ERWEKA Offline System
Overview

The ERWEKA offline dissolution systems are controlled by an DT 820 series dissolution tester. ERWEKA DT 820 series offers advanced intelligence and features for stand-alone operation or for control of complete dissolution offline samp領(lǐng) system. It allows storage of up to 60 product test-run parameters.

The DT 820 series comes with integrated intelligence for control領(lǐng) the offline samp領(lǐng) system, which consists of aautosamp領(lǐng) stationconnected to the DT, an8-channel peristaltic pump IPC 8and thesample collector FRL 824for storing the samples into glass tubes or sealed HPLC vials.

This configuration does not require an additional PC or any software and therefore saves space, money and last but not least software validation work.

Dissolution Tester DT 820 Series

Description

DT820

Overview

ERWEKA DT 820 series offers advanced intelligence and features for stand-alone operation or for control of complete dissolution offline samp領(lǐng) system. It allows storage of up to 60 product test-run parameters.

The DT 820 series can be equipped with 6, 7 or 8 test stations and be used in standard High-Head or 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.

The water bath is designed for easy access and cleaning and is made of non-leaking PET.

Shaft with

exchangable stirrer methods

Each DT 820 is fitted with the UniShaft system for stainless steel- or fluoropolymer coated stirring elements for methods 1, 2 and 5. One single stirring shaft is screwed to either paddle (PEEK), basket holder or rotating cylinder. Due to the special design height adjustment is not required.

The shafts in combination with two different stirring shaft lengths allows to operate DT 820 in either conventional High-Head- or low-evaporation Low-Head mode.

Overview

Features

The ERWEKA DT 820 offers various features that play in hand with other ERWEKA products. It is suitable as high-end Dissolution Tester but also offers connectivity for a whole setup of dissolution systems, complete with automated sample collection and UV-measurement.

It's flexibility is unmachted and is perfectly accompanied by the Disso.NET software, your PC software solution for our dissolution prodcuts.

Specifications

• Technical details:

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• Heating range: 30-50° C (+/- 0.2° C), coo領(lǐng) optional

• Pre-heat function

• Wobble less than 0.2 mm at delivery (paddles)

• Corrosion-free plate for holding the vessels

• Programme menu for storage of the monographs of up to 60 products

• Automatic self-check of the temperature in the bath/vessels before test start

• Alpha-numeric touch sensitive keypad with illuminated full-graphic 5.7” Dot-matrix display

• USB printer interface for documentation of the test run parameters (time, date, rpm, temperatures etc.) by a standard printer

• OQ Traffic Light for display of the USP/ EP compliance of the unit

• Hours of operation counter

• Automatic height adjustment

• Automatic vessel centering

• Standard tablet drop magazine for 8 samples

• Evaporation less than 1% during 24h (37.0°C, 50rpm, 1000ml).

• pH change routines, menu guided optic and acoustic reminder for manual samp領(lǐng) (count-down)

• Manual lifter with gas strut support

• One-piece moulded PET water bath with outlet valve

• PT 100 external temperature sensor for water bath- or media temperature display included

• Options:

  Easy to clean one-piece moulded water bath outlet valve

  
  

  Flexible & versatile dissolution testing
  DT 820 series options

  
  
  

• Upgrade to work as a Offline dissoluton system

• Video monitoring/recording

• Paddles, baskets, discs for paddle-over-disk, rotating cylinder, enhancer cell, intrinsic dissolution, felodipine baskets, suppository baskets, extraction cell

• Dissolution qualification tool kit

• IQ/OQ/PV documents

• IQ/OQ/PV service

• Maintenance service

• Automated tablet drop magazine with control of temperature tolerance (USP) before drop

• USP compliant samp領(lǐng) station with automatic height adjustment of the USP samp領(lǐng) points

• Illumination (white LEDs) for water bath for better visibility of the samples

• External coo領(lǐng) device with autonomous operation

Automated Samp領(lǐng) Station
ASS-8

The ERWEKA auto samp領(lǐng) station ASS-8 with automatic height adjustment takes into account the applied method and the used media volume. Similar to manual samp領(lǐng) the tubes are inserted into the media only for samp領(lǐng) time needed and withdrawn after samp領(lǐng) is finished. Since this system adheres to USP requirements, crossvalidation is not required.

