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Tablet Dissolution Tester DS 14000 (Basic) SMART Manufacturer/Supplier India

Tablet Dissolution Tester DS 14000 (Basic) SMART

The Labindia Tablet Dissolution tester DS14000 delivers proven quality for simple dissolution testing. Labindia Tablet Dissolution tester  DS 14000 is designed to support USP, BP, IP, JP specifications. The 12+2 (6+1 & 6+1) vessel configuration enables comparative studies.

The automated tablet dispenser allows all the tablets to be dropped simultaneously at the same time automatically once the desired temperature is reached.

Along with the 21 CFR Part 11 compliant software user authentication is performed for each and every operation done by the user. This Dissolution tester also provides a Data backup and restore facility with an Electronic signature available as standard.

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Standard Features of Dissolution Tester DS 14000 (Basic) SMART
  • Advanced, Micro-Controller based (ARM Core): User-friendly, complies with current USP, BP, IP, JP & EP specifications.
  • Moulded water bath with 12+2 (6+1 & 6+1) vessel configuration enables comparative studies.
  • Mono shaft design with easy changeover between Apparatus I & II eliminates routine height validation as per USP.
  • Automatic stirrer 25 mm depth positioning (as per USP requirement)
  • Paddles, Baskets and Vessels are laser marked with serial numbers for traceability.
  • Automated Tablet dispenser - drops 12 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 an external RTD Temperature Sensor (DTS - Digital Temperature Sensor)
Software
  • GLP COMPLIANCE:
  • QWERTY Keyboard for 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
  • Factory entered CUSTOMER NAME with Instrument Serial Number on report printouts make the system foolproof
  • Non-Volatile memory storage of 1000 test methods with parameters
  • Ease in operation:
  • 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
  • Built in report data storage facility
  • Error indication helps user to trace the problem
  • Protects Editing, Avoids invalid entries:
  • User interactive software for ease of operation with protection against invalid entries.
  • 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.
21 CFR Part 11 Compliance
  • Audit Trail for all activities with search facility, report generation and printing
  • 200 & More User ID’s with alphanumeric entries of user name, password and role based privileges selection
  • Multi-level roles with password protection, expir y & complexity 
  • User authentication is performed for each and every operation done by user
  • PDF report file can be created through print
  • USB Printing eliminates the need of serial port to connect with instrument. The user can take printout on any local or network printer as well
  • Electronic signature functionality
  • Data Backup & Restore facility available
  • LAN (Ethernet) connectivity for Data backup on Network shared folder
Regulatory Compliance
  • DS 14000 (Basic) SMART meets all requirements relating to validation, qualification and calibration.
  • Appropriate qualification documents (I.Q. / O.Q.) can be supplied with the instrument.
Typical Specification

 

Control

Micro Controller

Method Storage

Minimum 1000 methods with parameters

Software Compliance

21 CFR Part 11

Temperature Range

20˚C to 55˚C

Temperature Accuracy

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

Temperature Resolution

0.1˚C

Temperature Sensor

DTS - Digital Temperature Sensor

Evaporation Loss

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

Display

7’’ high resolution display with capacitive touch screen

Paddle/Basket Shaft Stirring Speed

20 to 350 RPM (20 to 250±1, 251 to 350±2)

Sampling Time Selectivity

Fixed / programmable (Varying Intervals)

Time Interval Selectivity

In steps of 1 Minute

Vessel Capacity

1000 mL

Water Bath

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

Maximum Number Of Intervals

50

Dissolution Process Time

1 min to 1200 hrs

Print Interface

USB / WiFi Direct enabled Printer

Data Backup Interface

USB / LAN Port

Electrical Power

110/220V AC - 50 Hz/60 Hz

Dimension (W*D*H)

115*60*70.5 cm

Weight

120 kg Approx

 

Additional Features (Optional)
  • Sinkers, USP 5 (Transdermal Paddle Over disk), USP 6 (Transdermal Rotating Cylinder), Intrinsic dissolution apparatus (rotating and stationary), Enhancer cell, Felodipine Basket, Sampling Cannula
  • Dissolution test vessel 100mL, 150mL, 250mL & 500mL with mini paddles
  • Dissolution qualification tool kit for mechanical calibration according FDA
  • Qualification document (IQ and OQ)
Tablet Dissolution Testers