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ISO14644 TR21- on demand webinar-web

ISO recently released a new Technical Report to help users of particle counters better understand how ISO 14644-1 and ISO 14644-2 work together and give helpful insights into how best to use particle counters in these two separate applications. In combination with the release and implementation of EU GMP Annex 1 for sterile manufacturing from August 2023, which required an understanding of particle counting equipment be better understood, including the limitation of sample tubing lengths, bends and tubing materials, the Technical Report reinforces best practices.

This webinar will outline what the content of the TR-21 is and how it relates to the use of particle counter applications and understanding.

What you’ll learn:

  • Understanding ISO 14644
  • Tubing lengths and bends
  • Tubing materials
  • Using particle counter sampling techniques

Who should attend:

  • Quality Assurance
  • Quality Control Specialists
  • Production Team Supervisors
  • Environmental Monitoring Team Members
  • Engineers
  • Facility Managers
  • Compliance Specialists
  • Operations Managers
  • Purchasing and Procurement Specialists

 

Webinar Presented By:
Mark Hallworth
Gerente Global de Ciências da Vida e Cientista Sênior de GMP, Particle Measuring Systems

Mark Hallworth é gerente global de ciências da vida e cientista sênior de GMP da Particle Measuring Systems. Durante a longa carreira de Mark em controle de contaminação, ele gerenciou o projeto, a instalação e a validação de mais de 200 projetos de sistemas de monitoramento ambiental em todo o mundo. Ele projetou vários produtos específicos para monitoramento ambiental farmacêutico, incluindo contadores de partículas para áreas explosivas e corrosivas e software compatível com 21 CFR parte 11 para teste e liberação de lotes. Ele atualmente dá palestras para o PDA, ISPE e outras sociedades farmacêuticas internacionais sobre monitoramento ambiental e projeto e validação de conformidade com GMP. Mark escreveu mais de 100 artigos técnicos sobre monitoramento ambiental e contribuiu para vários livros específicos para este campo. Ele recebeu o prêmio IEST James Mildon por “contribuições significativas para o avanço e aumento do conhecimento no campo do controle de contaminação”.

Get the experts in Particle Measuring Systems’ Advisory team to do your risk assessment for tubing particle loss.
Particle loss in transport tubing can occur due to a combination of various external factors. To assess the risk and potential impact on the finished product, it is crucial to conduct particle transportation tests. The primary objective of these tests is twofold: first, to quantify the resultant particle losses within a remote sampling system, and second, to provide documented evidence characterizing the efficiency of viable and non-viable monitoring processes. By addressing these aspects, manufacturers can gain valuable insights into the particle transportation dynamics in their remote systems and ensure appropriate measures are taken to maintain product quality.

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