Dissolution Tester DS 14000 SMART with Piston Pump
Tablet Dissolution Test Apparatus

The dissolution tester DS 14000 Smart with piston pump is the core of our dissolution testing product line. Intelligent sampling system is used where the sampling tubes are accurately moved to USP sampling position. For sample collection option of standard vials and HPLC vials is available. The needles can pierce through the septa and collect the samples so that there is no spillage.

1 million cycles for the piston pump are guaranteed with easy serviceability and maintenance. The 21 CFR Part 11 software is a standard with LAN connectivity for data backup on network shared folders. QWERTY Keyword for entries of Sample Name, Sample Number and Identification Number for authentication. More than 1000 methods can be stored due to large memory size.

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Standard Features of DS 14000 SMART with Piston Pump
  • Advance Micro – controller (Arm Core )User-friendly, complies with current USP , IP ,BP & 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
  • 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.
  • 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 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
  • 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
Typical Specification
Parameters
DISSO SMART 14000 with Piston Pump
DS14000 with Piston Pump
Dissolution Vessel

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

Display

7" Colour High Resolution Touch Screen Display

40*2 LCD Display (Alphanumeric)

RPM

20 to 350 RPM

20 to 250 RPM

RPM Accuracy

± 1 RPM

Temprature Range

20° to 55° degree

Temp Accuracy

± 0.1° C

Method

1000

15

User 

250

10

Role

4 Role(Admin,Manager,Supervisor,Operator)

2 Role(Admin & User)

Connectivity

USB,LAN,WiFi,Bluetooth

RS-232

Test Report

10000

Last Report

21 CFR Compliance

Yes (Optional)

Yes( EDC Software)

Auditrail

Yes

NA

E Signature

Yes

NA

Sampling Interval

50

30

Sample Interval Time

1 Min to 1200 hrs

1min to 720 hrs

Pump Used for Sample Collection

Piston Pump

Rinsing

Rinse

Cleaning Cycle

Programmable multiple cleaning & drying cycles

Sample Collector Type

Covered (no evaporation, protects samples from
dust, dirt & contamination)

Open

HPLC Vials Tray

Yes

Auto Tablet Dispenser

Yes

Manual

Tray detection & identification

Special sensor for detecting the alignment and
type of tray to prevent any human error

NA

Contact parts

All Contacts Parts are inert

Sample Collection

12*8*2 Sample Collection Tray Tray.(24*8 Optional)

12*6*2 Sample Collection Tray Tray.(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.

FAQs

1. Can I use a sinker when the USP monograph does not specify one?

Typically if a sinker is needed in a dissolution test the procedure will mention the fact. Where the use of a sinker is not specifically mentioned in the procedure, it is safest to assume that the use of sinkers would represent an alternative procedure.

2.How can I find the right filter for my dissolution procedure?

The right filter will not adsorb the analyte when the dissolution sample solution is filtered. A number of filter materials are available increasing the probability that a good match can be found. The adsorption of the analyte to the filter may be saturable, meaning that it can only adsorb a certain amount of the analyte. If that is the case, a specific discard volume of sample solution filtrate can be found that allows subsequent filtrate concentration to be representative of the concentration of analyte dissolved in the sample. Typically milliliter increments of filtrate are passed through the filter cartridge and collected separately. The response of the analyte is measured in each increment and compared with the unfiltered solution. The amount of discard is determined from the results.

3. What is the purpose of the PVT?

USP considers adherence to measurable dimensional and operational parameters to be a critical component of apparatus suitability. However, without a challenge to the apparatus demonstrating the ability to produce dissolution results from a standard material, mechanical qualification alone does not provide sufficient evidence that the apparatus is performing satisfactorily. Furthermore, the USP PVT relies on more than the reference standard material itself. The ranges for the geometric mean (GM) and the coefficient of variation (%CV) are an integral component of the PVT and are obtained from a multinational collaborative study conducted for each new lot of reference standard tablets. Those two statistics, GM and %CV, help the laboratory using the reference standard determine if their results are accurate within the context of ISO 5725-6, Accuracy (Trueness and Precision) of Measurement Methods and Results—Use in Practice of Accuracy Values. Accuracy is comprised of trueness and precision, which are embodied in the geometric mean and %CV, respectively. A discussion of these concepts can be found in an article by Walter Hauck, et al. in Pharmacopeial Forum 33(3), “Proposed Change to Acceptance Criteria for Dissolution Performance Verification Testing.”

4. Can I use peak vessels?

<1092> mentions peak vessels as noncompendial apparatus that may have some utility with proper justification.

5. Why aren’t the recommendations in the USP Dissolution Toolkit found ?

The USP Dissolution Toolkit contains enhanced mechanical calibration information. Agreement exists that additional controls can be imposed by tightening the mechanically measured attributes of Apparatus 1 and 2, insufficient data exists to determine the appropriate degree of change or that such tightening would necessarily improve the quality of the dissolution results obtained. Because the chapter is harmonized, any change to the description of Apparatus 1 or 2 would have to be agreed by the Pharmacopeial Discussion Group comprised of the European Pharmacopoeia, the Japanese Pharmacopoeia and USP. REF:USP.org

Dissolution Tester