IDS 1000

The IDS 1000 in-situ dissolution system with fiber optic technology brings direct measurement technology to dissolution testing.

IDS 1000

In-Situ Tablet Dissolution Testing System

The IDS 1000 in-situ dissolution system with fiber optic technology brings direct measurement technology to dissolution testing. Sample measurement is automated and self-contained, there is no need for samples to be pumped out of the dissolution vessels at all. The IDS 1000 includes an automated tablet drop magazine for the synchronous release of up to eight samples. The built-in vessel covers close the dissolution vessel completely, reducing evaporation to a minimum. The vessels are arranged in a 4 + 4 configuration, stirring speed, temperature and stirrer immersion position can be set using the WinDiss ARGUS software.

IDS 1000 In Situ Dissolution Testing System

IDS 1000 In Situ Dissolution Testing System

In-Situ Dissolution

IDS or In situ Dissolution System is about the application of direct measurement technology to Dissolution Testing. Traditionally, dissolution testing has been carried out on solid dosage forms using a standard dissolution tester. Samples of the dissolving active within the dosage form are taken for estimation from the dissolution tester either manually, or using more automated means such as a pump which has been connected to a suitable measurement device, usually a UV Spectrophotometer.

Using IDS 1000, not only can the whole process of sample measurement be automated, but can also be self contained, such that there is no need for samples to be pumped out of the dissolution vessels to external measurement facilities such as a spectrometer, because all that is needed for the measurements to be made is contained within the confines of the instrument itself.

 

The fiber-optic DAD spectrometer with multiplexer is integrated in the instrument head.

The fiber-optic DAD spectrometer with multiplexer is integrated in the instrument head.

Operating Principle

In the first instance the introduction of tablets or other dosage forms is as with a conventional dissolution instrument using a synchronous tablet drop magazine. The instrument is started according to the WinDiss32 Dissolution Software control, but the sampling sequences have been replaced by direct measurement technology within the dissolution vessel itself, with each measurement cycle accomplished in seconds rather than minutes.

The in-situ measurement is performed by fiber optic probes which are located in the centre of the stirring shafts of the dissolution tools, i.e. paddle or basket (USP App. 2 or 1). The fiber optic probe can be removed from the shaft so that various path length inserts can be employed for different active concentrations and extinction coefficient ranges.

Difference to Other Systems

This system is different for many reasons and brings a really new dimension to dissolution measurement. For example the fiber optic probes are easily accessible and can have various cell paths attached. In situ probe placement means fast measurement times and no fluid circulation. No more pump tubing to be qualified or fail during a dissolution run. It also means that there is no fluid perturbation inside the vessel from sampling probes as used in conventional measurement cycles.

It is also different from other instruments, in which attempts have been made to use fiber optic measurements, as this system has only one built in diode array spectrophotometer, but is still able to operate with 9 separate fiber optic sensor paths which are multiplexed to a central sampling unit. The biggest difference is that all IDS 1000 components, including the built-in Diode Array spectrophotometer are contained in a single housing, so that all optical components have a fixed geometry.

This coupled with no externally pumped liquids not only allows us to have very fast sampling sequences (useful for fast disintegrating and fast dissolving actives) but also means that the system does not contain unnecessary hardware, whilst still offering the advantage of a self-validation routine (SST or System Suitability Test) for all the on-board measurement hardware. This validation routine is activated before the start of each analysis.

The combination of self-validation, speed, precision and no external fluid circulation are very attractive options. The built in Diode Array Spectrophotometer also means that single wavelength measurements are no longer made, but whole spectra may be accumulated to optimize the analytical wavelength used. This also allows the use of first derivative techniques in order to analysis multi-component formulations with overlapping absorption curves.

Supportive Design

Today the instrument operator of such instruments expects not only conformity with the pharmacopoeia requirements, but also easy operation and accessibility to the test vessels. This means a dissolution bath should offer both good manual access as well as automation facilities. The IDS 1000 offers both. All test vessels are placed in a 4 + 4 line-up so that it is easy to remove spent samples and refill with medium. The clear-view Plexiglas water bath sits on vibration absorbing feet as does the built-in circulation pump. There are external temperature probes to better control both bath and medium temperature.

The depth setting of the stirrers is programmable. In fact 8 tool depth positions can be selected to meet all settings required for different test tools such as Paddles, Baskets, Transdermal Cylinders and so on. The PHARMA TEST IDS 1000 In-Situ Tablet Dissolution Tester exceeds all technical requirements which are currently described in the USP <711/724>, FDA, EP <2.9.3/4> and German Pharmacopoeias.

