Flow Controllers
Our 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, SMIs and Nasal Products.
Contact Us
Contact Us
Critical Flow Controller TPK 200iX®
The TPK 200iX provides critical (sonic) flow control for Delivered Dose Uniformity (DDU) testing and Aerodynamic Particle Size Distribution (APSD) measurement of Dry Powder Inhalers (DPIs), enabling laboratories to establish and verify the critical flow conditions required by the pharmacopoeias. It also controls airflow and sampling duration for a wider range of orally inhaled and nasal drug product (OINDP) testing applications.
Combining patent-pending flow control capability with guided test set-up, the TPK 200iX accommodates a broad range of test conditions, with a flow rate range of 5-100 L/min and extended test durations of up to 3,000 seconds.
Built-in method management, secure user access, audit trails and reporting support consistent, traceable testing and help laboratories meet GMP and 21 CFR Part 11 requirements. These capabilities are available whether the instrument is used independently or connected with Inhalytix®+, our specialist software for inhaler testing data management.
Establishing and verifying critical flow conditions
For DPI testing, establishing the appropriate airflow and pressure conditions is essential for reliable DDU and APSD measurements. The TPK 200iX supports this process through device resistance measurement, critical flow status alerts and pressure monitoring, helping analysts establish and verify the required critical (sonic) flow conditions.
Applications beyond DPI testing
The TPK 200iX can also be used for other inhaler and nasal testing applications, including testing breath-actuated MDIs and MDIs with spacers or Valved Holding Chambers (VHCs). This enables laboratories working across different device types to use the TPK 200iX for both critical flow control and other flow control requirements.
New to critical flow control?
Our Expert Solutions for Inhaler Testing Brochure provides further background on critical flow control for DPI testing.
Learn more about critical flow controlGuided test set-up and operation
The TPK 200iX features a 7-inch touchscreen interface that guides analysts through equipment configuration, test set-up and operation. Clear on-screen instructions and access to defined test methods help maintain consistent procedures while reducing repeated set-up steps.
Guided set-up: Step-by-step guidance helps analysts configure test parameters and prepare the instrument for testing.
Equipment configurator: Define and save equipment configurations for individual test methods, supporting consistent set-up across repeat tests. The optional QR Code Scanner enables compatible equipment details to be captured without manual entry.
Test management: Enables users to configure, confirm and record all critical parameters associated with the test run, including device resistance.
Run test: Shows live test progress and key operating information during the run, helping analysts monitor the test in real-time.
P1 rise-time logging: Displays the P1 pressure rise at the start of a test and reports the T90 value (the time taken to reach 90% of the target pressure), providing insight into pressure behaviour that may influence aerosol dispersion.
Additional features supporting test set-up and operation
The TPK 200iX incorporates a range of practical features designed to simplify test set-up, reduce manual intervention and help analysts follow consistent procedures. By automating routine tasks and supporting accurate configuration, these features help minimise potential sources of variability during testing.
Automatic vacuum pump control
Automatically switches Copley 7-series vacuum pumps on and off during testing, reducing unnecessary pump runtime and the risk of tests being initiated without vacuum. This helps avoid invalid tests, wasted product and additional cleaning.
Automated in situ impactor leak testing
Perform impactor leak tests as part of the instrument set-up process, helping verify system integrity before testing.
Automatic test duration calculation
Calculate test duration from the specified sampling volume and flow rate, eliminating the need for manual calculations.
Flow measurement compatibility
Interfaces with compatible flow measurement devices, including the FRS and DFM 2000, to support accurate set-up and verification of test flow conditions.
Equipment identification with the QR Code Scanner
The optional QR Code Scanner enables QR-coded Copley equipment to be electronically identified during test set-up. Equipment details, including model and serial number, can be captured and stored directly on the TPK 200iX against the relevant method and test record, reducing manual data entry.
When connected with Inhalytix®+, this information can also be synchronised with the wider digital test record.
Learn more about the QR Code ScannerTPK 200iX: Built-in method management and traceability
The TPK 200iX provides user access controls, method management, audit trails and reporting directly on the instrument, supporting controlled testing procedures and traceable records.
Test methods can be defined, saved and recalled for routine or repeat testing, reducing repeated parameter entry. Secure user access helps laboratories manage instrument permissions, while date- and time-stamped audit trails provide a record of instrument activities linked to individual users.
These capabilities support laboratories working to GMP and 21 CFR Part 11 requirements, without the need for additional software.
User management: Create and manage authorised users and access permissions directly on the instrument, maintaining control over instrument operation and test records.
Method management: Define, save and recall test methods directly on the TPK 200iX, reducing repeated parameter entry and supporting consistent test set-up.
Audit trail: Review date- and time-stamped records of instrument activities linked to individual users, supporting traceability, record review and audit requirements.
TPK 200iX/-R Technical Specifications | |
User interface: | 7” touchscreen |
Flow setting: | Manual and automated |
Flow rate range: | 5-100 L/min |
Pressure measurement: | |
P1 pressure measurement and accuracy P2 and P3 pressure measurement and accuracy | 0 to 16 kPA (± 1.0% full scale) 0 to 160 kPA (± 1.0% full scale) |
p1 rise-time logging and visualisation: | Yes |
Temperature and relative humidity measurement: | |
Temperature range and accuracy Relative humidity range and accuracy | -40°C – 80°C (± 0.15°C) 0 to 100 % RH ± 1.5 % RH -40°C – 80°C (± 0.15°C) 0 to 100 % RH (± 1.5 % RH) |
Vacuum pump control: | Automatic control of Copley 7-series vacuum pumps |
External trigger options: | MDI Actuation Sensor | Footswitch |
Spacer/VHC testing delay: | Yes |
Solenoid valve opening / closing time: | <100 ms / <100 ms |
Timer range: | 0.0 – 3,000.0s (resolution 0.1s) |
Dimensions (w x d x h): | 415 x 315 x 250 mm |
TPK 200iX and TPK 200iX-R
The TPK 200iX is available in standard and reversed configurations. The TPK 200iX-R provides the same functionality, with reversed pneumatic connections to support different inhaler testing set-ups.
Related Accessories
QR Code Scanner
Connects directly to the TPK 200iX to capture key identifiers from compatible QR-coded Copley equipment, helping record the equipment used against the relevant method and test record.
View Brochure
QR Code Scanner
Connects directly to the TPK 200iX to capture key identifiers from compatible QR-coded Copley equipment, helping record the equipment used against the relevant method and test record.
Temperature / Relative Humidity Sensor
Provides accurate data about environmental conditions
View Brochure
Temperature / Relative Humidity Sensor
Provides accurate data about environmental conditions
Footswitch
Enables precise synchronisation of actuation with the onset of flow
View Brochure
Label Printer
Streamlines laboratory data processing
View Brochure
Related Services
Training
We offer a range of training courses, presentations and seminars covering a wide range of topics.
Find Out More
Servicing
A comprehensive range of both in-house and on-site product servicing options are available
Find Out More
Support
Our team of experienced technicians and engineers are on hand to help and advise
Find Out MoreRelated News & Resources
