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Tablet Dissolution Tester DS 8000+ with Syringe Pump

Tablet Dissolution Tester DS 8000+ with Syringe Pump

The Labindia Tablet dissolution tester DS 8000 with Syringe pump is an ideal  semi automated system for the routine testing.  The User interactive software in dialogue mode ensures ease of operation with protection against invalid entries.

The syringe pump system can be configured for 6,7 or 8 syringes for sampling. The inert fluid path consists of Teflon carrier tubings, Gas tight glass syringes with teflon lunger and PEEK body valves.

Calibration and validation methods are built in for ease of operation. All reports and data can be printed with a printer using parallel or serial port.

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Standard Features of Dissolution Tester DS 8000+ with Syringe Pump
 
  • User-friendly, complies with current USP, IP, BP & EP and ASTM specifications.
  • Alphanumeric polyester soft keys for keyboard.
  • External vibration free Water Circulator for uniform water circulation with audible and low water level alarm.
  • 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.
  • Facility to monitor Vessel temp, with DTS Technology (Digital Temperature Sensor)
  • Easy placement and locking of vessels, the Ease-align system allows the vessels to simply slide into the place (Bionet Locking)
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 Sampling tubes are lowered in the media only at the time of sampling and withdrawn immediately after sampling, thus no part of the assembly contributes motion, agitation or vibration (500, 750, 900 & 1000 ml).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
  • 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 Instrument Controller with Operation Status Indications on the front panel for user information.
  • 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 port Rotary shear valves with SS Body
  • Volume accuracy better than ±2%.
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
Software
  • Alphanumeric entries of Sample Name, Sample Number and Identification Number for authentication.
  • Built-in Real Time Clock (RTC) for date and time on display and on printout.
  • Daily Auto Incremented Run Number and factory entered CUSTOMER NAME with Instrument Serial Number on report printouts
  • Non-Volatile memory storage methods with parameters.
  • Two tier password protection of Admin and User
  • Reports can be obtained even after Resetting / Power off / Power failure conditions.
  • Error indication helps user to trace the problem.
  • Audible indication for ready state of instrument.
  • Validation Software to validate RPM, Temperature, sampling volume & replenish volume.
Regulatory Compliance
  • DS 8000+ with Syringe Pump meets all requirements relating to validation, qualification and calibration.
  • Appropriate qualification documents (I.Q. / O.Q.) can be supplied with the instrument.
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
Typical Specification

 

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 / 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

Evaporation Loss

1% (at 50 RPM / 37˚C / 1000mL / 24hrs)

Paddle/Basket Shaft Speed Range

20 to 350 RPM

RPM Speed Accuracy

20 to 300 RPM ±0.5 RPM & Above 300 RPM ± 0.8 RPM

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 monoshaft

6 Channel Temperature Reader

Built-In

Report Format

a) GLP & Pharmacopeia compliant

b) Program parameter report

 

 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)

Tablet Dissolution Testers