UDT-818A-12 UNIVERSAL DISSOLUTION TESTER

Describe UDT- 818A-12 Universal Dissolution Tester

• The UDT- 818A-12 Universal Dissolution Tester, single drive tablet dissolution testing or individual speed control for front and back row of stirrers instrument for solid dosage forms as described in USP chapter <711/724> and EP section <2.9.3/4> as well as the BP , ChP and Japanese Pharmacopeia section <15>. And offers functions including audit tracking, authority management and electronic signature. It meets the FDA 21 CFR Part 11 and GMP/GLP requirements. All data integrity meets requirements of the pharmaceutical industry.
• The instrument features two additional vessels 250ml ( option) for media refilling and reference standard media. The UDT- 818A-12 Universal Dissolution Tester is the ideal choice for Biowaiver studies and dissolution method development.

Advantage

• Individual speed control for front and back row of stirrers
• 6 front line and 6 back line vessels for easy access in manual operation
• Rigid PP water bath cover, Dual vessel cover, totally eliminates media evaporation
• Centering Ring
• Temperature sensor in each dissolution vessel to examine and record individual temperatures
• Staggered start feature for convenient manual sampling
• Screen saver functionality offers most important information at a glance (stirrer speed, bath temperature, time to next sampling interval, elapsed time, media temperature )
• Backlight kit for easier dissolution test observation
• Programmable infinity test
• Shaft system to avoid re-adjustment of immersion depth
• Tight vessel seal cover design which limits media evaporation
• Water diffuser for even temperature distribution
• Vibration absorber to avoid vibration transfer into the USP/EP vessels
• Pump assembly to eliminate vibration transfer to the frame work
• Expandable to 2 or 3 speed zones, which provides different stirring rate, and shortens R&D duration
• Compatible with mini vessel apparatus, rotation cylinder apparatus, paddle over disk apparatus and flow-thru cell apparatus
• Compatible with basket/paddle method camera systems, which can record dissolution images
• UDT-818A-12 is compatible with UV, HPLC, fiber optics and dilution systems and performs online dissolution analysis
• Compatible with PERMETRO system to distinguish between the permeation of generic drugs and original drugs, whichcan exist as a pre-BE study

Features

• Automated temperature check and log at all sampling times
• Fully USP <711/724> and EP <2.9.3/4> compliant
• 12 stirred positions in a 6 + 6 arrangement
• Expandable to 2 speed zones, which provides different stirring rate
• Rigid motorized lift drive to raise and lower the head
• Individually coded Borosilicate vessels
• File up a nearly number of different test descriptions (methods)
• Instrument suitability check prior to start of a test run
• Vessel low evaporation sealing covers, Fold the hinged vessel cover to a 90° angle; slide the vessel cover over the shaft. Lay flat the hinged cover to 180°.
• Large drain hose for cleaning the bath
• CFR compliant method management and user admin with access control
• Thermo printer to print a test-log at the end of a run
• Optical and acoustic signals to inform about sampling intervals, timer count down function
• Status bar with traffic light information on display shows
• OQ, PQ interval warning with programmable interval
• Interfaces: USB port for remote control of the UDT-818A-12, RS-232 port to connect serial devices, I/O port for remote control of external instruments in automated applications.
• Calibration menu for stirrer speed, bath temperature

Shaft, Paddle, Basket

• The UDT- 818A-12 Universal Dissolution Tester Logan provides interchangeable shafts for Baskets (USP I) and Paddles (USP II). Made of stainless steel, meeting the standards of the US and UK Pharmacopoeia.
• Spindle and rotating basket used for 1 liter test cup, with separate code for each pair.
• Logan provides shafts with removable paddle blades and/or basket heads. Shafts can be held in the spindle while you change the paddle blade or basket head. If using this option, the joint between the shaft and paddle blade or basket head must be connected tightly. The O-ring on the setscrew is to seal the gap to make sure no media gets into it.

Vessel Centering System: 

The UDT- 818A-12 Universal Dissolution

Centering Ring: – Install a centering ring on each vessel. Slide the ring all the way to the top of the vessel.

Spring Clips: – Place the vessels into the vessel plate. Secure the vessels with the spring clips.

Lift Mechemism

• The upper drive is motorized and electronically controlled it offers eight programmable positions: an upper cleaning position and lower working positions are programmable depending on the type of stirring tool used. The upper position offers ideal access to the stirring tools and vessels for a change of tools and cleaning steps between the dissolution tests.
• The rigid design of the electronically driven lift mechanism ensures that the whole lift drive mechanism is positioned in a way so that the tool shafts are always kept parallel and at a 90° angle to the vessel walls when in the working position.