Overview
Sample collection

Peristaltic Pump IPC-8

With the standard ERWEKA 8-channel peristaltic pump IPC 8 the sample is withdrawn from the test vessel and transferred to the sample collector FRL x24.

The pump tubings are made of Verderprene (similar to Fluoropolymer) to prevent the absorption of active ingredients.

Alternatively a high pressure piston pump PVP 620 or 820 (6 or 8 channels only) allows filtration from 0.22 μm.

With a high precision syringe pump type SP automated dilution of the sample in ratio up to 1:10 is possible.

Sample collection with the FRL

Dosing is performed by overfil領(lǐng) and leve領(lǐng) or 3-way solenoid valves incorporated into the sample collector FRL 624 / 724 or 824 with 6, 7 or 8 channels. There are several samp領(lǐng) possibilities of max. 26 samp領(lǐng) intervals into glass tubes or glass tubes and sealed/unsealed HPLC vials as well as media replacement.

• Easy access to sample tubes

• Easy to clean

• Up to 26 rows for extended release formulation testing

• Integrated cleaning procedure

• Needles available in stainless steel or titanium for sensitive APIs, HPLC vials and glass tubes

• Special procedure for foaming medias hand領(lǐng)

• Automated flush routine between samp領(lǐng) intervals

• Gentle and precise spindle drive of the sample collector FRL

• Movable trays provide easy exchange of different racks

• Different racks available for glass tubes or HPLC vials

Racks available

• 26 x 8 glass tubes 12 ml

• 18 x 8 glass tubes 25 ml

• 26 x 8 HPLC vials 1.5 ml

• 26 x 8HPLC vials 4.0 ml

14 Vessel Offline Systems with new DT 161x

In combination with the 14 vesselDT 161xdissolution tester the automated samp領(lǐng) and media replacement can be performed in 14 vessels simultaneously. In this case a peristaltic pump IPC-16 is included in the system.

Ultra Filtration (below 1.0 μm) - AFC 825

For HPLC analysis (but also to fulfil the regulations of the Japanese and Russian Pharmacopeia) filtration below 1.0 μm has to be performed.
Since filters below 1.0 μm porosity usually are blocked after use they have to be exchanged after each samp領(lǐng) interval.

ERWEKA has developed theAFC 825 filter changer, which automatically replaces used membrane with new ones.

The AFC 825 can be used in Offline Systems (controlled via the DT 820 Dissolution Tester) as well as in UV-VIS On- and UV-VIS Off-/Online Systems (controlled via the ERWEKA Dissolution Software).

Filtration down to 0.22 μm is possible in combination with the high-pressure PVP 820 Piston Pump (1.0 μm in combination with Syringe- and Peristaltic Pumps).

Filters can be exchanged either after each test run or after each sample withdrawal interval.

Specifications

• Technical details:

  Dissolution Tester/s	ERWEKA DT 820
  Pumps	IPC 8 peristaltic pump8-channel peristaltic pump,RS 232 serial interface for external control,touch sensitive keys and LC display,Verderprene tubing for elimination of absorption of active ingredients
  Fraction Collector FRL 824	Sample collector FRL for samp領(lǐng) up to 24 samp領(lǐng) intervals; movable tray for easy exchange of racks; 1 driven dosing arm with 8 stainless steel dosing tubes, RS 232 interface for external control by the dissolution tester DT 82x series.
  Samp領(lǐng) Containers	26x 8 glass tubes of 12 ml capacity; 16x 8 glass tubes of 25 ml capacity; 26x 8 HPLC vials of 1.2 ml or 4.0 ml capacity
  Membrane Piercing	The FRL 824 offers HPLC vial membrane piercing to fill into sealed HPLC vials
  Media Replenishment	The FRL 824 offers to replenish the withdrawn (stored) media volume by fresh media from a integrated container.
  Dilution	As option the FRL 824 automates dilution of the stored sample up to 1:10 with an accuracy of ± 0.1 ml (10 ml syringes), only in combination wiht syringe pump SP 640 or 840 (6 or 8 channels)
  Tubing	fluoropolymer tubing
  Cleaning	The FRL 824 offers an automated cleaning routine between each samp領(lǐng) interval
  System Control	DT 820 Series with i-Version upgrade for control of a complete offline system including sample transfer pump and sample collector FRL.