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dispEASY Highend Benchtop StandAlone Disperser/Homogenisator

TPWII workstation

The SAD/SAH Homogenizer Extraction Module

The dispEASY module is a stand-alone version of the TPWII homogenization module that provides all the control and functionality in the TPWII >=v2.0 software. TPWII workstation

General information:
• Same dispersion parameters provided on TPW II software v2.0 and greater.
o Speed (20 K rpm)
o Pulses
o Pulse Time (sec)
o Large tablet clearance
o Large tablet parameters
o Vessel cycling
• Same hardware used on TPW II
o Homogenizer
o Probe with vessel plug
o Sampling cannula
o Elevator or other device to simulate large tablet operation and vessel cycling
o TPW II extraction vessel
• Parameters will have same boundaries as provided in TPW II software.
• Direct computer control with a simple instrument control screen that does not require 21 CFR part 11 compliance.
• Dispersion parameters can be entered and executed. It is also possible to recall stored methods if you are allowed to by password.
• Password security on applications and method.
• Easy vessel access for placing vessels into and out of homogenizer.
• Protective shield around vessel and probe during operation.
• Probe washing by “clean vessel” or manual cleaning.
• Abort function located on Homogenizer and software screen
• Mechanism to prevent operation of the equipment when vessel and safety shield are not in place.
• Beep when complete

Software Requirements
• In order to comply with 21 CFR part 11, PC control will not be available.
• All operating parameters will be input via a touchscreen and the embedded controller.
• Methods can be stored and resued if the operator has the right password.
• Optional direct printing of method parameters and probe speed via printer port.

Hardware Requirements
• TPWII Homogenizer
• TPW II Probe and vessel seal
• TPW II Extraction vessel
• Safety shield with lockout to prevent use without vessel and shield in place.
• Sampling cannula
• Mechanism for large tablet clearance and cycling. (Elevator & Stepper)

Regulatory / Agency Requirements:
• CE, CSA, FCC
• IQ, OQ, PQ Document set for user validation

Unit package inclueds:
• SAD/SAH. Includes dispersion unit, 2 TPW II Extraction Vessels, IQ/OQ Validation Document, and software.

Size:

300*400*800mm (W,L,H)
• Does not exceed height, length and width of current homogenizer with TPW II extraction sidecar.

Additional information:
Electrical:
• VA(max) 800VA
• Supply 100 VAC +/- 10%, 50-60Hz
120 VAC +/- 10%, 50-60Hz
230 VAC +/- 10%, 50-60Hz
240 VAC +/- 10%, 50-60Hz
Noise:
• Less than 70 dB under the following conditions:
1. All shields are secure in operating position
2. 20,000 rpm in 250ml water
3. homogenizer probe height is at zero
Performance:
• Speed 2,000 – 20,000 rpm +/- 10%
(30mm generator in 500ml water)
(10 second minimum pulse time)

Capacity:
• One Custom vessel, 50 – 500ml, TPWII compatible
• Available clear or tinted for photosensitivity.
Safety:
• Meets requirements of CE Low Voltage Directive
• Includes:
Vessel Safety Shield
Safety Shield Lock-out switch
Minimum safe volume sensor/switch

5000 RPM

8000 RPM

10.000 RPM

Ready, soak and settle.

Product Overview:

dispEASY Homogenizer Extraction Module

• Manual alternative to TPWII
  identical probe & vessel
• All TPWII Extraction Parameters retained
• 21 CFR:11 compliant
• All Extraction parameters can be transferred from TPWII software
• Automation transparency for manual methods
• Multiple step extraction
• Fully compliant with 21 CFR:11
• Safety- interlocks and shield
• Vessel cycling
• Direct Printing of Method Parameters & runs
  Programming
• All steps of TPWII screens maintained
• Touch TFT screen for data entry
• Direct printing of run data
• Prepared for different user roles (Administrator, Developer and Operator Levels with Password)
• Easy guided programming steps

  Sampling

• Prompts user to take sample
• Programmable height of sampling

  Vessel Cycling

• Feature of TPWII version 2.0
• Enables grinding of “sticky” tablets & capsules

  Safety

• Interlocked safety screen
• Automatic shut-off when door opens

  Summary

• 21 CFR :11 compliant
• Identical to TPWII extraction
• Manual labor saving tool