DSR-M

The dissolution sampling robot with media refilling and dilution option.

DSR-M

Dissolution Sampling Robot

The DSR-M dissolution sampling robot is designed specifically for the sample transfer and sample processing from a six to fourteen vessel dissolution bath. This unique versatile instrument allows samples to be collected over very short time intervals with great accuracy. The DSR-M can be equipped to collect, dilute or process samples for following UV-Visible or HPLC measurements. It can also be used for dissolution medium replenishment to conform to USP/EP volume loss rules.

DSR-M Dissolution Sampling Robot

DSR-M Dissolution Sampling Robot

Automated Sampling

To offer the highest volume precision, between six and fourteen piston pumps are used for sample removal and media refilling (optional), one dedicated pump for each channel. No time consuming pump calibration is needed. The advanced design of the system means that it is always ready for operation. The pumps are integrated into the DSR-M as a compact CAT-M piston pump module. The sample preparation station, Z-arm and needle, can be used to dispense into x-split septa-sealed HPLC vials or to dilute the samples for later UV/VIS analysis. Keeping the samples in sealed vials helps avoiding evaporation, especially if sustained release samples are tested.

The DSR-M can be connected to any Pharma Test PTWS-series dissolution bath. If the DSR-M is connected to a PTWS 820D, PTWS 620, PTWS 1220, PTWS D620 or PTWS 1420 dissolution bath the sampling probes are connected to its EPE auto sampling manifold. The motorized EPE sampling manifold lowers the sampling probes into the corresponding sampling position which can be set for either 500 or 900ml total media volume. Sampling cycle information is programmed directly at the dissolution bath using the method filing system.

Sampling Racks

Manual sampling from a dissolution test instrument is not only time consuming but also limits the reproducibility and is close to impossible if sustained release products have to be analyzed over prolonged time periods. The Pharma Test DSR-M provides a neat solution for this automation procedure. Up to 20 sampling cycles can be run (up to 10 if dilution is enabled). These are collected in two racks inside the DSR-M. The second rack is used either for sample collection or for sample processing, such as dilution. The unique rack design allows the user to use standard open vials or x-split septa closed HPLC vials using the same rack. The DSR-M racks are installed on a moveable tray to easily remove the filled vials and to refill the rack with empty vials. The DSR-M is completely enclosed by transparent acrylic glass to protect the operator from the moving arm and the samples from any external source.

Operation Principle

At the time of sampling the EPE automated sampling manifold of the PTWS dissolution bath is moved into the vessel media, the tubing lines are filled by the CAT-M piston pumps and the dispensing arm of the DSR-M moves to the fist sampling line. The pumps start to dispense. The samples are filled either into open glass vials or into HPLC vials. HPLC vials closed with x-split septa are supported as well. The DSR-M houses two racks: these can either be identical to support up to 20 sampling cycles or two different types of racks to perform sampling and subsequent media transfer with dilution to HPLC vials (optional CAT-DM dilution module required). In this case a maximum of 10 sampling cycles is supported.

Once sampling is finished, the pump direction is reversed to empty all tubing lines. In case the optional CAT-MRM media refilling module is installed, the volume sampled from the vessels is automatically replaced with fresh media. Then the EPE is automatically moved out of the vessels waiting for the next cycle to start.

If dilution of sampled media is enabled, dilution is performed once the all samplings are finished. The DSR-M will take the volume which needs to be diluted from the sampled media and dispenses it into an empty vial, adding the diluent while mixing both media using air.

 

Filtration and MFC-12

Filtration of the collected samples can be done using 5 to 20 micron filter tips which are attached to the sampling probes and also using the MFC-12 manual filter changer which is integrated into the DSR-M tubing and may hold round filters from 1 to 0.45 micron. Since these round filters pass liquid in one direction only, an additional DSR-MVS valve station is required to create a bypass for the return flow.

Dilution of Sampled Media

If dilution of sampled media is enabled the DSR-M will use the first of the two racks to collect the samples from the dissolution vessels and the second one will hold empty vials into which the diluted media will be dispensed. Once sampling is finished the DSR-M will perform the dilution. It will take the volume which needs to be diluted from the sampled media and dispenses it into an empty vial, adding the diluent while mixing both media using air. Dilution function requires the optional CAT-DM dilution module.

Technical Data of the Dilutor Pump

ParameterSpecification

Pump Head Volume 100µl
Dispensing Volume 5µl – 250ml or continuous dispensing
Flow Rate 0.1 – 20 ml/min. +/- 1% (related to pump head volume)
Coefficient of Variation CV Using additional piston pumps (CAT-RM module, optional)
Interface RS485 / RS232 for User Calibration
Pump Head Materials Al2O3, PVDF

We reserve the right to make technical changes without any prior notice.

The Piston Pumps

Unlike most systems the DSR-M does not use syringes but valve-less piston pumps. These pumps do not need any time consuming pre-filling and emptying cycles and change of valve positions. Also the dead volume is much smaller compared to conventional syringes and valve installations. A rinsing valve is connected to each sampling and refilling valve to clean them using fresh diluent or media to avoid clocking due to the recipients inside the collected media. Fast coupling systems allow the change of each individual pump head whenever this should become necessary. There are no wear and tear parts inside the pumps needing to be replaced; the precision is kept for the total life time.

