Tablet Dissolution Test Apparatus DS 14000 Basic Smart Piston Pump

DS 14000 SMART with Piston Pump

Tablet Dissolution Test Apparatus (6+2)

Dissolution Testing is extensively conducted in the pharmaceutical sector to be aware of the drug release pattern as well as the physiological availability and bioavailability of formulated tablets or capsules. LabIndia is renowned for producing high-end quality apparatus that caters to the pharmaceutical industry. The system is controlled by the 21 CFR Part 11 compliant with Audit Trail search facility, report generation and printing.

DS 14000 SMART with Piston Pump is one of the latest one in the series of dissolution tester. The dissolution tester has low evaporation lids in a conical shape which help in reducing media loss during the long run. The state-of-the-art design of DS 14000 SMART with Piston Pump dissolution tester has easy placement and locking of the vessel as well as have the facility to monitor the Vessel temperature with an external Temperature Sensor. Clients can print customised PDF reports from this dissolution tester which would help them in studying the quality of the drugs.

Call On: 022-25986110

Mail On: sales.mfd@labindia.com

Standard Features of DS 14000 SMART with Piston Pump

Advance Micro – controller (Arm Core )User-friendly, complies with current USP , IP ,BP,IP & EP and ASTM specifications.
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 )
Vessels, paddles and Basket are Laser marked with serial numbers for traceability
Automated Tablet dispenser drops 12 dosage form at single instance
The conical shape low evaporation recover y lids reduces media loss during long run.
Easy placement and locking of vessels, the Easealign system allows the vessels to simply slide into the place (Bionet Locking).
Facility to monitor Vessel temp ,with an external Digital Temperature Sensor
7’’ Colour High resolution Display with touch screen interface
External vibration free flow water circulator

21 CFR Part 11 Compliance for DS 14000 (with Piston Pump) SMART

Audit Trail for all activities with search facility, report generation and printing.
200 and more User ID’s with alphanumeric entries of user name, password and role based privileges selection.
Multi-level roles with password protection,expiry & complexity
User authentication is per formed 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 and Restore facility available.
LAN (Ethernet) connectivity for Data backup on Network shared folder

Software

QWERTY Keyword 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
Non-Volatile memory storage of 15 methods with parameters.

Regulatory Compliance

DS 14000 SMART 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 (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, Teflon coated Paddles, Gold plated Baskets
Dissolution test vessel : Peak Vessel 1000mL, 100mL, 150mL, 250mL & 500mL with mini paddles
Dissolution Qualification tool kit for mechanical calibration according FDA
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 & records the temperature of individual vessel at specified sample points.
Inert PTFE Fluoropolymer Carrier Tubing

Piston Pump - PP 12

Piston Pump - PP 12 is ideal for sample withdrawal from12 channels.
The Piston Pump - PP 12 with inert ceramic rotor overcomes all absorption issues.
Accuracy better than +2%(@10mL)
Rinse function for reducing carryover issues.
Surfactant Media Compatibility.

Sample Collection

12 X 8 X2 sets of samples can be collected. For more sampling interval, 24 X 8 collection trays are available.
Option of 1.5ml & 2ml HPLC vials 24*8 tray is available.
Wide mouth vial to minimise SLS spillover problem due to foaming Characteristics
Auto recognition sensor for tray with alarm facility for collection sample
Easy positioning with respect to vials or test tube tray for easy changeover

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