Built on Copley’s heritage of TPK models, an international standard in the field of DPI testing equipment, the new TPK 2100 is ideally suited to the needs of formulators and quality control scientists, setting a new benchmark for the set-up, control and documentation of all the parameters associated with the measurement of delivered dose and aerodynamic particle size distribution (APSD) by cascade impaction, in accordance with the US and European Pharmacopoeias.
Designed to replace the well-established TPK 2000, significant new features are built into the TPK 2100. A new ‘fly-by-wire’ flow control valve allows operation to be automated so that data generation is both more efficient and reproducible.
Inhaler pressure drop, P1 and test flow rate are accurately and rapidly set by the TPK 2100 during test set-up, whilst in-line flow measurement can be accommodated and in-situ impactor leak testing is fully automated for the first time.
The user is warned if the important P3/P2 ratio is greater than 0.5, giving full confidence that tests are conducted under sonic flow conditions, whilst notification is also given if the set flow rate and impactor leak rate are outside acceptable limits.
Data output to a printer and computer are standard, with enhanced monitoring and reporting of critical in-test parameters, whilst remote control via USB allows the TPK 2100 to be integrated into larger automated systems, where required. Finally, the new instrument allows users to emulate the previous generations of TPK, promoting interchangeability and integration into existing standard operating procedures (SOPs).
Mark Copley, Sales Director at Copley Scientific, said: “Delivered dose and aerodynamic particle size distribution are critical quality attributes for DPIs, as they indicate the amount of drug that will be received by a patient and broadly where drug particles are likely to deposit within the respiratory system. It is well recognised that these parameters impact clinical efficacy and both US and European Pharmacopoeia publications specify discriminatory testing methods accordingly.
I am particularly pleased that the initial feedback we received at RDD Europe for this new instrument was extremely positive and to have confirmed that the advancements we have incorporated into the TPK 2100 will make a substantial difference to productivity and efficiency in the execution of these important tests by our customers.”
In addition to the launch of the new TPK 2100, a new TPK 2100-R is being released in parallel. This is a reversed version where the flow inlet and outlets are swapped over to allow for different arrangements of testing equipment to be set up on the laboratory bench.
