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Complies with USP, IP, JP, EUR, specifications Supports USP 1, 2, 5, 6 and intrinsic test methods Ideal for sustained and controlled release products 8 stations with easy Snap-Fit shafts for paddles and baskets Moulded water bath with sturdy top plate Magnetically coupled water circulating pump for precise temperature control of the water bath Programmable wake-up for temperature control

Precise individual vessel centering system 20 programmable protocols and 12 programmable sampling intervals Facilitates Online / Offline automation Online validation and printout of test parameters Motorised telescopic lift Ergonomic design for user friendly operation Designed to minimise routine validation

Incorporates various safety features Automatic height adjustment on method selection Simultaneous Dispensing of tablets at push of button Validation of individual vessel temperature Integrated self managing vessel lids Motorised sampling manifold which lowers and retracts automatically at precise time and position as programmed Low evaporation and condensation recovery lids

he ELECTROLAB TDT08L is a microcontroller based 8station dissolution testing system which conforms to USP, IP, JP and EUR Pharmacopoeia specifications. The instrument supports USP 1, 2, 5, 6 and intrinsic dissolution test methods. The unit has been designed for user friendly operation and supports a menu driven 20 x 4 character backlit LCD display. The TDT-08L is provided with a microcontroller based stepper motor drive which gives precise RPM. The water bath is attached to an isolated water circulating pump with a temperature controller to ensure a uniform set temperature in the bath. The pump is isolated from the water bath to eliminate vibration. The water bath is moulded to prevent leakage and shaped for easy cleaning to comply with GLP. It is provided with quick release couplings for ease of operation. A sturdy top plate is provided to support the 8 vessels. The vessel is precisely aligned in the center with re-

spect to the paddle by the self centering ring and can be interchanged without disturbing the centering thus eliminating routine validation. The instrument is provided with a sturdy telescopic motorised lift mechanism. This mechanism uses non-contact sensors for precise height positioning to meet USP re-

quirements. Adjustable legs have been provided to level the instrument perfectly. No knurlings, no threading just a bayonet type Snap-Fit locking mechanism for the paddles and basket shafts. This ensures a quick changeover between method selection and positively locks, positions and engages the shafts.

The microcontroller based stepper motor drive ensures a precise speed control in the range of 25 to 200 RPM with an accuracy better than 0.5 RPM . The drive has been designed to eliminate vibration which makes it ideal for sustained and controlled release product tests. The built-in tachometer monitors, validates and generates RPM data which can be printed during the test.

The advanced microcontroller along with the PT100 sensor and water circulating pump controls the temperature in the water bath in the range of 30.0C to 40.0C with an accuracy better than 0.2C. No routine calibrations are required since the system auto calibrates itself.

Twelve programmable sample intervals are provided. Each programmable from 1 minute to 24 hours. An audio-visual alarm indicates the end of each interval.

The TDT-08L has an option for online and offline automated sampling. The sequence for the automated sampling is initiated at the end of A mobile external probe each sample interval. is provided to monitor the temperature in individual test vessels or the water bath.

The TDT-08L can be used for automated online and offline sampling using a multi-channel peristaltic pump and a manifold. The peristaltic pump is supplied with a high performance chemical resistant tubing for longer working life.
REPLENISHMENT VESSEL

A manifold is used for better tube management & precise positioning of sampling points in all the test vessels. A scale is provided on the manifold to set the sampling height according to the media volume (500, 900 or 1000 ml) for paddles and baskets.
MANIFOLD

The precision PTFE carrier tubes are used to avoid adsorption and are also chemically resistant. An SS in-line sintered filter prevents the coarse particles from being sampled. The sample volumes are programmable from 1 to 25 ml.
BLANK

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DISSOLUTION VESSELS DISSOLUTION VESSELS

PERISTALTIC PUMP

G LIN MP SA

PERISTALTIC PUMP

SPECTROPHOTOMETER FRACTION COLLECTOR

Off-line Sampling The peristaltic pump samples the programmed volume from each vessel and delivers it to a fraction collector. The programmed volume can then be replenished in each vessel if opted for. The software is designed to empty the trapped volume in the tubes and thus prevent contamination of the samples.

On-line Sampling This method uses a spectrophotometer in a closed loop system. The peristaltic pump is used for circulating the media into flow-through cells of the spectrophotometer. The microprocessor based peristaltic pump is designed to communicate directly with the spectrophotometer and collect the data for absorbance levels, which is then tabulated and printed directly.

