What Does Fully Automated Dissolution Testing Mean?
Fully automated dissolution testing in this case means sampling, measuring, and result calculation are automated. The user adds the samples when prompted to do so by the system and takes care of filling and cleaning of the vessels.
What Configurations Does Pharma Test Offer?
The online ADS systems are so called „closed loop“ dissolution systems. The basic building blocks for an ADS automated online dissolution systems are a dissolution testing instrument type PTWS 120, PTWS 820, PTWS 620, PTWS 1220 or PTWS D620, a pumping system for sample transfer, a UV/VIS spectrophotometer with cell changer and the powerful control software package WinDiss ARGUS. The pump can either be a high precision piston pump or a cost effective peristaltic pump.
Unlike the off-line systems where samples are removed from the dissolution vessels and stored either for transfer to a measurement system or for further preparation (e.g. dilution), the samples here are circulated in a closed loop. This means there is no sample volume loss over the time of the dissolution test. At programmed time points the sample circulation is stopped and either a single point absorbance reading or a full UV spectrum of each vessel is collected.
Basically any dissolution testing instrument can be incorporated into an ADS system. The dissolution testing instrument can be equipped with a movable EPE auto sampling system, an ITM individual media temperature monitoring system, a manual or automated tablet drop magazine and 6 to 12 stirred testing stations. Many available UV/VIS spectrophotometers offer 6, 8, 12 or 16 cell changer.
There is no need for a staggered start option here as all samples are simultaneously delivered into the flow-cells of the connected UV/VIS spectrophotometer and measured at equal time points, complying with the USP requirement of the 2% time limit for sampling from all vessels. Attached to the tip of the sampling probes are exchangeable filter tips. A rinsing time has to be taken into account to allow enough time to fill up all tubing with a representative sample. This may take between 15 to 45 seconds prior to the actual measurement. The reading time will be approximately 5 to 10 seconds for 8 vessels. In this case all samples can be analysed in approximately 1 minute. The WinDiss ARGUS software offers full flexibility in programming the sampling and measuring times so that you can adapt the timing to the release behaviour of the samples being tested.
The fully automated fibre-optic IDS 1000 in-situ dissolution test system incorporates a UV diode-array detector, a 9-channel multiplexer and holds up to 8 fibre dip probes which measure straight inside the media. Fast sampling sequences, a full spectra scan is available for all connected vessels in less than 30 seconds, immediate result display, minimum change over time from test to test are some of the advantages offered by the IDS 1000.
The ADS systems and the IDS 1000 are driven by the WinDiss ARGUS dissolution software package. The control of the entire system as well as the data handling, calculation and reporting is performed by the 21 CFR Part 11 compliant software. It includes various drivers for different types of dissolution baths, pumps, spectrometers and auto-samplers.
On the left you can see an overview of our fully automated dissolution testing solutions. Click on the images for more information about system performance, accessories, calibration tools and consumables.
As we are offering a full selection of various instrument drivers (photometer, dissolution baths, pumps, auto samplers) we ask you to contact us for more information and consultation depending on your particular requirements.
- Sampling, measuring, and result calculation are automated
- Online, closed loop systems with integrated spectrophotometers
- Systems composed of Pharma Test dissolution bath, spectrophotometer and peristaltic pump
- Controlled by WinDiss ARGUS software package