Friability of Granules
The Friabimat SA-400 was originally designed as a method to effectively determine the friability of hard pellets and granules prior to further processing, for example, drum coating under precisely defined, controlled and reproducible conditions. The instrument is particularly useful in detecting variations in mechanical properties between different formulations and batches and is a convenient tool in both research and development and quality control applications. The instrument has now been included in the 8th edition of the European Pharmacopoeia under Chapter No. 2.9.41 Friability of Granules and Spheroids.
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FRIABIMAT – SA-400
DESIGN AND CONSTRUCTION
The Friabimat was originally designed as a method to effectively determine the friability of hard pellets and granules prior to further processing, for example, drum coating under precisely defined, controlled and reproducible conditions. The instrument is particularly useful in detecting variations in mechanical properties between different formulations and batches and is a convenient tool in both research and development and quality control applications.
Following review, the instrument has now been included in the 8th edition of the European Pharmacopoeia under Chapter No. 2.9.41 Friability of Granules and Spheroids. This describes the Friabimat under Method B Oscillating Apparatus 2.9.41.-2.
The Friabimat’s range of application has since been extended to include hard coated and uncoated tablets and other dosage forms which fall outside the scope of the standard friability tester. For the purpose of the test, the sample to be tested is confined within a standard 105 ml glass bottle (measuring approx. 85 mm high x 49 mm i.d. with twist-off cap) which serves as the sample container.
During operation, this sample container is secured by means of a spring clip to the sample container holder horizontally mounted on the end of an oscillating arm having an arc of 37 degrees at a radius of 152 mm from the centre of oscillation.
The abrasive action is generated by the horizontal shaking movement of the oscillating arm which causes the samples to rub against and collide with each other and/or the internal surfaces of the sample container. The intensity of the abrasive action and the duration of the test can be adjusted via the controls mounted on the front panel between 0 and 400 oscillations per minute and 0 and 9999 seconds respectively. This enables the user to optimise the test conditions the test conditions applicable to each formulation and reproduce it at will.
Average test times are between 2 and 4 minutes. The combination of these short test run times together with the use of inexpensive, commercially available glass bottles as the sample container means that it is possible to carry out tests economically in batches as opposed to singularly on an infrequent basis.
The Friabimat measures 440 x 300 x 220 mm and weighs 13 kilos.
- Adjust the number of oscillations to the desired frequency by adjusting the thumb wheel switches on the rotary speed adjuster mounted on the front panel to the appropriate setting (between 0 and 400 oscillations per minute).
- Now set the test duration using the push button timer (between 0 and 9999 seconds).
- Note: Shake for about 240 seconds at approx. 400 oscillations per minute for hard dose forms, or, for example, 120 seconds at 140 oscillations per minute for soft dose forms. Optimise these settings according to the dosage form concerned.
- The Friabimat is now ready for operation.
- Take a sample of the formulation to be tested and remove any fine particles present in the sample using a 355 micron sieve.
- Weigh out approx. 10 grams (m1) of the product into a sample container ensuring that the twist off cap is well secured. Now place the sample container into the spring clip fastening on the Friabimat provided to secure it and close the safety lid.
- Start the test by pressing the appropriate key on the timer. The unit will switch off automatically on expiration of the preset time. The time remaining to the end of the test is displayed on the timer duringoperation.
Note: The Friabimat is fitted with a safety interlock which automatically pause operation if the safety cover is opened during atest. The test can be re-started once again by simply closing the lid.At the end of the test, sieve as at the start of the test and re-weigh (m2). Perform three tests and calculate the mean value.
Express the results in terms of % weight loss using the formula (m1-m2) x 100 divided by m1.
- Quantifiable friability of hard tablets, granules and pellets
- Bi-directional horizontal shaking action
- Programmable shaking rate (0-400 oscillations per minute)
- Programmable test times (0-9999 seconds)
- Stainless steel case for production environments
- Clear acrylic lid with magnetic interlock for safe operation
- Interchangeable glass sample containers for rapid throughput
- Oscillation frequency verification certificate (optional)
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