Dissolution Guide

Our broad range of dissolution testers





Our Dissolution Program USP 1-7

Media Preparation

MediPrep 820 series ..............................28

We offer the perfect companions to

ERWEKA offers dissolution testers for every single harmonized your dissolution tester for fast media

preparation and filling of vessels.

USP/EP/JP dissolution method – starting from USP 1 up to USP 7.

USP methods 1, 2, 5 and 6

USP methods ..........................................4

Test station positions ...............................6

USP methods 3 / 7

RRT 10 BioDis .......................................31

We offer a broad range of dissolution

Low-head, high-head &

testers - from manual testing with the

The RRT 10 BioDis for automatic disso-

cleaning position .....................................7

DT 126 / 128 Light up to the high-volu-

lution testing of different extended and DT 126 / 128 / 1212 Light .........................8

me tester DT 1610 Series.

sustained release dosage forms.

DT 720 Series ........................................10

DT 820 Series ........................................11

DT 1410 Series ......................................12

DT 1610 Series ......................................13

USP 4

USP 4 Flow-Through Cell DFZ ll ...........32

Cell design .............................................34

Dissolution Systems

USP method 4 is supported by our

Levels of Automation .............................14

Disso.NET USP 4 ..................................36

Flow-Through Cell DFZ ll, available as

Dissolution Offline System ....................16

stand-alone or as a system.

USP 4 stand-alone system ....................37

Our semi-automated dissolution

Dissolution Online System UV-Vis .........18

USP 4 open/closed offline system ........38

systems are available as Offline, Online Dissolution On-/offline System UV-Vis ...19

LMT 2 ....................................................39

and On-/Offline Systems for UV-Vis

Dissolution On-/Offline System HPLC ....20

and HPLC analytic.

Chewing Gum Tester DRT

DRT ........................................................30

Our dissolution tester for testing of in vitro release of substances into sur-Fully automated Dissolution

RoboDis II ..............................................22

world exclusive

rounding liquid medium.

System RoboDis II

The productivity booster for fully

automated, 24/7 non-stop dissolution

testing with up to 40 batches.

Disso.NET 2018 Software

Disso.NET 2018 .....................................26

Dissolution Options

General Options ....................................40

Vessels & Mini Vessels ..........................41

ERWEKA offers a broad range of op-

Our advanced dissolution software

Dissolution Accessories ........................42

tions for all of its dissolution testers and solution Disso.NET 2018 controls all

systems.

Consumables ........................................46

our dissolution systems.

Mechanical Calibration ..........................47

Sampling Manual ...................................48

Sampling Automated .............................49

Pumps

Pumps for dissolution systems .............21

Dissolution System Options ..................50

Every dissolution system needs a

pump – we offer several options suited

to different needs.

2

3

Dissolution Guide

Our Dissolution Program USP 1-7





USP methods overview

USP method 1 –

USP method 5 –

Basket

Application

Advantages

Paddle over Disk

Application

Advantages

■ Immediate / Extended and

■ Lots of experience (oldest

■ Transdermal patches

■ Standard equipment

delayed release forms

method, more than 200

■ Floating dosage forms

(USP 2 - paddle)

■ Tablets

monographs in USP)

■ Unguents

■ Capsules

■ No sinker necessary

■ Emulsions

■ Beads

■ pH change possible

■ Agitation method:

■ Floating dosage forms

Rotating Stirrer

■ Agitation method:

Rotating Stirrer

USP methode 6 –

Rotating Cylinder

Application

Advantages

USP method 2 –

■ Transdermal patches

■ Standard equipment can

Paddle

Application

Advantages

■ Agitation method:

be used

■ Tablets

■ Lots of experience

Rotating Stirrer

■ Variable volumes

■ Capsules

■ Easy to use and robust

■ Big patches useable

■ Beads

■ pH change possible

■ Immediate / extended and

delayed release forms

■ Agitation method:

Rotating Stirrer

USP method 7 –

Reciprocating Holder

Application

Advantages

■ Transdermal patches

■ Small volumes possible

USP method 3 –

■ Extended release dosage

■ Holder can be varied

forms

■ Easy pH change

Reciprocating Cylinder

Application

Advantages

■

■ pH profiles

Low solubility drugs

■ Easy pH change

■

■ Agitation method:

Tablets / Capsules

■ Hydrodynamic can be

■

Reciprocation

Implants

influenced by varying dip

■ Granulates & Powders

and rate

■ Suppositories

■ Stents

■ Cremes / Dialysis

Different holder types:

■ Agitation method:

■ Acrylic Rod:

Fluid Movement

Extended release tablets

■ Angled Disk:

Transdermal system

■ Fluoropolymer cylinder:

Transdermal system

USP method 4 –

■ Spring holder:

Flow-Through Cel

Application

Advantages

Extended release tablets

■ Low solubility drugs

■ Laminar flow possible

■ Reciprocating holder:

■ Tablets / Capsules

■ Easy media change

Transdermal system

■ Implants

■ pH profile possible

■ Granulates & Powders

■ 2 system setups:

■ Suppositories

■ open system (permanent

■ Stents

fresh media)

■ Cremes / Dialysis

■ closed system (long-term

■ Agitation method:

tests over many days)

Fluid Movement

4

5

Dissolution Guide

USP methods overview





Test station positions

Low-head, high-head und

cleaning position

ERWEKA’s dissolution testers offer two different operating modes which differ by the position of the head, and a third position for cleaning.

Shaft high-head for

PTFE paddle & basket

Shaft low-head for PTFE

paddle

Schematic view of ERWEKA

test stations

Shaft low-head for

paddle & basket

ERWEKA’s dissolution tester can be equipped with The dissolution testers of the DT 720 and 820 series Shaft high-head for

6 to 8 (12 to 14) test stations. Even though all of the always come with inlets for 8 vessels, which are paddle & basket

testers are offered with a different number of sta-covered with blinds, if a DT with 6 or 7 test sta-Low-head operating mode (LH)

tions, they differ from product line to product line.

tions is ordered.

The low-head mode is the standard mode and The dissolution tester DT 126 light comes with a usually comes in conjunction with a system confi-Dissolution testers with less then 8 stations can be fixed number of 6 test stations, its bigger sibling, guration with automated sampling station (ASS-8).

upgraded by ERWEKA service.

the DT 128 light comes with 8.

Benefits are the closed vessels and therefore low evaporation.

Vessel configuration example

High-head operating mode (HH)

Cleaning position

DT 726 or DT 826

The high-head mode is best used for manual tes-The cleaning position is the upmost position of ting and manual sampling. To reduce evaporation, the dissolution testers’ head. It makes cleaning vessels are covered with a cover. Manual sampling effortless and easy.

is easier in high-head mode. Longer shafts have to be selected on purchasing for high-head mode.

6

7

Dissolution Guide

Test station positions | Low-head, high-head und cleaning position





Manual dissolution testing, simple and compact DT light Series

DT 126 light

The ERWEKA DT light Series delivers the proven ERWEKA quality in a comprehensive package for Highlights

Specifications

a budget for simple dissolution testing with USP

■ 100 % USP/EP/JP compliant

■ High-head with 6 test stations

method 1, 2, 5 and 6. The DTs are equipped with 6,

■ Compact design saving lab space

■ Dimensions (width / depth / height): 8 or 12 test stations and a fixed drive head (high-head), allowing easy access to each 1000 ml vessel.

