Proveris expands product portfolio with new Kinaero Cx™ pMDI Collection System for delivered dose uniformity (DDU) and aerodynamic particle size distribution (APSD) testing

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.

Pushing Through the Uncertainty: New in vitro Analytic Tools to Help Keep Your Development Projects on Track

Pushing Through the Uncertainty: New in vitro Analytical Tools to Help Keep Your Development Projects on Track

 Wednesday May 27, 2020

9:00 am, New York, USA EDT

2:00 pm, London, UK BST | 6:30 pm, New Delhi, India IST | 9:00 pm, Beijing, China CST

What time is this for me?

Alberto Correia, VP Technical Services
Linda Liao, Senior Field Applications Scientist

Drug development costs are reported to exceed $1B USD, with daily revenues ranging from $1-3M. Shortening the time to market is critical to maximize return and secure a competitive advantage. Strategies that increase efficiencies and reduce cost are paramount.

For generic drug development in the OINDP space, striving toward a waiver of clinical endpoint testing is a route many are exploring. The FDA has shown commitment to this approach with its release of a product-specific guidance document highlighting alternative in vitro tests to demonstrate bioequivalence.

Innovator drug developers can also benefit from the data generated using these novel techniques to help guide key decisions early on regarding device selection, formulation development, and IVIVC.

In this webinar we will review the current landscape and discuss new tools and techniques that can be used to accelerate your development projects. We will demonstrate the importance of employing new in vitro analytical methods early on in your OINDP development projects in order to gain valuable insight and reach approval faster than you thought possible.


Proveris Laboratories offers OINDP development expertise to biopharmaceutical companies, including contract services using new innovative techniques. Register to gain access to scientific data demonstrating how these novel tools are being used by Proveris to assist in maintaining projects and accelerating development.

Key takeaways:

Who will benefit from attending: