Dissolution Testers
HPLC On-/Offline System

A high degree of automation and flexibility is offered by the new half-automated on-/offline dissolution testers. It is based on the fully validated ERWEKA Disso.net software and offers automated dissolution testing, fraction collection, UV-VIS or HPLC analysis as well a combination of all. The on-/offline dissolution system uses an innovative flow-through system of sealed PEEK-vials. The samples are  withdrawn from the dissolution testers through tip filters from 1 µm porosity by a peristaltic pump.

In case of filtration from 0.45 µm porosity, the membrane filter changer AFC 825  or double filtration station in combination with the high precision piston pump PVP (filtration of 0.22 µm) can be used to the PEEK block of sealed flow-through vials integrated in the auto sampler.

Download the Online System Spec Sheet here.


Overview
Connectivity

HPLC Online connection or chromatograph systems

Our on-/offline dissolution testing system offers connection to equipment of all main manufacturers of HPLC systems for e.g. Shimadzu, Agilent and Waters as well as the possibility of a connection to different chromatograph systems like Empower (Waters) or Cerity (Agilent).

UV-VIS Online Connection

In addition to the HPLC connection the ERWEKA on-/offline dissolution system offers the possibility to include a UV-VIS spectrophotometer (ERWEKA, Perkin Elmer, Shimadzu, Analytic Jena, Agilent) into the closed-loop sample withdrawal system, either between the sample transfer pump and the PEEK flow-through vial block or the PEEK flow-through vial block and the return to the dissolution tester.

Therefore the ERWEKA on-/offline dissolution system can be used as:

  • sample collection device (max. 324 samples; incl. sample tempering)
  • a HPLC online system in combination with virtually any brand of HPLC device
  • an UV-VIS online system (incl. virtual dilution by various path length with optimized flow-through cuvettes)

Capacity
Connect up to two dissolution testers

The ERWEKA on-/offline dissolution system allows to connect two ERWEKA dissolution testers via two individual sample transfer pumps to one autosampler with two embedded PEEK flow-through vial blocks (no cross contamination).

Either none, one or both of the dissolution testers, in addition to the HPLC online system, can be fitted with a UV-VIS spectrophotometer inside the close-loop sampling system.


Dissolution Testers

Full Control
Disso.Net Software

The ERWEKA Disso.net software is the perfect 21 CFR Part 11 compliant companion to our dissolution tester systems. The software offers support of all methods manageable with the ERWEKA DT dissolution testers as well as the automated RoboDis II.

Disso.net helps you with standard dissolution jobs, handles qualifying tasks and provides control over each single function and connected device (e.g. dissolution tester or UV/VIS spectrophotometer). Our audit trail generates a detailed protocol recording all events and time. The software includes an easy to handle method editor for highest repeatability. After finishing the dissolution test, Disso.net creates reports with your corporate logo as PDF-file or exports your results (e.g. as XML-file).


Video
Monitoring

An automated system runs without user observation. In order to determinate the cause in case of unexpected results, ERWEKA offers video monitoring of  six dissolution vessels of one or two connected dissolution testers.The video monitoring allows recording of each test-run in combination with real-time overlapping dissolution profile to identify disturbances such as coning etc. and to get the visual impression of 24 hours in 2 minutes.

The video monitoring is a very powerful tool for method development as well for troubleshooting.

Dissolution Testers

Specifications

  • Technical details:
    • Video recording of the dissolution process in time-lapse mode
    • Up to 6 cameras supported
    • Overlapping real-time dissolution curve
    • Support for formulation and dissolution method development
    • USB 3.0 cameras with USB 3.0 Hub – connect only one cable
    • Updated low-light capabilities

     

  • Options: Depending on your requirements and needed system setup, a broad range of options is offered. Please contact our sales representative for more information.
    Dissolution Tester: One or two ERWEKA DT 720 or DT 820 series dissolution tester
    Pumps: 8-Channel Peristaltic Pump (IPC 8). Pump tubings are made of Verderprene (similar to fluoropolymer) to prevent the absorption previously associated with peristaltic pumps and PVC tubing. Via the serial RS 232 interface the pump is controlled from the external PC<Optional:
    Valve-free piston pump PVP for high precision and high throughput,  maintenance free
    Sample Collection: for HPLC: CTC sample collector with up to 324 HPLC vials (optional cooled)
    Spectophotometers: ERWEKA SPM or Shimadzu 1800 including 8 position cell changer, dissolution kit, additional tubing/connectors and upgraded validated HPLC online dissolution software for online UV-VIS analysis incl. protocols Analytic Jena Specord 205 or Agilent 8453, including 8 position cell changer, dissolution kit, additional tubing/connectors and upgraded validated HADs dissolution software for Online UV-VIS analysis incl. protocols
    System Control: ERWEKA Disso.net Software: Windows based, CFR 21/11 compliant. ERWEKA driver to connect and control ERWEKA DT dissolution testers
    System Tubing System tubing PTFE
    Cells: Cuvettes for UV-VIS Spectrophotometers with fluoropolymer tubing (0.8 mm o.d.) and screwfittings are available with various path length (1 mm, 2 mm, 5 mm, 10 mm)
    IQ/OQ/PV: IQ/OQ/PV documents are available, IQ/OQ/PV service is available
    Video Video recording of dissolution test of 6 vessels