■ High-head mode for easy access to the vessels 510 mm / 450 mm / 660 mm

■ Universal shafts with attachments for Method 1,

■ Weight: 30 kg

2 (paddles included), 5 and 6 available The shafts can be replaced easily and the unique

■ Easy cleaning of the water bath and the water bath of moulded PET is equipped with the set-up area

time-proven ERWEKA water outlet for easy clea-



■ External flow through heater reduces influence of ning. The external flow through heater reduces external vibrations and ensures constant temperature the influence of external vibrations and ensures a

■ Simple control using symbol keypad with LED

constant temperature. Every accessory that comes display for temperature, RPM and runtime into contact with the dissolution sample is instal ed

■ Manual sampling using height adjustable holder for USP sampling points

in Germany. Therefore our DT light Series has the DT 128 light

ERWEKA made in Germany quality.

All these features make sure that the ERWEKA DT

Specifications

light Series is the perfect entry-level device for the

■ High-head with 8 test stations

world of dissolution testing.

■ Dimensions (width / depth / height): 642 mm / 482 mm / 680 mm

100%

■ Weight: 38 kg

USP/EP/JP

compliant

Manual

testing

DT 1212 light

NEW

LED display and symbol keypad for easy control Specifications

Low-evaporation vessel

covers are included

■ High-head with 12 test stations

■ Dimensions (width / depth / height): 932 mm / 444 mm / 656 mm

■ Weight: 60 kg

Art. No.

Dissolution Tester DT 126 / 128 Light

19996

DT 126 Light Dissolution Tester with 6 test stations 20412

DT 128 Light Dissolution Tester with 8 test stations 25025

DT 121 Light Dissolution Tester with 12 test stations 8

9

Dissolution Guide

DT light Series





Dissolution Tester

Dissolution Tester

DT 720 Series

DT 820 Series

ERWEKA DT 820 series offers advanced intelligence and features for Highlights stand-alone operation or for control of a complete dissolution offline The ERWEKA DT 720 series has been designed in accordance with 100%

sampling system. It allows storage of up to 60 product test methods.

100%

USP/EP/JP

USP/EP/JP

USP/EP/JP requirements for testing tablets and other dosage forms.

compliant

It combines state-of-the-art with excellent and user-friendly design.

The DT 820 series can be equipped with 6, 7 or 8 test stations and compliant

The high-head and low-head operating modes offer highest flexi-be used in high-head or low-head mode. It offers an OQ traffic light bility. The tester can be used as a stand-alone device as well as a USP

to show USP/EP/JP compliance, a low evaporation cover as well as Direct control of

methods 1,

dissolution system equipped with an automated sampling station, an external temperature sensor for checking the water bath.

offline system

2, 5 and 6

possible

operated via the ERWEKA Disso.NET 2018 software.

The water bath is designed for easy access and cleaning and is made The manual lifter column with gas-strut support allows effortless and Online System

of non-leaking PET. Centering rings ensure correct position of vessels USP

with UV-Vis or

rapid lifting and lowering of the drive head in just a few seconds.

and stability for withdrawal of samples. The standard configuration methods 1,

HPLC

Tablets, pellets and other dosage forms are inserted in the drive comprises a temperature sensor.

2, 5 and 6

head via the manual tablet drop magazine. Samples are withdrawn for analysis through special, membrane sealed sampling openings High-head

High-head

and low-

and low-

inside the drive head. The evaporation is less than one percent during head mode

head mode

24 hours (37° C, 50 rpm, 1000 ml).

The extensive use of carbon fibre eliminates metal usage and therefore reduces the risk of corrosion to a minimum. Test run parame-Art. No.

Dissolution Tester DT 820 Series

ters can be documented via the USB-A printer interface (optional).

18324

DT 826/1000 LH/HH Dissolution Tester with 6 test stations 18325

DT 827/1000 LH/HH Dissolution Tester with 7 test stations Art. No.

Dissolution Tester DT 720 Series

18326

DT 828/1000 LH/HH Dissolution Tester with 8 test stations 18316

DT 726/1000 LH/HH Dissolution Tester with 6 test stations 18317

DT 727/1000 LH/HH Dissolution Tester with 7 test stations 18318

DT 728/1000 LH/HH Dissolution Tester with 8 test stations 10

11

Dissolution Guide

DT 126 / 128 Light | DT 720 series | DT 820 Series





Dissolution Tester

Dissolution Tester

DT 1410 Series

DT 1610 Series

The ERWEKA DT 1610 series offers advanced intelligence and fea-Highlights

tures for stand-alone operation or for control of a complete dissolution offline sampling system. It allows storage of up to 60 product 100%

USP/EP/JP

test methods.

compliant

The DT 1610 series can be equipped with 12, 13 or 14 test stations arranged in 2 rows, which can be operated in high-head and low-USP

methods 1,

head mode.

2, 5 and 6

It offers an OQ traffic light to show USP/EP compliance as well as an external temperature sensor for checking the water bath tempe-Test 12/13/14 tablets or

rature. The water bath is designed for easy access and cleaning.

2 batches with 6 or 7

Art. No.

Dissolution Tester DT 1610 Series

Direct control of

high volume

18328

DT 1612 (LH/HH) 1000 ml Dissolution Tester with 12 test stations offline system

18329

DT 1613 (LH/HH) 1000 ml Dissolution Tester with 13 test stations 18330

DT 1614 (LH/HH) 1000 ml Dissolution Tester with 14 test stations Easy

cleaning

The DT 1410 series is based on the proven DT 720 series and can Highlights be configured for 12, 13 or 14 test stations arranged in two rows.

100%

USP/EP/JP

The DT 1410 provides the possibility of performing one test with 12, compliant

13 or 14 tablets or two tests with 6 resp. 7 tablets. The substantial advantage is that two USP tests can be carried out with one test bath at equal test conditions. Besides, the unit is offered with vari-USP

methods 1,

ous vessel sizes (400 ml, 1000 ml) and is available with high-head 2, 5 and 6

(maximum access) and low-head (low-evaporation version; for automation) mode.

Test 12/13/14 tablets or

The DT 1410 series is made for users with generic products or high 2 batches with 6 or 7

capacity in mind. Due to the configuration, the device allows to run DT 1614 with ASS-14

two different batches of the same product or two different products automated sampling

with the same dissolution monograph at the same time.

High volume Online

station

System with UV-Vis

or HPLC

Manual and

Art. No.

Dissolution Tester DT 1410 Series

semi-automated

18319

DT 1412 (LH/HH) 1000 ml Dissolution Tester with 12 test stations 18320

DT 1413 (LH/HH) 1000 ml Dissolution Tester with 13 test stations 18321

DT 1414 (LH/HH) 1000 ml Dissolution Tester with 14 test stations 12

13

Dissolution Guide

DT 1410 Series | DT 1610 Series

Levels of Automation

ERWEKA offers several products for different types automated testing. Our Dissolution On-/Offline For fully automated 24/7 testing and 100% reproof automation levels. The semi-automated Disso-System with UV-Vis or HPLC analysis automates ducibility of all tests, we offer the RoboDis II - a real lution Offline System for automation of three steps five steps of the dissolution process. In addition productivity booster with fully automated testing of the dissolution process or a semi-automated with a MediPrep 820 the media preparation can of up to 40 batches including setup, media prepa-Dissolution Online System are perfect entry-le-also be automated.

ration and cleaning automation.

vel systems into the world of 100% USP/EP/JP, Media preparation

Tablet drop, stirring of

Automated

Sample collection into

Analysis of samples

Setup

and filling

baskets or paddles

Sampling & Filtration

2nd Filtration

glass vials / HPLC vials

(UV-Vis or HPLC)

Cleaning process

1.

2.

3.

4.

5.

6.

7.





8.


Manual


MediPrep 820

Testing

Semi automated

MediPrep 820

optional

Sample collector

Dissolution Offline System

Semi automated

MediPrep 820

optional

UV-Vis

Dissolution Online System with UV-Vis

Semi automated

Semi automated

MediPrep 820

optional

UV-Vis

Sample collector

Dissolution On-/Offline System with UV-Vis Dissolution On-/Offline System with UV

Semi automated

Semi automated

MediPrep 820

optional

Sample collector

HPLC

Dissolution On-/Offline System with HPLC

Fully automated Dissolution System RoboDis II 14

15

Dissolution Guide

Levels of Automation





Semi-automated dissolution testing

Dissolution Offline System

DT 820 Series

The ERWEKA Dissolution Offline System is the ideal semi-automatic solution for dissolution testing with automated sampling and sub-ERWEKA dissolution testers of the DT 820 series are 100 % compliant to USP

sequent sample storage for later analysis. The system is controlled methods 1, 2, 5 and 6. By default the Offline System is equipped with a DT

820 in low-head mode and can be also optionally operated in high-head mode.

by a DT 820 series dissolution tester with advanced intelligence.

The DT 820 series equipped with i-Version comes with integrated intelligence for controlling the offline sampling system, which con-PVP 820 Series

sists of an auto sampling station ASS-8 connected to the DT, a pump (peristaltic or piston) and the sample collector of the FRL series for The practically maintenance-free piston pump transports the test medium storing the samples in glass tubes or sealed HPLC vials.

with high precision and pressure via eight channels to the compact sample collector of the FRL 854 series. IPC pump optionally available.

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

FRL 854 Series

Highlights

The sample collector FRL 6/7/854 offers a space-saving footprint and a pre-100%

cise dosing for up to 26 rows with 8 channels.

USP/EP/JP

USP methods

compliant

1, 2, 5 and 6

Direct control of

the complete

Sample collector

system by DT 820

FRL 6/7/854

NEW

Art. No.

Dissolution Offline System

25371

Standard Offline Dissolution System with PVP 654 and new FRL for DT 826

25373

Standard Offline Dissolution System with PVP 764 and new FRL for DT 827

25370

Standard Offline Dissolution System with PVP 864 and new FRL for DT 828

25376

Standard Offline Dissolution System with PVP 1220 and new FRL for DT 1612

25378

Standard Offline Dissolution System with PVP 1420 and new FRL for DT 1614

Big volume testing with DT 161x and FRL 854/2

16

17

Dissolution Guide

Dissolution Offline System





ERWEKA Systems

ERWEKA Systems

Dissolution Online System UV-Vis

Dissolution On-/Offline System UV-Vis

The ERWEKA Dissolution Online System is the perfect semi-automatic Highlights solution for dissolution testing with automated UV-Vis online analysis.

The ERWEKA Dissolution UV-Vis On-/Offline System is the ideal Highlights 100%

system configuration for spectrophotometers. With the connected USP/EP/JP

The DT 720 series with the integrated, automated ASS-8 sampling PC, the On-/Offline System can be conveniently controlled via our 100%

compliant

USP/EP/JP

station transports freshly sampled media directly to the UV-Vis ana-advanced Disso.NET software. Moreover, the software offers full compliant

lysis device (several brands available). There, the samples can be control over all components and storage of all test results.

measured and the results can then be stored within our advanced Controlled by

Disso.NET dissolution software, which controls the online system.

Disso.NET

After analysis has been completed, the samples are comfortably Controlled by

stored by our very own sample collector FRL 654/754/854 for later Disso.NET

Our Disso.NET software can control different UV-Vis spectrophoto-HPLC analysis or as reference standard.

meters like Shimadzu UV-1800, Analytik Jena Specord 210/8 and USP

methods 1,

210/16 or the Agilent Cary 8454. These photometers are fully integra-USP

2, 5 and 6

ted in our systems and the test results are displayed in our software.

Art. No.

Dissolution On-/Offline System UV-Vis

methods 1,

2, 5 and 6

25372

UV-Vis On-/Offline Dissolution System Agilent 8454 6 channel for DT 726

Integrated

Art. No.

Dissolution Online System UV-Vis

UV-Vis

25379

UV-Vis On-/Offline Dissolution System Analytik Jena Specord 210/16 for DT 1410

Advanced

analysis

UV-Vis

25306

UV-Vis Online System with Shimadzu 1900, IPC 8 for DT 72x + Disso.NET

analysis

18465

UV-Vis Online System AGILENT with IPC 8 for DT 72x + Disso.NET

18472

UV-Vis Online System with Analytik Jena Specord 210/16 for DT 141x LH

Sample collector

24242

UV-Vis Online System with Analytik Jena Specord 210/16 for DT 141x HH

and storage

Big volume testing with DT 141x and Analytik Jena Specord 210/16

Big volume testing with DT 141x and Analytik Jena Specord 210/16

18

19

Dissolution Guide

Dissolution Guide

Dissolution Offline System | Dissolution Online System UV-Vis Dissolution On-/Offline System UV-Vis





ERWEKA Systems

Overview

Dissolution On-/Offline System HPLC

Pumps for Dissolution Systems





Peristaltic pumps

ERWEKA piston pumps

Pump

IPC 8 / 16

PVP 620 / 720 / 820

PVP 1220 / 1420

The ERWEKA HPLC On-/Offline Dissolution System, 100 % compliant Highlights with all harmonized pharmacopoeias, is the perfect semi-automated Channels

8 or 16

6, 7 or 8

12 or 14

solution for HPLC online analytic and features a high degree of auto-100%

USP/EP/JP

mation and flexibility. It combines ERWEKA’s high quality dissolution Valves

-

-

-

compliant

tester (DT 720 series) with CTC sampling and online HPLC chromatography. The system is controlled by the fully validated ERWEKA Accuracy

+/− 0.5 ml

+/− 0.5 ml

+/− 0.5 ml

Disso.NET software and offers a high efficient sample management.

Controlled by



Disso.NET

Dilution

-

-

-

In addition, the HPLC On-/Offline Dissolution System uses an innovative flow-through system of sealed PEEK-vials. For pumping the test Media replacement

Standard

Standard

Standard

media from the dissolution tester to the CTC sampler two solutions USP

methods 1,

Only when first filtration with

can be implemented: a peristaltic pump or an ERWEKA piston pump.

2, 5 and 6

Double filtration

poroplast filters. No media

No media replacement possible

No media replacement possible

In case of filtration from 1 µm porosity, test samples can be withdrawn (optional)

replacement possible when

when double filtration

when double filtration

from the vessels through poroplast filters using a peristaltic pump.

double filtration.

