Copley Scientific has launched a super capacity pump, the SCP5, to efficiently meet requirements for high flow rate dry powder inhaler (DPI) testing, in accordance with USP and Ph.Eur. methodologies. The powerful, oil lubricated SCP5 generates flow rates up to 100 L/min (the limit required for all DPI testing) under the stable, sonic flow conditions necessary for robust aerodynamic particle size distribution (APSD) measurement, when used with all the pharmacopoeial specified cascade impactors. A quiet and space-efficient option for high flow rate generation, the SCP5 incorporates a flow control valve and regulated inlets that also enable testing of other types of orally inhaled and nasal drug products (OINDPs), for maximum flexibility.
Cascade impaction is used to measure the APSD of all OINDPs. Successful analysis relies on the application of a stable controlled air flow at an appropriate rate for the product, which for low resistance DPIs can be as high as 100 L/min. Of the pharmacopoeia specified impactors routinely used, the NGI has the highest flow resistance and therefore presents the greatest challenge in terms of ensuring the sonic flow regime that underpins flow stability.
The SCP5 shares the neat bench top design and robust engineering of the existing Copley Scientific range of high performance, low maintenance, oil-free rotary-vane vacuum pumps that, together, span the full range of testing requirements for OINDPs. With a 420 mm by 600 mm footprint and weighing in at 70 kg it provides an alternative to the common practice of linking up two high capacity pumps to generate sonic flow conditions through the NGI at high flow rates. Two complete sets of vacuum inlets ( one regulated, one unregulated on either side of the pump) allow optimal positioning of the pump relative to other test equipment on the laboratory bench. The vacuum is drawn by a 1.5kW oil lubricated rotary vane pump that incorporates sound and vibration insulation, resulting in exceptionally low noise levels for its size and power. Quick release hatches allow for easy internal access for routine maintenance.