The combination of intelligent hardware and state-of-the-art software gives the TDT-08L a leading edge. The instrument is provided with advanced features to cover the industry requirements. The menu driven software gives a series of easy to understand prompts for setting parameters and prevents invalid entries. User defined 20 programmable protocols are retained within the unit in a non-volatile memory to save time for frequently repeatable operations. System Diagnostics The instrument checks for hardware status when the power is switched on and

displays errors, if any. On starting the test it checks that all parameters have reached their set values, like RPM, temperature and stirrer unit position. Programmable Wake Up The temperature controller and water circulating pump starts at a programmable preset day and time, with a real time clock to save manhours. Status Indicator The current status of the instrument is continuously reflected on the panel and any deviation from the set parameters are also indicated on the panel as an audio-visual alarm.

The instrument ensures that parameters like RPM and temperature are validated online. A report of these parameters can be printed during or at the end of the test. Routine validation like vessel to paddle centering; paddle height; shaft wobbling; are eliminated due to superior design of the instrument. However these parameters can be verified with the ELECTROLAB Validation Kit.
ION ELECTROLAB TABLET DISSOLUT VALIDATION REPORT TESTER

Model No : TDT-08L Sr. No. User Product Batch Name No. : TDT 0110014

Start Date : 27 /10 / 2001 Start Time : 10 : 00 Hrs

_____ ________________________ :________________________ __ ________________________ : ________________________ __________________ ________________________ : ________

Set Parameters : RPM : 100 Print Temperature : 37 . 0 C

Interval : 02 Min

Actual Temp C 37 . 0 37 . 0 36 . 9 37 . 0

Dev. Temp C 00 . 0 00 . 0 00 . 1 00 . 0

Validation Report

8 merlon jars with lids 8 paddles-SS316(USP Apparatus 2) Moulded water bath Circulating water pump with heater External probe

Validation Kit includes tachometer, thermometer, depth guage, centering device, centering / wobble guage and level guage

the initial tests in any product development work. The apparatus includes holder, punch, die, surface plate, punch remover and KBr press.

Basket shaft (SS316) Basket (SS316) 40 mesh USP Apparatus 1 Gold plated basket Glass jar (clear or amber) Sinker in 3 different sizes Teflon coated paddle Individually serialised paddle Transdermal disc (apparatus 5) Transdermal cylinder (apparatus 6) Mini jar conversion kit (250 ml) Evaporation Retarding disc Basket Holder with Clip and without Clip Enhancer Cell

Auto Sampler Accessories Validation Kit IQ, OQ documents Intrinsic Dissolution Apparatus determines the dissolution rate per unit time per unit area of pure compounds by immersing a fixed amount of material in a dissolution medium with only a fixed area exposed. This is a powerful characterisation tool that is one of
12 channel peristaltic pump MarpreneTM tubing for 12 channel peristaltic pump (durable and chemically resistant) PTFE carrier tubing Sampling manifold SS filters (10 to 15 microns) Fraction Collector (6 x 12 vial position) Automated Sampling Manifold Tablet Dispenser S.S. Disposable Filters

Parameters

Range 25 - 200 30.0C to 40.0C

Accuracy 1 Stepper Motor Drive 0.2C Approx 27 min 1 kw PT 100

Resolution 1 0.1C

Special attention has been given to safety factors which have been incorporated in the system to help in both man-made failures as well as machine failures. These are the test does not start till set parameters like temperature and paddle position are achieved. a thermal cutout is provided to cut off the power to the heater when the temperature exceeds a safety limit. the lift motor is provided with position sensors as well as a time-out safety cutout. the instrument is also provided with a power failure recovery feature. positive engagement of paddles to prevent them from coming out or losening.

RPM Drive Temperature Stabilisation Time Heater Sensor Circulation Sampling Interval Range No. of Intervals Volume Range Bath Water requirement Material Display Printer Interface Power Weight Dimensions (mm)

Magnetically coupled pump capacity = 10 litres/min 1 min - 23 hrs 59 min 0.01% 12 1 - 25 ml 27 litres Perspex 20 x 4 character LCD Centronics parallel port 220 / 230 V AC 10%, 50 / 60 Hz, 1.2 KVA (110 V AC, 60 Hz on request) Net 60 kgs (Approx) H 975(max) 645 (min) x W 505 x D 705 1 min

401, Tirupati Industrial Estate, I. B. Patel Road, Off Western Express Highway, Goregaon (East), Bombay 400 063 India Tel: 91 22 5690 40 80 91-22-326 033 22 91-22-287 221 11 Fax: 91 22 5690 40 83 email : electrolab@vsnl.com Website : www.electrolabindia.com

IPR Cons / CD / april 2003

Our Other Product s

Pooled Dissolution Tester (2 and 4 litre jar) 6-Station Dissolution Tester Tablet Disintegration Testers Automated Tablet Friabilators Tap Density Testers Peristaltic Pumps Programmable Tablet Hardness Tester Electromagnetic Sieve Shaker

