Inhalation

INH1218

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Information from companies that provide quality/compliance-related products and services that may be useful in research and development or manufacturing. Content is provided by companies, with no preference intended. 20 December 2018 Inhalation 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. Quality/ComplianCe Comprehensive qualification services MSP, a division of TSI, offers a comprehensive line of qualification services for pharmaceutical inhalation testing systems worldwide. We have thorough knowl- edge of USP guidelines and can provide the equipment and regular service required for compliance. MSP also understands the methods needed for a range of generic applications and can assist in understanding those USP guidelines. Our suite of equipment, calibration, men- suration and qualification services ensure your systems remain operable. MSP, a division of TSI US: +1 651 287-8113 www.mspcorp.com Calibration, mensuration and qualification services According to the Good Manufacturing Practice (GMP), the test methods used to characterize inhaled drug products must meet proper standards for accuracy and traceability. Consequently, pharmaceutical com- panies should establish procedures to ensure the fitness- for-use of instruments that generate data supporting product testing. Copley Scientific offers solutions for in-house and on-site calibration, mensuration and qualification of your products to meet this need. Copley Scientific UK: +44 1159 616229 www.copleyscientific.com Automated inhaler testing solutions Astech Projects specializes in the supply of automated inhaler testing equipment for all device types including DPI, MDI and BAI. Astech's award-winning X-Prod- ucts ® range, which includes Xelair ® , Xelize ® and Xelox ® , provides robust, durable and consistent testing for Dose Content Uniformity (DCU) and Particle Size Deter- mination (PSD), including Andersen and NGI Impac- tors. Custom automation solutions are also available for waste firing, physical device testing, emitted dose weight, vision and inspection. Astech offers a compre- hensive maintenance and support service called REACTS ® , providing peace of mind for the lifetime of the system. Astech Projects UK: +44 1928 571797 www.astechprojects.com Testing services to support development Gateway Analytical strives to support foreign particu- late characterization investigations and API sizing, counting and identification studies during drug devel- opment and manufacturing processes. Our unique forensic-based testing methods allow us to support pharmaceutical issues faster, producing results in as lit- tle as 24 hours from sample receipt. We are FDA regis- tered, cGMP complaint, DEA licensed and ISO 17025 certified. We ensure that all testing is performed to pro- vide results efficiently and effectively, while maintain- ing the highest quality standards. Gateway Analytical US: +1 724 443-1900 www.gatewayanalytical.com

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