Microbial & Particle Risk Assessment of a Cleanroom & Filling Line Contamination
Filling Line Contamination can be generally avoided through an effective contamination monitoring system, starting with a risk assessment.Ā
Knowledge Category: Air
Understand and Mitigate Variability in Particle Counter Results
Establishing and maintaining cleanroom performance of aerosol particles in a cleanroom often requires the use of multiple particle counters with varying design parameters and display settings. Commonly, cleanroom personnel employ the use of multiple optical particle counters (as defined in ISO 14644-1) to report an array of airborne particle counts. This paper is a summary of the basic methods cleanroom personnel may use to ensure that the data that is reported by different aerosol particle counters can be compared effectively. This is accomplished by making sure differences are understood and appropriate data conversions can be made to make meaningful comparisons.
Particle Loss in Tubing: An Analysis
In discussing acceptable particle losses in tubing, there are many factors. Transportation of particles in tubing between a sample inlet and the optics of particle counters has at many times been at the forefront of discussion regarding the truth of readings. When the validation implications of losses due to various forces are reviewed, the certainty of the result is always in question. So, what are these forces, what are the losses, and what are the acceptable results? This paper addresses these issues to allow for a better understanding of the problem.
Environmental Monitoring Best Practices Handbook *New Volume 2026*
The second volume of the Environmental Monitoring Handbook for Pharmaceutical Manufacturers provides updated guidance on monitoring in glove boxes and isolators, microbial sampling criteria, Annex 1 (2022) changes, and particle loss in transport tubing. It offers a clear, practical understanding of environmental monitoring tools, techniques, and riskābased approaches for compliant, wellācontrolled operations.