The friability tester has now become an accepted standard throughout the pharmaceutical industry for determining the resistance of uncoated tablets to the abrasion and shock experienced in manufacturing, packing and shipping operations.
Friability Testers FR and FRV Series are designed in accordance with the specifications as laid down in Eur. Ph. Chapter 2.9.7 and USP Chapter <1216>. The standard FR Series operates at a constant speed of 25 rpm +/- 1. It is available in two variants, with either one (Model FR 1000) or two (Model FR 2000) test drums. Similar in construction to the fixed speed FR Series, the Friability Series FRV differs only in having variable speed between 20 and 60 rpm.
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TABLET FRIABILITY TESTERS
PHARMACOPOEIA COMPLIANCE AND VALIDATION
In order to meet your individual requirements, Copley provide a three tier approach to regulatory compliance and validation.
- Each Friability Tester is checked by our quality control department prior to despatch and supplied as standard with a Certificate of Compliance documenting the test protocol used and certifying conformity with the appropriate Pharmacopoeia.
- In addition to this general Certificate of Compliance, some of you have asked us for specific certification on certain critical components, for example, the Friability Drum. If you require this additional service, please refer to the appropriate ordering information on Numbering and Certification. This service includes the numbering of the individual component concerned and the provision of a detailed certificate indicating the actual measurements relating to that component and the metrology equipment (and its traceability) used in measuring them.
- Finally, all systems are available for our engineers to come on-site to perform fully documented IQ/OQ.
DESIGN AND CONSTRUCTION
Designed in accordance with the specifications as laid down in Eur. Ph. Chapter 2.9.7 and USP Chapter <1216>, the FR Series forms the basis of our range of friability testers for uncoated tablets. The standard FR Series operates at a constant speed of 25 rpm +/- 1. It is available in two variants, with either one (Model FR 1000) or two (Model FR 2000) test drums. Similar in construction to the fixed speed FR Series, the Friability Series FRV differs only in having variable speed between 20 and 60 rpm.
The speed is controlled via the membrane keypad in steps of 1 rpm. The variable speed allows the operator to subject the tablets under test to varying stresses and therefore determine an optimum for each type. As on the FR Series, the duration of the test can be selected in either revolutions of the drum (1 – 999,999) or time (up to 99 hours, 59 minutes, 59 seconds). During the test run, the nominal test duration and remaining test duration, in either revolutions or time, is indicated on the LCD screen, together with the selected speed. The control of all models is provided by a membrane keypad linked to a 4-line 20 character back-lit LCD screen.
The Friability Drum has been designed for testing the rolling and impact durability of tablets and has a single curved baffle which allows the tablets to be tested to rise and then drop through a distance of approx. 156 mm. Premature fracture or sign of wear at the edges indicates that such tablets may not withstand the
rigours of transportation. All Friability Drums are now fitted with an aperture such that it is no longer necessary to remove and open the Friability Drum in order
to load and remove the samples. At the start of the test, the drum automatically revolves until the aperture(s) faces the operator so that the tablets can be loaded. On
completion of the test, the drum stops and then reverses automatically emptying the contents of the drum into the waiting collection tray(s).
All Friability Drums are completely interchangeable, i.e. they will fit either side of the tester. Abrasion Drums for carrying out tests into attrition are also available as an optional extra. The Abrasion Drum comprises of a drum 20 cm diameter with a series of baffles, which carry the tablets to a predetermined height before sliding off and reproduces the action of the tablets rubbing against each other during transport. All testers can be equipped with a choice of either USP Friability Drums
and/or Abrasion Drums. Dual drum units can, for example, be fitted with one Friability and one Abrasion Drum, thus allowing comparisons to be made between the two parameters under identical test conditions.
