Critical Flow and Breath Actuation Control

Copley’s Critical Flow Control TPK range and Breath Actuation Control BAC range are designed based on the requirements set out by both the European and the United States Pharmacopoeia for testing MDIs, DPIs, Nebulisers, ADIs and Nasal Products.

TPK 2100 - Critical Flow Controller

The new, third generation Critical Flow Controller Model TPK 2100 is designed to provide (and document) all of the critical parameters employed in the delivered dose uniformity (DDU) testing and aerodynamic particle size distribution (APSD) measurement of Dry Powder Inhalers (DPIs). It can also be used as a Breath Actuation Controller (BAC) for testing Metered Dose Inhalers (MDIs) with Spacers/Valved Holding Chambers (VHCs) and breath-actuated MDIs in accordance with Ph.Eur. 0671 and USP Chapter <1602>.

Product Features

  • Conforms to specifications - both Ph.Eur. Chapter 2.9.18 and USP Chapter <601>
  • “Fly-by-wire” flow control valve - allows operation to be automated
  • P1, P2, P3, PD & PA measurement
  • Integrated timer for control of solenoid valve
  • 2-way/2-port solenoid valve
  • 4-line LCD display of all parameters
  • Illuminated start button and multi-function keypad
  • P1 range 0-15 kPa, resolution 0.01 kPa
  • P2 (and PA) & P3 range 0-120 kPa, resolution 0.1 kPa
  • Timer range 0-600.0s, resolution 0.1s
  • Solenoid valve opening/closing time 25/25 ms
  • High-speed automatic test set-up function
  • Automatic calculation of P3/P2 ratio (sonic flow)
  • Setting and counting the number of test actuations
  • External temperature/humidity sensor module
  • Flowmeter DFM4 & DFM 2000 interface
  • USB printer port interface for data output
  • TTL interface for remote actuation (Footswitch/MDI Actuation Sensor)
  • USB interface for data output and remote actuation
  • User calibration function
  • Storage of calibration time/date
  • Total impactor Delta-P function (PD)
  • Spacer/VHC testing actuation delay function
  • Fully automated in situ impactor leak testing function with pass/fail
  • Automated setting of P1 or flow rate (Q) during test set-up
  • Critical Flow Controller TPK emulation function (basic run test mode)
  • Automatic calculation of test duration from volume and flow rate
  • Measurement and recording of P1 and P3/P2 for each actuation
  • Inlet/In-line flowmeter modes
  • Warning if P3/P2 > 0.5, Q > 100 L/min and Q > 5% from set value
  • Reports: Test set-up, Run test, Leak test, Delta-P and Calibration

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