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  5. USP 4 Semi-automated Open loop

USP 4 Semi-automated Open loop

Full description
The open loop system set-up is historically the one used to guarantee sink conditions (from 2 to 5 times inferior to saturation concentration) to test poorly soluble compounds. The open loop is also well adapted to ER, MR, SR dosage forms due to its media selection ability which allows a pH change on the fly.

Semi-automated systems ensure that all sequential steps during the dissolution run are reproducibly executed without requiring user interaction until the post-run activity. In a semi-automated USP 4 system configuration the pump will start the flow as soon as the temperature will be stabilized and the fractions will be collected and/or UV-Vis measurements will be done - automatically. At the end of the test the media circuit will be flushed automatically as well.

Choose Your USP 4 Analytical Configuration


Off-line
An open off-line system allows for:
control of flow rate and temperature
continuous filtering of samples
programming of methods including pH changes (media selection)
automated collection of fractions in large glass tubes

UV-Vis On-line
An open UV-Vis on-line system allows for:
control of flow rate and temperature
continuous filtering of samples
programming of methods including pH changes (media selection)
automated UV-Vis measurements and dissolution results calculation, storing and reporting

UV-Vis On/Off-line
An open UV-Vis on/off-line system allows for:
control of flow rate and temperature
continuous filtering of samples
programming of methods including pH changes (media selection)
automated collection of fractions in large glass tubes
automated UV-Vis measurements and dissolution results calculation, storing and reporting

CE 7smart Semi-Automated UV-Vis On/Off-line Open Loop


The most flexible USP 4 system to change pH, maintain sink conditions, collect fractions and /or get results on the fly automatically

Adapted to a great variety of dosage forms

Driven by 21 CFR, Part 11 compliant ready WinSOTAXplus Advanced Dissolution Software

Use of any major brands of UV-Vis spectrophotometers including the SOTAX Specord Plus models

Temperature monitoring, accurate flow rate by valveless ceramic piston pump, filter saturation detection

Compliance
The CE 7smart complies with the actual USP, EP, JP requirements and can be used in R&D and QC for compendial and non-compendial methods.

Designed for cells
The cell holder of the CE 7smart can integrate and maintain in temperature all kind of compendials and non-compendial cells for the testing of tablets, capsules, powders, APIs, lipophilic forms, suppositories, suspensions, liposomes, microspheres, semi-solid, implants and medical devices.

Flow-rate accuracy
The CE 7smart has been designed to ensure a precise circulation of media through seven cells. With its firmware, the apparatus can control different types of pistons and peristaltic pumps which are easily connected to the CE 7 smart using color-coded fittings.

Firmware control
Methods, samplings, and run protocol are driven by the instrument firmware. The front panel keypad with graphic display shows method parameters such as sampling times, media, temperature, flow rate, cell type and volume.

User-friendliness
One cell holder for easy load and unload of seven cells without fitting or screwing mechanism allows for easy operation of the system.

Monitoring and safety
Bypass for overpressure due to eventual filter saturation, user protection, over-fill and over-temperature bath sensors, in-flow temperature monitoring complete the instrument.
Product specification

Components



CE 7smart Dissolution Apparatus

The cells of the CE 7smart are designed for MR (modified release), CR (controlled/continuous release) and ER (extended release) tablets, capsules, suppositories, powders, pellets, APIs, implants, medical devices, ophtalmic devices, drug eluting stents, creams, gels, suspensions, microspheres, liposomes and nanospheres.

The apparatus is suitable for R&D and QC, manual and automated sampling, firmware or software driven, linked to UV and fraction collector for HPLC analysis.

It is an evolution of the original Flow-Through Cell system designed by Dr Langenbucher and SOTAX 35 years ago and is compliant to USP, EP and JP for small volume dissolution and poorly soluble compound testing under sink conditions.

CP 7-35 Piston Pump

The CP 7-35 pump is equipped with 7 valveless, self-priming ceramic pump heads, ensuring a very high level of consistency and accuracy.

Due to design, this pump maintains consistency and efficiency even if it is placed before the filtration. It overcomes problems associated with pumping viscous media.

The CP 7-35 is constructed with inert material including ceramic heads and pistons with Teflon media tubings. The flow rate can be adjusted automatically from 4 to 35 mL/min using the control panel and it can also be adjusted channel per channel.

UV-Vis Sample Analysis and Reporting

UV-Vis analysis being the final step of the dissolution process, SOTAX dissolution systems allow integration of different analytical processes and combine results in a powerful data management software.

The WinSOTAXplus Dissolution Software allows full control of all common UV-Vis spectrophotometers. Dissolution samples can be withdrawn, filtered, conveyed, and measured in “Absorbance” at single- or multiwavelength in flow through cuvettes. The readings are calculated, reported, and stored in a 21 CFR, Part 11 compliant SQL database.

Seamless integration with Specord Plus®

SOTAX also offers its own UV-Vis solution: the Specord Plus 200 or Specord Plus 210 UV-Vis spectrophotometers are fully integrated in the dissolution systems. Both devices exceed Pharmacopeia requirements and have a true double beam with reference compensation. Using two symmetrical 8-position cell changers, they are ideal for double on-line and double on-/off-line system
configurations. As a standard, the Specord Plus series comes with a 10 year warranty on optics.

Off-line (open loop)
The splitting valve on the fraction collector C 613 or C615 ensures representative sampling and storing of the successive fractions in 65 mL glass tubes according to the time intervals. Fractions are stored in up to 7 or 16 rows.


WinSOTAXplus Advanced Dissolution Software


Professional Data Management

Developed in close cooperation with industry experts and system users, theWinSOTAXplus software is based on a deep understanding of today's dissolution user requirements and allows implementation of a fully 21 CFR, Part 11 compliant data management system for all XtendTM configurations and automation levels.

The WinSOTAXplus software offers user-friendly control of your complete system. Whether used stand-alone or in a networked environment, the modern client-server architecture can be flexibly implemented for different needs. From data capture to analysis with customized reporting and exporting features - the software fulfills all R&D and QC requirements.

For advanced data management, specific user-group definition and bi-directional data transfer to ELN/LIMS are available. Simple batch analysis alongside assisted data review is possible with customized reports and method creation including product specifications. Spend less time on compliance paperwork with highlighted pass/fail reports alongside enhanced temperature, rpm, and pH recording throughout the test. Comprehensive standard monitoring and customized system suitability requirements are stored and executed per product to ensure proper SOP execution.


Optional Components for Your Configuration

MPS Media Preparation Station

Accurate media preparation plays a vital role in all subsequent processes. The MPS Media Preparation Station allows operators to degas, heat, and dispense the exact volume of dissolution media required for each method.

Degassing at the USP and FDA recommended levels, the MPS is a mobile unit assisting in bringing 10 – 20 L of degassed and heated media to your dissolution system. By inserting the dispensing nozzle into individual vessels, precise and gravimetrically validated dispensing of media at 1’500 mL per minute without re-aeration is achieved. Once dispensing has been completed, the MPS can be simply connected to the next DI water inlet to start its automated cleaning routine – while the dissolution test runs.
Downloads
CE 7smart Flow-Through Cell Dissolution Apparatus
English Brochure
Piston pump
MPS
Станція підготовки середовищ MPS

To get information about: «USP 4 Semi-automated Open loop» contact us by phone (044) 229 15 31 or fill in the form.
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