How to Choose the Best Particle Monitoring Sample Point Locations in Cleanrooms
Designing an effective environmental monitoring (EM) program requires more than simply placing particle counters in convenient locations. In pharmaceutical cleanrooms and controlled manufacturing environments, particle sample point location directly impacts your ability to detect contamination, maintain product quality, and meet regulatory requirements.
Poorly selected sampling locations can result in:
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Inaccurate contamination risk assessments
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Non-representative monitoring data
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Missed contamination events
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Increased deviation investigations
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Compliance challenges during inspections
Why Sample Point Location Matters for Environmental Monitoring
Both EU GMP Annex 1 and ISO 14644 standards emphasize the importance of risk-based sampling strategies that reflect process risk, personnel flow, airflow patterns, and critical product exposure points. The placement of particle monitoring sample points must align with:
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Critical Control Points (CCPs) where product or materials are exposed
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Airflow patterns that may carry contaminants into the monitored area
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Equipment and operator positioning that may introduce or disrupt airflow
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Regulatory expectations for data integrity and contamination control
Optimized sample point placement allows manufacturers to generate actionable, meaningful data that supports contamination control strategies and withstands regulatory scrutiny.
Get Expert Guidance on Particle Monitoring Sample Point Location
To help contamination control professionals make informed decisions, Particle Measuring Systems developed the technical paper:
“Choosing the Most Suitable Particle Sample Point Locations.”
In this paper, you’ll learn:
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How to evaluate your cleanroom layout for optimal particle counter placement
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Best practices for determining sampling locations in unidirectional vs. turbulent airflow environments
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How personnel, equipment, and facility design impact sample point location
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How to integrate sample point placement into your overall Contamination Control Strategy (CCS)
Whether you’re building a new cleanroom or updating your current environmental monitoring program to meet the latest EU GMP Annex 1: 2022 requirements, this paper provides practical, science-based guidance to optimize your particle monitoring plan.
👉 Complete the form to get the paper now and strengthen your environmental monitoring program with properly designed sample point locations.
