EU GMP Annex 1 provides guidance on choosing effective cleanroom sampling points.
Definition:
Cleanroom Sample points include particle counters and microbial monitors.
- Identification of critical areas by HACCP analysis and process understanding
- Choose points within the critical areas according to defined criteria
- When performed this way, you can demonstrate a thorough evaluation based on scientific criteria that any sampling point was considered
Define final points based on available space, environmental design, evaluation of product and primary container closure exposure.
Contamination Control Advisory Team: Utilities
Our team can help you with your utilities sampling monitoring plan by doing a scientific analysis, through risk-based techniques, of Purified Water, Water for Injection, Pure Steam, and Gases systems for:
- Points of Use assessment
- Sampling frequency
- Sampling procedure
- Risk mitigation activities
Learn more… Get the full paper here.
Learn how the PMS Advisory Team can help you:
