Dissoluutiolaitteet
Digitaaliset dissoluutiolaitteet
Digitaalinen DT 950 sarjan dissoluutiolaite
The ERWEKA DT 950 Series is our first digital dissolution tester on the market, equipped with the most advanced technology for the requirements of today and the challenges of tomorrow.
With state-of-the-art embedded PC technology, the DT 950 is the first of its kind. The 7″ touch display with a modern user interface focuses the user on the most important task the DT 950 has to fulfill – 100% USP/EP/JP compliant dissolution testing, without distractions and errors. For this purpose, we have designed the ERWEKA TestAssist, an intelligent helper that guides the user step by step through the con-figuration of the dissolution test, provides assistance and makes sure that only compliant parameters can be entered.
In addition to the modern user interface, the DT 950 is completely future-proof. With our „Upgrade your DT“ programme, it can be upgraded at a later date – e.g. from 6 up to 8 test stations, with an automatic tablet drop or an automatic sampling station, if the DT 950 is to be upgraded to a dissolution system at a later date. A switch form low-head to high-head mode is also easily possible at all times. Thanks to the advanced embedded system, software functions for the touch display can also be added later.
With all these innovations, however, we have not lost sight of the most important thing: The DT 950 Series are 100% USP/EP compliant.
Specifications
- OQ traffic light system displays the qualification status of the unit
- Automatic vessel centering
- Standard tablet drop magazine for 8 samples
- Evaporation less than 1 % during 24 h (37° C, 50 rpm, 1000 ml)
- Manual lifter with gas-strut support
- One-piece moulded PET water bath with outlet valve
- External PT 100 temperature sensor for reviewing the water bath and media temperature
- Heating range: 30-50° C (+/- 0.2° C), cooling optional
- Wobble less than 0.2 mm at delivery (paddles)
- Automatic self-check of the water bath/vessel temperature before test run
- Large 7“ touch display, the gateway to our embedded technology.
- USB printer interface for documentation of the test run parameters and results (time, date, rpm, temperatures etc.)
Digitaalinen DT 9510 sarjan dissoluutiolaite
The ERWEKA DT 9510 Series is the bigger sibling of the digital DT 950 Series dissolution tester.
Controlled by the same embedded PC, every component of the DT 9510 is focused on reliable, high volume digital dissolution testing: The test stations (up to 14) are driven by a single, powerful motor and the big waterbath holds the temperature stable due to the thermal inertia of water. This ensures that parallel testing of two batches of samples can be done at precisely the same conditions, making comparsion between the two as reliable as possible and 100% USP/EP compliant.
With the new optional AirLift system, the dissolution head of the DT 9510 can be simply raised and lowered by the press of two buttons. Furthermore, DT 9510 Series has the same features as it‘s smaller sibiling – digital dissolution testing is done with the help of the latest version of the testing assistant TestAssist and samples can be automatically dropped into the vessel by the optinal automatic tablet drop.
Specifications
- OQ traffic light system displays the qualification status of the unit
- Automatic vessel centering
- Standard tablet drop magazine for 14 samples
- Evaporation less than 1 % during 24 h (37° C, 50 rpm, 1000 ml)
- Manual lifter with gas-strut support
- One-piece moulded PET water bath with outlet valve
- External PT 100 temperature sensor for reviewing the water bath and media temperature
- Heating range: 30-50° C (+/- 0.2° C), cooling optional
- Wobble less than 0.2 mm at delivery (paddles)
- Automatic self-check of the water bath/vessel temperature before test run
- Large 7“ touch display, the gateway to our embedded technology.
- USB printer interface for documentation of the test run parameters and results (time, date, rpm, temperatures etc.)
Automaattinen dissoluutio järjestelmä RoboDis II+
In the standard configuration, RoboDis II+ tests up to 10 batches in accordance with USP methods 1 (Basket) or 2 (Paddle). The parallel sampling approach enables very short cycle times for recording of detailed drug release profiles to be selected by the user. Integrated System Suitability Tests (SST) and video monitoring ensure a high degree of reliability. Like all ERWEKA products, RoboDis II+ is fully USP/EP/JP compliant.
RoboDis II+ Safety Systems
RoboDis II+ performs routine tasks more precisely than any human operator – but without a human operator all its powerful fully automatic features would be worth nothing. It is the human operator who defines the test methods, checks results for plausibility and interprets the data obtained. To enable him or her to focus on these tasks, we have equipped RoboDis II+ with a number of safety features.
