Analytical

Tablet Dissolution Test Apparatus DS 8000+ with Syringe 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 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 & JP 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)

» Online & offline sampling facility

» System has legs (adjustable) having vibration dampeners for levelling as per USP requirements.

» System has sturdy motorised telescopic lift

» System suppor ts polypropylene / SS tip full flow filers (approx. 10 microns)

 

REGULATORY COMPLIANCE

• DS 8000 meets all requirements - validation, qualification & 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 part of the assembly contributes motion, agitation or vibration (500, 750, 900 & 1000 ml).

• 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 & records the temperature of individual vessel at specified sample

points.

• Syringe filer manifold (8 Nos. disposable syringe filter can be inserted) (OPTIONAL)

SYRINGE PUMP FOR AUTOMATIC DISSOLUTION TEST

• Multi-Syringe Pump system designed for automatic Sample Collection from Dissolution Bowls of Labindia Dissolution Test Apparatus DS8000 .

• Perform Rinsing the sample tubing path, Replenishing the blank media volume to bowls and Sample Dilution tasks (Optional for

future development)

• Controlled through Labindia dissolution Instr ument Controller with Operation Status Indications on the front panel for user infor mation.

• Inert fluid path consisting of Teflon carrier tubing, Gastight Glass Syringes with Teflon Plunger and PEEK body Valves.

• Proprietary high-efficiency and maintenance-free Stepper motor drive system.

• Long-life 4 por t Rotary shear valves with SS Body

• Volume accuracy better than 1%.

• Built in Clean function executed at the end of each test to ensure the entire liquid path is clean for the next r un avoiding cross contamination and carryover effects.

• Validation protocol to validate the Sample, Replenishing, Rinse Volume

• All syringes & valves operated synchronously for parallel selection.

• Zero setting for each syringe.

 

SPECIFICATIONS

• No. of Syringes              = 6, 7, 8 (Gastight, ZDV syringes with PTFE Plunger tip)

• Syringe Volume              = 12.5ml

• Valves                             = 4 Port, Fluro Polymer Inert Rotary valves with SS body

• Syringe Drive                  = Stepper motor based.

• Volume                            = 0.5mL to 10.5mL. Programmable.

• Sampling Accuracy         = Better than +/- 1% without tubings

• Min. Sample Interval (10mL) = 5 mins: with TR & Vol. Replenishing,

• Carrier Tubing type          = Teflon, 1/16” OD

• Interface                           = RS232C - Proprietary for Labindia DS8000+/DS14000+.

• Power requirements         = 90-270Vac, 60/50Hz. 50W

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 & car ryover

• 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 & 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 with PVDF coated bath-top plate / F ront 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

• Replenishing mode selectivity: User selectable

• Maximum Number of Intervals: 30

• Dissolution Process Time: 1 min. to 720 hours

• Sampling volume range: 0.5 - 10 ml

• No of positions: 8 Nos. of paddles / baskets with monoshaf t

• 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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