Mark Hallworth will be presenting in the Barrier Track at ISPE 2016 Aseptic Processing Technology Conference, held Feb. 29 – March 1 in Arlington, Virginia. Mark is the Pharmaceutical Sales Manager, North America, for Particle Measuring Systems, and has managed the design, installation and validation of more than 300 environmental monitoring system projects worldwide. He currently lectures for the PDA, ISPE and other international pharmaceutical societies on environmental monitoring and GMP compliance design and validation. Mark has authored many papers including Choosing the Most Suitable Non-Viable Sample Point Locations. For his presentation at ISPE, he will be discussing environmental monitoring challenges in isolator technologies.
Presentation details:
Ambient Monitoring Systems in Isolated Automatic Filling Lines
Monday, February 29, 12:00 – 12:30 p.m.
Problem or Opportunity Statement:
The location of, and justification for environmental sample locations is increasingly difficult in enclosed isolator fill/finish production lines. There are many lessons learned over the years in how best to approach these issues both theoretical and practical.
Learning Objectives:
At the conclusion of this education session, participants will be able to:
- Understand what parameters affect the location of environmental monitoring in isolators
- Determine how best to apply the ‘most suitable’ limits to tolerance limits