The DSR-M dissolution sampling robot is available in these configurations:

No. of Pump ChannelsPump ChannelsSampling CyclesMedia ReplacementDilutionIncluded Racks
DSR-M6-056Up to 20OptionalNA2x 5-10ml Ø12mm
DSR-M6D-056Up to 20, up to 10 with dilution enabledOptionalYes, included1x 5-10ml Ø12mm; 1x HPLC
DSR-M6-156Up to 18OptionalNA2x 15ml Ø16mm
DSR-M6D-156Up to 18, up to 9 with dilution enabledOptionalYes, included1x 15ml Ø16mm; 1x HPLC
DSR-M6-206Up to 18OptionalNA2x 20-25ml Ø16mm
DSR-M6D-206Up to 18, up to 9 with dilution enabledOptionalYes, included1x 20-25ml Ø16mm; 1x HPLC
DSR-M8-058Up to 20OptionalNA2x 5-10ml Ø12mm
DSR-M8D-058Up to 20, up to 10 with dilution enabledOptionalYes, included1x 5-10ml Ø12mm; 1x HPLC
DSR-M8-158Up to 18OptionalNA2x 15ml Ø16mm
DSR-M8D-158Up to 18, up to 9 with dilution enabledOptionalYes, included1x 15ml Ø16mm; 1x HPLC
DSR-M8-208Up to 18OptionalNA2x 20-25ml Ø16mm
DSR-M8D-208Up to 18, up to 9 with dilution enabledOptionalYes, included1x 20-25ml Ø16mm; 1x HPLC
DSR-M12-0512Up to 20OptionalNA2x 5-10ml Ø12mm
DSR-M12D-0512Up to 20, up to 10 with dilution enabledOptionalYes, included1x 5-10ml Ø12mm; 1x HPLC
DSR-M12-1512Up to 18OptionalNA2x 15ml Ø16mm
DSR-M12D-1512Up to 18, up to 9 with dilution enabledOptionalYes, included1x 15ml Ø16mm; 1x HPLC
DSR-M12-2012Up to 18OptionalNA2x 20-25ml Ø16mm
DSR-M12D-2012Up to 18, up to 9 with dilution enabledOptionalYes, included1x 20-25ml Ø16mm; 1x HPLC
DSR-M13-0513Up to 20OptionalNA2x 5-10ml Ø12mm
DSR-M13D-0513Up to 20, up to 10 with dilution enabledOptionalYes, included1x 5-10ml Ø12mm; 1x HPLC
DSR-M14-0514Up to 20OptionalNA2x 5-10ml Ø12mm

DSR-M system configurations

Features

  • Features integrated valve free piston pumps for high precision
  • Modular design allows auto media refill, dilution and sample transfer into sealed vials for six to thirteen station dissolution baths
  • Up to 20 sampling cycles (up 10 cycles with dilution function)
  • Less than 1% transfer error
  • Supports 0.45 micron filtration using MFC-12 manual filter changer and DSR-MVS valve station
  • Sampling sequences are programmed directly at the Pharma Test dissolution bath
  • Stand-alone mode available to support third party dissolution baths

Technical Specifications

Number of sampling cyclesUp to 20 samples from a maximum of 14 vessels (up to 10 samples from 13 vessels with dilution enabled)
Sampling volume0.1 ml to 25.5ml and depending on available vial sizes
Sampling accuracy±1% in relation to testing vessel volumes over a complete dissolution run with 20 samplings
Flow rateMinimum 1 ml/min.; maximum 41 ml/min.
Media refillingUsing the same piston pumps and tubing lines via optional CAT-MRM module
Sample processingUsing optional CAT-DM dilution module with X-Y-Z arm and septum single piercing needle
Dilution factorMaximum 1:100
DisplayBacklit LCD
Data entryFunction keys
Materials usedAll wet parts: 99.7% Al2O3, Teflon or PEEK
Tubing1.0mm ID to 1.6mm OD FEP, PTFE or PEEK (not included in supply scope)
Dispensing probe positioning± 0.8mm
Sample processing probe± 0.5mm
Repeatability± 0.3mm
InterfacesRS232 port, analogue signal I/O port
Power110/230 Volt, 50/60 Hz
Instrument dimensionsApprox. 45cm x 55cm x 53cm (width x depth x height)
Packaging dimensionsApprox. 80cm x 120cm x 75cm (width x depth x height)
Net weightApprox. 49kg
Gross weightApprox. 64kg
CertificationAll components certified to USP / EP requirements
CE / EMC certificationAll CE / EMC Certification provided
ValidationAll IQ & OQ documents included

We reserve the right to make technical changes without any prior notice.

Options

  • CAT-MRM media refilling module
  • CAT-DM dilution and sample transfer module
  • MFC-12 manual filter changer
  • DSR-MVS valve station

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