ADS-L 620

Fully Automated Tablet Dissolution Testing System

The online dissolution system ADS-L 620 consists of a Pharma Test dissolution tester PTWS 620, the DAD UV/VIS spectrophotometer TIDAS® L and a multi-channel pump. The system is controlled by the 21 CFR Part 11 compliant user friendly WinDiss ARGUS dissolution software. All instruments are compliant to regulations from USP/JP/CP/EP/USFDA/ASTM and come with a 2 years warranty. One company is responsible for the support of all components.

The PTWS 620 Dissolution Tester

The PTWS 620 is a 6+2 position dissolution bath with an automated lift system for the instrument head. An automated sampling manifold EPE is used to perform dissolution tests as per USP Apparatus 1, 2, 5 and 6. Each 316 stainless steel tube which is part of the EPE sampling system can be equipped with in-line filters to avoid the transfer of undissolved particles into the measurement cells of the spectrometer. The tablet magazine includes magnetic holders for the tube cleaning device.

The TIDAS® L UV/VIS DAD Spectrometer with Cuvette Changer

J&M’s latest models of laboratory spectrometers, the TIDAS® L series of diode-array spectrometers, follow an approach of integration. The diode array technology gives you rapid results over the full spectrum with each measurement. It features an integrated Windows based PC with a large, high-resolution touch screen running the WinDiss ARGUS and the additional spectrometer software TIDASDAQ 3. By integrating the PC into the spectrometer unit the TIDAS® L instruments make excellent use of the limited bench space in today’s typical laboratories. The instruments can also easily be connected to the company’s network.

Furthermore, the TIDAS L spectrometers feature an additional E-ink display which acts as a smart type plate. It shows data like your lab asset or inventory number, the date of last calibration or the due date of the next calibration. Due to the unique nature of the E-ink displays, this information remains visible even when the instrument is turned off. This makes it easy to assess the condition of instrument at a glance. The light in the TIDAS® L is transferred over solarization resistant fiber optic cables from the light source to the detection system. No parts are moving in the light path which gives a very high robustness, reproducibility and stability compared to scanning spectrometers. The use of certified optical fibers in combination with optimized measuring cells ensures reliable measurement results. The TIDAS® L offers an 8-cell changer with 3 additional ports for fiber optic probes. The fiber optic channels can be used to get more detailed information about the dissolution process. All optical parts for these 2 additional channels are included. Only fiber optic probes needs to be added to the system.

The TIDAS® L is the perfect spectrometer for dissolution online tests:

• Very fast measurements of the complete spectra. Six cuvettes are measured in about 8 seconds.
• More information due to the availability of the complete spectral data results in a higher robustness. Other wavelengths and wavelength ranges can be used to perform scattering and turbidity corrections.
• Multicomponent analysis can be performed easily with a Diode Array spectrometer. Interval times remain very short.

WinDiss ARGUS Software

WinDiss ARGUS is a revolutionary scientific dissolution data management software tool for instrument control and advanced data acquisition, management, processing and reporting – designed by users for users. Whether you perform dissolution tests occasionally or several times each day WinDiss ARGUS will make you more productive in running tests and analyzing results. WinDiss ARGUS simplifies how you collect and report dissolution test results by letting you choose the analysis template that matches the way you work. Whether you are in a QC department concerned about data security, compliance and validation, or need maximum flexibility in the R&D area, WinDiss ARGUS can help your lab to perform more efficiently. Intuitive wizards help anyone in your lab work better – your next dissolution test is running in just a few clicks.

Bringing you faster to reliable results:

• Access dissolution data quickly using relational database technology
• Correct turbidity in your spectra at a second wavelength or by second derivative
• Analyze multi component drugs with models created by CAMO’s The Unscrambler
• Drives spectrophotometers, baths and accessories of the market leaders
• Controls offline sampling, online measurement, fiber optics and even multiple baths systems
• Allows seamless growth from single workstations to a dissolution laboratory network
• Designed for a data-secured regulatory lab environment

Tubing Connection

The tubing is made out of inert Teflon (PTFE). PTFE has been shown to be suitable for most of the APIs. The IPC pump tubing itself is made out of suitable inert “Pharmed” tubing.

High Quality Cuvettes

We only use high quality flow-through cuvettes which are designed for dissolution tests. Most important is the material and the accuracy of the path length. Pharmacopoeia recommends having a path length tolerance of at least +/-0.005cm. Path lengths of 10mm down to 0.1mm are available in accordance with USP and EP. According to the law of Lambert Beer the decrease of a path length from 10mm to 1mm is equal to a dilution of 1:10. Therefore smaller path lengths are used in case the concentration of the product is high.

Principle Online Dissolution Testing System

The multi-channel IPC pump is used to transfer the media from the vessels to the spectrometer. The samples here are circulated in a closed loop so that there is no sample volume loss over the time of the dissolution test. At the programmed time point the sample circulation is stopped and either a single point absorbance reading or a full UV/VIS spectrum of each vessel is collected. The control of the entire system as well as the data handling, calculation and reporting is performed by the 21 CFR Part 11 compliant WinDiss ARGUS Software.