Analytical

Tablet Dissolution Test Apparatus DS 14000+ 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 dr ug from the solid state is defined as the amount of dr ug 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 suppor ts USP 1, 2, 5 & 6. Apparatus for Intrinsic test & stationar y 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 12+2 (6+1 & 6+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 12 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 shaf t without any special tool as per pharmacopeia requirements.

• State-of-the-art design:

» Easy placement and locking of vessels, the Easealign 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 14000 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.

• 12 bowls temperature monitoring system automatically measures and records the temperature of individual vessel at specified sample points.

 

PUMP SYSTEM - PP 12

• Piston Pump - PP 12 is Microprocessor controlled and is ideal for sample withdrawal from 12 channels

• The inert 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

• 12 X 6 X 2 sets of samples can be collected. For more sampling interval, 24 X 6 collection trays are available.

• Option of 1.5ml & 2ml HPLC vials 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

 

ADDITIONAL FEATURES

• Facility to RINSE the entire sampling path in between sampling time points to reduce 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

 

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: 29 litres capacity with built-in water level sensor.

• Bath Circulation: External vibration free water circulator

• Temperature Range: 20°C to 55°C

• Temperature Resolution: 0.1° C

• Temperature 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: 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.

• Maximum Number of Intervals: 30

• Dissolution Process Time: 1 min. to 720 hours.

• 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: 210-230 V AC ± 10%, 50 Hz. - 60 Hz.

• Environmental Operating Conditions:

a) Operation: Indoor.

b) Temperature: Ambient to 45° C.

c) Humidity: 5 to 90% non-condensing.

• Dimensions: 115 x 60 x 70.5 cms. (W x D x H)

• Weight: 140 kgs. approx.

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