Pharma test DSR-M
Piston Pump Piston Workstation
The Pharma Test DSR-M dissociation sampling and collection system is designed for automated sampling, filtration, and sample dispensing in dissociation tests. It can be seamlessly integrated with the PTWS series dissociation testers and quantitative delivery pumps, and is suitable for continuous dissociation sampling at multiple time points for immediate, sustained-release, and long-acting formulations.
I. Fully compliant with the United States Pharmacopeia (USP) <711/724> and the European Pharmacopoeia (EP) <2.9.3/4> standards, ensuring that the dissolution test meets international regulatory requirements.
II. The system supports simultaneous and precise sampling of 6 to 8 slots and is equipped with a syringe-type microporous membrane filtration module, which can effectively prevent particles from entering the collected samples and ensure sample purity.
III. A variety of sample collection racks are available (including standard HPLC/UPLC sample vials and test tube trays), and a syringe tray sealing plate is optional to prevent solvent evaporation, meeting the needs of multivariate analysis.
IV. Through connection and programmable control with the dissolution analyzer main unit, it can accurately perform pipeline pre-rinsing, automatic sampling, multi-point collection, and equal-volume media replacement according to the preset schedule, completely eliminating the time difference and operational error of manual sampling, and ensuring the reproducibility and data integrity of dissolution curve data.
Equipment Introduction
Fully Automated Sampling & Fraction Collection
When connected to the PTWS series dissolution apparatus and peristaltic/piston pump, it can automatically perform sampling, collection, dispensing and pipeline cleaning according to the preset time schedule, realizing completely unattended testing.
Precise control of sampling time eliminates the time delay and operational errors of manual sampling, significantly improving the reproducibility of dissolution curves.
Fully automated sample dilution and liquid handling
Equipped with a high-precision micro-liquid processing module, it can automatically add diluent directly to HPLC/UPLC sample vials or test tubes after sampling, completely replacing the tedious manual pipetting and volume adjustment operations.
It supports programmable and flexible dilution ratios (such as 1:1 to 1:100 and above), which can be set independently for different sampling time points or dissolution vessels, perfectly meeting the analytical linearity requirements of sustained-release formulations and highly active drugs.
It features automatic repeated aspiration and expulsion homogenization and intelligent pipeline rinsing procedures to ensure uniform sample mixing and completely eliminate cross-contamination (carryover).
It supports automatic addition of internal standards, buffers, or stabilizers, and after dilution, it can be directly connected to mainstream HPLC/UPLC autosamplers for analysis.
All dilution parameters, volumes, and ratios are fully recorded by WinDiss ARGUS software and included in audit tracking, fully complying with GMP and 21 CFR Part 11 specifications.
Versatile Sample Rack Configurations & High-Throughput Collection
Supports standard 1.5 mL / 2.0 mL HPLC/UPLC sample vials, and can also be equipped with sample collection racks of various specifications suitable for test tubes (such as 10 mL / 12 mL, etc.).
It features a multi-row collection point design (supporting up to dozens of sampling time points), making it ideal for multi-point, long-term sustained-release/controlled-release formulation dissolution curve testing.
Automatic Media Replacement Functionality
After each sampling point is completed, the system can automatically replenish each dissolution vessel with an equal volume of preheated fresh medium, strictly maintaining the total volume in the dissolution vessel in accordance with the pharmacopoeia specifications (USP/EP requirements).
Anti-Evaporation & Cross-Contamination Prevention
The sampling needle is equipped with a precision lifting mechanism, which pierces or extends into the sample bottle only during sampling and dispensing. At other times, it can be equipped with a dedicated sealing cap or septum pressure plate to effectively prevent the evaporation of volatile solvents (such as alcohol-containing media).
It features intelligent pipeline pre-flushing and evacuation functions to completely eliminate cross-contamination between sampling points.
High modular compatibility and seamless workflow integration.
It can be flexibly combined with various sampling power units such as PT-SP peristaltic pump and CAT-S piston pump.
The collected sample vials can be directly transferred to various brands of HPLC/UPLC autosamplers (such as Waters, Agilent, Shimadzu, etc.), maximizing laboratory workflow efficiency.
Compliant with GMP and 21 CFR Part 11 standards.
The system operation is uniformly controlled by WinDiss ARGUS software or the dissolution instrument host, which fully records sampling logs and audit traces to ensure data integrity.
Product Features
High-precision multi-point automatic sampling; media volume compensation.
Multi-specification sample tray compatibility
Seamless bonding
HPLC/UPLC analysis
Precision X-Y-Z axis automatic puncture; anti-sample evaporation design.
Overall Specifications
Product Model : DSR-M
Manufacturer : Pharma Test Apparatebau AG (Germany)
Version Specification : Version 2.0
Product positioning and operating principles :
A fully automated robotic workstation designed for 6 to 12 cup (up to 13 cup) dissolution testers, featuring automated sampling, dispensing, online dilution, and solvent replenishment.
Suitable for ultra-short time interval sampling, as well as long-term unattended fully automated sampling and collection of long-acting/controlled-release formulations (SR/CR).
