ZYMARK
Sotax

www.sotax.com

Instrumentation –

 

Automated Workstations for Pharmaceutical Processing

Zymark has worked with the pharmaceutical industry's most expert automation chemists to design and test this 3rd generation replacement for the Prelude Workstation.

The TPW3, Tablet Processing Workstation accurately automates traditional method steps to disperse, extract or dissolve active pharmaceutical ingredients or other analytes within a vessel that contains between 50 and 500 mL of extraction solvent. A high shear Rotor Stator mixer is primarily used to disperse the sample matrix. Dispenses can be set to accurately achieve specified concentration or deliver a specified quantity.

Other capabilities include filtration, dilution, mixing, online LC, and on line UV analysis. The TPW3 can also perform most of the basic methods as the APW3 - Active Ingredient Processing Workstation.

Improved Quality of Analysis - The TPW3 improves the quality for everyday laboratory tasks by eliminating technique dependency. Accuracy is assured by gravimetric verification of each method step.

Increased Productivity - The labor saved by TPW3 allows more time for other, more critical challenges. Many tasks performed by TPW3 can do the work of one or more analysts.

Fully Compliant - The TPW3 is primarily intended for use within the regulated pharmaceutical industry around the world. Compliance has been taken into consideration for all aspects of use.

Features:

• TPW3 gravimetric control reports the exact reagent volume for each dispense. This value is retained in the compliant database to determine dilution factors
• Since each step is controlled by accurately defined parameters there is no technique dependency. This includes the conditions controlling extractions and dilutions
• Timing between the method steps, including HPLC injection, is identical for every sample resulting in a uniform sample history
• Methods may also be overlapped so that the output tube of one method may be the starting point of another method
• The TPW3 includes an interface to Water’s Empower® IITM. The TPW3 can also be connected with an on-line generic HPLC and UV spectrophotometer
• The TPW3 is designed to allow multiple dilutions and HPLC injections so that different concentrations from the same extraction can be analyzed
• Design of experiments, or DOE, is facilitated by the ability to designate analytical parameters as variables. This is a powerful tool that realizes the full potential of automated method development
  
  

 

CTS

 

The fastest and most reliable system for automated Content Uniformity Testing and Composite Assay Testing on the market!

Product Details

 

• Simultaneous sample processing, up to three times faster than comparable systems available in the market
• Up to 240 samples in 16x150 mm tubes or up to 80 samples in 32x115 mm tubes
• Sample volumes from 25 to 1000 ml of solvent
• Superior handling of tablets, capsules, effervescent tablets, powder pellets and liquids.
• Brushless homogenizer motor for maintenance-free use
• Fully compatible with all the most common UV/Vis spectrophotometers on the market
• Direct injections into 1 or 2 HPLC systems for on-line real time analysis.
• Off-line sampling for sample archival
• Complete control via 21 CFR part 11 compliant software with LIMS access
• The unique cleaning design, allows for less organic solvent requirement for a complete run

 

 

Sotax AT7 smart Dissolution Bath

The workhorse for every dissolution laboratory designed with the Autocompliance™ concept which eliminates daily routine validation. The SOTAX AT 7smart Dissolution Bath can be used as a standalone unit or upgraded to a semi-automated system.

Product Details

• Compact and space-saving design
• Complies with the latest USP/FIP and FDA/ASTM regulations
• Seven stirrer stations with identical test conditions for 6 test samples and 1 placebo or blank solution
• Easy method handling with front key pad
• Off-line programming for fraction collection built-in
• Different sampling methods possible
• Protocol printout of test parameters incl. temperature, rpm, sampling times by any printer
• Integrated vessel lids; i.e. no manual removal or positioning of vessel lids
• Elimination of routine validation due to unique Autocompliance™ concept: automated vessel centering and stirrer positioning.
• Handy feeder device for test samples with simultaneous and staggered tablet feeding
• RS-232-C interface utilize for PC communication, automation or for printer connection
• Base modular concept permits substantially customized automation solutions with additional hardware and WinSOTAX advanced dissolution software

Dissolution testing USP 4

For over 30 years, SOTAX has been developing USP Apparatus 4 Flow Through Cell Dissolution with experts in academia and industry. Today, SOTAX is a worldwide market leader with expertise in method development and feasibility studies, automated sampling, on-line real time analysis, UV Fiber Optic, and customized solutions for unique drug delivery systems

SOTAX CE 7smart Automated Flow-Through (USP 4) Dissolution System with easy media and pH changes for optimal in-vivo simulation!

 

Product Details

 

• Designed for R&D and QC
• Method of choice for extended release and poorly soluble products
• Used in QC for implants and Drug Eluting Stents
• Cell block with 7 specific flow-through cells
• Adapted to specific cell types for testing of APIs, powders, tablets, capsules, suspensions, suppositories
• Used for apparent dissolution on APIs
• Automatic test preparation functions and integrated cleaning functions at the end of the test
• Has to be linked to a piston pump CY7-50 or CP7-35 to have an optimal and compliant  flow-through manual system
• Can be upgraded to semi-automated USP 4 systems easily.

 

Tablet Hardness Testing

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

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
• 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