Proveris Scientific Corporation, a leading provider of instrumentation and services to advance the science of aerosol and spray products, adds Kinaero Cx™ pMDI Collection System to its product portfolio to automate the pMDI shaking, priming, dose sample collection, and fire-down for DDU and APSD testing.
The Kinaero Cx system incorporates proven Vereo® Automated Actuator technology to precisely control product shaking, actuation parameters, and shake-to-fire timing enabling consistent dose delivery for HPLC analysis. Compliance with EU Annex 11 and US FDA 21 CFR Part 11 is ensured by the operation and data management software with technical controls for electronic records, electronic signatures, audit trails, and data/system/user traceability. As an alternative to manual operation, the system offers benefits such as minimizing both the risk of out-of-specification shots and the downtime that could result from analyst fatigue or CAPA investigations.
The Kinaero Cx system’s flexible design simplifies testing by offering a single platform for DDU and APSD sample collection. Utilizing a unique snap-fit design for the back-end adapter to both the DUSA tube and the waste collector, the system allows for easy installation and removal for sample prep when performing DDU testing. In addition, quick set up for APSD testing is achieved with a cascade impaction kit for placement and orientation of either the Anderson cascade impactor (ACI) apparatus with vertically stacked sample plates or the next generation impactor (NGI) with horizontally placed sample plates.
The Kinaero Cx system enables a fast, smooth workflow for unparalleled ease of use. Sample collection is performed in three quick and easy steps, with control provided through our intuitive software and local database for data storage. Analysts set up methods to specify shots into the dosage sampling unit apparatus (DUSA), cascade impactor throat, and waste collector locations. An on-board sensor confirms the inhaler positioning for mating inhalers of different geometries to these three locations. There is no teaching required and users can easily switch between different inhaler types using device holder inserts adapted to various inhaler geometries.
The Kinaero Cx system offers increased throughput when used alongside the Kinaero™ pMDI High Throughput Fire-Down System. The Kinaero Fire-Down System precisely automates shaking and actuation to waste of up to 10 devices simultaneously, ensuring uniform dose delivery for every shot when transitioning between the beginning, middle, and end of life stages for an inhaler device. Both systems utilize a powerful common software platform which offers all tools to ensure full regulatory compliance (FDA 21 CFR Part 11).
Proveris Scientific’s Senior Product Manager, Ian Flaherty, commented: “An aim for the product design team at Proveris is the evolution of our product portfolio to allow customers to meet complex regulatory requirements and produce consistent high quality data. Our 25-plus years of experience in the OINDP space has taught us much about the potential for automation in reducing the variability associated with inhaler testing. The Kinaero Cx takes these learnings a step further and is designed to be an accessory to our very well-known Vereo Actuator, providing another layer of automation to benefit our customers. The solution is elegant and easy to use, and the powerful software platform will meet our customer’s strict demands for ensuring data integrity and traceability.”
The Kinaero Cx system in all its functionality will be demonstrated in the Proveris workshop at the upcoming RDD 2022 conference in Orlando, Florida. Whitepapers with published data will be made available, upon request, following the workshop on May 3rd, 2022.
About Proveris Scientific
Proveris Scientific Corporation advances the science of respiratory drug delivery products by driving new technology development for high performance spray characterization, capture, and analysis, while leveraging its expertise, experience, and core technologies. With customer success as its central motivating force, Proveris Scientific adds value to a global customer base with “complete solutions” which include product innovation, technical services, systems, consumables, and educational training. Since its founding in 1995, the company has accelerated the development of top spray and aerosol drug products and has deployed its systems at more than 100 pharmaceutical development and manufacturing sites around the globe. Proveris’s systems are the industry standard and are used by the FDA, CFDA, and the pharmaceutical industry to generate submission-ready data. Proveris is certified to ISO 9001:2015 by TUV Rheinland of North America, Inc., and has more than 20 patents issued on its technology.