Considerable attention was paid to the design of the FR and FRV series to ensure that the number of actions necessary to perform a test are kept to a minimum. Consequently, once the method (number of revolutions or time) has been selected and the test duration set, it is only necessary to press the START key to initiate the test. The standard test procedure is to take a sample of 10 tablets (a sample equivalent to 6.5 grams should be taken if the tablets weigh less than 650 mg), the weight of which has already been determined (W1). The tablets should be de-dusted prior to weighing. The tablets are then placed into the test drum and allowed to rotate 100 times. The tablets are then reweighed (W2), having first removed any accumulated dust, and the results calculated in terms of % weight loss utilising the formula (W1-W2) x 100 divided by W1. In general, a maximum weight loss of not more than 1% is acceptable for most tablets. If necessary, repeat the test twice more
basing the result on the mean of the three tests.
FR 1000 / FRV 1000 = 290 x 360 x 350 mm (w x d x h)
FR 2000 / FRV 2000 = 342 x 360 x 350 mm (w x d x h)
Higher Raman Sensitivity Than Ever Before Possible
The HyperFlux PRO Plus redefines what is possible with process measurements using the power of Raman spectroscopy. The newly re-designed HTVS component enhances the spectral throughput by an order of magnitude over conventional designs providing superior photon management. This allows process measurements to be done faster and with better sensitivity.
- More accurate identification and quantitation
- Faster measurement
- Lower laser power operation
- Flexible chemometric options including Unscrambler, Simca-P+, Pirouette, Eigenvector.
- 21CFR11 and IQOQPQ option for GMP applications.
- 8-channel multiplex option.
- ATEX option available with OPIS35
Hyperflux PRO Plus - HTVS Raman Spectrometer
ATEX rated. On-line/In line and Reaction monitoring
Tornado’s HyperFlux PRO Plus is a complete Raman spectroscopy system including a proprietary HTVS-enabled spectrometer, a high-quality stabilised laser, multiple laser safety interlocks, temperature monitoring and dynamic re-calibration, and automated system health monitoring and fault detection. This powerful, reliable, and easy-to-use instrument is contained in a small, lightweight, cost-effective package which is readily deployed in both in-line process and laboratory settings.
The HyperFlux PRO Plus redefines what is possible with process measurements using the power of Raman spectroscopy. The newly re-designed HTVS component enhances the spectral throughput by an order of magnitude over conventional designs providing superior photon management. This allows process measurements to be done faster and with better sensitivity. The HyperFlux PRO Plus is perfect for ATEX situations where the highest sensitivity is required. Put Raman to work in your process measurement scheme.
The HyperFlux PRO Plus offers customisable bandpass, resolution, and throughput configuration delivering high-performance with versatility to meet your application requirements:
- 4 cm-1 spectral resolution with no slit
- Configurable for a variety of applications
- Stand-off and immersion probe optics
- No moving parts for superior stability
High signal throughput allows: Faster measurements, better detection limits, reduced laser power to preserve samples and the potential for use of anti-stokes signal.
Proven real world applications:
- Monitoring of polymer curing processes
- Following crystalisation (crystalization) processes
- Monitoring extrusion processes
- Optimisation of chemical reactions in manufacturing
- Real-time detection of process anomalies and excursions
- Analysis of fuel mixtures
Plus many other examples...
|Laser Power||20mW to 475 mW|
|Bandpass||Configurable to Measurement Requirements|
|Probes||Immersion and Non-Contact|
|Unit size and weight||18.4 x 8.5 x 5.4 inches, 22 lbs
(46.7 x 21.6 x 13.7 cm, 9.9 kg)
|Input power requirements||100/240V AC line power @ 15A|
|Temperature limits||0 to 35°C, 20-80% humidity (non condensing)|
|Fiber Length||up to 3 meters standard
longer lengths can be fabricated upon request.
|Number of Channels||8 (with serial multiplexer)|
|Computer and OS requirements||Windows 7, 2 GHz dual-core with
4 Gb RAM, 250 Gb HD, and USB2.0
|Software||Process communications options|
Click Here to download the Hyper Flux PRO Information Sheet
Click to view SpectralSoft software Spec. Sheet
Click to view ‘Quantitative analysis of Biochemical Components’ Application Note
Click to view Application Note: ‘Focus on Spectroscopy – High Throughput Virtual Slit (HTVS) Design Addresses the Trade-off between Resolution and Throughput in Raman Spectrometers’
Unit 21, Waterford Business Park,
Cork Road, Waterford
Ireland, X91 P224