If a filtration from 0.45 µm porosity is required, the membrane filter CTC sample collector

changer AFC 825 or a double filtration station in combination with and storage for HPLC

Required type of

sample collector

FRL 624 / 724 / 824

FRL 624 / 724 / 824

FRL 624 / 724 / 824

a high-precision ERWEKA piston pump PVP can be used instead.

Connecting the system to the Disso.NET software provides not only DT Offline / DT Online

DT Offline / DT Online

easy und precise system operation, but also significantly facilitates Online HPLC

System compatibility

DT Offline / DT Online

DT On-/Offline

DT On-/Offline

DT On-/Offline

the test process through the automatic recording of sampling times, chromatography

temperature and rotation speed in each vessel (= documentation of Filtration down to 0.22 μm for flat

Filtration down to 0.22 μm for

all system actions).

Basic pump

membrane filters, low maintenance

Advantage

flat membrane filters,

possible with DT 14x/16x,

even at high throughput,

Best choice for fully automated

needs regular replacement of tubing

Best choice for

dissolution systems

Advanced intelligence with excellent, user-friendly design as well as dissolution systems

dissolution testing with highest efficiency are hence offered by the ERWEKA HPLC On-/Offline Dissolution System.

Art. No.

Dissolution On-/Offline System HPLC

24425

HPLC On-/Offline Dissolution System with PVP 620 piston pump with CTC II 20

21

Dissolution Guide

Dissolution Guide

Dissolution On-/Offline System UV-Vis | Dissolution On-/Offline System HPLC

Disso.NET | Pumps for Dissolution Systems



Fully automated: RoboDis II

The flexible specialist

The Produtivity Booster

for R&D

for Quality Control

Many types of dosage forms

Planned productivity with 10, 20 or 40 batches The RoboDis II can handle several types of dosage forms. No matter what Productivity can be easily scheduled with the RoboDis II. For example, the you use - tablets, granulates or powders - RoboDis II is the ideal, flexible and system can autonomously handle up to 40 batches during the weekend fully automated dissolution system for all your usage needs. It even handles and then present all the results to the laboratory employee on the following Japanese Sinkers with a size of up to 34 mm with ease!

workday for evaluation. With video recording and time-lapse function, a visual inspection of the completed test process is possible afterwards.

Versatile filtration

High volume – 40 batches

Filtration with the RoboDis II has no boundaries - inline poroplast filters, membrane filters down to 22 µm and even double filtration are supported.

Testing, testing, testing - that is what the RoboDis II does best. The 40

batch option allows volumes that are usually only matched by a multitude of semi-automated systems, demanding a lot more laboratory space and staff then ERWEKA‘s RoboDis II.

pH half change and pH full change

(USP methods A & B)

Parallel approach

The fully automated ph change (both half and full possible) is supported by the RoboDis II. Just configure your method using the powerful Disso.NET soft-The RoboDis II is following a parallel test approach: Tablet drops, sampling ware and run your test – the RoboDis II will automatically take care of the rest.

and emptying of the vessels are all done in parallel.

Broad range of analytics available

Robotic precision & integrated error control RoboDis II supports a broad range of analytical devices. UV-Vis spectropho-Every dissolution step is fully automated and is completely tracked by the tography, chromatography using HPLC or even a combination of both – the system itself. This means, that all tasks performed by the RoboDis II during RoboDis II handles and controls all of them.

a test are identically repeated in the next test, thus removing the human error factor completely. The system offers highest reliability and allows the laboratory employees to concentrate on the analysis of the provided data.

6 reference standards

Mandatory in R&D: Flexible reference standards for quick testing of several for-Space-saving footprint

mulations. Thanks to an integrated standard changer system, the RoboDis II handles them with ease.

To match the RoboDis IIs productivity with semi-automated systems, at least three units and operators are needed to perform 10 batches per day.

Do the math!

22

23

Dissolution Guide

Fully automated: RoboDis II





The Productivity Booster

RoboDis II

The fully automated dissolution system is already Highlights used in quality control and R&D by several multina-tional companies and has brought a huge increase 100%

USP/EP/JP

Controlled by

in productivity. It fully automatically handles 10, 20

compliant

Disso.NET

or 40 batches of dissolution testing USP method Simultaneous tablet insertion allows

pH change in accordance with USP

1 basket or method 2 paddle in a parallel appro-high accuracy of processes.

method A (Half Change) is possible.

ach, therefore enables very short sampling points USP

System

methods 1

Suitability

of 5 minutes, depending on product and method.

and 2

Tests (SST)

As all ERWEKA products, the RoboDis II works 100% conform to all harmonized pharmacopoeias in every aspect.

10, 20 or 40

batches in

Video

one test run

monitoring

All steps of the dissolution process - media preparation, filling, setup of dissolution tester, testing, automated sampling, online analytics (UV-Vis or Online UV-Vis

or HPLC

HPLC) and the whole cleaning process are per-analysis

formed without the need of user intervention.

The whole system is controlled by the ERWEKA Disso.NET software, from the robot arm to media Different tools for different applications pH half change

preparation and analytic devices.

are available.

or full change

Supported by several integrated System Suitability Tests and light sensor checks, this system runs Vacuum

absolutely precise and reliable, minimizing human degassing

error. It is human error proofed so to say.

Automatic cleaning and result checks of the cleaning process (SST).

10, 20 or 40 Batch sample magazine

Continuous verification of processes

24/7 testing with LED light bar and six for continuous testing 24/7.

with controlling sensors.

ethernet cameras.

24

25

Dissolution Guide

RoboDis II





Easy documentation with industry proven features The new

The documentation features of the Disso.NET 2018 are vast: Easily gen-Disso.NET 2018 dissolution software

erate reports about products, tests, audit trail, measurement conditions, UV-Vis and HPLC workflows and export data as PDF, XML and Excel format.

The ERWEKA Disso.NET 2018 is the perfect 21 CFR Part 11 compliant companion to all our Dissolution Systems, ranging from Dissolution Offline over Online to On-/Offline Systems up to the fully automated RoboDis II system and the USP 4 Flow-through-cell Systems.*

The software helps you with standard dissolution jobs, easily handles qualification tasks and provides control over each single function and connected devices (e.g. dissolution tester with UV-Vis spectrophotometer). After finishing those tests, Disso.NET creates extensive reports with corporate logos for PDF-file export or exports your results in XLS or XML.

Our extensive Audit Trail according to latest 21 CFR part 11

thoroughly documents all changes done to the system (what, who, when and why) and can be easily searched and filtered by the Audit Trail Viewer.

Supports Dissolution Systems, RoboDis II and USP 4

The Disso.NET 2018 supports all ERWEKA Dissolution Systems, the fully automated RoboDis II and even our USP 4 Flow-Through-Cell systems.*

Full Audit Trail according to 21 CFR Part 11

NEW!

The new Audit Trail feature is implemented throughout the whole software, tracking each and every change (What, Who, When and Why). If data is changed by the user (e.g. when editing methods), the software requires a reason entered by the user. In combination with our easily search- and filterable audit trail viewer, changes to the system and its data can be easily traced back to its origin and originator. With Disso.NET

2018, it is not possible to delete data from the system Art. No.