Speed Control Zones:

• One speed zone, two speed zone or three speed zone control system, which test drugs at different speeds under the same condition, saves time and improves efficiency.

Ultra-fast heating system

• The ultra-fast heating system is installed on an easy to remove platform within the housing. Access to pump, heater and all safety sensor system is possible without to move the bath from its qualified position. The connections between the heater and the bath are made by “quick connect fittings” for easy connection and disconnection. Water is pumped through the system using a powerful, yet quiet, circulation pump. The pump itself is (to limit vibration transmission) and the flow-through heater is protected from overloading (overheating in case of control electronics failure) via a thermal fuse as well as a thermo switch for added security.
• With service and maintenance in mind, access to the compact pump and heater section is easily achieved without having to move the main body of the instrument.

Water Bath: Before filling the water bath, please close the Drain faucet valve. The valve is closed if the faucet handle is perpendicular to the drainpipe.

Filling Water Bath: Do not overfill the water bath. If the vessels are not installed do not fill above the red mark.

Quick Connector: Before turning on the heater, make sure that the quick connector on the right side of the machine is securely connected.

Temperature Probe: Before turning on the heater, insert the Temperature Probe into the hole in the vessel plate. The UDT-818A-12 has an auto-shut-off switch safety feature. The heater will shut off automatically when the temperature goes over the safety limit and it will automatically reset when the heating system has cooled down. Before turning on the heater, prime the pump by pumping water through a drain hole. The heater has a 20 second delay, which allows the user to check if the water is circulating. If the water is not circulating, shut off the heater by pressing the HEATER button and prime the pump again.

Vessel Covers

-Hinged
Fold the hinged vessel cover to a 90° angle; slide the vessel cover over the shaft.

Lay flat the hinged cover to 180°. Let it cover the vessel entirely.

-Fixed

Newer Models use Vessel Covers attached to the Tablet Dropping Tray

Sampling Manual

• Use any manual sampling device such as syringes, vacuum tubes
• Place the sampling inlet probe into the vessel cover-sampling hole
• Take samples

Sampling Manifold (Optional)

• When Sampling Manifold is in operation, install filters are on the sampling probes.
• At the sampling interval, lower the sampling manifold into the vessels. The sampling probes can be adjusted on the probe holder.
• Once the sampling manifold drops to the desired position, pull up the syringes mounted on the syringe manifold to get the desired sample volume.
• Sampling tubes are linked to the syringe manifold located on the right side of the drive head. An automated or manual sampling device can be connected there.

Dissolution camera Recording system ( Otion):Tablet dissolution image for both Basket/Paddle methods can be recorded with camera system for effective observation.

Basket saver: Through a patended design, basket saver provides fast and safe handling of baskets; the deformation of baskets can be avoided.

Integrated Design: Built in accessory compartment stores paddle blades, baskets and other parts, making operation more convenient.

Unique Dual Vessel Covers Design: Effectively reduces solvent evaporation and ensure accuracy of experimental data.

Standard Scope of  Supply: The UDT- 818A-12 Universal Dissolution Tester comes ready to use with the following standard scope of supply:

• • One set of stainless steel 316 Shaft paddles
  • One set of stainless steel 316 Paddle Teflon Coated or Paddle Blade
  • One set of stainless steel 40 Mesh Basket
  • One set of 1000ml Borosilicate glass vessels
  • One set of depth adjustment balls
  • One bottle of water preservative 1000ml or AquaClear SF- Water Biocide Economy Pack 24ea
  • One Plexiglass Water Bath
  • Cabinet Assembly for stocking basket and paddle
  • Basket Holder
  • Automated sampling manifold
  • 12-Position Tablet Dropping Tray / Vessel Cover
  • Comprehensive documentation folder including:

Example Runtime Report: The UDT- 818A-12 Universal Dissolution Tester features a built-in thermo printer for result reporting

Option spairing with autosampler: In addition to the standard scope of supply Logan offers a broad range of accessories and options including:

• Configuration of vessel temperature probes: Plug in each temperature sensor into each jack as per number indicated on the rear panels. There are total of 12 (optional) temperature sensors.
• Direct control of peripheral instruments via I/O port such as DSC-800 System
• • SCR-DL Sample Collector
  • SYP-8L2B-10ML Eight Channel (8x 10 mL) Syringe Pump
  • DSC-800 Dissolution Sampling Collector

Automated Tablet Drop Magazine: The Tablet Dropping Tray accessory automates the process of tablet dropping.  It drops the tablets simultaneously, thereby marking the beginning of each test with far greater precision than manual techniques allow.  This feature ensures compliance with regulatory requirements.

