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Tablet Dissolution Tester DS 8000 with Piston Pump

Tablet Dissolution Tester DS 8000+ with Piston Pump

The Labindia dissolution tester DS 8000 with piston pump is a prefect semi automatic dissolution testing solution to carry precise and efficient drug dissolution. Mono shaft design allows easy changeover between apparatus I and apparatus II thus eliminates routine height validation checks as per pharmacopeia.

Piston pump PP 08 is microprocessor controlled and ideal for sample withdrawal from 6, 7 or 8 channels. All types of media like surfactant are compatible without any effect on the sample volumes.  This dissolution tester contains an inert ceramic rotor in the piston pump PP 08 overcomes all absorption issues.

Over head design of the sample collector give electronic safety for fail safe operation. With a choice of trays the user has a flexibility to choose between test tubes or standard vials that can be used in dissolution testing.

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Standard Features of Tablet Dissolution Tester DS 8000+ with Piston Pump
  • Advanced, Micro-Controller based: User-friendly, complies with current USP, BP, IP, JP & EP specifications. It fulfills all requirements relating to ASTM & FDA Mechanical Calibration.
  • 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 recovery 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)
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 alarm 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
Pump System - PP 08
  • Piston Pump PP-08 is ideal for sample withdrawal from 6, 7/8 channels.
  • The Piston Pump - PP 08 with inert ceramic rotor overcomes all absorption issues
  • Accuracy better  than ±2% (@10 ml)
  • Rinse function for reducing carryover issues
  • Surfactant Media Compatibility
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.
  • Sampling tubes are accurately moved to the USP sampling position i.e. a zone midway between the surface 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.
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.
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 Specification
Parameters
DS 8000+ with Piston Pump
Control

Micro controller based (Advanced version of microprocessor).

Display

40 x 2 line back lighted liquid crystal display (LCD)

Keyboard

Alphanumeric splash waterproof polyester soft 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

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

Maximum Number of Intervals

30

Sampling Volume Range

0.5 - 25.5 ml

Sampling Volume Accuracy

For 10mL, ± 0.2mL

Replenishing mode selectivity

User selectable

Rinsing Functionality

Optional

Dissolution Process Time

1 min. to 720 hours

Channel Temperature Reader

Built-In

Report Format

a) GLP & Pharmacopeia compliant
b) Program parameter report

Output

a) Printer

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)

 

LABINDIA reserve the right to change specification without notice as part of its continuous product development.

Software
  • GLP Compliance:
  • 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 make the system foolproof.
  • Non-Volatile memory storage of 15 methods with parameters.
  • Validation Software to validate RPM, Temperature, sampling volume  & replenish volume.
  • Protects Editing, Avoids invalid entries: Two tier password protection - Admin and User
  • Ease in operation: Dissolution RUN can be started with last run parameters.
  • Facility to view Set Parameters during RUN.
  • Auto Start facility to continue the dissolution analysis in case of short power  interruption (especially useful for long duration analysis of sustained  release tablets).
  • Reports can be obtained even after Resetting / Power off / Power failure  conditions.
  • Error indication helps user to trace the problem.
  • Alarms and Indications: Audible indication for ready state of instrument.
  • Wake-up Alarm: This unique feature automatically turns the bath heater ON at a predetermined time.
Tablet Dissolution Testers