Biocontamination Course
4/5
Gain mastery in cleanroom biocontamination control using practical strategies aligned with ISO 14644 and EU GMP Annex 1. Develop skills in designing environmental monitoring programmes, performing root cause analysis, and implementing CAPA to create safer, compliant cleanroom environments and minimise microbial risks in essential operations.

4.0 in the evaluation
from 4 to 360h flexible workload
valid certificate in your country
What will I learn?
Acquire hands-on skills to manage and probe biocontamination in cleanrooms. Master ISO 14644 classifications, EU GMP Annex 1 guidelines, airflow dynamics, filtration systems, and pressure management. Implement robust environmental monitoring, microbial data trending, and root cause analysis techniques. Enhance protocols for cleaning, gowning, HVAC operations, and material transfer while building effective EM programmes, CAPA processes, and verification strategies for sustained compliance and operational reliability.
Elevify advantages
Develop skills
- Master cleanroom standards by applying ISO 14644 and EU GMP Annex 1 effectively.
- Design comprehensive environmental monitoring plans for ISO 5–7 areas with strategic sampling.
- Analyse microbial trends from EM data, set alert limits, and identify risks promptly.
- Conduct root cause investigations with on-site checks, data mapping, and robust CAPA actions.
- Optimise contamination control through improved cleaning, gowning, HVAC, and material handling.
Suggested summary
Before starting, you can change the chapters and workload. Choose which chapter to start with. Add or remove chapters. Increase or decrease the course workload.What our students say
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