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  4. USP 4 Manual Open Loop

USP 4 Manual 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.

When dissolution is performed manually, every process step before, during, and after the test is executed manually by the user. This is the most technician-dependent way of testing. For a manual system in an open loop set-up, this requires the lab scientist to change the fraction tubes or bottles and clean the circulation tubes manually.

CE 7smart Manual Open Loop



Entry level USP 4 system to change pH, maintain sink conditions and collect fractions
Adapted to a great variety of dosage forms
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.
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.

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 Manual Open Loop» contact us by phone (044) 229 15 31 or fill in the form.
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