Dissolution Tester DT 1610 Series Dissolution Tester USP Apparatus 1, 2, 5 and 6

The ERWEKA DT 1610 series offers advanced intelligence and fea-tures for stand-alone operation or control of complete dissolution offline systems. It allows storage of up to 60 product test-run parameters. The DT 1610 series is based on the DT 820 series and can be equipped with 12, 13 or 14 test-stations arranged in two rows. It can be operated in High-Head and Low-Head mode.

It offers an OQ traffic light to show USP / EP compliance as well as an external temperature sensor for checking the water bath.

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The water bath is designed for easy access and cleaning. Due to io

the configuration the unit offers to test two different batches of the lut

same product or two different products with the same dissolution parameters at the same time.

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, 6, 5, 2

The DT 1610 Series Highlights:



■ Dissolution tester with 12,13 or 14 test stations



■ External, independent flow-through heater aratus 1p



■ Three different locking positions for High-Head, Low-



■ Pre-heating function, programmable for each weekday p

Head and cleaning position of test head



■ Calibration routine for temperature sensor and heater



■ Low-Head mode for quick and convenient closing of



■ Quick exchange of stirring methods using same P AS

the vessel

shafts

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■ High-Head mode for maximum access to each



■ pH change routines, menu guided vessel



■ Print out of test protocol



■ Optimized cover design for lowest evaporation



■ User management, password protected



■ Easy and fast lifting of the drive head by manual lifter



■ Optimized vessel access and easy cleaning with gas strut support

■ Independent external PT 100 temperature sensor



■ Easy programming via alpha-numeric touch-sensitive foil keypad



■ Integrated system suitability test with documentation print out of temperature and rotational speed



■ Automatic check of the temperature in the bath /

vessel before test start

Easy to clean acrylic water bath with outlet valve The DT 1610 Series comes with built-in intel igence for full system control





DT 1610 Series

Specifications

Options

Dissolution tester for USP methods 1 (Basket), 2 (Paddle),

+ Automatic tablet drop magazine with temperature 5 (Paddle over Disk) and 6 (Rotating Cylinder) with 12, 13

check (according USP) before drop or 14 test stations (DT 1612, DT 1613, DT 1614)

+ USP compliant sampling station ASS-14 with automatic height adjustment of the USP sampling points 100% USP / EP / JP compliant

+ Upgrade for control of offline sampling dissolution system (i-version)

Fulfil s all specifications in accordance with FDA “Mecha-

+ Offline components (pump, sample collector) nical Calibration”

+ Vessels 1000 ml, glass or amber glass (UV protected), 400 ml glass vessels

5.7“ display, alpha-numeric touch-sensitive foil keypad

+ Paddles, baskets, discs for paddle-over-disk, rotating Evaporation less than 1% (50 rpm / 1000 ml / 37° C / 24 h) cylinders, enhancer cell, intrinsic dissolution, felodip-ine baskets, suppository baskets, extraction cell, USP

Lifter column with gas strut support for effortless lifting

“japanese sinker“

and lowering of the drive head

+ Dissolution qualification tool kit for mechanical calibration according FDA

USB-A printer converter

+ IQ / OQ / PV documents, IQ / OQ / PV service

+ Maintenance service

Product memory for storage of up to 60 methods Rotational speed 20-220 rpm ± 4 %

External, independent high-power heater, heating range: 30 - 50 °C, even distribution of temperature Wobble less than 0.5 mm (paddles) Standard manual tablet drop magazine for max. 14

samples

OQ traffic light for display of USP / EP compliance of the unit

The DT 1610 series with optional automated sampling station Acoustic and optic reminder of manual sampling point controls a complete offline system (with IPC peristaltic pump and (29 intervals)

FRL sample collector) without the need for a PC.

RS 232 interface for PC connection Technical specifications of products described are stated without war-ERWEKA GmbH

Pittlerstr. 45

ranty and subject to change any time without futher notice.

sales@erweka.com

63225 Langen

v.1.1.4.19

+49 6103 92426-200

Germany