ISO 14644-2:2015 Cleanroom Monitoring FAQ

This ISO 14644-2 questions and answers paper is a follow up to the webinar, “ISO 14644-2:2015 Cleanroom Monitoring”. Many thoughtful questions were asked about cleanroom practices and the most recent to the ISO standard. Questions submitted during and after the webinar are answered below. If you have any additional queries for our experts, submit them directly here.

Topics in this paper include:

Basics
Other Standards
Cleanroom Classification
Microbial Monitoring
Particle Size
Calibration and Verification
Monitoring Frequency
Tubing
Locations and Positioning
Applications
Risk Assessment
Alert and Action Limits

Examples of the questions and answers included here are:

What are the key factors to keep in mind when working on a new cleanroom facility?
To access materials to better address this wide-ranging topic, navigate to Particle Measuring Systems’ Knowledge Center. The following application note is a great place to start when designing a new cleanroom: Quality By Design and Single-Use Air Sampling Approaches.

Should I use cumulative or differential particle data from my instrument?
All standards, including ISO, GMP, etc. always refer to cumulative particles.
Differential value can be used for investigation and troubleshooting purposes.

Which parameters, other than particles, should be monitored in the cleanroom?
Several operating conditions in addition to operation performance should be monitored based on your
specific process and product risk evaluation. The ISO standards list parameters such as temperature,
differential pressure, humidity, and ventilation performance, but you are not limited to these few.

What is UDAF?
UDAF stands for Uni-Directional Air Flow cleanrooms.

How do I acquire documents ICH 29 and Technical Report No. 13?
Here is the ICH 9 document link.
The PDA Technical report number 13 must be purchased form this website.