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Dissolution Tester with Peristaltic Pump

Tablet Dissolution Tester DS 14000 with Peristaltic Pump

For high through put the tablet dissolution tester DS 14000 with peristaltic pump is a perfect solution for dissolution testing as it confirms to the latest USP, EP, BP, IP standards. The paddles, baskets and shafts of the dissolution tester are serialised for traceability.

The Alpha numeric keypad of the dissolution tester helps in the easy control of the entire dissolution apparatus. The efficient and versatile 24 channel peristaltic pump of Swiss make Ismatec transports samples from the dissolution vessels to the sample collector with high accuracy. Click n Go cassette design ensure longevity of the tubings and sample accuracy.  

User can perform dissolution testing using two buffers for application like enteric coated tablets.

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Standard Features of Dissolution Tester DS 14000 with Peristaltic Pump
  • User-friendly, complies with current USP, IP, BP, IP & 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 12 dosage form at single instance.
  • The conical shape low evaporation recovery lids reduces media loss during long run.
  • Facility to monitor Vessel temp, with DTS Technology (Digital Temperature Sensor)
Additional Features
  • Facility to RINSE the entire sampling path in between sampling time points to reduce 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 Sampling tubes are lowered in the media only at the time of sampling and withdrawn immediately after sampling, thus no par t of the assembly contributes motion, agitation or vibration.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 surface of media and the top of paddle/basket parameters, not less than 1 cm from the vessels wall as selected in the method.
  • 12 bowls temperature monitoring system automatically measures and records the temperature of individual vessel at specified sample points.
Peristaltic Pump
  • Imported Pump with click-n-go Cassette design for volume accuracy.
  • Fixed length pump tubings with stopper for sampling volume accuracy.
  • Volume calibration through software.
  • Tygon pump tubings for SLS Compatibility with long life.
  • Imported Pump with Planetary drive for very accurate pumping.
  • High repeatability on all Channels.
  • 24 actively driven stainless steel rollers.
Sample Collection
  • 12 X 6 X 2 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 spill over problem due to foaming characteristics
  • Easy positioning with respect to vials or test tube tray for easy changeover
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.
Regulatory Compliance
  • DS 14000 with Peristaltic Pump 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 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 

29 litres capacity with built-in water level sensor 

Bath Circulation 

 External vibration free water circulator 

Temperature Range 

   20°C to 55°C 

Temperature Resolution 

   0.1° C 

Temperature 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 

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. 

Sampling Volume Range 

0.5 - 25.5 

Replenishing mode selectivity 

User selectable. 

Rinsing Functionality 

Optional 

Maximum Number of Intervals 

30 

Dissolution Process Time 

1 min. to 720 hours. 

6 Channel Temperature Reader 

Built-In 

Report Format: 

a) GLP & Pharmacopeia compliant

b) Program parameter report 

Output 

a) Printer: Compatible for desk jet, inject and dot matrix printer

b) RS232C: For PC Connectivity c) 21 CFR Part 11 compliance software available (Optional) 

Power 

210-230 V AC ± 10%, 50 Hz. - 60 Hz. 

Environmental Operating Conditions 

a) Operation: Indoor.

b) Temperature: Ambient to 45° C.

c) Humidity: 5 to 90% non-condensing. 

Dimensions 

115 x 60 x 70.5 cms. (W x D x H) 

Weight 

140 kgs. approx. 

Tablet Dissolution Testers