2 modules8 lessons~5 h

Cleanroom Qualification and EM Programme Design

Qualify cleanrooms and design a risk-based environmental monitoring programme that stands up to inspection.

What you'll be able to do

✓ Tell classification, qualification and monitoring apart
✓ Plan HVAC and cleanroom qualification tests with Annex 1 guidance values
✓ Classify a room by ISO 14644-1 including locations and sample volume
✓ Apply Annex 1 microbial limits during qualification and routine use
✓ Design EM locations, methods and frequencies from a documented risk assessment
✓ Set alert levels, recognise adverse trends and plan requalification

MODULE 1QualificationStandards, tests, classification and microbial state.
- Grades, ISO classes and what qualified meansFree preview
- The qualification testsFree preview
- Particle classification by ISO 14644-1
- Microbial qualification and limits
MODULE 2The EM programmeDesign, levels, trending and requalification.
- Designing the EM programme by risk
- Alert levels, action levels and trending
- Requalification, change and case studies
- Final exam (25 questions)

Who is this course for?

Anyone who qualifies cleanrooms or runs the EM programme.

Is there a certificate?

Yes, after the lessons and a 25-question final test (pass mark 70 %), with a QR verification page.

Which standards does it follow?

EU GMP Annex 1 (2022), ISO 14644-1, -2 and -3, FDA aseptic guidance and Schedule M.