Issue link: https://www.e-digitaleditions.com/i/1056686
Inhalation December 2018 21 Automated actuation for accurate reproducible data Critical quality attribute testing of pMDI devices requires fire-down of doses between life stages and through the life of the device. Consistent actuation parameters for dose delivery and APSD, as well as fire- down, ensure uniform conditions and result in accu- rate, reproducible data. Proveris Scientific's Kinaero ™ fire-down system provides precise shaking and actua- tion control with a self-contained evacuation system. e system seamlessly integrates consistent actuation parameters into the entire pMDI testing workflow. Software controls ensure traceability for regulatory 21 CFR Part 11 compliance. Proveris Scientific Corporation US: +1 508 460-8822 http://www.proveris.com R&D and QC software Fusion QbD ® –configured with the Fusion Product Development and Fusion Inhaler Testing modules— make an ideal toolset for respiratory drug product R&D and QC. Scalable from standalone to enterprise, it fully supports Part 11 compliance and contains an integrated workflow management system for enhanced data integrity. In addition, it supports USP Apparatuses 1-6, PhEur Apparatuses C, D, E, FSIs, FSAs and DUSAs, meets all PSD calculation and reporting requirements for USP 601 and PhEur 2.9.18 and con- tains closed-loop automated HPLC testing via Chem- Station, Chromeleon and Empower. S-Matrix US: +1 707 441-0404 www.smatrix.com Simulation to support benchtop testing The use of simulation, particularly in the support of benchtop testing, can be an underutilized solution to satisfying the wants and needs of customers while also realizing increased profits. e use of Computational Fluid Dynamics (CFD) parallel to and in support of benchtop testing provides obvious value to all parties. Respiratory analysis is an area where benchtop testing paired with simulation offers significant value. Great insight can be gained from using benchtop tests to ana- lyze drug transport into the lungs, from simple experi- mental setups to fully 3D-printed lung models. Siemens US: +1 631 549-2300 www.siemens.com/mdx Partnering to meet FDA reliability expectations Next Breath is a full-service cGMP-compliant laboratory specializing in the analytical testing of drug delivery sys- tems. We provide guidance and support for understand- ing the expectations for new combination drug products. To meet the needs of new FDA Combination Product Guidelines, we offer extensive services to test actuation force, reliability studies, in-use studies, and performance during shipping. Our team of dedicated scientists can help you navigate these distinct expectations, even during investigational new drug applications. Next Breath US: +1 410 455-5904 www.nextbreath.net