Tablet Dissolution Test Apparatus DS 8000+ with Piston Pump
DISSOLUTION TEST APPARATUS
Dissolution Tests are conducted to determine the drug release patterns, physiological availability and bioavailability of for mulated drug products. It is also used as a quality control tool. The Dissolution rate of a drug from the solid state is defined as the amount of drug substance that goes into solution per unit time under standardised conditions of liquid / solid inter face, temperature, and solvent composition.
LABINDIA brings to you the State-of-the-art Dissolution Testing Apparatus in elegant design with advanced features, which supports USP 1, 2, 5 & 6. Apparatus for Intrinsic test & stationary basket methods are available.
STANDARD FEATURES
• Advanced, Micro-Controller based: User-friendly, complies with current USP , IP & EP specifications.
• Splash waterproof keyboard: Alphanumeric polyester soft keys for keyboard.
• Moulded water bath with 6+2 (3+1 & 3+1) vessel configuration enables comparative studies.
• External vibration free Water Circulator: for uniform water circulation, with audible, low water level alarm, with indication on
display for safety.
• Mono shaft design with automatic adjustment for 25 mm depth setting with easy changeover between Apparatus I & II
eliminates routine height validation as per USP.
• Paddles, Baskets and Vessels are laser marked with serial numbers for traceability.
• Tablet dispenser - drops 6 dosage form at single instance.
• Low Evaporation Lids:
» The conical shape low evaporation recover y lids reduces media loss during long run.
» Integrated pre-centered lids; no manual removal or positioning of lids. This ensures automatic vessel centering and precise positioning
of paddle/basket with shaft without any special tool as per pharmacopeia requirements.
• State-of-the-art design:
» Easy placement and locking of vessels, the Ease-align system allows the vessels to simply slide into the place (Bionet Locking).
Once placed, vessels do not float even when empty.
» Facility to monitor Vessel temp., with DTS Technology (Digital Temperature Sensor)
REGULATORY COMPLIANCE:
+ • DS 8000 meets all requirements relating to validation, qualification and calibration.
• Appropriate qualification documents (I.Q. / O.Q.) can be supplied with the instrument.
INTELLIGENT SAMPLING SYSTEM
• Automated sampling as per USP Specifications. Sampling tubes are lowered in the media only at the time of sampling and withdrawn
immediately after sampling, thus no par t of the assembly contributes motion, agitation or vibration.
• Sampling tubes are accurately moved to the USP sampling position i.e. a zone mid way between the sur face of media and the top of
paddle/basket parameters, not less than 1 cm from the vessels wall as selected in the method.
• 6 vessels temperature monitoring system automatically measures and records the temperature of individual vessel at specified sample
points.
PUMP SYSTEM - PP 08
• Piston Pump - PP 08 is Microprocessor controlled and is ideal for sample withdrawal from 6 channels
• The Piston Pump - PP 08 with incert ceramic rotor overcomes all absorption issues
• High flow rates of 25 ml / min can be achieved with accuracy better than ±5%
• Rinse function for reducing carryover issues
• Surfactant Media Compatibility.
SAMPLE COLLECTION
• 10 X 6 or 16 X 6 sets of samples can be collected. For more sampling interval, 24 X 6 collection trays are available.
• Option of 1.5ml & 2ml HPLC vial tray is available.
• Over Head Design for electronic safety and fail safe operation
• Sensor to locate proper position of tray with alar m facility for collection of sample
• Wide mouth vial to minimise SLS spillover problem due to foaming characteristics
• Easy positioning with respect to vials or test tube tray for easy Changeover
ADDITIONAL FEATURES
• Built-in Validation software.
• Facility to RINSE the entire sampling path in between sampling time-point to eliminate contamination & carryover
• Specially developed cleaning system to clean the entire sampling path after each run.
• Facilities to perform the dissolution test using two buffers (Buffer changing) to cater the application of enteric coating tablets.
• Recovery Test facility to study 100% Drug Dissolution.
• Split & on-time interval
REPORTS
Selectable Report Format, complying with GLP requirements.
RUN REPORT
a) Report giving Run No., Set parameters and Actual parameters during the dissolution process.
b) Diagnostic functionality repor t to ensure proper working of the system
c) Printout of each vessel temperature and paddle/basket speed at every sampling interval for validation.
d) Validation repor t for Temperature, RPM, Sample Volume and Replenishing Volume.
TYPICAL SPECIFICATIONS
• Control: Micro controller based (Advanced version of microprocessor).
• Display: 40 x 2 line back lighted liquid crystal display (LCD)
• Keyboard: Alphanumeric splash waterproof polyester sof t keys.
• Method Storage: 15 programs with parameters.
• Data Storage: Available with Non-Volatile memory.
• Water Bath: 17 litres capacity with built-in water level sensor / Front located drain tap for easy draining of the water bath.
• Bath Circulation: External vibration free water circulator.
• Temperature Range: 20°C to 55°C
• Temperature Resolution: 0.1ºC
• Temperature Control Accuracy: up to 45°C ±0.1°C & >45°C up to 55°C ±0.2°C
• Temperature Sensor: DTS - Digital Temperature Sensor
• Paddle/Basket Shaft Speed: Range 20 to 250 RPM ±1%
• Dissolution Vessel: option for Polycarbonate / Glass Vessels (clear, amber, peak vessels, 250, 150 & 100 ml. dissolution vessels available)
• Sampling Time Selectivity: Fixed/Programmable (varying intervals)
• Time Interval Selectivity: In steps of 1 minute
• Sampling Volume Range: 0.5 - 25.5 ml
• Replenishing mode selectivity: User selectable
• Rinsing Functionality: Optional
• Maximum Number of Intervals: 30
• Dissolution Process Time: 1 min. to 720 hours
• Syringe Filter Compatibility: MDI, WHATMAN, MILLIPORE & AXIVA (25 mm diameter) (Cer tified filters available from LABINDIA)
• 6 Channel Temperature Reader: Built-In
Report Format: a) GLP & Pharmacopeia compliant b) Program parameter repor t
Output:
a) Printer: Compatible for deskjet, inject and dot matrix printer
b) RS232C: For PC Connectivity
c) 21 CFR Part 11 compliance software available (Optional)
• Power: 110 / 220 V AC - 50 Hz / 60 Hz
• Environmental Operating Conditions: a) Operation: Indoor. b) Temperature: Ambient to 45ºC. c) Humidity: 5 to 90% non-condensing.
• Dimensions: 71.5 x 60 x 70.5cms (W x D x H)
• Weight: 80 kgs. approx. (Basic Dissolution System)