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Considerations for Navigating ISO 22442-3:2007 Viral Inactivation Studies

About

Date/Time

March 20, 2024

ACCESS ON-DEMAND WEBINAR HERE

 

What is ISO 22442?

EN ISO 22442 is the standard for medical devices that use tissues from preclinical models and their derivatives. Manufacturers must show that they can effectively inactivate and remove viruses from raw materials and finished products. The types and amounts of non-human materials in medical devices differ, including bovine/porcine heart valves and hemostatic sponges, among others.

 

What is ISO 22442-3:2007?

ISO 22442-3:2007 is a specific part of the ISO 22442 series that focuses on the requirements for the characterization and qualification of non-human tissues and their derivatives used in the production of medical devices. It provides detailed guidelines for assessing the biological safety of these materials, including considerations for sourcing, processing and risk evaluation.

 

What are viral inactivation studies?

Viral inactivation studies are scientific investigations focused on evaluating methods and techniques to eliminate or deactivate viruses that can present in medical devices. Medical devices that sometimes utilize non-human tissues include catheters, cardiovascular heart valves and vascular grafts, orthopedic bone void fillers and viscosupplements as well as wound care dressings and hemostats.

In order for the EN ISO 22442-3 study process to be as successful as possible, a few important decisions need to be made, including:

  • Virus selection — titre, handleability and relevancy to the non-human tissue being investigated must be taken into account
  • Appropriate study design — the right expert CRO can make sure you’re meeting the requirements of different regulatory bodies

 

What else will be covered in the EN ISO 22442 webinar?

Our speakers will explain the use of non-human tissue and derivatives in developing medical devices and how they’re able to enhance performance, stabilize formulations, and improve properties.

They’ll also walk through:

  • When and what to think about when pursuing a viral inactivation study
  • The ISO 22442-3 study process steps — and the decisions you’ll have to make in the process
  • Considerations for molecular screening and batch release
  • Common regulatory hurdles and what you can do about them
  • NAMSA case studies addressing these questions and concerns

 

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Speaker

Chris Ball, PhD

Technical Specialist

Chris, who joined NAMSA in 2022 through the acquisition of Perfectus Biomed, is responsible for the management and delivery of a range of bespoke projects in microbiology and molecular. Chris develops and leads R&D initiatives, plans and executes client projects and provides technical expertise to support operational processes. Chris has worked as a study director and obtained profound knowledge of setting up, planning, and performing viral clearance studies. Before working with NAMSA, Chris obtained his PhD from the University of Liverpool in 2014 and then went on to investigate molecular and immunopathogenesis aspects of infectious bronchitis virus (IBV), avian metapneumovirus (aMPV), Mycoplasma spp and other poultry diseases, using in vitro, ex vivo and in vivo systems in his postdoctoral research associate position, before joining Perfectus in 2021.

Jane Arnold-Round

Principal Regulatory Consultant

Jane Arnold-Round has over 25 years of experience in the medical device industry, working with a broad range of medical device technologies and organizations from start-ups to multinationals. She worked as a Notified Body reviewer for over 15 years at BSI as a Medical Device Product Specialist with particular responsibility in the wound-care sector. Prior to joining NAMSA in 2018, she was a Regulatory Consultant for 14 years. Jane’s current focus involves complex submissions for high-risk devices, including development of regulatory and clinical strategies, design dossier and technical file compilations, device-drug consultations, clinical evaluations and regulatory due diligence.

Thomas Miles

Head of Technical Operations (NAMSA Cheshire)

Tom joined NAMSA in 2022 through the acquisition of Perfectus Biomed and is responsible for technical oversight and facilities management for laboratory operations at Cheshire. He has extensive experience in cell culture, virology assays, multiple biological therapeutics, and in vitro toxicology. Drawing on a broad experience in the MedTech/Pharmaceutical industry, Tom supports client project development with a Techno-commercial mindset. Tom has worked in both operational/project management and technical-focused roles, supporting medical device and pharmaceutical manufacturing, before joining Perfectus in 2021.