Ancillaries

Representative breathing patterns should be employed during inhaler testing that characterise the age and condition of the patients to be treated (paediatric to geriatric, mild to severe impairment of the lungs).

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.

Both DDU and APSD data can be severely compromised if the inlet flow rate (the flow rate at the entrance to the induction port or DUSA) used during testing is inaccurate and/
or inconsistent, generating discrepancies with regard to its effects on both the cascade impactor itself and the inhaler under test.

Specially moulded from high-quality silicone rubber, Copley mouthpiece adapters guarantee an airtight seal between the inhaler and test apparatus for the most accurate results.

At the heart of every inhaler testing system is the Pump. The Pharmacopoeias are careful to point out that “a vacuum pump with excess capacity must be selected in order to draw air at the designated volumetric flow rate” through the system and in the case of Dry Powder Inhalers, to generate sonic flow.
Copley offers a choice of three pumps dependent on the set-up concerned and the capacity required.

Copley Inhaler Testing Data Analysis Software (CITDAS) offers a standardised approach to the entry, analysis and reporting of Aerodynamic Particle Size Distribution of drug output from MDIs, DPIs and Nebulisers in accordance with the USP and Ph. Eur.