System Suitability Tests
In each individual process step, RoboDis II+ self-checks by means of integrated System Suitability Tests (SSTs). Several built-in light barriers validate the steps performed by Robo Dis II+, thus preventing false starts.
Full Documentation
Each step of the test is logged in accordance with the industrial standard 21 CFR Part 11. This will enable you to check, for example, whether RoboDis II+ actually did test all 40 batches completely over the weekend.
High-Quality System Components
RoboDis II+ is built with tried-and-tested, reliable system components, amongst them, e.g., ERWEKA’s maintenance-free PVP pump and the robot arm made by the internationally renowned pneumatics manufacturer Festo. The use of premium components guarantees maximum precision and lowest downtimes.
Video Recording
RoboDis II+ optionally records the entire dissolution process with six integrated video cameras. This allows validating the entire test upon completion, or overlaying the dissolution curve on a time-lapse video recording. Thanks to the LED light strip the water bath can be illuminated at night, allowing 24 hour video recording without the need for external lighting.
Offline DT dissoluutiojärjestelmät
DT82x ja näytteen kerääjä FRL 6/7/854
The ERWEKA Dissolution Offline System is the ideal semi-automatic solution for dissolution testing with automated sampling and subsequent sample storage for later analysis. The system is controlled 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 consists 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 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.
Specifications
- ERWEKA DT 820 Series with touch sensitive keys and LC display for full control of the Offline System
- Practically maintenance-free piston pump PVP 820
- Sample collector FRL 854 (of up to 26 sampling intervals) with movable tray for easy exchange of vessel racks
- Fluoropolymer tubing
- Different sampling containers available – 26 x 8 glass tubes of 12 ml capacity, 16 x 8 glass tubes of 25 ml capacity or 26 x 8 HPLC vials of 1.2 ml or 4.0 ml capacity
- Optional dilution possible
- Integrated cleaning routine of the FRL 6/7/854
- System control by DT 820 i-version
Online DT dissoluutiojärjestelmät
DT950 ja näytteen kerääjä ASS-9
The ERWEKA dissolution online systems are the perfect, semi-automatic solutions for dissolution testing with automated UV/VIS online analyses.
The DT 950 with the integrated, automated ASS-9 sampling station transports freshly sampled media directly to the UV/VIS analysis device (several brands available). There, the samples can be measured and the results can then be stored within our advanced Disso.NET dissolution software.
ERWEKA offers different types of UV/VIS analysis devices, such as the Shimadzu 1900i, the Analytic Jena Specord 210/8 or the Agilent Cary 8454. All combined with our dissolution tester DT 950 and a peristaltic pump IPC 8 and all controlled by the Disso.NET PC software.
Specifications
- Dissolution tester DT 950 series
- IPC 8 peristaltic pump, controlled via RS 232 interface by connected PC with Disso.NET
- Different brands of spectrophotometers available
- System controlled by Windows based, CFR 21 part 11 compliant ERWEKA Disso.NET software
- Brand name PC with Windows 10 available
- Cuvettes for UV-Vis spectrophotometers with fluoropolymer tubing (0.8 mm o.d.) and screw terminals with various path lengths available (1 mm, 2 mm, 5 mm, 10 mm)
On-/Offline DT dissoluutiojärjestelmät
Puoliautomaatinen DT950 dissoluutiojärjestelmät
The ERWEKA dissolution UV-Vis On-/Offline system is the ideal system configuration for spectrophotometers. With the connected PC, the On-/Offline system can be conveniently controlled via our advanced Disso.NET software. Moreover, the software offers full control over all components.
After analysis has been completed, the samples are comfortably stored by our very own sample collector FRL 6/7/854.