Individual Media Temperature Monitoring System ( Option): Monitoring system for 12 vessels inside the UDT- 818A-12 dissol. bath. Used to measure online the actual temperature of the dissolution media

Electric movable Auto-Sampling System ( Option):

• Electric movable Auto-Sampling System for UDT- 818A-12 , includes 2×6 stainl. steel sampling tubes, stepper motor and gear drive, connecting socket to adapt the system with the master unit (without tubing installation). The EPE is used to withdraw samples while the sampling tube is inside the vessels, at the end of a sampling sequence the tube is automatically moved out of the vessel and the system remains in its upper home position waiting for the next cycle
• The samples may also be filtered through a membrane or other filters. At each sampling point, the syringe pump takes samples from the vessels and flushes out the sampling lines. After flushing the line, the samples return to the same vessels. This system does not send any sample to waste. The time, speed and temperature will be recorded at the beginning of each test as well as when samples are being taken.

Automatic sampling pump system after the dissolution process

1. Model: DSC-800 SYSTEM

• This system supports automating the process of sucking out the dissolution medium solution of each tablet after finishing the dissolution process for quantification (Sampling, aspiration, control).
• The automatic cleaning process, which is started immediately after the end of the test, helps to prolong the life of the equipment system.
• Supports data audit tracking and compliance with FDA 21 CFR Part 11 requirementsSystem components include:
  • Sampler model SCR – DL
  • Sample pump model SYP- 12 -10ml

DSC-800 Series System Controller: And other modules to implement automatic sampling system, making experiments more accurate and efficient.

Detailed description of each component: Set of sampler

2. Model SCR – DL: Compatible with HPLC systems of all chromatographic brands

• No sample discharge system
• Sample return station to limit waste
• Built-in filter holder for additional filtration
• Replaceable media tank integrated in the sample collector

Volumetric Accuracy: 0.1 mL

• 240 sample tubes (adjustable, vials or test tubes)
• Zero Dead Volume needle type
• SCR-DL located above the DSC-800

Controller Sample suction pump: Model SYP- 12 -10ml

• High torque motor driven with encoder feedback loop
• Control syringes up to 12 -10ml
• Precise needle ensures accurate sampling and avoids human error
• Syringe control
• Max volume 10ml
• Accuracy 0.1 mL
• Precise needle ensures accurate sampling and avoids human error
• After each sampling, the lines are cleaned

System controller

• Model DSC-800 Series
• Control of the pump and sample collector with the main solubility meter
• Sampling time within 4 minutes
• Standalone device, easy to place in any position
• Color touch screen control
• Connect to the printer
• Volumetric Accuracy: 0.1 mL
• Support multiple operating languages
• Built-in printer
• Can be used in automatic mode or manual mode.
• Up to 8 samples can be taken in the dissolving beaker at the same time and placed in the Autosampler Collector tray, HPLC vial pre-filled tray or test tube.
• 20 programs can be stored for use in automatic mode, the programs can be overwritten if the user wants to change them.

Installation modes, including:

• Auto Mode And Manual Mode
• Temperature, Date/Time, Language and Password
• Print Set
• Special interface for company engineers
• Other modes: Delivery Head Column, Delivery Needles, Bath Heating Temp Set (The minimum temp is 0 °C, max is 99 °C), Transfer Volume, Stirring, Test-Speed, onstant mode, Pulse Mode, …..
• In addition, to optimize the automatic process, fully automatic operation can be upgraded with the following automatic buffering station system.

Extended upgrade function

• Connect Autosamplers and syringes for increased performance, accuracy and connectivity with other instruments such as UV-Vis/HPLC, automatic pill drop trays, Control/Calibration/Validation software and external printer.
• Connect to HPLC/UV-Vis meter, optical system and dilution system, ready for online analysis
• Unattended system, with functions such as sample dissolution, sampling, substitution, dilution, UV-Vis or HPLC injection, online reading, data analysis, dissolution curve plotting, printing reports, etc., including the entire solubility analysis experimental procedure.
• Dedicated software connection for HPLC/UV-Vis
• Connects the Membrane Permeability System for drugs, studies the solubility curve, and to differentiate membrane permeability for generics and for generic drugs, providing data to support the test BE and improve the success rate of the BE testing process.
• Connection of Autosampler and syringe for increased efficiency and accuracy, ability to control multiple dissolvers at the same time, ability to connect to control up to 4 dissolvers at the same time
• Expandable to 2 or 3 optional speed zones, creating different stirring speeds and reducing R&D time
• Optional camera system to record images of the dissolution process
• Temperature sensor in each tank for optional independent temperature logging and testing

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