Disso.NET

25349

Disso.NET 2018 dissolution software full version (Q4 2018) 25343

Upgrade license Disso.NET from Version 2.x to Disso.NET 2018

Full Audit Trail

Support for

according to

USP methods

25344

Upgrade license Disso.NET from Version 3.x to Disso.NET 2018

Automated prompt for reason of change

21 CFR Part 11

1, 2, 4, 5 and 6

25111

IQ/OQ documents for Disso.NET 2018 Dissolution Software 25350

Software module for Disso.NET 2018 UV-Vis Photometer Qualification (Q1 2019) MS SQL

User

Database

Management

*Disso.NET 2018 with USP 4 support available Q2/2019

26

27

Dissolution Guide

Disso.NET 2018 dissolution software



Advanced media preparation

in less than 15 minutes

MediPrep 820 Series

The ideal companion for our dissolution systems Highlights

The MediPrep 820 series offers quick and easy pre-100%

USP/EP/JP

paration of up to 8 liters dissolution media in less compliant

than 15 minutes. In a single pass, the media for dissolution tests can be precisely mixed, heated, degassed and gravimetrically filled into vessels.

8 liters media

for dissolution

Foaming media like SDS (Sodium Dodecyl Sulfate) testing

can also be used.

Gravimetrically controlled filling can be done at the Automatic

integrated dosing port or with the optional remote cleaning

filling hand directly into the vessels.

The MediPrep 820 provides one inlet for premixed Automatic

media and one outlet for waste water. In compari-degassing

son, MediPrep 821 and 822 offer additional inlets for media concentrates or premixed media. To prevent cross contamination, an automated cleaning Gravimetrically

procedure is integrated.

controlled filling

Art. No.

MediPrep 820

Foaming media

possible

18605

MediPrep 820

MediPrep 821 with one additional inlet for 18606

concentrates/premixed media

Printer

MediPrep 822 with two additional inlets for 18607

support

concentrates/premixed media

28

29

Dissolution Guide

MediPrep 820 Series





Chewing Gum Tester

Multiple media pH change dissolution

DRT

testing for USP 3 and 7

Highlights

RRT 10 BioDis

100%

Movement by

USP/EP/JP

pneumatic

With the ERWEKA RRT 10, automatic dissolution testing of different Highlights compliant

cylinder

extended and sustained release dosage forms has become easier than ever before. This unit is perfectly suited for simulating the pH

100%

USP/EP/JP

Up to 6 test

changes within the human body. By placing different media in each Mobile cart

compliant

stations

row, the device reflects varying in vivo gastrointestinal conditions of the body. An automatic sample transport between the rows allows world exclusive

the reliable testing of the extended or sustained release from different 3 configurations

Temperature

Easy

dosage forms in various pH zones. The simple to program RRT 10

available

controlled

cleaning

is the perfect unit for multiple media pH changes for IV/IVC testing water bath

and dissolution profiling of a variety of release dosage forms (e.g.

tablets, coated tablets and oblongs).

Automated

evaporation

cover

Vessels are placed inside an acrylic water bath with an outlet valve for easy cleaning and the automatic cover system of the RRT 10

reduces media evaporation.

Different tools

available

Testing for in vitro release of substances from samples into surrounding liquid medium



The ERWEKA DRT is the perfect device for testing The test cell, the upper and lower jaw can then be USP 3

USP 7

USP 3 & USP 7

of in vitro releases of substances from chewing easily removed. A water circulation system controls gums and other dosage forms, that have to be and regulates the water temperature in the test cell masticated, into the surrounding liquid medium. around the media.

The vertical up and down strokes of the lower jaw Height of stroke

100 mm

20 mm

100 mm & 20 mm

(changable)

in combination with a revolving movement of the The chewing gum test apparatus is used to masti-upper jaw provide ideal mastication of the che-cate gums and then analyzes the speed at which wing gum and at the same time an agitation of the various substances leave the gum (release). In Vessel types

300 ml & 1000 ml

50 m, 100 ml, 300 ml & 1000 ml

50 ml, 100 ml, 300 ml & 1000 ml for reciprocating cylinder

for different types of tools

for different types of tools

test medium.

addition, the device is very helpful for developing candy chewing gums, but it can also be used for For manual sampling, emptying and cleaning the unusual purposes such as testing of snuff bags.

User changeable method

lower jaw with the test cell can be lowered into a down position, so that the chewing process stops.

Art. No.

RRT 10 BioDis

Art. No.

Chewing Gum Tester DRT

BioDis dissolution tester RRT 10 USP method 3

18532

18620

DRT 1 Chewing Gum Tester (1 test station), incl. manual with 8 rows

BioDis dissolution tester RRT 10 USP method 7

18621

DRT 2 Chewing Gum Tester (2 test stations), incl. manual 18533

with 8 rows

18622

DRT 3 chewing Gum Tester (3 test stations), incl. manual BioDis dissolution tester RRT 10 USP method 3 & 7

18534

18623

DRT 4 Chewing Gum Tester (4 test stations), incl. manual user changeable, 8 rows

18624

DRT 5 Chewing Gum Tester (5 test stations), incl. manual 18625

DRT 6 Chewing Gum Tester (6 test stations), incl. manual 30

31

Dissolution Guide

DRT | RRT 10 BioDis





The highlights of the new

USP 4 Flow-Through Cell DFZ II

Compact & corrosion-resistant housing The new ERWEKA flow-through cell tester DFZ II mentation of dissolution tests. The new leaner cell can be used for various applications thanks to its bodies ensure an improved cell warming and can The smaller footprint with clear arrangement of cells in one line saves laboratory wide range of available cell types, e.g. for testing be heated individually. All USP 4 DFZ II systems space and offers a perfect visual control of the cells at all times. In addition, poorly soluble products or low-dose formulations can be easily controlled with the Disso.NET USP 4

the tube organizer on the back of the device prevents mixing up the cel tubes.

with sustained release.

dissolution software via a controller.

Innovations as the new cell design with increased leak-tightness and the optimized tubing system with quick locks allow a fast preparation and imple-Standardized cell head

The new cell head fits all offered cell bodies and thus enables a faster assembly of cells while offering lower purchasing costs. Through a quick lock in the cell head faster tube mounting is also possible.

Increased leak-tightness

Due to reducing the number of seals to 3 pieces per cell and using flat seals with an increased sealing surface, the process safety can be heightened.

Optimized cell bodies and

individual cell heating

The reduction of the cell body provides a better heating and faster preparation of cells. Each cell can be heated individually via a rotary switch.

Easier cleaning

Due to the 3-way-valve for water emptying on the back of the device, the Highlights

water bath cleaning can be handled much easier. In addition, simple water temperature and water level control are possible with the water level pointer (colour coding) and the two openings for PT 100 sensors on the device cover.

100%

USP/EP/JP

Independent, closed

compliant

flow-through system

Variety of

Controlled by

different cells

Disso.NET USP 4

available

32

33

Dissolution Guide

USP 4 Flow-Through Cell DFZ II





Quick lock system on

New improved

universal cell head

Cell design

Different cells

for different purposes

Accompanying our flow-through systems, we offer a variety of different cells with a new improved design for different purposes - from the standard tablet cell to granulate & powder cells to cells for implants, suppositories and stents.

