USP 4 Dissolution Testers

The ERWEKA DFZ II range of flow-through cell dissolution testers 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).

The new DFZ II boasts innovations such as the new cell design with increased leak-tightness and the optimized tubing system with quick locks, allowing a fast preparation and implementation of dissolution tests. The new leaner cell bodies ensure an improved cell warming and can be heated individually. All our USP 4 dissolution testers can be easily controlled with the Disso.NET USP 4 dissolution software via a PC. Download the USP 4 Spec Sheet here.

All DFZ II dissolution testers come with 7 test stations for different types of USP 4 cells (12.0 mm / 22.6 mm tablet cell, powder and granulate cell, suppository cell, implant cell, and more). Our cells now have a new, improved design, catering 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 other cell bodies along with the new standardized flat seals (only 3 pieces per cell: connection, head and heating jacket). The optimized cell bodies with decreased cell wall thickness guarantee an improved cell heating. 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 preparation and performance of dissolution tests.

Disso.Net USP 4

The ERWEKA Disso.net software is the perfect 21 CFR Part 11 compliant companion to the USP 4 dissolution system. The software offers support of all USP / EP dissolution cells used in our USP 4 systems. It also supports cells for special applications (e.g. dialyse cell) and visual guides for formulation placing in the respective cells. Disso.net helps you with standard USP 4 dissolution jobs, handles qualifying tasks and provides control over each single function and connected device (e.g. connected pump, Flow-Through cell, sample collector and/or UV/VIS spectrophotometer). Our audit trail generates a detailed protocol recording all events and timings. The software includes an easy to handle method editor for highest safety in GMP environment. After finishing the dissolution test, Disso.net USP 4 creates reports with your corporate logo as PDF-files and/or exports your results as XML files.

Stand-Alone System

The ERWEKA stand-alone USP 4 system is perfect for performing simple release tests with manual sampling. This dissolution system comes with either a IPC peristaltic pump or the ERWEKA HKP 720 piston pump, and the ERWEKA DH 2000i heater. This is the perfect entry-level USP4 dissolution system for small budgets.

Open Offline System

Infinite media testing and sample collection with the ERWEKA Open Offline flow-through dissolution system. The Open system is the perfect solution for dissolution testers which require an unlimited supply of fresh media (e.g. low soluble drug substances). The sample collector collects the complete or representative sample over a certain time for storage and later analysis. Due to integrated 3-way valves the system can automatically split for waste and sampling purposes.

Main Components

Flow-Through cell DFZ II+ heater
HKP 720 piston pump – 100% USP 4 compliant
Sample Collector FRL 724
PC with Disso.net USP 4 Software

Closed Offline System

Extensive long term testing with the independent Closed flow-through dissolution system. The Closed system is the perfect solution for dissolution tests which requires low media volume for long term dissolution tests and/or to increase sensitivity of the analytical method (e.g. implants).

Main Components

DFZ II Flow-Through cell + heater
HKP 720 piston pump – 100% USP 4 compliant
Sample Collector FRL 724
Peristaltic pump IPC 8 or syring pump SP
LMT 720 closed-loop unit. Continuous media stirring by magnetic stirrers.
PC with Disso.net USP 4 Software

Closed Online System

Comprehensive long-term testing with integrated analysis. Our USP 4 Closed Online flow-through dissolution system features automated analysis of the test media via a software controlled, integrated UV/Vis spectrophotometer, resulting in an automated USP 4 workflow.

Furthermore, all features of the stand-alone system can be applied to our online system: the valve-free piston pump with highest precision and the low-vibration heater steadily holds the requested temperature of the water bath. And our new and improved USP 4 cells are also integrated into the software dialogs, making the use of the system as easy as possible.

Main Components

DFZ II Flow-Through cell + heater
HKP 720 piston pump – 100% USP 4 compliant
LMT 720 closed-loop unit. Continuous media stirring by magnetic stirrers
Uv/Vis Spectrophotometer
PC with Disso.net USP 4 Software

Different USP 4 Flow-Through-Cells

Different cells for different purposes available – e. g. for implants, granulates & powders, suppositories, stents, cells with cream adapter or with a dialysis adapter.

LMT 2 – Easy media transfer

With the compact ERWEKA media transfer station LMT 2 a closed loop for performing long-term dissolution tests according to USP 4 can be easily created. The LMT 2 is used as a medium reservoir and ensures an optimal media mixing and distribution through the whole release test. The optimized tubing system with a new tube holder and rotatable bottle caps (safety caps) makes handling easier and saves valuable laboratory space.