inside the drum

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Features

  • 1 friability drum made from Plexiglas (optional incl. anti-static coating), in compliance with the USP, EP and DAB pharmacopoeia
  • LED display informing of adjusted rotation speed and operating time (or number of revolutions)
  • Programmable number of drum revolutions or rotating time
  • All IQ, OQ, DQ/QC documentation included in the standard supply scope

Advantages

  • LED display showing actual and target settings
  • GLP compliant stainless steel housing
  • Dual operation mode adjustment; number of revolutions or rotation time
  • Easy to operate and set-up

Technical Specifications

Parameter Specification
Display LED Display
Data Entry Functional Keys
Setting number of revolutions 1 to 9999
Setting rotation timer 1 to 9999 seconds
Drum rotation speed

PTF 10E/20E

Fixed to 25 rpm

Accuracy ±1 rpm

PTF 10ER/20ER Adjustable speed between 20 – 70 rpm

Accuracy at 20 – 30 rpm ±1 rpm, >30 rpm ±2 rpm

Bench Space Requirement W 350.0 x D 400.0 mm
Certification All components certified to USP / EP requirements
CE / EMC Certification All CE / EMC Certification provided
Validation All IQ & OQ documents included

We reserve the right to make technical changes without any prior notice.

Included in the Standard Scope of Supply

  • PTF 10E/ER includes one friability drum as per USP <1216> and EP <2.9.7> monograph
  • Comprehensive documentation folder including:
    • User manual
    • DQ/QC instrument compliance test certificate
    • User manual
    • QC/DQ testing certificate
    • IQ documentation
    • OQ documentation
    • Conformity declaration
    • CE/EMC declaration
    • Instrument logbook

Options

  • 10° feet to test tablets > 650mg or odd shaped samples
  • Tablet abrasion drum with lamellas
  • Friability drums with anti-static coating
  • Certified equipment for instrument functional (operational) qualification

 

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