The new standardized cell head fits all offered cell bodies and facilitates along with the new standardized flat seals (only 3 pieces per cell: connection, head and body) handling and assembly of the cells. The optimized cell bodies with decreased cell wall thickness Support disc

guarantee an improved cell heating.

Filter

Thanks to this new cell concept, the cells can be mounted easier to the new flow-through tester DFZ II and thus enable a faster prepa-Metal sieve

Tablet cell 12 mm

Tablet cell 22.6 mm

Granulate &

Implant cell

Suppository cell

ration and performance of dissolution tests.

Powder cell

Filter holder

Seal

Cell

Tablet holder

New quick lock system on the cell head

Special temperature calibration head.

Stents cell

Tablet cell 22.6 mm

Tablet cell 22.6 mm

Tablet cell 22.6 mm

Tablet cell 22.6 mm

allows instant tube removing.

with one-way

with cream adapter

with glass beads &

with glass beads &

Seal

dialysis adapter

tablet holder

without tablet holder

Highlights

Variety of

different cells

available

Standardized

Tool for removing the

cell head

filter holder

Cell body

34

35

Dissolution Guide

Cell design DFZ II





Easy entry into USP 4 dissolution testing USP 4 Dissolution Testen with automated analytic USP 4 Stand-Alone System

USP 4 Closed Online System

The USP 4 Closed Online System is our solution Highlights

with automated analytic for the USP 4 flow-through cell. The software controlled USP 4 system integ-100%

rates USP 4 flow-through cell testing with directly USP/EP/JP

connected analytic UV/Vis online measurement, conform

resulting in an automated USP 4 workflow.

Flow-through cell

The ERWEKA stand-alone flow-through cell sys-Highlights

Furthermore, all features of the stand-alone sys-with 7 test

7x

tem is perfect for performing simple release tests tem can be applied to our online system: the val-stations

with manual sampling. Therefore, the new flow-100%

ve-free piston pump with highest precision and the USP/EP/JP

through cell tester DFZ II offers with the ERWEKA low-vibration heater steadily holds the requested Software

compliant

controlled by

piston pump HKP 720 and the ERWEKA heater DH

temperature of the waterbath. And our new and Disso.NET

2000i an easy entry into testing with USP 4 systems improved DFZ II USP 4 cells are also integrated for a small budget.

Flow-through cell

into the software dialogs, making the use of the with 7 test



system as easy as possible.

Integrated

7x

stations

UV-Vis

The valve-free piston pump transports the test analytic

medium with highest precision via seven channels to the flow-through cells and automatically adopts Art. Nr.

USP 4 Stand-Alone System

Simple release testing

the setting of the flow rate. With the low-vibration with manual sampling

UV-Vis Online System DFZ II, HKP720, IPC 8, 25354

heater the water in the water bath can be quickly Shimadzu 1900, Controller+Disso.NET

Audit Trail

heated to the required temperature.

UV-Vis Online System,HKP720,DFZ II -Temp.,IPC8,S-25355

himadzu1900,Controller,Disso.NET

Art. No.

USP 4 Stand-Alone System

23437

DFZ II Stand-Alone Flow-through-cell with HKP 720

DFZ II Stand-Alone Flow-through-cell with 23439

HKP + temperature sensor

23440

DFZ II Stand-Alone Flow-through-cell with IPC-8

36

37

Dissolution Guide

Dissolution Guide

Disso.NET USP 4 | USP 4 Stand-Alone System USP 4 Closed Online System





USP 4 Open Offline System

Easy media transfer with the

LMT 2

With the compact ERWEKA media transfer station LMT 2 a closed Highlights loop for performing long-term dissolution tests according to USP

4 can be easily created. The LMT 2 is therefore used as a medium 100%

USP/EP/JP

reservoir and ensures an optimal media mixing and distribution compliant

through the whole release test.

Art. No.

USP 4 DFZ ll Open Offline System

Features of the automated USP 4 Open

The optimized tubing system with a new tube holder and rotatable Open Offline System, DFZ II with HKP 720, FRL 724, Wide range of

Offline System

23441

bottle caps (safety caps) makes handling easier and saves valuable Controller, Disso.NET USP 4

vessel sizes

laboratory space. Using standardized laboratory glass bottles as Open Offline System,DFZ II, temp.sensor, HKP 720,

■ Handling of unlimited media for testing of low 23442

media vessels also enables an easier media transport for saving and soluble drug substances

FRL 724, Controller, Disso.NET

further analysis. The glass bottles are available in 500 ml as standard

■ Fully USP compliant

Open Offline System, DFZ II, IPC-8, FRL 724, Improved

23443

size and optionally in the sizes 100 ml, 250 ml and 1000 ml. With the tubing

■ Automated sample collection

Controller, Disso.NET

comfortable keypad the stirring speed can be easily set.

■ Sampling of complete fractions into glass vials 18590

Manual switching valve for pH change USP 4

■ Sampling of representative fractions by splitting Electronic switching valves 4x for pH change into waste and glas vials

18591

Optimal media

for up to 4 media

distribution

Full dissolution software solution for Flow-Through Cel USP 4 Closed Offline System

Disso.NET 2018 USP 4*

The ERWEKA Disso.NET USP 4 Software is the Highlights perfect companion for our USP 4 systems. The software takes over full control of our USP 4 systems and offers support for all USP/EP dissolu-Audit Trail

tion cells used in these systems. It also supports cells for special applications (e.g. cell with cream adapter) and visual guides for formulation placing Easy control of the

Art. No.

USP 4 DFZ ll Closed Offline System

in the respective cells.

USP 4 systems

Features of the USP 4 Closed Offline

with Disso.NET

Closed Offline System DFZ II, HKP 720, IPC-8, FRL

23446

System

Disso.NET helps you with standard USP 4 disso-724, Controller, Disso.NET

lution jobs, handles qualifying tasks and provides Closed Offline System DFZ II, temp.sensor, HKP 720, MS SQL

23447

control over each single function of the connected IPC-8, FRL 724, Controller,

■ Specific amount of min. 2 ml to max. 32 ml of Database

media is pumped through the cell continually devices (e.g. pump, flow-through cell and sample LMT 2 Closed Loop unit for USP 4

17923

■ Media transfer station LMT 2 with 8x 1000 ml collector). In addition, the software includes an easy incl. 500 ml bottles (7 pcs)

vessels

to handle method editor for comfortable program-100 ml glass bottle (7 pcs.) for LMT 2

19897

■ Fully USP compliant

Advanced report

(safety cap not included)

ming of dissolution methods (for highest safety in

■

generation

Fraction collection with 3-way valves

GMP environment). Our audit trail also generates 19898

250 ml glass bottle (7 pcs.) with safety cap for LMT 2

■ Long duration test runs with optimized media detailed protocols of all events and times and thus 20376

1000 ml glass bottle (7 pcs.) for LMT 2

evaporation

enables tracing changes at any time.

■ Media replacement possible

18602

Filter for USP 4, 0.7µm, 25 pcs, 25 mm

*available Q1/2020

18603

Filter for USP 4, 1.4µm, 25 pcs, 25 mm

38

39

Dissolution Guide

USP 4 Open Offline System | USP 4 Closed Of USP 4 Open Of

fline System | LMT 2

fline System | USP 4 Closed Of





Dissolution Tester

Vessels and

General Options

Mini Vessels

Art. No.

