Tablet Dissolution Tester DS 8000 (Basic) SMART
Tablet Dissolution Test Apparatus

The new dissolution tester DS 8000 Basic Smart uses the Advances Micro-controller technology ( Arm Core) and complies with current USP, IP, BP, EP specifications. THe Smart dissolution tester has 7” colour high resolution display with touch screen display. The Ease align technology allows the vessels to simply slide into the place for easy placement and locking.

The tablet dissolution tester DS 8000 (Basic) is uniquely designed to support USP 1,2,5 & 6. External water circulator with heater is vibration free and ensures a constant temperature throughout the dissolution vessel. The software is user friendly with 200 and more User ID’s with alphanumeric entries of user name, password and role based privileges selection.  

Tablet dissolution tester DS 8000 Basic smart is Fully compliant as the 21 CFR Part 11 guidelines and meets all requirements relating to validation, calibration and qualifications along with appropriate documentation.

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 Tablet Dissolution Tester DS 8000 Basic Smart
Standard Features of Dissolution Tester DS 8000 (Basic) SMART
  • 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 6 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
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.
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
Regulatory Compliance
  • DS 8000 (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
Parameters
DISSO SMART 8000 Basic
DS8000 Basic
Dissolution Vessel

Option for Polycarbonate / Glass Vessels (clear, amber, peak vessels, 250, 150 & 100 ml dissolution vessels available). Also 2 litre Vessel Available

Option for Polycarbonate / Glass Vessels (clear, amber, peak vessels, 250, 150 & 100 ml dissolution vessels available). Also 2 litre Vessel Available

Display

7" Colour High Resolution Touch Screen Display

40*2 LCD Display (Alphanumeric)

RPM

20 to 350 RPM

RPM Accuracy

± 1 RPM

Temprature Range

20? to 55? degree

Temp Accuracy

± 0.1? C

6 Channel Temperature Reader

Yes

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

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

Yes

Water Bath

Clear acrylic molded water Bath 

Clear acrylic molded water Bath 

Water Level Sensor
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

Tablet Dissolution Testers