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.

Lynn Jordan joins Proveris as Applications Laboratory Manager

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 Lynn Jordan has joined Proveris as Applications Laboratory Manager.

Lynn joins Proveris with more 25 years of experience in applications and bioanalytical science, laboratory services management, and technical sales at life science technology and instrumentation providers, including:  New England Nuclear, Amicon, Zymark, Waters Corporation, Perkin Elmer, and Biotage. Lynn has a reputation as a strong leader and accomplished scientist with expertise in the introduction of new assays and technologies for sample preparation, analysis, and automation in the life sciences.

In her role at Proveris, Lynn will lead the fulfillment of contract test services, working collaboratively with field sales to meet and exceed technical support standards and customer expectations. Lynn will also play an integral role in product development and R&D projects, adding a customer perspective to the functional specifications. In addition, she will contribute to the development of promotional materials, seminars, and workshop presentations.

Lynn is the author of four publications and contributed to a chapter in “Automated Solid Phase Extraction,” published by Marcel Dekker. Lynn has a bachelor’s degree in Chemistry from Russel Sage College and has completed master’s course work in Separations Sciences from Rensselaer Polytechnical Institute.

 

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 pharmaceutical industry to generate submission-ready data and regulatory agencies such as the US FDA and China NMPA (National Medical Products Administration). 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 welcomes back Joseph Werbeck

Proveris Scientific welcomes back Joseph Werbeck as Senior Director to manage its global technical services organization 

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 services organization with the addition of Senior Director of Technical Service, Joseph Werbeck.

Joe will be responsible for managing the Proveris global Technical Services organization and will report to Vice President, Alberto Correia. Joe previously worked for Proveris from 2014 –2018 as Director of Technical Services.  With this experience he is uniquely qualified to drive service activities for exceptional customer satisfaction in the post-global COVID-19 shutdown period.

Joe has more than 20 years of experience in senior technical service, project management, and field engineering roles gained from his time with industry leaders such as: 908 Devices Inc., Seahorse Bioscience (a division of Agilent Technologies), Bruker Daltonics, and ESI Group.

Joe holds a Bachelor of Science, Management degree from University of Phoenix, Associates in Electronics degree from DeVry University, and a Master’s in Project Management from Boston University.

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 Laboratory Services Team

Proveris Scientific Expands its Laboratory Services Team

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 laboratory services staff by adding Applications Chemist Mohamed Eldam to its team.

Mohammed will provide expert scientific support for customer projects in the GLP/cGMP compliant analytical laboratory, Proveris Laboratories. He will perform contract test services on branded and generic OINDPs (Orally Inhaled and Nasal Drug Products), generate application data, validate customer methods/create new methods, lead investigations of deviations, and implement solutions.

Mohammed has extensive experience working on pre-clinical pharmaceutical research, discovery and product development projects, using/maintaining laboratory equipment (HPLC, FTIR and Gas Chromatography), and managing inventory gained at leading pharmaceutical companies, including Azurity Pharmaceuticals, Eurofins Lancaster Laboratories at Pfizer, Milipore Sigma, and DSM Pharmaceuticals Inc.

Mohammed holds a Bachelor’s degree in Chemistry from Worcester State University.

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 announces its laboratory compliance with cGMP

Proveris Scientific announces its laboratory compliance with cGMP (Current Good Manufacturing Practices)

Proveris Scientific Corporation, a leading provider of services and technology to advance the science of spray and aerosol products, today announced it is expanding its contract test services laboratory to allow for compliance with cGMP (current Good Manufacturing Practices). This achievement demonstrates Proveris Scientific’s continued pursuit of excellence and mission to help its customers bring optimally-performing orally inhaled and nasal drug products (OINDP) to patients around the world.

Proveris Scientific’s cGMP compliant laboratory operation will now offer submission grade contract test services, as well as development projects, release testing, and stability studies. Compliance with these practices offers customers assurance that test services performed on their drug products meet the highest of quality standards for regulatory submission. The company will also continue to maintain certification to ISO 9001:2015 for both products and services.

The quality system meets both the FDA and EMA cGMP regulations and guidance documents, ensuring systems are in place covering critical areas. These areas include instrument and system validation, personnel training and monitoring, document controls, and control of processes and facilities. It also includes all guidelines relating to process validation, comprehensive corrective and preventive action (CAPAs), vendor qualification, and best laboratory practices, as well as design and management reviews.

Proveris Scientific is the industry leader in providing spray characterization products and technologies for the OINDP market and are experts in spray and aerosol product evaluation. The company has been manufacturing instruments for over twenty-five years and performing OINDP test services for over fifteen years.

“We are excited to elevate our laboratory from its humble beginnings over 15 years ago as the genesis for countless development projects with our customers around the world to the level required for cGMP compliance. This achievement confirms our commitment and continued investment in the OINDP arena and to accelerating the development efforts we are involved in with our customers around the world,” commented Founder and CEO, Dino J. Farina.

“As a testament to our high standards of excellence, we are proud to add cGMP compliance in our laboratory services offering as another milestone in our history,”

commented President, Chip Leveille. “I am very proud of our team here, who make dedication to quality products, services, and the success of our customers a daily focus. It is a great feat for all of us to see our quality culture culminate into this achievement.”

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. The company operates under an ISO 9001:2015 certified quality management system and its laboratory operations are cGMP compliant.

 

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.