Training Objectives
- Understand ISO 14644-based cleanroom classifications and regulatory context.
- Identify sources of contamination and apply contamination control principles.
- Perform cleanroom gowning, hygiene, and behavioural protocols.
- Implement cleanroom monitoring, cleaning, documentation, and qualification.
- Assess risk, set up alert/action limits, and manage cleanroom compliance effectively.
Training Duration
2 Days (8 hours/day including breaks)
Target Audience
- QA and Regulatory Personnel
- Assembly and Production Personnel
- Engineering and Maintenance personnel
Day 1 – Cleanroom Fundamentals, Classification & Contamination Control
| Module | Key Learning Points |
| Introduction to Cleanrooms | Definition, cleanroom function, and relevance in the medical and pharmaceutical industries |
| Why Cleanrooms Matter | Limitations of sterilization; importance of contamination control for product and patient safety |
| Regulatory Framework Overview | ISO 14644, ISO 13485 (clauses 6.3 & 6.4), ISO 14698, MDD/MDR, EU-GMP Annex 1 |
| Key Definitions & Cleanroom Parameters | Cleanroom definition, air quality parameters, pressure differential, humidity, and air changes |
| Types of Cleanrooms | Laminar flow, RABS, isolators, airlocks; advantages & applications |
| Cleanroom Classifications | ISO Classes 1–9, particle concentration limits, mathematical correlation (Cn = …) |
| Cleanroom Design Requirements | Air handling units (AHU), HEPA filters, static pressure zones, and cleanroom layout |
| Contamination Control & Sources | Human, equipment, environmental sources; non-viable vs viable contamination |
| End-of-Day Review & Group Q&A | Recap quiz and participant-led discussion |
Day 2 – Personnel Practices, Qualification & Validation, Monitoring, Documentation & Compliance
| Module | Key Learning Points |
| Personnel Hygiene & Behaviour Protocols | Humans as a major contaminant source; health, behaviour, restriction protocols |
| Gowning Techniques | Gowning procedure steps: hairnet, gloves, coveralls, booties; do and don’ts |
| Cleaning & Maintenance of Cleanrooms | Cleaning agents/tools, schedule, line clearance, disinfection rotation |
| Monitoring Program & Frequency | Particle counters, microbial samplers, trend analysis, sampling locations |
| Alert/Action Limits & Documentation | Setting levels, escalation process, documentation, and traceability requirements |
| Bioburden Control & Impact on Sterilization | Sources of bioburden, sampling methods (air, surface), and impact on process validation |
| Cleanroom Qualification & Validation | As-built, at-rest, and operational qualification steps; documentation requirements |
| Prohibited Items in Cleanrooms | List of banned materials, surfaces, behaviours, and their justifications |
| Case Study / Scenario-Based Group Activity | Apply learning to realistic cleanroom non-conformance scenarios |
| Post-Test Assessment | To gauge understanding and retention |
| Closing Summary & Feedback Session | Training recap, Q&A, participant feedback collection |
Training Methodology:
- Instructor-led Presentations – Covering theoretical & regulatory aspects
- Audit Case Studies – Real-world examples of cleanroom qualification, validation, and routine monitoring issues
- Video Demonstrations –video demonstration on cleanroom set-up and operation
- Assessments & Competency Checks – Quizzes, practical case analysis, and a final exam
Training Materials Provided:
- PowerPoint slides
- Participant manual
- Audit checklists
- Cleanroom behaviour guide
- Sample validation protocols
Assessment and Certificate
- Post-training Quiz/Test
- Group Activity: Audit Simulation
Interested with this course? Send us enquiries below!
