DS 8000+ with Piston Pump
Tablet Dissolution Test Apparatus

In the pharmaceutical industry, dissolution testing is one of a crucial process that has to be conducted as a part of quality control. To do the dissolution testing efficiently, Labindia has designed DS8000+ with Piston Pump which has 6,7 or 8 vessel configuration. Dissolution Tester has to be in accordance with the pharmacopeia guidelines for getting accurate results.  Labindia's Dissolution Tester DS 8000 (Basic) is explicitly designed to support USP 1, 2, 5 & 6 and is compliant with USP, BP, IP, EP, IP specifications and ASTM 2503-13.

The Piston Pump of this tablet dissolution test apparatus is controlled by the microprocessor, ideal for withdrawing samples from 6 channels and has an inert ceramic rotor that helps in overcoming all the issues regarding absorption. DS8000+ with Piston Pump is equipped with Intelligent sampling system enabling automatic sampling as per the USP specifications. The dissolution tester automatically measures and records the temperature of the individual vessel at specified sample points that saves time for the users.

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Standard Features of DS 8000+ with Piston 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)
Sample Collection
  • 12 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 vials 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
Pump System - PP 08
  • Piston Pump - PP 08 is ideal for sample withdrawal from 6 ,7/8channels.
  • The Piston Pump - PP 08 with inert ceramic rotor overcomes all absorption issues.
  • Accuracy better than ±2%.(@10mL)
  • 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.
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 Piston 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 & carryover
  • 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
DS8000 with Piston Pump
DS8000 with Syringe Pump
Dissolution Vessel

Option for Polycarbonate / Glass Vessels (clear, amber, peak vessels, 250, 150 & 100 ml dissolution vessels available). Also 2 litre Vessel Available

Display

40*2 LCD Display (Alphanumeric)

40*2 LCD Display (Alphanumeric)

RPM

20 to 250 RPM

RPM Accuracy

± 1 RPM

Temprature Range

20° to 55° degree

Temp Accuracy

± 0.1 ° C

Method

15

User 

10

Role

2 Role(Admin & User)

2 Role(Admin & User)

Connectivity

RS-232

RS-232

Test Report

Last Report

Last Report

21 CFR Compliance

Yes( EDC Software)

Auditrail

NA

E Signature

NA

Sampling Interval

30

Sample Interval Time

1min to 720 hrs

Pump Used for Sample Collection

Piston Pump

Syringe Pump

Sampling Volume Range

0.5ml- 25ml

0.5ml-10ml

Rinsing

Rinse

Cleaning Cycle

Yes

Sample Collector Type

Open

HPLC Vials Tray

Yes

Option for 1.5ml & 2ml HPLC tray

Auto Tablet Dispenser

Manual

Tray detection & identification

NA

Contact parts

All Contacts Parts are inert

Sample Collection

10*6 or 16*6. 24*6(optional)

Automatic Vessel Centering

Yes (Complies as per US FDA division of
pharmaceutical analysis (Ref. Document no.
DPA-LOP.002)

Center Shaft

± 0.5mm

Lift Mechanism

Motorized (Automatic) for accurate height

Heater

Isolated temperature controller (vibration-free & precise) with wake up & sleep modes (saves time & energy) (1KW)

Shaft

MonoShaft - Easy Switch Over between Paddle & Basket

Height Adjustment

Automatic height adjustment

Apparatus

 Unique design of USP apparatus
I, II, V, VI & intrinsic dissolution can be used. Also Small Volume Dissolution kit 250ml & 150ml can be used.

Laser Marking on Accessories

Yes

Water Bath

Clear acrylic molded water Bath 

Water Level Sensor

Yes

Power Failure

Yes


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

Dissolution Tester