Specifications
- Brand name PC with Windows 10 available
- Dissolution tester DT 820 or DT 950 series
- IPC 8 peristaltic pump, controlled via RS 232 interface by connected PC with Disso.NET
- Different brands of spectrophotometers available
- System controlled by Windows based, CFR 21 part 11 compliant ERWEKA Disso.NET software
- Cuvettes for UV-Vis spectrophotometers with fluoropolymer tubing (0.8 mm o.d.) and screw terminals with various path lengths available (1 mm, 2 mm, 5 mm, 10 mm)
- Sample collector FRL 6/7/854 for sampling of up to 26 sampling rows, with movable tray for easy exchange of vessel racks
- Different sampling containers available: 26 x 8 glass tubes of 12 ml capacity, 16 x 8 glass tubes of 25 ml capacity or 26 x 8 HPLC vials of 1.2 ml or 4.0 ml capacity
Dissolutio laitteet USP 1, 2, 5, 6
DT Light dissoluutiolaitteet
The ERWEKA DT light Series delivers the proven ERWEKA quality in a comprehensive package for a budget for simple dissolution testing with USP method 1, 2, 5 and 6. The DTs are equipped with 6, 8 or 12 test stations and a fixed drive head (high-head), allowing easy access to each 1000 ml vessel.
The shafts can be replaced easily and the unique water bath of moulded PET is equipped with the time-proven ERWEKA water outlet for easy clea-ning. The external flow through heater reduces the influence of external vibrations and ensures a constant temperature. Every accessory that comes into contact with the dissolution sample is installed in Germany. Therefore our DT light Series has the ERWEKA made in Germany quality.
All these features make sure that the ERWEKA DT light Series offers the perfect entry-level devices for the world of dissolution testing.
Specifications
- USP methods 1 (Basket), 2 (Paddle), 5 (Paddle over Disk) and 6 (Rotation Cylinder) with 6, 8 or 12 test stations – USP method 2 included
- 100 % USP / EP / JP compliant
- Fulfills all specifications in accordance with FDA “Mechanical Calibration”
- USB-A printer interface (for selected printers) USB-B interface for firmware updates RS 232 interface for heater control
- External PT 100 temperature sensor
- Rotational speed 20 - 250 rpm
- Heating range: 30 - 50 °C (± 0,2 °C)
DT 820 dissoluutiolaite
The ERWEKA DT 820 series offers advanced intelligence and user-friendly features for stand-alone operation or control of a complete dissolution offline sampling system. It allows storage of up to 60 product test run parameters that can be recalled for future tests.
The unit can be equipped with 6, 7 or 8 test stations and be used in standard high-head or low-head mode. It provides an OQ traffic light to show USP/EP compliance as well as an external temperature sensor for checking the water bath temperature.
The water bath, made of non-leaking PET, is effortlessly accessible and allows for easy cleaning.
Specifications
- Menu-guided pH routines
- Visual and acoustic reminder for manual sampling (countdown)
- OQ traffic light system for displaying the USP/EP compliance of the unit
- Operation hours counter
- Automatic height adjustment
- Automatic vessel centering
- Standard tablet drop magazine for 8 samples
- Evaporation less than 1 % during 24 h (37° C, 50 rpm, 1000 ml)
- Manual lifter with gas-strut support
- One-piece moulded PET water bath with outlet valve
- External PT 100 temperature sensor for reviewing the water bath and media temperature
- Heating range: 30-50° C (+/- 0.2° C), cooling optional
- Pre-heat function
- Wobble less than 0.2 mm at delivery (paddles)
- Corrosion-free plate for holding the vessels
- Product memory for storing the monographs of up to 60 products
- Automatic self-check of the water bath/vessel temperature before test run
- Alpha-numeric touch sensitive keypad with illuminated full-graphic 5.7” dot matrix display
- USB printer interface for documentation of the test run parameters and results (time, date, rpm, temperatures etc.)
Digitaalinen DT 950 sarjan dissoluutiolaite
The ERWEKA DT 950 Series is our first digital dissolution tester on the market, equipped with the most advanced technology for the requirements of today and the challenges of tomorrow.
With state-of-the-art embedded PC technology, the DT 950 is the first of its kind. The 7″ touch display with a modern user interface focuses the user on the most important task the DT 950 has to fulfill – 100% USP/EP/JP compliant dissolution testing, without distractions and errors. For this purpose, we have designed the ERWEKA TestAssist, an intelligent helper that guides the user step by step through the con-figuration of the dissolution test, provides assistance and makes sure that only compliant parameters can be entered.
In addition to the modern user interface, the DT 950 is completely future-proof. With our „Upgrade your DT“ programme, it can be upgraded at a later date – e.g. from 6 up to 8 test stations, with an automatic tablet drop or an automatic sampling station, if the DT 950 is to be upgraded to a dissolution system at a later date. A switch form low-head to high-head mode is also easily possible at all times. Thanks to the advanced embedded system, software functions for the touch display can also be added later.
With all these innovations, however, we have not lost sight of the most important thing: The DT 950 Series are 100% USP/EP compliant.
Specifications
- OQ traffic light system displays the qualification status of the unit
- Automatic vessel centering
- Standard tablet drop magazine for 8 samples
- Evaporation less than 1 % during 24 h (37° C, 50 rpm, 1000 ml)
- Manual lifter with gas-strut support
- One-piece moulded PET water bath with outlet valve
- External PT 100 temperature sensor for reviewing the water bath and media temperature
- Heating range: 30-50° C (+/- 0.2° C), cooling optional
- Wobble less than 0.2 mm at delivery (paddles)
- Automatic self-check of the water bath/vessel temperature before test run
- Large 7“ touch display, the gateway to our embedded technology.
- USB printer interface for documentation of the test run parameters and results (time, date, rpm, temperatures etc.)
DT 1610 dissoluutiolaite
he ERWEKA DT 1610 series offers advanced intelligence and features for stand-alone operation or the control of a complete dissolution offline sampling system. It allows storage of up to 60 product test run parameters.
The DT 1610 series is based on the proven DT 820 (similar user interface, e. g. keypad, display and menu structure) and can be equipped with 12, 13 or 14 test stations arranged in two rows. The unit can be operated in high-head as well as low-head mode.
It provides an OQ traffic light system to show USP/EP compliance and an external temperature sensor for checking the water bath temperature. The water bath is designed for easy access and cleaning.
Additionally, the DT 1610 series enables testing of high capacities. Thanks to the exceptional configuration, the device allows running two different batches of the same product or two different products with the same dissolution monograph at the same time.
Specifications
- OQ traffic light for display of the USP/EP compliance of the unit
- Dissolution tester for USP methods 1 (basket), 2 (paddle), 5 (paddle-over-disc) and 6 (rotating cylinder) with 12, 13 or 14 test stations (1612, 1613, 1614)
- 100 % USP/EP/JP compliant
- Fulfils all specifications in accordance with FDA “Mechanical Calibration”
- 5.7“ display, alpha-numeric touch sensitive foil keypad
- Evaporation less than 1 % during 24 h (37° C, 50 rpm, 1000 ml)
- External high-capacity flow-through heater with a heating range of: 30-50° C (± 0.2° C)
- Manual tablet drop magazine for max. 14 samples (low-head)
- Openings in the drive head for an easy sample withdrawal
- External temperature sensor for water bath temperature display and documentation
- Wobble less than 0.5 mm at delivery (paddles)
- Acoustic and optic reminder of manual sampling (29 intervals)
Digitaalinen DT 9510 sarjan dissoluutiolaite
The ERWEKA DT 9510 Series is the bigger sibling of the digital DT 950 Series dissolution tester.
Controlled by the same embedded PC, every component of the DT 9510 is focused on reliable, high volume digital dissolution testing: The test stations (up to 14) are driven by a single, powerful motor and the big waterbath holds the temperature stable due to the thermal inertia of water. This ensures that parallel testing of two batches of samples can be done at precisely the same conditions, making comparsion between the two as reliable as possible and 100% USP/EP compliant.
With the new optional AirLift system, the dissolution head of the DT 9510 can be simply raised and lowered by the press of two buttons. Furthermore, DT 9510 Series has the same features as it‘s smaller sibiling – digital dissolution testing is done with the help of the latest version of the testing assistant TestAssist and samples can be automatically dropped into the vessel by the optinal automatic tablet drop.
Specifications
- OQ traffic light system displays the qualification status of the unit
- Automatic vessel centering
- Standard tablet drop magazine for 14 samples
- Evaporation less than 1 % during 24 h (37° C, 50 rpm, 1000 ml)
- Manual lifter with gas-strut support
- One-piece moulded PET water bath with outlet valve
- External PT 100 temperature sensor for reviewing the water bath and media temperature
- Heating range: 30-50° C (+/- 0.2° C), cooling optional
- Wobble less than 0.2 mm at delivery (paddles)
- Automatic self-check of the water bath/vessel temperature before test run
- Large 7“ touch display, the gateway to our embedded technology.
- USB printer interface for documentation of the test run parameters and results (time, date, rpm, temperatures etc.)