Vibration Absorbers

The special design, in which the pump and heating system (as well as the mains  electronic boards) are accessible without having to move the instrument, coupled with the fact that the water bath is placed on vibration absorbers virtually eliminates any vibration transfer and offers easy maintenance facilities. The built-in circulation pump is specially isolated for absolute vibration free operation. The measurable vibration is even lower than that of systems which use a separate heating circulator system that is placed to the same bench. The electronic control system monitors water level, pump flow, stirrer speed and temperature.

Test Procedure

  • No need to remove any samples
  • No worries about USP 1% limit for volume inaccuracies
  • All USP rules regarding sampling position followed
  • Comes with USP/EP App. 2 stainless steel paddles
  • Literature to support similar results to conventional testers
  • Easy access to all user serviceable parts
  • All IQ and OQ paperwork of the instrument is included in the standard supply scope

Operating Principle of the DAD Spectrophotometer

A complete new design of detector and optics is implemented inside the IDS 1000 F/O Dissolution Test System. The result is a spectrophotometer which is optimized for the use of fiber technology offering state of the art performance. Combined with a 9-channel multiplexer it is possible to acquire 8 channels with fiber probes directly inserted to the hollow shafts of the vessels. The ninth channel allows reference measurement for each measurement cycle and boosts the instrument performance to a real double beam spectrophotometer. With respect to maintenance and service all components are easily accessible. It guarantees highest demands on robustness and reliability. The inbuilt solution inside the IDS 1000 reduces footprint and offers highest comfort for complete system validation.

Operating principle of a diode array spectrometer

Operating principle of a diode array spectrometer

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.

Features

  • Fiber optic guides take the measurement to the sample (vessel)
  • Fiber guides made from stainless steel
  • Interchangeable tips for cell path variation
  • All fiber guides plug into multiplexer input on front panel
  • Measurements made with hollow shaft technology
  • 316 Stainless steel fabrication throughout
  • Paddles or baskets just screw into mono shaft
  • Paddle “windows” allow good flow through of medium
  • System set up to work with almost all USP tools
  • Choose USP 1 or USP 2 as well as USP 5
  • Special tools for trans-dermal patches and creams
  • Easy tool change over
  • Qualify the 25mm position for paddles and all other tools are automatically in correct working position.
  • Synchronous tablet drop with auto-magazine
  • Program controlled tablet drop for all vessels while stirrers don’t move
  • Tablet magazine doubles as low-loss vessel cover
  • Can hold oblongs as well as round dosage forms
  • UV measurements made using a DAD Spectrophotometer
  • State-of-the-Art high performance DAD Spectrophotometer
  • Built in multiplexer means only one spectrometer needed
  • Excellent drift characteristics Easy access to all serviceable parts (e.g., lamps)

Advantages

  • SST, System Suitability Test prior to the start of an analytical sequence.
  • Easy access to lamp and power supply – without having to physically move the bath or the housing of the complete test equipment. Supports service and maintenance in an efficient way.
  • Fast acquisition of all 9 channels in less than 20 seconds
  • Real sequential dual beam operation with reference and intensity compensation
  • Much higher response time, up to 50 times faster compared to existing systems
  • A special highlight is the possibility of high speed kinetic measurements at a free selectable channel with up to 50 spectra per second.
  • Fiber probes can be adapted or exchanged very easy
  • No mechanical moving parts inside the active optical path, up to 10 times better drift and noise behaviour compared to competitive systems
  • In-situ measurements reduce error impacts by sample transportation inside tubes and pumps.
  • No additional space for photometer is required, the footprint of IDS 1000 includes all spectrophotometric components
  • Fitted optical construction, calculated not “tried out”, providing maximum light gain and thus outstanding signal to noise ratio and drift stability
  • UV-resistant aperture adjuster and optimized light fibers, a nearly unlimited possibility to use various types of measuring cells or arrangements
  • Multi-layer light filter to suppress second order effects
  • High process stability due to ceramic housing with no moving parts for best thermal and mechanical stability, a guarantee for accurate and correct results
  • Wavelength stability and reproducibility allows to measure absorbance values also at the slope of the signal. There is no necessity to measure always in the peak maximum.
  • Easy handling, maintenance and service, no complicated and time-consuming calibrations necessary for simple validation
  • Modern data processing allows unmatchable measurement speed, easy setting of analysis parameters, saving time and money
  • High acquisition speed offers fast channel multiplexing or high speed kinetic measurements
  • Various interfaces like Ethernet, RS 232, ISA, PCI or PCMCIA available, providing maximum flexibility and future connectivity
  • Multiplexer Unit
  • State of the art design and functionality. Produces no additional noise or drift!
  • The multiplexer wheel and the shutter are the only moving parts in the system
  • The multiplexer can switch in less than 500 ms between each channel and can
  • Address all channels in less than 5 seconds.
  • Simple interface via RS 232 and full control by spectrophotometer
  • Easy access for service by exchangeable components