General Options

Art. No.

Vessels

18331

2000 ml version, additional price for DT 62x/72x/82x 18365

Vessel for DT, glass, 1000 ml, numbered 18332

Print LAN converter for the data transfer to network printers 18366

Vessel for DT, UV-resistant amber glass, 1000 ml, numbered 18333

External cooling device for DT with autonomous operation 18367

Vessel for DT, glass, 2000 ml, numbered 18334

Evaporation cover for DT HH manual sampling 18368

Vessel for DT, UV-resistant amber glass, 2000 ml, numbered 21795

Evaporation cover with anti-rotation device for DT HH with ASS- 8 /14

19115

Vessel with peak for DT, glass, 1000 ml 18335

Illumination of the DT water bath

18370

Rack for 8 vessels

Glass vessel and UV-resistant vessel

18336

Automated tablet drop magazine for DT 72x/82x Water stabilizer 100 ml, blue

18371

Rack for 8 paddles, baskets

18337

Automated tablet drop magazine for DT 141x/161x 18372

Rack for 16 paddles, baskets

18338

Video system USB 3.0 with 6 cameras for dissolution test monitoring 18339

Spare part kit for DT 6/7/82x

22342

Water stabiliser with colour indicator for DT, 100 ml blue Art. No.

Mini vessels

18373

Mini vessel for DT, glass, 400 ml, numbered 18374

Mini vessel for DT, UV-resistant amber glass, 400 ml 60 ml, 100 ml and 400 ml Vessel

18375

Conversion kit for 400 ml Mini vessel (excluding vessel) The 400 ml Mini vessel apparatus is a

18378

Automated sampling station (LH) for Mini vessel 400 ml, for DT-72x/82x reduced scale of the USP method 2,

19978

Automated sampling station (HH) for Mini vessel 400 ml, for DT-72x/82x commonly used for low-dose formulations and poorly available drugs.

20482

100 ml Mini vessel, Mini paddle Fluoropolymer, incl. conversion kit HH DT vessel Evaporation cover for DT HH

Evaporation cover with anti-rotation device 20575

60 ml Mini vessel, Mini paddle Fluoropolymer, incl. conversion kit HH DT

for DT HH with ASS-8/14 sampling station 21598

60 ml Mini vessel amber glass, Mini paddle and Adaption for HH Dissolution Tester 22399

Conversion kit 1000 ml to 400 ml including Mini vessel and Mini paddle LH

Art. No.

CoC (Certificate of Compliance)

22398

Conversion set 1000 ml to 400 ml including Mini vessel and Mini paddle HH

18395

CoC for basket, per basket

20267

CoC for basket holders for LH / HH, per holder 18414

CoC for paddle over Disk, per Disk

60 ml Mini vessel, Mini paddle

20268

CoC paddle, per paddle

PTFE coated, incl. conversion

kit HH DT Vessel

20269

CoC for shaft LH / HH, per shaft

22444

CoC for bundle, paddle, basket holder

18369

CoC for vessels, per vessel

20272

CoC for mini vessel, per vessel

22449

CoC for rotating cylinder, per rotating cylinder 40

41

Dissolution Guide

General Options | Vessels and Mini Vessles





Dissolution Accessories

Art. No.

DT Shafts for USP Methods 1, 2, 5, 6

Art. No.

Paddles USP 2

22391

Shaft unit LH for basket or paddle (st. steel) or Bundle (st. steel), incl. carrier, numbered 22403

Paddle, stainless steel, numbered

22436

Shaft unit LH for paddle (PTFE coated), numbered 22404

Paddle (PTFE coated) for 1000 ml, numbered 22438

Shaft set (2) LH for bundle basket holder + PTFE coated paddle, numbered 22405

Paddle (PTFE coated) for 2000 ml, numbered 22394

Shaft unit HH for basket or paddle (st. steel) or Bundle (st. steel), incl. carrier, numbered 22406

Bundle, paddle and basketholder, stainless steel, numbered 22437

Shaft unit HH for paddle (PTFE coated), numbered 22407

Bundle, paddle (PTFE coated), and basket holder, stainless steel, numbered Paddle, stainless steel, numbered

22439

Shaft set (2) HH for Bundle basket holder + PTFE coated paddle, numbered Shaft high-head for

PTFE paddle & basket

Bundle, paddle (PTFE coated) &

Shaft low-head for

basket holder, stainless steel

PTFE paddle

Shaft high-head for paddle & basket Shaft low-head for

paddle & basket

Art. No.

Paddle over Disk USP 5

18412

Paddle over Disk spacer to use standard paddle and shaft 18413

Paddle over Disk USP 5, for holding transdermal patch, mesh 125 µm, numbered NEW: Basket holder, stainless steel,

2 O-rings, numbered

21443

Paddle over Disk, high and low head USP 5, 2 9/16 inch, numbered 21444

Paddle over Disk, high and low head USP 5, 3.5 inch, numbered Art. No.

Baskets USP 1

22402

Basket holder, stainless steel, numbered 18391

Basket, mesh 10, stainless steel, numbered Paddle over Disk USP 5, for holding

18392

Basket, mesh 20, stainless steel, numbered transdermal patch, mesh 125 µm, numbered 18393

Basket, mesh 40, stainless steel, numbered 18394

Suppository basket, plastic

Baskets mesh 10, 20 and 40 (standard)

42

43

Dissolution Guide

Dissolution Accessories





Art. No.

Rotating Cylinders USP 6

Art. No.

Sinkers

22408

Rotating cylinder, stainless steel, short, numbered Japanese sinkers, set of 6 pcs, stainless steel, 18379

Spider sinkers, plastic,

USP compliant

22409

Rotating cylinder, stainless steel, long, numbered set of 6

18380

Spider sinkers, plastic, set of 6 pcs

Rotating Cylinder

Japanese sinkers,

set of 6

Art. No.

Extraction Cell

Extraction Cell

18421

Extraction cell, ID=20/27 mm, acc. to EP 2.9.4

22252

Extraction cell, ID=32/38 mm, acc. to EP 2.9.4

22253

Extraction cell, ID=40/45 mm, acc. to EP 2.9.4

22254

Extraction cell, ID=50/52 mm, acc. to EP 2.9.4

Art. No.

Enhancer Cell

Enhancer cell set, incl. 200 ml vessel round bottom 22400

and mini paddle HH

Enhancer Cell

Enhancer cell set incl. 200 ml flat bottomed glass, 22401

mini paddle, HH shaft

Vessel for Enhancer cell, 200 ml, glass, Wood Apparatus

18382

rounded bottom

for 1 test station

Enhancer cell (fluoropolymer) for testing creams, Art. No.

Felodipine basket

18384

ointments, gels

18422

Felodipine stationary basket for low-head use 21612

Vessel for Enhancer cell, 200 ml, glass, flat bottom V-shaped low head vessel cover (plastics) for fixing 18423

Felodipine basket

V-shaped vessel cover (PTFE coated) for fixing 18424

Felodipine basket

18425

Felodipine stationary basket for high-head use Low-evaporation high-head vessel cover (plastics) for 18426

fixing Felodipine basket

22411

ERWEKA Wood Apparatus (intrinsic) for 1 test station Art. No.

