Biocontamination Course
Gain mastery in controlling biocontamination in cleanrooms through practical application of ISO 14644 standards, EU GMP Annex 1 requirements, environmental monitoring program design, root cause investigations, and CAPA implementation. Learners will create safer, fully compliant cleanroom settings while minimising microbial risks in essential manufacturing and operational processes. This course delivers actionable strategies for sustained contamination prevention and regulatory adherence.

from 4 to 360h flexible workload
valid certificate in your country
What will I learn?
This course equips you with hands-on skills to manage and probe biocontamination in cleanrooms. You will cover ISO 14644 classifications, EU GMP Annex 1 guidelines, airflow patterns, filtration systems, and pressure management. Gain expertise in environmental monitoring, microbial data trending, and root cause analysis methods. Enhance protocols for cleaning, gowning, HVAC operations, and material transfer. Develop strong environmental monitoring programs, CAPA processes, and verification strategies for consistent compliance and safety.
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 using intelligent sampling.
- Analyse microbial trends from EM data, establish alert limits, and identify risks promptly.
- Conduct thorough root cause investigations with on-site assessments, data mapping, and CAPA execution.
- Optimise contamination control through improved cleaning, gowning, HVAC, and material handling practices.
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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