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USP 4 DFZ ll

USP 4 DFZ ll
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USP 4 DFZ ll

Product catalog summary
Overview of USP 4 DFZ II Flow-Through Systems
The USP 4 DFZ II is a versatile flow-through cell tester by ERWEKA, designed for testing various pharmaceutical formulations, including poorly soluble products and low-dose sustained release formulations. Key innovations include enhanced leak-tightness, optimized tubing systems, and improved cell warming capabilities. The system is fully compliant with USP, EP, and JP standards and can be controlled via the Disso.NET USP 4 software.
Key Features
  • Standardized Cell Head: Fits all cell bodies, reducing costs and assembly time.
  • Increased Leak-Tightness: Fewer seals and improved sealing surfaces enhance process safety.
  • Optimized Cell Bodies: Improved heating and faster preparation with individual cell heating options.
  • Compact Design: Space-saving and corrosion-resistant housing with easy visual control.
  • Easy Cleaning: Simplified water bath cleaning with a 3-way valve and easy temperature control.
Cell Design and Types
The system offers a variety of cell types for different applications, including tablet, granulate, powder, stent, suppository, and implant cells. The quick lock system facilitates easy tube removal and cell mounting.
Disso.NET USP 4 Software
This software provides comprehensive control over the USP 4 systems, supporting various dissolution cells and offering features like audit trails, advanced report generation, and method editing for GMP environments.
System Configurations
  • Stand-Alone System: Ideal for simple release tests with manual sampling, featuring a piston pump and heater.
  • Closed Online System: Suitable for long-term testing with automated UV/VIS analytics, using a fixed media volume.
  • Open Offline System: Designed for poorly soluble products, allowing unlimited media supply and easy pH changes.
  • Closed Offline System: For low-dose formulations with sustained release, enabling detailed cumulative release analysis.
Technical Specifications
The document provides detailed technical specifications for various components, including dimensions, weight, power requirements, and interface options for the DFZ II, IPC 8 pump, FRL 724, LMT 2, and HKP 720.
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Catalog excerpts

USP 4 DFZ ll-2

The highlights of the USP 4 Flow-Through Cell DFZ II The 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 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...

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USP 4 DFZ ll-3

Compact & corrosion-resistant housing The smaller footprint with clear arrangement of cells in one line saves laboratory space and offers a perfect visual control of the cells at all times. In addition, the tube organizer on the back of the device prevents mixing up the cell tubes. Easier cleaning Due to the 3-way-valve for water emptying on the back of the device, the 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....

 Open the catalog to page 3
USP 4 DFZ ll-4

Quick lock system on universal cell head Advanced, non-leaking Cell design Accompanying our flow-through systems, we offer a variety of different cells with a improved design for different purposes - from the standard tablet cell to granulate & powder cells to cells for implants, suppositories and stents. Support disc Filter Metal sieve The 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...

 Open the catalog to page 4
USP 4 DFZ ll-5

Different cells for different purposes Granulate & Powder cell Implant cell Suppository cell Stent cell Tablet cell 22.6 mm with one-way dialysis adapter Tablet cell 22.6 mm with cream adapter Tablet cell 22.6 mm with glass beads & tablet holder Tablet cell 22.6 mm with glass beads & without tablet holder Special temperature calibration head

 Open the catalog to page 5
USP 4 DFZ ll-6

Full dissolution software solution for the Flow-Through Cell Disso.NET USP 4 The ERWEKA Disso.NET USP 4 Software is the 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 dissolution cells used in these systems. It also supports cells for special applications (e.g. cell with cream adapter) 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 of the connected devices (e.g....

 Open the catalog to page 6
USP 4 DFZ ll-7

Easy entry into USP 4 dissolution testing USP 4 Stand-Alone System The ERWEKA stand-alone flow-through cell system is perfect for performing simple release tests with manual sampling. Therefore, the flow-through cell tester DFZ II offers in a system with the ERWEKA piston pump HKP 720 and the ERWEKA heater DH 2000i an easy entry into testing with USP 4 systems for a small budget. The valve-free piston pump transports the test medium with highest precision via seven channels to the flow-through cells and automatically adopts the setting of the flow rate. With the low-vibration heater the water in...

 Open the catalog to page 7
USP 4 DFZ ll-8

Long-term testing with automated UV/VIS analytic USP 4 Closed Online System The closed ERWEKA offline flow-through cell system is excellently suited for testing low-dose formulations with sustained release (e.g. implants). It allows performing comprehensive long-term dissolution tests with small media volumes. A fixed media volume (100 - 1000 ml) is continuously led via the ERWEKA media transfer station LMT 2 in a circle through the system and pumped through the flow cells. With the integrated UV/VIS analytic, samples can be automatically drawn from the media reservoir at software controlled time...

 Open the catalog to page 8
USP 4 DFZ ll-9

Infinite media testing and sampling USP 4 Open Offline System The open ERWEKA offline flow-through cell system is the perfect solution for testing poorly soluble products that need unlimited amounts of fresh media to dissolve. It also offers the opportunity to quickly and easily exchange media with different pH-values within one test run and is thus perfectly suited for IV/IVC testing. With the ERWEKA sample collector FRL 724 representative samples are taken over a certain period for later analysis (up to 18 sampling intervals with 25 ml rack possible). Thanks to the integrated threeway valves a...

 Open the catalog to page 9
USP 4 DFZ ll-10

Comprehensive long-term testing USP 4 Closed Offline System The closed ERWEKA offline flow-through cell system is excellently suited for testing low-dose formulations with sustained release (e.g. implants). It allows performing comprehensive long-term dissolution tests with small media volumes. Highlights Comprehensive long-term testing A fixed media volume (100 - 1000 ml) is continuously led via the ERWEKA media transfer station LMT 2 in a circle through the system and pumped through the flow cells. With the sample collector FRL 724 several samples are taken at different times for further analysis...

 Open the catalog to page 10
USP 4 DFZ ll-11

Easy media transfer with the LMT 2 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 therefore 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. Using standardized laboratory glass bottles as media vessels also enables an easier media transport for saving and further analysis....

 Open the catalog to page 11
USP 4 DFZ ll-12

ca. 8 kg (without media cells & water) 11 kg (without media bottles) Media vessel Water bath 6 liter volume, level indicator, emptying via 3-way-valve Stirring principle Flow-through heater, cell warming of stations individually switchable Magnetic stirrer with 8 stirring positions Stirring volume Connecting block Connecting block with safety valve in each station Temperature control External PT100 temperature sensor; PT100 temperature sensor in each station (optional) Tablet cell 22.6 mm (standard) Tablet cell 12 mm Suppository and capsule cell Powder & Granulate cell (USP+EP) Stent cell Implant...

 Open the catalog to page 12

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.