Technical Specifications IDS 1000

Parameter Specification
System Basis IDS 1000 Dissolution Tester incl. hollow shaft stirrer shafts with exchangeable stirring inserts for paddles, baskets, transdermals etc
Drive system 24 V DC motor drive, microprocessor controlled continuous speed adjustment
Speed Range 25 – 250 rpm, ± 1 rpm
Heating System 1 KW heater with vibration free mounted circulation pump, inside bath stainless steel water diffuser
Temperature Control 1 control and one safety sensor, overheating cut-out and thermo fuse, external temperature probe to read media temperature prior and after test
Temperature Range 25.0° C – 45° C, ± 0.2° C
Test Vessels 8 round bottomed USP 1 litre glass vessels, individual numerical coding, 1 vessel for standard and 1 for medium (blank)
Stirrers 8 off 316 stainless steel mono-shafts with 316 stainless steel blades screwed into the mono-shafts
Tablet Introduction 1 automated magazine which drops 1 sample automatically at start of a run into the dissolution vessel during which time the stirrers are stopped
Sample Analysis UV Diode Array spectrophotometer incl. multiplexer to select 8 positions and a reference cell, wavelength range 190 – 610 nm, resolution 0.8 nm/Pixel; long term stability and wavelength accuracy <0.1nm; integrated Halogen and Deuterium lamp.
Dip Probes 6 to 8 fiber optic dip probes are placed inside the hollow stirrer shaft. Inserts are used to adapt path length from 1 to 20 mm
Reference Cell reference cell holder connected by a fiber optic link to the DAD Spectrometer: takes sample standard solution during an automated run
Calibration Setup 8 off 50ml plastic beakers are used to calibrate the dip probes when required. Simply place the holder underneath the stirrer and run a software controlled calibration procedure
Control Direct PC control, Windows 2000/XP
Software WinDiss32 IDS Dissolution Software, fully 21CFR Part11 compliant software package
Validation All instrument IQ and OQ paperwork available

Technical Specifications Integrated Tidas Detector

Parameter Specification
Diode Array Detector TIDAS Detector element with 1024 diodes
Spectral range 190 nm – 610 nm
Spectral resolution 0.8nm per pixel
Optical grating 248 L/mm
Baseline noise specification Extremely low at < 50­ AU peak to peak without smoothing
Wavelength accuracy Long term stability < 0.1nm

Repetitive Accuracy is < 0.1nm

Temperature Drift < 0.005nm / °C
Scattered light < 0.1% @ 340nm (D2 lamp)
Light sources Integrated D2
Light source Built in light source with light transfer using fiber guides
Lifetime D2 lamp has a life of approx. 1500 hours
Data Integratio Data integration time approximately 100ms per channel
Bench space required Approx. 1100 x 800 mm bench space
Net / Gross weight Approx. 95 / 135 kg

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

Included in the Standard Scope of Supply

  • IDS 1000 electric tablet magazine and PP vessel cover
  • Stirrer Shaft Center Adjustment Cover, to Adjust and Qualify Stirrer-Vessel Centricity
  • Reference cell holder for IDS 1000
  • One set of batch coded 1000ml Borosilicate glass vessels
  • One set of depth adjustment balls
  • One bottle of ALGEX water preservative
  • DAD detector for ultrafast measurements of the complete spectra
  • 21 CFR part 11 compliant WinDiss ARGUS software for optimized dissolution test procedures
  • Comprehensive documentation folder including:
    • User manual
    • DQ/QC instrument compliance test certificate
    • IQ documentation
    • OQ documentation
    • Instrument logbook
    • Compliance certificates for vessels and stirring tools

Options

  • Amber coloured vessels (for UV protection) – Instrument Calibration set for USP / EP OQ procedures
  • Dip probes with different path length: 1 – 20 mm

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