Biocontamination Course
Gain mastery over biocontamination control in cleanrooms using practical strategies aligned with ISO 14644 standards and EU GMP Annex 1 requirements. The course covers designing environmental monitoring programs, conducting root cause analysis, implementing CAPA actions, and optimizing cleaning, gowning, HVAC, and material handling to build safer, compliant facilities that minimize microbial risks in vital manufacturing processes.

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 study ISO 14644 classifications, EU GMP Annex 1 guidelines, airflow patterns, filtration systems, and pressure management. Then, implement strong environmental monitoring, microbial data trending, and root cause analysis methods. Enhance protocols for cleaning, gowning, HVAC operations, and material transfer. Finally, create effective EM programs, CAPA processes, and verification strategies for consistent, regulation-compliant cleanroom performance.
Elevify advantages
Develop skills
- Master cleanroom standards by applying ISO 14644 and EU GMP Annex 1 effectively.
- Design environmental monitoring programs for ISO 5-7 areas using intelligent sampling techniques.
- Analyze microbial trends by interpreting data, setting alert limits, and identifying risks quickly.
- Conduct root cause investigations with on-site inspections, data mapping, and robust CAPA implementation.
- Optimize contamination control 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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