Pharma Alliance Group DT-8...• Complies with USP, IP, JP and EUR specifications • Online/automated sampling capable • Microcontroller based stepper motor for precise RPM •

• Complies with USP, IP, JP and EUR specifications • Online/automated sampling capable

• Microcontroller based stepper motor for precise RPM • Built-in support for ICALIS software connectivity and communi-cation controls

• Supports USP 1,2,5,6 and intrinsic test methods • Motorized telescopic lift reduces vibration against plate and bath

• 8 stations with easy Snap-Fit shafts for paddles and basket • Online validation and print out of test parameters

• Molded water bath with ultra rigid top plate • Automatic height adjustment on method selection

• Magnetically coupled water circulating pump for precise tempera-ture control

• Simultaneous dispensing of tablets via an automated dispens-ing platform [Optional]

• Programmable wake-up temperature control • Validation of individual vessel temperature

• Precise individual vessel centering system • Integrated self managing vessel low evaporation lids eliminate > 99% of volume due to evaporation loss

• 20 programmable protocols and 12 programmable sampling inter-vals

• Motorized sampling manifold automatically lowers and re-tracts at precise time and position

• Available also in 12 vessel configuration for increased laboratory efficiency and lower operating costs

• Ideal for sustained and controlled release products

• Advanced ELT heating technology allows instrument to reach op-erational temperature in less than 20 minutes

• Includes 6 month AquaClear biocide protection against algae water bath growth for cleaning free operation

28319 West Industry Drive Visit us at: www.pharma-alliance.net Email: [email protected] Valencia, CA 91355 Tel 661.294.7955 Fax Server: 661.793.6502

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The DT8 is a micro-controlled 8 station dissolution tester is a microcontroller based, 8 station dissolution testing system which conforms to USP,1P, JP and EUR Phar-macopoeia specifications. The instrument supports USP 1, 2, 5, 6 and intrinsic dissolution test methods. The unit has been designed for user friendly opera-tion and supports a menu driven 20 x 4 character backlit LCD display. The DT8 is provided with a mi-crocontroller based stepper motor drive which gives precise RPM. The water bath is attached to an isolated water circu-lating 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 molded to prevent leakage and shaped for easy cleaning to comply with GLR. It is pro-vided with quick release couplings for ease of opera-tion. A sturdy top plate is provided to sup-port the 8 ves-sels. The vessel is precisely aligned in the center in relation 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 robust telescopic motorized lift mechanism. This mechanism uses non-contact sensors for precise height positioning to meet USP requirements. Adjustable legs have been provided to perfectly level the instrument. For the attachment of paddle and basket, the in-strument does not require any knurling or thread-ing steps. The unique Snap-Fit locking mechanism ensures a quick changeover between method se-lection which positively locks, positions, and en-gages the shafts.

Pharma Alliance Group DT-8


RPM

Temperature

Time

The micro-controller based stepper motor drive, ensures a precise speed control in the range of 25 to 20 RPM, with an accuracy exceed-ing ± 0.5 RPM. The drive has been designed to eliminate vibration, which makes it ideal for sustained and controlled release tests. The built-in tachome-ter monitors, validates and gener-ates RPM data. This information is available to be printed during the test.

The advanced micro-controller along the PT100 sensor and water circulating pumps, controls the temperature in the water bath within the range of 30.0 º C to 40.0 ºC; and with an accuracy exceeding 0.2ºC. No routine calibrations are required since the system is capable of auto calibration. A mobile external probe is provided to monitor the termperature in each individual vessel or the water bath itself.

Twelve programmable sample intervals are provided. Each is pro-grammable from 1 minute to 24 hours. An audio/visual alarm indi-cates the each of each sample interval. The DT8 has an option for online and offline automated sampling. The sequence for the automated sampling is initiated an the end of each sample interval.



