2. Bathless Tablet Disintegration Instrument with Auto Endpoint Detection
sensIR 3200
Bathless Tablet Disintegration Instrument with Auto Endpoint Detection

3. Overview
Distek’s sensIR 3200 uses proven bathless heating to offer a disintegrator without the hassle and inconveniences associated with conventional water bath-based instruments. By eliminating the water bath and utilizing a sleek modular unit, Distek’s sensIR 3200 offers two, four or six disintegration test stations in the smallest footprint of any comparably equipped model.

4. Features Auto Endpoint Detection Bathless Heating
Using “Patent Pending” Near Infrared (NIR) eliminates the need for modified fluted disks
Saves time and increases throughput
Bathless Heating
Heat media from ambient to 37°C in approximately 8 minutes
Eliminates problems associated with water baths such as slow heating and algae growth

5. Features Advanced User Interface Integrated Temperature Sensor
Store 100 reports
Run three unique methods simultaneously
Manage 50 users
Set qualification reminders
Integrated Temperature Sensor
Monitor and document individual beaker temperatures for improved compliance
Scalability
Available in 2, 4, or 6 positions

6. Auto Endpoint Detection
Uses Near Infrared Sensors (NIR - 950nm)
Typical excipients and API’s absorb at wavelengths less then 400nm
Continuously monitors the transmittance through the Max and Min stroke
Absorbance and light scattering are not an issue because absorbance measurements are not being calculated, only transmittance is being used
Patent Pending
Base of each tube – 1 Transmitter and 3 Receivers for optimal coverage
Summary circuit totals the 3 receivers of each tube

7. Auto Endpoint Detection
Does not require use of Modified Fluted Disks unlike competition
Allows users to conform to monographs not requiring fluted disks
Built-in intelligence determines presence of tablet
Increases efficiency of labs – users can start test, drop samples and walk away to perform more productive tasks
When running Method or Manual Run, home screen will show if a sample is still whole, or has disintegrated for each tube & basket

8. Auto Endpoint Detection
Triangle indicates that the endpoint detection is enabled and the sample is still present
The individual basket temperature & dpm (dips per minute) are also visible

9. Auto Endpoint Detection
Check mark indicates that the disintegration of the sample for the respective tube is now complete

10. Auto Endpoint Detection
The Report Summary shows the actual disintegration endpoint detection of the samples for each tube & basket

11. Auto Endpoint Detection
It also shows the basket temperature (Last, Min, Max & Delta)

12. Disintegration Process as seen by Near Infrared (NIR)
Position 1
Position 2
This graph shows Transmittance shortly after the sample has been introduced. (1) indicates the basket is at the highest point and the tablet is blocking its maximum amount of light. (2) indicates the basket is at its lowest point and the tablet is out of the light path, allowing for maximum transmittance.

13. Disintegration Process as seen by Near Infrared (NIR)
As the tablet disintegrates, blocking less light, the difference between the minimum and maximum intensity becomes smaller.

14. Disintegration Process as seen by Near Infrared (NIR)
As the tablet nears total disintegration, the intensity of transmittance between minimum and maximum are nearly equal.

15. Disintegration Process as seen by Near Infrared (NIR)
The system determines disintegration is complete when the difference in transmissions at position “1” and position “2” reaches a certain value. This is then marked as the endpoint.

16. Disintegration Process Setting Sensitivity
The “sensitivity” setting changes the value of this difference which is considered endpoint. The higher the setting, the less close the two values need to be before endpoint is considered reached.

17. Bathless Heating
Heat media from ambient to 37°C in approximately 8 minutes
High watt (270 w) flexible heater jacket rated to 150°C
Patent Pending
Basket reciprocates in the vessel during preheat to ensure uniform heating
Integrated Temperature Sensor
Monitor and document individual beaker temperatures for improved compliance
Eliminates the need for manual verification of the temperature prior to tablet introduction

18. Bathless Heating
Eliminates problems associated with water baths such as slow heating and algae growth
Water bath systems can take 30–45 minutes to heat up
Uses approximately 50% less electricity than a water bath system
Heating algorithms control temperature, ±1°C
Significantly better than industry standards
USP <701> allows ±2°C

19. Advanced User Interface
The sensIR 3200 User Interface Includes robust features such as:
Touch screen display
Ability to store 100 reports and records
Run three unique methods simultaneously
Manage up to 50 users
Set qualification reminders and much more

20. Advanced User Interface Login Screen
Login screen with names and passwords

21. Advanced User Interface Dashboard
The Dashboard screen provides the ability to:
Raise/lower baskets
Select Method or Manual Run
Select a specific vessel

22. Advanced User Interface Manual Run
The Manual Run screen provides the ability to program:
Temperature
Media volume (mL)
Dips/Minute
Endpoint Detect (On/Off)

23. Advanced User Interface Create New Method
The Create New Method screen provides the ability to program:
Temperature
Media volume (mL)
Dips/Minute
Duration
Endpoint Detect (On/Off)
Print Report (On/Off)

24. Advanced User Interface Install the Basket
When a new Method or Manual Run is started, the sensIR 3200 will ask to install the baskets to start the test.

25. Proper Basket Installation
Thumb latch for easy installation or removal of the basket assembly

26. Advanced User Interface Introduce the Dosage
After the beakers have reached the temperature:
In Manual Run - you manually raise the baskets, introduce the dosage & select Start.
In Method Run – you will be prompted to begin, the baskets will automatically raise, introduce the dosage, the baskets will lower and the test will begin.
If using Auto Endpoint Detection & all samples have disintegrated, the baskets will automatically raise in both Manual & Method Run (even if programmed time has not been reached)

27. Advanced User Interface Basket Height Adjustment
The basket heights can be adjusted at the top and bottom of the stroke, if needed.

28. Advanced User Interface Run three unique methods simultaneously
The sensIR 3200 can run the same method in all position or 3 unique methods can be run simultaneously (Three unique methods can be run simultaneously with the for 4 or 6 position systems only.)
Eliminates the wait time for one method to complete before starting a new/different method
Increases productivity
The unique methods can be started at the same time, or while another method is running

29. Scalability The sensIR 3200 is available in 2, 4, or 6 positions
Modular design allows for the addition of extra modules
A four position system can be upgraded to a six position system.
Upgrade must take place at the Distek office
NOTE: The two position system has a different base and therefore cannot be upgraded

30. Scalability
Independent modules continue to operate allowing for repairs
Expands laboratories capacity without the need to purchase a new instrument
Saves money and minimizes downtime

31. Thank you! Distek, Inc. 121 North Center Drive
North Brunswick, NJ 08902
Phone: •