Inhalation

INH0218

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Information about product development/contract testing that may be useful in research and development or manufacturing. Content is provided by companies, with no preference intended. 24 February 2018 Inhalation Generic inhalation devices Merxin is a generic medical device company that supplies inhalation devices "off the shelf and ready to use," including a generic blister DPI for fluticasone and salmeterol, generic capsule DPI for tiotropium and generic soft mist inhaler for tiotropium, olodaterol and combi- nations. Merxin also supports its clients to accelerate the filing of inhaled finished dosage forms based on its device platforms, assisting with human factor stud- ies, peak inspiratory flow studies, leachable and extractables studies, CE marking, integration of the for- mulation in the devices and full regulatory support. Merxin UK: +44 1223 787300 www.merxin.com High-throughput fire down system Proveris Scientific's innovative new product Kinaero™ High-roughput Fire Down System is designed to help customers worldwide with pMDI product development. Built to replicate human usage of devices, the Kinaero system automates the fire down process (wasting) of up to 10 pMDI devices in force- or position-driven modes. e unit is benchtop-sized and has a large touchscreen display for easy method set up and operation. It features a com- pletely self-contained evacuation system, new software with product-focused operation and data management, and a local database for data storage and retrieval, with controls for compliance with US 21 CFR Part 11 regulations. Proveris Scientific Corporation US: +1 508 460-8822 www.proveris.com Issue Focus This section of Inhalation provides information that may be useful in research and development or manufacturing. Content is provided by the companies listed. No product endorsement or preference is intended. Product develoPment/ contract testing Next Generation Impactor (NGI) MSP Corporation, a TSI Company introduced the Model 170 Next Generation Impactor (NGI) in 2001 to improve the accuracy and convenience of particle size distribution testing of inhalable drug products. Over a decade later, with more than 1,000 units in use worldwide, the NGI is now the industry global standard. With a factory in-use-margin of no less than 50% on all of its all-316 stainless steel nozzle pieces, complete flow resistance characterization, controlled cup surface roughness and o-ring-free connections, there is only one NGI. MSP remains committed to manufacturing the NGI with utmost fidelity to its original design and solely to the highest standards of quality, including ISO 9001:2008. MSP Corporation, a TSI Company US: +1 651 287-8100 www.mspcorp.com

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