Samples can be collected directly in standard open sample vials or test tubes, or injected via a triaxial robotic arm into HPLC sample vials equipped with sealing gaskets to prevent solvent evaporation during long-term testing.
It fully complies with the European Pharmacopoeia (EP) and the United States Pharmacopeia (USP) regulations regarding compensation for volume loss from dissolution sampling.
High-precision valveless piston pump module :
Integrates CAT-M compact piston pump modules with 6 to 13 independent channel dedicated piston pumps, each channel driven independently.
It adopts valveless piston pump technology, eliminating the delays in filling, emptying, and switching valves of traditional syringe pumps. It has a very small dead volume, requires no lifetime calibration, and has no easily worn parts.
Each sampling valve is connected to a cleaning and flushing valve, which can be used to clean the pipeline with fresh diluent or medium to prevent excipient crystals from depositing and clogging the pipeline.
The quick-release pump clamp design makes maintenance and replacement extremely convenient.
Sampling tray and collection capacity :
It features a built-in dual-extraction sample tray, supporting up to 20 rounds of sampling per test (10 rounds when online dilution mode is enabled).
Dual sample tray design: The first tray is used to collect the original sample solution, and the second tray is used to receive the online diluted sample or to perform multiple sample processing.
Sample tray versatility: A single sample tray is compatible with standard open vials, glass tubes, or sealed cap HPLC sample vials.
Automatic solvent replenishment and single-pipe bidirectional transmission technology :
The optional CAT-MRM automatic solvent replenishment module automatically starts equal-volume replenishment immediately after sampling to maintain the sink condition of the dissolution cup.
Innovative shared piping design: Sampling and replenishment share the same set of transmission piping, eliminating the need for additional return pipes between the dissolution instrument and the sampler, significantly simplifying piping complexity and shortening the transmission path.
Sample filtration system configuration :
Front-end filtration: A 5 to 20 µm porous filter head can be installed at the front end of the sampling probe.
Precision online filtration: Optional MFC-12 manual membrane changer (compatible with 1 to 0.45 µm circular membranes), which, together with the DSR-MVS solenoid valve station, establishes a bypass reflux channel for quick membrane replacement between each test cycle.
Online automatic dilution and pneumatic mixing functions :
Optional CAT-DM online dilution and sample transfer module, equipped with a three-axis (XYZ) driven robotic arm and puncture needle.
The dilution ratio can reach up to 1:100; the system automatically draws the set original sample into an empty sample bottle, adds diluent, and mixes it simultaneously with oil-free clean air.
Technical specifications and measurement parameters :
Sampling cycles: up to 20 sampling cycles (supports up to 13 dissolving tanks; 10 cycles in dilution mode).
Sampling volume range: 0.1 ml to 25.5 ml.
Sampling accuracy: Transfer error less than 1%.
Pump flow rate range: 1 ml/min to 41 ml/min.
Diluting ratio range: up to 1:100.
Robotic arm positioning accuracy: injection probe ±0.8 mm, sample processing probe ±0.5 mm.
Positioning repeatability: ±0.3 mm.
Wetted parts: High purity 99.7% alumina ceramic (Al2O3), polytetrafluoroethylene (Teflon) and polyetheretherketone (PEEK).
Compatible piping specifications: FEP or PTFE corrosion-resistant piping with an inner diameter of 1.0 mm to an outer diameter of 1.6 mm.
Operation control, safety protection and connectivity integration :
Control Mode:
Online mode: It can connect to the Pharma Test PTWS series or PT-DT70 dissolution analyzer, and the sampling time point, probe immersion depth (such as 500 ml / 900 ml position) and dispensing schedule can be directly programmed by the dissolution analyzer method management system.
Independent operation mode: Supports independent operation when paired with third-party dissolving instruments from various brands.
Display: Backlit LCD display with function buttons.
Communication interface: RS-232 serial port, analog signal I/O interface.
Fully enclosed transparent acrylic protective cover: The fully enclosed transparent acrylic cover completely isolates the movement of the robotic arm, ensuring the safety of operators and preventing samples from being contaminated by the external environment; both the cover and the sample drawer can be quickly disassembled for cleaning.
Mechanism specifications and electrical requirements :
Power requirements: 110 / 230 V, 50 / 60 Hz.
Packaging and shipping dimensions: approximately 120 × 80 × 75 cm (D × W × H).
Machine net weight / gross weight: approximately 49 kg / 64 kg.
Standard Scope of Supply :
DSR-M main unit (with built-in CAT-M piston pump module)
Complete original manufacturer's certified folder:
Operation Manual
Installation confirmation file
Operation confirmation document
Instrument Maintenance Log
Certificate of Conformity
Optional accessories :
CAT-DM Online Sample Dilution and Sample Transfer Module
CAT-MRM Solvent Automatic Equal Volume Compensation Pump Module
MFC-12 Manual Filter Membrane Replacer (for 0.45 µm / 1 µm filter membranes)
DSR-MVS Return Bypass Solenoid Valve Station
EPE Electric Automatic Sampling Manifold Module (for use with PTWS Series Dissolution Instrument)