Understanding ISO 14644 Technical Report 21 Airborne Particle Sampling Techniques

On Demand | Duration: 60 min

Webinar on demand 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.

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 lengthsbends 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 Presentato da:
Mark Hallworth
Global Pharma and Sr. GMP Advisor Life Sciences Division

Mark Hallworth è il Global Pharma and Sr. GMP Advisor Life Sciences Division presso Particle Measurement Systems. Nel corso della lunga carriera di Mark nel controllo della contaminazione, ha gestito la progettazione, l’installazione e la convalida di oltre 200 progetti di sistemi di monitoraggio ambientale in tutto il mondo. Ha progettato diversi prodotti specifici per il monitoraggio ambientale farmaceutico, inclusi contatori di particelle per aree esplosive e corrosive e software conforme a 21 CFR parte 11 per test e rilascio di lotti. Attualmente tiene conferenze per PDA, ISPE e altre società farmaceutiche internazionali sul monitoraggio ambientale e sulla progettazione e convalida della conformità GMP. Mark ha scritto oltre 100 articoli tecnici sul monitoraggio ambientale e ha contribuito a diversi libri specifici in questo campo. Più recentemente, Mark è stato membro del comitato tecnico internazionale ISO 14644-21 responsabile della revisione e della revisione dello standard. È stato insignito del premio IEST James Mildon per i “contributi significativi al progresso e all’incremento delle conoscenze nel campo del controllo della contaminazione”.

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