A central theme of the new ISO 14644 Technical Report 21 (TR 21) focuses, in section 4.0, on the difference between cleanroom classification and monitoring, this presentation will review the core differences between these points and associated instrumentation choices described in section 5.2 that best meet these needs. Classification is centered on the quality of the measurement and the best, most accurate measurement that can be taken when considering instrumentation differences; monitoring is a function of measurement over time, so the quality of the data becomes key, which may require different instruments for understanding the changes to ‘normal’ conditions.

What you’ll learn:

• Introduction to the new ISO 14644 Technical Report 21
• Understanding the difference between classification and everyday cleanroom monitoring
• Instrumentation choices associated with the regulatory needs
• Ensure data quality by understanding changes to normal conditions

Who should attend:

• QA & QC
• Production and manufacturing teams
• Environmental monitoring experts
• Biologists
• R&D team
• Biopharmaceutical engineers
• Automation managers
• Regulatory experts