Biocontamination Course
Acquire mastery in controlling biocontamination within cleanroom settings using hands-on methods aligned with ISO 14644 and EU GMP Annex 1. Design effective environmental monitoring programmes, perform root cause evaluations, and implement corrective actions to foster safer, regulation-compliant facilities and minimise microbial hazards in vital processes.

4 to 360 hours flexible workload
valid certificate in your country
What will I learn?
This course equips you with practical expertise to manage and investigate biocontamination in cleanrooms. You will explore ISO 14644 classifications, EU GMP Annex 1 requirements, airflow dynamics, filtration systems, and pressure regimes. Gain proficiency in environmental monitoring, microbial data trending, and root cause analysis techniques. Enhance protocols for cleaning, gowning, HVAC maintenance, and material transfer, while developing resilient environmental monitoring programmes, corrective and preventive actions, and verification strategies to ensure compliant and dependable operations.
Elevify advantages
Develop skills
- Mastery of cleanroom standards: implement ISO 14644 and EU GMP Annex 1 effectively.
- Design of environmental monitoring: create ISO 5–7 plans featuring intelligent sampling strategies.
- Analysis of microbial trends: evaluate monitoring data, establish alert thresholds, and identify risks promptly.
- Conduct root cause investigations: perform site inspections, analyse data patterns, and initiate robust corrective actions.
- Optimise contamination control measures: refine cleaning, gowning, HVAC systems, and material handling procedures.
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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