Dissoluutio-ohjelmisto
Dissonet 4.0
The ERWEKA Disso.NET 4 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.
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.
According to 21 CFR Part 11
Disso.NET 4 features a comprehensive audit trail, tracking all changes throughout the system (what, who, when and why). Whenever an authorised user makes changes to any data on the system that needs to be tracked, an audit trail prompt appears and forces the user to enter a reason for this change. Whenever data is created from scratch (e.g. a new method), the system automatically evaluates this audit entry and automatically adds a reason (e.g. “created”).
All audit data can be comfortably searched and filtered using our new Audi Trail Viewer – allowing easy tracking of any change to the system with a consecutive audit number. This new feature complies to 100% to latest regulatory rules
Disso.NET Editor
All main features of the Disso.NET 4 are located in separate windows, enabling a clear focus on the task at hand. These editors can be used to change media, edit filters and create new measurement, evaluation and medium preparation methods.
Even for UV calculations, Disso.NET offers a unique interface specifically focused on its main task.
USP 3 ja 7 laitteet
BioDis RRT 10
With the ERWEKA RRT 10, automatic dissolution testing of different extended and sustained release dosage forms has become easier than ever before. This unit is perfectly suited for simulating the pH-changes within the human body. By placing different media in each row, the device echoes varying in vivo gastrointestinal conditions of the body.
An automatic sample transport between the rows allows the reliable testing of the extended or sustained release from different dosage forms in various pH-zones. The simple to program RRT 10 thus, is the perfect unit for multiple media pH-changes for IV/IVC testing and dissolution profiling of a variety of release dosage forms (e. g. tablets, coated tablets and oblongs).
100 % USP/EP/JP compliant and controlled by touch
The RRT 10 is 100 % compliant to the USP/EP/JP standards and available as either USP method 3, USP method 7 or as a combination device of both USP methods 3 and 7. It comes with an external flow-through heater, which minimizes vibrations to the device. Moreover, the unit offers a mobile touch display, which is easy to use and provides convenient control.
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.
Specifications
- 8 rows with 6 stations (standard configuration) and 2 vials for reference purposes or 7 test stations without reference positions
- Water bath of 30 liters capacity, clear acrylic glass
- Heating rate 1500 W, 30-50° C, accuracy +/- 0.2° C
- External PT 100 temperature sensor
- 300 ml USP compliant cylindrical flat bottomed glass vessels (standard configuration)
- USP compliant glass reciprocating cylinders, fitted with stainless steel screens with different mesh sizes (automated centering inside the vessel)
- Whole range of USP compliant holders, for non-eroding formulations, made of stainless steel or polytetrafluoroethylene
- Speed adjustable from 5-40 strokes/min., accuracy better than +/- 5 %
- USP 3 height stroke – 100 mm
- USP 7 height stroke – 20 mm
- Automated vessel cover to reduce media evaporation
- Control via color touch screen, password-protected access to firmware with OQ functions and product memory
USP 4 laitteet
DFZ II
The new ERWEKA flow-through cell tester DFZ II can be used for various applications thanks to its wide range of available cell types, e.g. for testing poorly soluble products or low-dose formulations with sustained release.
Innovations as the new cell design with increased leak-tightness and the optimized tubing system with quick locks allow a fast preparation and implementation of dissolution tests. The new leaner cell bodies ensure an improved cell warming and can be heated individually. All USP 4 DFZ II systems can be easily controlled with the Disso.NET 3.X software via a controller.
New improved Cell design
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 heating jacket) handling and assembly of the cells. The optimized cell bodies with decreased cell wall thickness guarantee an improved cell heating.
Dissoluutio median valmistus
MediPrep 820 ja 1622 laitteet
The MediPrep 820 series offers quick and easy preparation of up to 8 liters dissolution media in less than 15 minutes. The MediPrep 1622 only needs 25 minutes to prepare dissolution media – 3 times faster than manually done according USP! In a single pass, the media for dissolution tests can be precisely mixed, heated, degassed and gravimetrically filled into vessels. Foaming media like SDS (Sodium Dodecyl Sulfate) can also be used.
Filling can be done at the integrated dosing port or with the optional remote filling hand directly into the vessels.
The MediPrep 1622 additionally provides two inlets for premixed media and one outlet for wastewater. To prevent cross contamination, an automated cleaning procedure is integrated.
