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Tablet Dissolution Tester DS 8000+ with Piston Pump & Automatic Filter Changer

Dissolution testing is considered one of the most important Quality control test performed on pharmaceutical dosage forms. The Labindia dissolution tester DS 8000 can be configured with a piston pump and automatic filter changer. Main concern of analysts is sample filtration process after collection of sample. Hence to overcome this the dissolution tester along with the pump and filter changer was developed by Labindia to ease the dissolution testing procedure.

Automatic filter changer FC 08 is controlled by the Dissolution tester for sample withdrawal from 6, 7 or 8 lines. Any standard 0.45 micron syringe filters with 25mm diameter can be used. Upto 96 filters can be stored for uninterrupted sample filtering for 16 sampling points. Used filters are automatically removed and replaced with new ones.

FC 08 is used in conjunction with high pressure piston pump PP 08 with filtration down to 0.2 micron syringe filters for UPLC analysis.

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Tablet Dissolution Tester DS 8000+ with Piston Pump and Automatic Filter Changer
Standard Features of Dissolution Tester DS 8000+ with Piston Pump & Filter changer
  • 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)
Piston Pump-PP08
  • 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.
Filter Changer-FC 08
  • Automatic Filter changer FC 08 is Microprocessor controlled and designed to filter 6, 7, or 8 sampling lines simultaneously.
  • Accessory for Inline Filtering of Sample before collection through Syringe Filters
  • FC 08 is used in conjunction with high pressure LABINDIA Piston Pump-PP 08 with filtration
  • High Storage capacity – up to 96 filters at a time gives uninterrupted filtered sample collection for 16 Sampling Points.
  • Individual channel Sensors to ensure filters are in place.
  • Incase the syringe filter is missing, automatic switch-over of valves to collect unfiltered sample, with an indication in the printout
Regulatory Compliance
  • DS 8000+ with Piston Pump & Filter Changer 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
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 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.
Typical Specification
Parameters
DS 8000+ with Piston Pump & Filter Changer
Dissolution Vessel

option for Polycarbonate / Glass Vessels (clear, amber, peak vessels, 250, 150 & 100 ml. dissolution vessels available)

Display

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

RPM Accuracy

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

Temperature Range

20°C to 55°C

Temp Accuracy

up to 45°C ±0.1°C & >45°C up to 55°C ±0.2°C

6 Channel Temperature Reader

Built-In

Method

15 programs with parameters.

Replenishing mode selectivity

User selectable

Time Interval Selectivity

In steps of 1 minute

Syringe Filter Compatibility

MDI, WHATMAN, MILLIPORE & AXIVA (25 mm diameter) (Certified filters available from LABINDIA)

21 CFR Compliance

Yes (optional) with EDC software.

Audit trail

Yes (Optional)

E Signature

Yes (Optional)

Sampling Interval

Fixed/Programmable (varying intervals)

Sample Interval Time

In steps of 1 minute

Automatic Vessel Centering

option for Polycarbonate / Glass Vessels (clear, amber, peak vessels, 250, 150 & 100 ml. dissolution vessels available)

Report Format

a) GLP & Pharmacopeia compliant
b) Program parameter report.

Lift Mechanism

Motorized (Automatic) for accurate height

Heater

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

Shaft

Range 20 to 350 RPM

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

17 litres capacity with built-in water level sensor / Front located drain tap for easy draining of the water bath

 

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

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 of 15 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.
Tablet Dissolution Testers