SII

Physical Testing

Tablet Hardness Testing

 

FMS

 

 

 



 

 

 

 

 

 

 



 

 

 

 

 

Product Details

 

  • Manual or automated testing of the most important physical parameters (weight, thickness, diameter or length and hardness)  of up to 10 different products or batches, e.g. tablets, dragées, oblongs, effervescent tablets or similar drug delivery systems.
  • Separates all shapes and sizes of tablets with ease, using the vibration-free Auto Separator, no manual adjustments required
  • Equipped with the Auto Alignment™ device (patented) which automatically aligns even the most difficult of tablet shapes,
    to prevent erroneous hardness measurements
  • HT 100 has ten chambers with a capacity of 115 ml each (equivalent 200 medium-sized tablets) for the automated handling
    of up to 10 different products or batches
  • Unique tablet weighing station eliminates problems associated with tablet debris and dust
  • Two hardness measurement principles “Constant Speed” or “Constant Force”, measuring range as standard 2 to 1000 Newton
  • Simplified calibration method
  • Controlled by our 21 CFR Part 11 compliant and LIMS capable Q-Doc quality documentation software for Windows 2000/XP
  • Optionally available with fully functional built-in computer


 

Tablet Hardness testing is also called tablet breaking force and measures the tablet mechanical integrity.
The tablet breaking force is depending on the tablet geometry. If the tablet shape is not round e.g. oblong shapes the user has to place, in a reproducible way, carefully the tablets in the instrument: the Tablet Hardness Tester.
Understanding that problem, SOTAX has been the first to develop a unique patented system called Auto Alignment™ which will align your oblong tablets for you with accuracy and reproducibility!
SOTAX Tablet Hardness Testers solve another classic problem  faced with tablet hardness testers: some instruments are using a constant loading rate e.g. 20 N per sec or a constant platen movement e.g. 1 mm per sec and therefore a comparison between two units is sometimes difficult. SOTAX instruments can always been parametered in both modes. You will find more details clicking on instruments pictures or here whether you need a manual, automated or fully automated instrument.

 

 

Disintegration Testing

 

CALIPER

 

Product Details

  • Disintegration time testing unit with two basket-rack assemblies
  • 3 and 6 tubes baskets
  • Each basket-rack assembly can be controlled, started and stopped individually for individual disintegration time tests
  • Automatically lowers the baskets at test start and raises the baskets at test end
  • Acoustic signal on completion of test run time
  • Electronic temperature sensor for display and documentation of temperature in each beaker
  • Operating conditions programmable on front key pad with graphic display
  • Report printout with test results, statistics and temperature protocol
  • Connection to PC with RS-232-C and to printer with parallel interface
  • Validated Windows 2000/XP Q-Doc quality documentation software which fully complies with 21 CFR Part 11

 

 

 

 

 

Friability Testing

 

FMS

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

It has always been important to test the ability of tablets to withstand mechanical stresses. Their resistance to chipping and surface abrasion is determined by tumbling them in a rotating cylinder. The percentage weight loss after tumbling is called the friability of the tablets.
SOTAX offers two kind of instruments. They both have drums that are not subject to static build-up and comply with the EP, USP, DAB requirements.
The automated model F1 can be linked to a balance and a printer

 

 

 

 

TD1

CALIPER

 

A very compact microcontroller-based Tap Density Tester for simple measuring of the tapped density.

 

Product Details

  • Complies with USP, EP and ASTM specifications
  • Supports both USP 1 and USP 2 test methods
  • Testing of powders, granulates, pellets, flakes and other bulk substances
  • Two cylinder holders with easy snaplock mechanism for 100 ml and 250 ml cylinders
  • Simultaneous rotating and tapping motion assures an evenly packed surface
  • 24 x 2 alphanumeric LCD display
  • User-friendly operation with menus, helpline and current status indicators
  • Calculation of test results like tapped density, compressibility index and Hausner ratio
  • Printer port for documenting test results as per GMP/GLP standards

 

 

 

 

 

 

Q-Doc

Q-Doc – the quality documentation package for accurate electronic acquisition of measured values and electronic signatures.

Product Details


  • LIM System:
    • Data acquisition from different instruments CALIPER
    • Calculate data for preset product specifications
    • Decision for product specifications
    • Simple pass / fail of batch
    • Archive
    • Reports of each specification and batch
  • Network environments, e.g.:
    • Single system with one or more devices
    • Two PC’s each connected with one or more devices can be used simultaneously
    • Server solutions can be tailored to your specific requirements 
  • Graphic view of devices with real time status
  • Data from different devices can be collected simultaneously
  • Delayed start function
  • Automated decision in principle, using electronic signature for confirmation
  • Different search functions allow the status of every batch in every
  • Export to Excel
  • Help system for administrators and users
  • Context-based online help system
  • Currently available in English or German language
  • Fully complies with 21 CFR part11

 




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