About TDT- 08L In Pharmaceutical laboratories, an increasingly important role is being played by release studies. These determine the amount of active substance in a pharmaceutical dosage form dissolved in a defined medium within a defined period of time. The different pharmacopoeia has suggested precisely standardized conditions for dissolution testing apparatus. The aim is to achieve optimum reproducibility of results. The following are some of the requirements laid down: dimension tolerances of the test vessel geometry of Paddles and Baskets specifications for centering and the tolerances permitted absence of any vibration that could influence the test revolution speed and temperature

All components coming in the contact with the dissolution media must be chemically inert. The ELECTROLAB TDT 08L Dissolution Test Apparatus has introduced a new version which includes a Tablet Dispenser and a Motorized Sampling Manifold which fulfills the requirements laid down in USP, IP, BP, and EUR Pharmacopoeia. Integrating this unit with Sampling Pump and Fraction Collector or UV Spectrophotometer automates the task of sampling. The TDT 08L with 8 stirring stations is ergonomically designed to eliminate numerous routine manual operations. Since all the 8 stirring station is equipped with the stirrer, the user can use one test vessel for the replenish media, one can be used to test a placebo or an empty capsule shell simultaneously with the 6 samples under the same test conditions. The bayonet type Snap- Fit locking mechanism for paddles, basket and other shafts ensures a quick changeover between them. The height of the stirrer to the vessel is automatically adjusted precisely as per the method selected (1, 2, 5, 6 and intrinsic dissolution test) without additional equipment and device. The test vessels are provided on the periphery for ease of the sampling. The critical centering of vessels is precisely aligned in the center with respect to the paddle by self centering ring and can be interchanged without disturbing the centering thus eliminating routine validation. Adjustable legs are provided at the base of the instrument for the leveling of the instrument. The user is guided through a series of prompts on 20 X 4 characters LCD Display. The online menus and prompts make the operation of the instrument very easy and user friendly. The water bath is attached to an isolated water circulating pump with a temperature controller to ensure a uniform set temperature in the bath. The pump is isolated from the water bath to eliminate vibration. The water bath is moulded to prevent leakage and shaped for easy cleaning to comply with GLP. It is provided with quick release coupling for ease of operation. The advance microcontroller along with PT100 sensor and water circulating pump controls the temperature in the water bath in range of 30.0C to 40.0C and can be controlled within 0.1C.

Individual temperature probes to each vessel for validating temperature during sampling and generating a print out during the test can be provided. A standard mobile external probe is provided to monitor and validate the temperature in the individual test vessel or in the bath. The microcontroller based stepper motor drive ensures a precise speed control in range of 25 to 200 RPM with accuracy better than 0.5 RPM. The built in tachometer monitors, validates and generates RPM data which can be printed during test. Twenty individual protocols can be programmed, stored, recalled for each test. Sixteen programmable sampling intervals can be set. The TDT 08L supports a simple and effective automatic online and offline sampling using a multi channel peristaltic pump and a manifold. The peristaltic pump is supplied with high performance chemical resistant tubing for longer working life. The latest version is provided with dispenser plate which is integrated with self managing vessel lids for low evaporation and condensation recovery of media and tablet dispensing for simultaneous dispensing of tablet at a push of button. A Motorized sampling manifold is used for better tube management & precise positioning of sampling points in all the test vessels. Sampling height according to the media volume (500, 900 or 1000 ml) for paddles and baskets can be programmed. The precision PTFE carrier tubes are used to avoid adsorption and are also chemically resistant. An option of SS in line filter and disposable filter prevents the coarse particles from being sampled. The sample volumes are programmable from 1 to 25 ml. Off line sampling: The peristaltic pump samples the programmed volume from each vessel and delivers it to a fraction collector. The programmed volume can then be replenished in each vessel if opted for. The software is designed to empty the trapped volume in the tubes and thus prevent contamination of the samples. On line sampling: This method uses a spectrophotometer in a closed loop system. The peristaltic pump is used for circulating the media into flow-through cells of the spectrophotometer. The microprocessor based peristaltic pump is designed to communicate directly with the spectrophotometer and collect the data for absorbance levels, which is then tabulated and printed directly. The advance features such as: Simultaneous Dispensing of tablets at a push of button. Validation of individual vessel temperature. Integrated self managing vessel lids. Motorised sampling manifold which lowers and retracts automatically at precise time and position as programmed Low evaporation and condensation recovery lids gives the TDT 08L with Diving manifold a leading edge, and fulfils the industry requirement.