Analytical

Tablet Dissolution Test Apparatus DS 8000+ with Piston Pump and Filter changer

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 supports 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 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, 7, 8 channels

• The Piston Pump - PP 08 with iner t 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 car ryover issues

• Surfactant Media Compatibility

 

FILTER CHANGER - FC 08

• Automatic Filter changer FC 08 is Microprocessor controlled and designed to filter 6, 7, or 8 sampling lines simultaneously.

• Accessory for Inline Filtering of Sample before collection through Syringe Filters

• FC 08 is used in conjunction with high pressure LABINDIA Piston Pump-PP 08 with filtration down to 0.22 & 0.45 μm

• High Storage capacity – up to 96 filters at a time gives uninterrupted filtered sample collection for 16 Sampling Points.

• Individual channel Sensors to ensure filters are in place.

• Incase the syringe filter is missing, automatic switch-over of valves to collect unfiltered sample, with an indication in the printout

 

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

 

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)

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