Analytical

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)

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