Standard Accessories

• 8 Dissolution Vessels with covers • 8 Stainless Steel Paddles • Molded Water Bath • Circulating Water Pump • External Temperature Probe

• Stainless Steel Paddles • Stainless Steel Baskets • Gold Plated Baskets • Tablet Sinkers - Assorted Sizes • Teflon Coated Paddles • Transdermal Disks [ USP 5] • Small Volume Vessel - 250 ml • Basket Holder with/without clips • Enhancer Cells • Intrinsic Dissolution • USP 6

Optional Accessories

Spec

ifica

tions

• Thermal shut-off is provided with cut off power to the heater if temperature ex-ceeds preset safety limit

• Lift motor is equipped with position sen-sors as well as time out safety shut off

• Built in automatic power failure recovery • Positive engagement of paddles to pre-

vent from loosening and falling off. • Automatic start up prevention system if

parameter such as temperature and position have not been met

Parameter Range Accuracy Resolution RPM 25-200 RPM ± 1 1

Drive Stepper Motor Drive

Temperature 30.0 º C to 40 º C ± 0.2 º C 0.1 º C

Stabilization Rate Approximately 27 min

Heater 1 kw

Sensor PT 100

Circulation Magnetically coupled pump capacity: 10 liters/min

Sampling Interval Range 1 min—23 hrs 59 min ± 0.01% 1 min

No. of Intervals 12

Volume Range 1-25 ml

Bath

Water Capacity 27 Liters

Material Perspex

Display 20x4 Character LCD

Printer Centronics Parallel Port

Power 110 V AC, 60 Hz or 220/230 V AC ± 10%, 50/60 Hz, 1.2 KVA [110

Weight Net 60 Kgs

Dimensions [ In] H Min 26 to H Max 39 | L28 | W20

Safety Features

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The DT8 is a versatile instrument capable of being used both offline as well as online via the use of a peristaltic pump and a manifold. The pump tubing is supplied with a high per-formance chemical resistant tubing for longer operational life. A manifold is used for better tubing manage-ment and precise positioning of sampling points for all the vessels. A scale is provided on the manifold to set the sampling height according with the media volume [500,900 or 1000 ml] for both paddles and baskets. The precision PTFE carrier tubes are used to avoid adsorption and are chemically resistant. An stainless steel line sintered filter prevents the coarse particles from being incorporated in the sample. The sample volumes are pro-grammable from 1 to 25 ml.

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The combination of intelligent hardware and state of the art software, provides the DT8 with an unprecedented lead within the realm of dissolution testers. The instrument has been engineered with advanced features to ensure that all industry needs have been ad-dressed. The menu driven software provides for a series of easy to follow prompts, in order to set up operational parameters as well as to prevent invalid entries.

Users can define up to 20 programmable pro-tocols that are retained within the unit’s non-volatile memory. This feature allows for the repeated use of frequently used entries. The instrument checks for hardware status when the power is initially switched on and displays any errors , if found. Upon starting, the test verifies that all parameters have reached their set values including, RPM, tem-perature and stirrer unit position.

The temperature controller and water circulat-ing pump, can be programmed to begin at a preset day and time. This is a time saving feature that saves time, energy and reduces the life of the water heater, by eliminating the practice of leaving the dissolution tester run-ning overnight.

The current status of the instrument is con-tinuously updated on the panel. Any deviation from the set parameters are also indicated via the audio/visual alarm.

The peristaltic pump samples the programmed volume from each vessel and deliv-ers it to a fraction collector. The programmed volume can then be replenished in each vessel if desired. The software is designed to empty the trapped volume in the tubes, thus preventing contamination of the samples.

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 spectropho-tometer. The microprocessor based peristaltic pump is designed to communicate directly with the spectrophotometer and collect the data for absorbance levels, which are then tabulated and printed.


System Diagnostics

Programmable Wake Up

Status Indicator On Line Sampling

Off Line Sampling

Documents

Pharma Alliance Group DT-8...• Complies with USP, IP, JP and EUR specifications • Online/automated sampling capable • Microcontroller based stepper motor for precise RPM •