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.

Proveris Scientific announces joint scientific poster presentation with H&T Presspart at RDD 2020 Digital Conference

Proveris Scientific announces joint scientific poster presentation with H&T Presspart at RDD 2020 Digital Conference

Proveris Scientific Corporation, a leading provider of services and technology to advance the science of spray and aerosol products, today announced that on April 26 at RDD 2020 Digital Respiratory Drug Delivery Conference, Proveris will present a joint poster with H&T Presspart, Blackburn, Lancashire, UK entitled, “The Effect of Ethanol Concentration on pMDI Evaporation Fraction.”

The subject of the study is introducing a technique to quantify the evaporation fraction using a novel measurement method applied to a time-synchronized image sequence of the aerosol spray from pressurized metered dose inhalers (pMDIs). In order to demonstrate the effectiveness of the technique, the study used non-commercial pMDI product samples with three different ethanol concentrations, but identical devices provided by H&T Presspart. The results show the higher the ethanol concentration, the lower the evaporation fraction.

The FDA May 2019 product specific guidance for beclomethasone dipropionate delivered by MDI lists evaporation rate of the aerosol as an in vitro characterization study that is representative and/or predictive of the clinical effect in the deep lung. Due to the aerosolization mechanism of pMDI products, aerodynamic properties such as evaporation rate impact drug delivery and lung deposition. Currently, there are limited evaporation rate studies and technologies available to effectively study the variable bulk mass of aerosols without interrupting the spray.

The non-impaction laser imaging technology of the well-established Proveris SprayVIEW® measurement system offers meaningful insight into drug product evaporation. The approach is significant as it offers Generic OINDP developers a tool for performing in vitro bioequivalence comparisons between Test and Reference products. 

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, China NMPA (National Medical Products Administration), 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

About H&T Presspart

H&T Presspart is a pharmaceutical component and device manufacturer for the respiratory drug delivery market, specializing in high-precision injection moulded plastic and deep-drawn metal components. With more than 40 years’ experience, H&T Presspart has a worldwide reputation for competence, quality and innovation in the respiratory drug delivery market. As the healthcare and pharmaceutical sectors continue to evolve, bringing revolutionary drugs to the market, H&T Presspart’s wealth of experience and expertise helps clients in the pharmaceutical industry make the best decisions early in the product and device development process. H&T Presspart’s Inhalation Product Technology Centre (IPTC) supports our customers’ new product developments and strategic initiatives. Founded in 1970 and acquired by the Heitkamp and Thumann group in 2002, H&T Presspart has 3 European manufacturing sites with sales offices around the world.

Lee Dalton joins Proveris as Director of Sales for North America

Lee Dalton joins Proveris as Director of Sales for North America

Proveris Scientific Corporation, a leading provider of services and technology to advance the science of spray and aerosol products, today announced that experienced life sciences professional Lee Dalton has joined Proveris as Director of Sales for North America.

Lee joins Proveris with 25 years of experience in account management, business development, and technical sales at life science technology and instrumentation providers including Biotage AB, Abazyme, SeqLL, LLC, GE Healthcare, Cambridge Biomedical, and Zymark. He has worked throughout the Americas supporting scientists in all laboratory areas with their analytical challenges, from sample preparation and analysis to data analysis reporting. 

“Lee has proven experience and expertise in providing the right instrument and laboratory service solutions to pharmaceutical and biotech companies, from discovery through commercialization. We are confident that Lee will be a strong customer advocate and focus on providing our customers with the highest quality solutions that will enable them to be successful.” said Ben Okorodudu, Vice President of Sales for Proveris.

“I am excited to join the Proveris family at a time when the company is investing in key areas such as R&D and its support team”, said Lee. “I believe that Proveris is a unique company that provides an environment allowing for personal and professional growth through unmatched dedication to quality and customer support.”

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, China NMPA (National Medical Products Administration), 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.

Proveris Scientific Expands its Technical Service Team

Proveris Scientific expands its technical service team with the addition of engineer Juan Osvaldo Moliére Velez

 Proveris Scientific Corporation, a leading provider of services and technology to advance the science of spray and aerosol products, today announced that it has expanded its technical service team with the addition of engineer Juan Osvaldo Moliére Velez.

Juan will be based at Proveris Headquarters in Hudson, Massachusetts, providing in-house support to Proveris field engineers and directly to customers. He will also be travelling to customer sites to assist with servicing instruments and to train customers on test procedures developed in-house. 

He has 10-plus years of experience, most recently at Illumina where he spent three years installing new gene sequencers, performing preventative maintenance, and on-demand service. Prior to that he served as a field service engineer at Qiagen where he supported customers of the Modaplex system providing direct support and service for in-house systems.

Juan is a mechanical engineer with an educational background based on design and manufacturing prototypes. He has worked for the aerospace industry which provided him with intimate knowledge of jet engine turbines and experience in regulated industries. He has leveraged this knowledge in multiple roles in the medical industry. Juan will report to Proveris Scientific’s VP of Technical Services, Alberto Correia. 

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, China NMPA (National Medical Products Administration), 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.