PHARMA TEST – PTF 200

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Hãng sản xuất: PHARMA TEST

Model: PTF 200

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Features

Fully USP <1216>, EP <2.9.7> and JP <14> compliant
Determine friability and abrasion (optional) of uncoated tablets
Programmable for number of drum revolutions or rotating time
Connect a balance to determine the sample weight (optional, weight can be entered manually)
Connect USB flash drive to copy methods and store test reports
Integrated protocol printer (optional)
User and method management system

Advantages

Drum is easy to open for loading and cleaning, alternatively use discharge opening for loading
Graphical LCD screen showing actual and target settings
Integrated protocol printer reduces bench space requirements
Detailed result report including weight loss calculation and evaluation of the results
Automated sample discharge at the end of a test run
Dual operation mode: number of revolutions or rotation time
Variable drum rotation speed or locked speed mode
Determine the sample weight by balance to automatically calculate weight loss
Programmable qualification interval timer reminds the user to perform instrument calibration
Dedicated calibration programs and reports
Copy methods between instruments by using a common USB flash drive
Export test reports as text files
IQ/OQ documents included free of charge

Technical Specifications

Parameter	Specification
Number of Test Drums	2, 1 right side, 1 left side
Drum Rotation Speed Range	15 – 100rpm
Speed Accuracy	±1 rpm
Number of Rotations	Adjustable 2 – 9999, switchable to time mode
Testing Time	Adjustable 2 – 9999 seconds, switchable to rotations mode
Method Management	Up to 256 test descriptions (methods) can be stored on the instrument
User Management	Up to 32 users with selectable user right levels can be stored on the instrument
Result Data Storage	Store copies of result reports by connecting a USB flash drive
Display	LCD with color-changing backlight
Keyboard	Keypad with function keys and click wheel
Interfaces	USB type A host port to USB type B device port to connect flash drives, for PC communication and firmware update LAN port for PC communication RS-232 printer port for optional external printer RS-232 balance port
Instrument Housing	Polished stainless steel housing with plastic frame
Power	110/230 Volt, 50/60 Hz
Instrument Dimensions	Approx. 50cm x 42cm x 47cm (width x depth x height)
Packaging Dimensions	Approx. 60cm x 60cm x 50cm (width x depth x height)
Net /Gross Weight	Approx. 18 / 23 kg
Certification	All components certified to USP / EP requirements
CE / EMC Certification	All CE / EMC Certification provided
Validation	All IQ & OQ documents included

PTF 200

Double Drum Tablet Friability Test Instrument

PTF 200 is a double drum tablet friability and abrasion test instrument. It is manufactured in compliance to the USP <1216>, EP <2.9.7> and JP <14> Pharmacopoeias. The instrument features an automated sample discharge at the end of a test and the possibility to connect an analytical balance.

Complete Compliance

One of the testing criteria for mechanical strength of tablets and cores according to the USP <1216>, EP <2.9.7>, JP <14> and other pharmacopoeia is friability and abrasion testing. During the process of coating, transportation and packing the tablet will lose some amount of weight. To measure this 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 baffle that extends from the middle of the drum to the outer wall.

Automated Discharge

Clean the samples from any dust prior to the test. Weigh the samples and introduce them into the drum of the instrument. The drum can easily be opened for loading and cleaning. Alternatively it is possible to use the discharge opening to load the samples without opening the drum. Select a test method and start the run. The LCD with color-changing backlight shows the test status and results. Once the test is finished the drum revolution stops and the samples are discharged into a collector. The collector is made from clear Plexiglas and is magnetically fixed to the instrument base plate. It can easily be removed for cleaning and secured back into the proper position. The samples then have to be inspected for broken tablets, de-dusted and weighed again. The weight difference before and after the test is determined as friability; this usually should not exceed 1%.

Different Speed Settings

A silent DC geared motor rotates the drums at a fixed speed of 25 rpm or at a selectable speed (setting can be locked). 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 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. A friability drum with an additional anti-static coating is available as an option.