Biocontamination Course
4/5
Acquire expertise in controlling biocontamination within cleanrooms using practical approaches aligned with ISO 14644 standards and EU GMP Annex 1 requirements. Develop skills in designing environmental monitoring programs, conducting root cause analysis, and implementing CAPA measures. This training helps build secure, regulation-compliant cleanroom settings while minimising microbial hazards in vital manufacturing processes.

4.0 in rating
flexible workload of 4 to 360h
valid certificate in your country
What will I learn?
This course equips you with hands-on skills to manage and probe biocontamination in cleanrooms. Gain knowledge on ISO 14644 classifications, EU GMP Annex 1 guidelines, airflow patterns, filtration systems, and pressure management. Master environmental monitoring techniques, microbial data trending, and root cause analysis methods. Enhance protocols for cleaning, gowning, HVAC operations, and material transfer to create strong EM strategies, CAPA processes, and validation plans ensuring consistent compliance and safety.
Elevify advantages
Develop skills
- Master cleanroom regulations by implementing ISO 14644 and EU GMP Annex 1 effectively.
- Design comprehensive environmental monitoring for ISO 5-7 zones using strategic sampling methods.
- Analyse microbial trends from EM data to establish alert limits and detect issues promptly.
- Conduct thorough root cause probes with on-site assessments, data mapping, and robust CAPA actions.
- Optimise contamination prevention through improved cleaning, gowning, HVAC, and material handling practices.
Suggested summary
Before starting, you can change the chapters and the 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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