Copley Scientific rounds off a year of range renewal with two product upgrades
06 th November 2018, Nottingham, UK : Copley Scientific is closing a year of innovation and renewal across the inhaled product testing range with two upgrades that further enhance routine analysis : a new Mixing Inlet and a firmware update for the TPK ™ 2100 Critical Flow Controller. The Mixing Inlet allows application of a patient -representative inhalation profile during aerodynamic particle size distribution ( APSD) measuremen t and is used to achieve better in vitro in vivo correlations (IVIVCs) . The new , one -piece , all 316 stainless steel construction is design ed to be more robust and chemically inert for the drug recovery process . The TPK ™ 2100 Critical Flow Controller is a key accessory for flow rate control in dry powder inhaler testing (DPI) that now offers enhanced logging and recording capabilities as a result of the latest firmware update (Version 2.00) . Find out more about both products by contacting : firstname.lastname@example.org
The APSD of inhaled products is a Critical Quality Attribute , measured using a cascade impactor, typically either the Andersen Cascade Impactor (ACI) or Next Generation Impactor (NGI). Cascade impactors are precision instruments that operate at a constant volumetric air flow rate. T he Mi xing Inlet decoupl es flow through the test product from that entering the impactor making it possible to apply a clini cally realistic inhalation profile during measurement while meeting the constraint of constant flow, at a calibrated rate , at the inlet to the impactor.
Available in both ACI and NGI versions , the new Mixing Inlet has a 316 stainless steel construction to aid drug recovery and optimise drug/solvent compatibility . A one -piece , rigid design offers enhanced induction port support and protects the sharp edge of the inner cone from damage ; the avoidance of internal ‘O’ rings also eliminat es a potential source of lea ks. By gently mix ing sample -laden air with any supplementary air required , the Mixing Inlet pro duce s a homogeneous test flow for the impactor, w hile minimising internal drug loss es.
The key function of the TPK ™ 2100 is to control the air flow entering the impactor for DPIs , ensuring stable , critical flow and a defined pressure drop across the inhaler - 4 kPa when applying compendial test methods. Th is pressure drop (P1) is now recorded and logged for every test provid ing a traceable record of compliance and correct inhaler operation . This additional PR_COP_JOB_ 1012 2 | Page functionality further boosts the utility of the TPK ™ 2100 ; existing units can be upgraded to the latest software version for a fee .
To see Copley’s full range of equipment fo r inhaled drug testing download “Quality Solutions for Inhaled Testing” from : http://www.copleyscientific.com/downloads/brochures