Biocontamination Course
Gain mastery in biocontamination control for cleanrooms using practical approaches aligned with ISO 14644 standards and EU GMP Annex 1 guidelines. Learn to design effective environmental monitoring programs, perform root cause analysis, and implement CAPA measures. Develop skills to create safer, compliant cleanroom settings and minimise microbial risks in key manufacturing processes, ensuring reliable operations and regulatory adherence.

flexible workload from 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. You will cover ISO 14644 standards, EU GMP Annex 1 rules, airflow patterns, filtration systems, and pressure management. Gain expertise in environmental monitoring, microbial data trends, and root cause analysis methods. Enhance practices in cleaning, gowning protocols, HVAC operations, and material transfer, while building strong environmental monitoring setups, CAPA processes, and verification strategies for dependable, regulation-compliant cleanroom work.
Elevify advantages
Develop skills
- Master cleanroom standards: implement ISO 14644 and EU GMP Annex 1 effectively.
- Design environmental monitoring: create ISO 5-7 plans with efficient sampling strategies.
- Analyse microbial trends: review data, define alert limits, and identify risks quickly.
- Conduct root cause probes: perform site inspections, analyse data, and lead CAPA actions.
- Optimise contamination controls: improve 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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