Dissolution Tester Trust-E

Dissolution Tester Trust-E

The TrustE Dissolution Tester are 21 CFR Part 11 compliant dissolution testers with a data integrity operating system. They are designed to minimise routine validation and are internationally regulatory compliant. The dissolution testers have easy access to all physical parameters to allow for easy cleaning and mechanical qualification. The dissolution testers are available with 8 or 14 stations for your testing needs.

Key Features of the Trust-E:

Key Design Features:

• Easy access to all physical parameters for cleaning and mechanical qualification
• Minimal routine validation due to the design
• Sturdy bath top plate that is corrosion free
• All sample contact parts are made of inert materials
• Versatility allows adaptation to USP 1, 2, 5, 6 intrinsic and special height (45 mm) apparatus
• Transparent and amber coloured vessels-capacity ranging from 100 ml to 4 L
• Sampling manifold dives the individual cannulas and vessel temperature probes to the appropriate sampling zone based on the method
• Wake up and sleep mode for the temperature controller saves time and conserves energy

Sample Collector Benefits:

Automation Compatible:

• High performance ZDV (Zero-Dead-Volume) syringe pump for precise and accurate sampling
• 2 axis movement of sample collector arm enables piercing of pre-cut septa for HPLC vials
• Enclosed sample collector prevents contamination and excess evaporation of samples
• Rinsing: There are two programmes available for rinsing in the dissolution tester, the Split-Rinse and the Loop-Back. The Split-Rinse is a programmable rinse volume purged to waste in multiple cycles to avoid carryover. Loop-Back circulates the rinse volume through the transfer tubing back to vessel to eliminate waste volume
• Dilution with Stirring: Simultaneous purging and mixing of the aliquot and diluent for homogeneous sample preparation (Patented). Automated dilution of aliquot is possible by using replenishment media or mobile phase

Features Exclusive to the Trust-E14

14 Station Benefits:

• Efficient tool for biowaver, ANDA, and SUPAC-MR where n=12
• Consistent results with a single dissolution water bath over two separate dissolution water baths
• Incubation of replenishment media under same conditions to the dissolution media
• 14 stations dissolution tester saves 67% on bench space, 64% on electricity and 63% on water
• Isolated temperature controller for precise temperature control and no disruptive vibrations

Motorised Lift Mechanism:

There is a motorised lift mechanism in the 14-station version of the Trust-E that is hands-free and has quiet operation. There is an automatic stirrer height positioning for USP 1, 2, 5, 6 and intrinsic test methods.

AutoDropSync^TM (Optional):

Simultaneous dropping of dosage in non-rotating media as well as user defined test start once the media temperature is attained. The AutoDropSync^TM can accommodate dosages and sinkers of up to 24mm.

Snap-Fit^TM Shaft:

A unibody construction of Snap-Fit^TM shaft provides a wobble free operation and accurate height adjustment as well as facilitating quick changeover between methods.

Multi-stage Filtration:

There is a 2 or 3 stage filtration ranging from 10 µ - 15 µ, 0.45 µ to 0.22 µ and proximity to the filter manifold which reduces variability caused by automation.