Funnel for granulates

18429

Manual hydraulic press for Wood Apparatus Plastic funnel with extension for pouring 18381

granulates / powder

Plastic funnel

Felodipine stationary

basket

44

45

Dissolution Guide

Dissolution Accessories





Consumables

Art. No.

Inline Filters

18430

Filters (1.000 pcs), Poroplast, 1 µm

18431

Filters (1.000 pcs), Poroplast, 4 µm

18432

Filters (1.000 pcs), Poroplast, 10 µm

21702

Filters (10.000 pcs), Poroplast, 10 µm

18433

Filters (1.000 pcs), Poroplast, 20 µm

18434

Filter, stainless steel, 20 µm

18435

Filter, stainless steel, 50 µm

Different types of filters

18436

Filter, stainless steel, 100 µm

Art. No.

Membrane Filters

22954

Filter (200 pcs) Pall Acrodisc nylon 0,45 µm, 25 mm, Autopack for AFC

22955

Filter (200 pcs) Pall Acrodisc glasfibre 1 µm, 25 mm, Autopack for AFC

22956

Filter (200 pcs) Pall Acrodisc nylon 0,2 µm, 25 mm, Autopack for AFC

18500

1 pack of filters (200 pcs), membrane 0.45 µm ROBY

18501

1 pack of filters (200 pcs), membrane 0.7 µm ROBY

18502

1 pack of filters (200 pcs), membrane 1 µm ROBY

Mechanical Calibraion

Art. No.

Tools Mechanical Calibration

Art. No.

PVT Reference Tablets

18437

Dissolution tester qualification kit

18441

Prednisone tablets, 1 pack (30 pcs)

18438

Dissolution tester validation kit according to FDA, certified 18442

Prednisone, 250 mg

18439

Qualification kit (upgrade) according to Mechanical Calibration standards of FDA 18440

Validation tool for height adjustment, certified Art. No.

QA Dokumente

20477

IQ/OQ/PVT documents for DT 126/128 light IQ/OQ/PVT documents for DT 62x/72x/82x Series /

18443

Mechanical Calibration acc. FDA

IQ/OQ/PV documents for DT 141x/161x Series, 18444

Mechanical Calibration according FDA

Refernce Tablets

46

47

Dissolution Guide

Consumables | Mechanical Calibration





Manual Sampling

Automated

Sampling

Art. No.

Manual Sampling

18357

Manual sampling cannula LH USP 1 (basket), stainless steel 18355

Manual sampling cannula LH USP 2 (paddle), stainless steel 18361

Manual sampling cannula HH USP 1 (basket), stainless steel 20422

Manual sampling cannula HH USP 2 (paddle), stainless steel 20411

Manual sampling cannula LH USP 1 (basket), stainless steel for 2000 ml vessel 20425

Manual sampling cannula LH USP 2 (paddle), stainless steel for 2000 ml vessel Art. No.

Automated Sampling

18363

Syringe connected to stainless steel sampling probe Cleaning reservoir (acrylic glass)

18340

DT-i-Version upgrade for DT 72x/ 82x/141x/161x 18364

Eppendorf single handedly operating sampling pipette, LH DT

standard ASS-8 sampling station

18341

ASS-8 LH autom. sampling station, PTFE coated tubing 3.0 mm, DT 72x/82x 21329

Manual sampling cannula with refill tube for 60 ml vessel HH-USP 2 (paddle) 18342

ASS-8 LH PT 100 autom. sampling station LH, PTFE coated tubing 3.0 mm 18343

ASS-8 HH autom. sampling station, tubing PTFE coated 3.0 mm 18344

ASS-8 HH PT 100 autom. sampling station, fluoropol. tubing 18345

Auto Sampling Station ASS-8 for preconfigured DT (without motor) 18348

Titanium sampling tubes for ASS-8 autom. sampling station 18349

Titanium sampling tubes for ASS-14 auto sampling station 18346

PT 100 Electronic temperature sensors (8) Manual sampling cannula, LH USP 1 with

18347

DFS Double Filtration Station for DT Systems syringe connected to stainless steel sampling probe 18350

Cleaning reservoir (acrylic glass) standard ASS-8

18352

Cleaning reservoir for ASS-8 sampling station w. Disso.NET

18351

Cleaning reservoir for ASS-16 for DT 141x/161x 18353

Spare part kit for DT 82x w. ASS-8

18354

Spare part kit, DT82x w. ASS-8 autom. sampl. station & 8 temp.sensors Syringe connected to stainless steel

sampling probe

Automated sampling station ASS-8 on

top of a DT from the DT 720 series

Manual sampling cannula, HH USP 1 with

syringe connected to stainless steel sampling probe 48

49

Dissolution Guide

Manual Sampling | Automated Sampling





Dissolution System Options

Art. No.

Filtration

18497

AFC 825 - 12 V membrane filter exchange system for 6 stations 18499

AFC 825 - 16 V membrane filter exchange system for 8 stations Sampling into UV-Vis glass tubes

Art. No.

Glass tubes for FRL

18512

Glass tubes 12 ml, 100 pcs. for FRL Rack 18513

Glass tubes 25 ml for FRL, 100 pcs.

18514

Glass tubes amber glass 25 ml, 100 pcs.

AFC automatic membrane

Art. No.

Cuvettes for UV/Vis

filter exchange system

18515

Cuvette, 0.1 mm path length

18516

Cuvette, 0.2 mm path length

18517

Cuvette, 0.5 mm path length

18521

Cuvette, 10 mm path length, flow-through optimised (standard) Art. No.

FRL sample collector

18518

Cuvette, 1 mm path length

18506

Titanium filling tubes for FRL 820/824

18519

Cuvette, 2 mm path length

18507

Rack for 26 x 8 glass tubes, 12 ml, including 250 glass tubes 18520

Cuvette, 5 mm path length

18508

Rack for 18 x 8 glass tubes 25 ml, including 150 glass tubes 19945

All-quartz cuvette with two optical path lengths, 10 and 1 mm 18509

Rack for 26 x 8 HPLC vials, 1.8 ml

18522

Cuvette, 20 mm path length, (only AGILENT) 18510

Rack for 26 x 8 glass tubes, 4.0 ml

18511

Recalibration rack for HPLC vials 1.8 ml and 4.0 ml Rack with HPLC vials

Art. No.

Others

18523

Pre-heating unit for substitute media (offline systems only) Art. No.

QA Documents

23172

Metrohm ph-meter for usage with Disso.NET

18529

IQ/OQ/PVT documents for Offline System

18530

IQ/OQ/PVT documents for Online System

18531

IQ/OQ/PVT documents for On-/Offline System UV-Vis 50

51

Dissolution Guide

Dissolution System Options



Contact

Are you curious and want to find out more?

Head over to our website and download our product brochures, watch videos of our equipment in action or find the ERWEKA dealer of your country.

E-Mail: sales@erweka.com

Tel.:

+49 6103 92426-200

Fax:

+49 6103 92426-999

support@erweka.com

www.erweka.com

spareparts@erweka.com

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ERWEKA GmbH

Pittlerstr. 45

E-Mail: sales@erweka.com

63225 Langen

Telefon: +49 6103 92426-200

Technical specifications of products described are stated without warranty and subject to change at Germany

Fax:

+49 6103 92426-999

any time without further notice. v.3.2.6.19