Apply ISO 14644-1 classification and airflow design principles to cleanroom HVAC systems.
Engineering & Maintenance
Contamination Control and Facilities Engineering for Cleanrooms
Covers ISO 14644-1 classification, HVAC and filtration design, environmental monitoring, gowning discipline and cleaning validation for cleanroom facilities.
🗓️Duration5 training days
📚Content4 modules · 8 sessions
🎓On completionAccredited attendance certificate
About the programme
Course Overview
A cleanroom that passes its classification test on installation day can still drift out of control within months if pressure cascades sag, filters load unevenly or gowning discipline slips, and the resulting contamination event may not surface until a batch fails release testing. This course covers ISO 14644-1 classification methodology, airflow design and HEPA and ULPA filtration selection for pharmaceutical, electronics and other controlled environments, then moves into the particle and microbial monitoring programmes that catch drift before it becomes a deviation. Participants learn to specify gowning protocols, material transfer procedures and personnel behaviour controls, and to validate cleaning and disinfection programmes against a facility's specific microbial risk profile. Sessions cover qualification and requalification testing, building management system configuration for continuous pressure and humidity trending, and the maintenance planning needed to service HVAC components without breaching contamination control. The course finishes with facility upgrade and continuous improvement planning, leaving participants able to run a cleanroom facility that stays inside its classification day after day.
Expected Learning Outcomes
Select and size HEPA and ULPA filtration and pressure cascade systems for contamination control.
Design and interpret particle and microbial environmental monitoring programmes.
Specify gowning, behaviour and material transfer controls that minimise contamination ingress.
Validate cleaning and disinfection programmes against a facility's microbial risk profile.
Plan cleanroom qualification and requalification testing aligned with classification standards.
Configure facility monitoring systems and plan maintenance that preserves contamination control.
Who Should Attend
Facilities engineers designing or operating pharmaceutical and electronics cleanrooms.
Quality and validation professionals responsible for contamination control programmes.
HVAC engineers specifying cleanroom filtration and pressure cascade systems.
Microbiologists and environmental monitoring specialists in regulated manufacturing.
Maintenance teams servicing cleanroom HVAC and building management systems.
Project engineers planning cleanroom construction or classification upgrades.
Course Modules
Select any module to see its sessions and points.
01Cleanroom Classification and Design Principles
2 sessions · 8 points
Session 1ISO 14644 Classification and Airflow Design
- Apply ISO 14644-1 classification methodology to define particle count limits for cleanroom grades.
- Design unidirectional and non-unidirectional airflow patterns matched to process contamination sensitivity.
- Calculate air change rates and HEPA or ULPA filter coverage needed to sustain target cleanliness classes.
- Specify room pressure cascades and airlock design to prevent cross-contamination between zones.
Session 2HVAC Systems and Filtration for Cleanrooms
- Select HEPA and ULPA filtration stages and filter housing designs for terminal and recirculating air systems.
- Design make-up air, humidity control and temperature stability systems for process and personnel requirements.
- Evaluate fan filter unit versus ducted HVAC configurations for cleanroom retrofit and new-build projects.
- Assess energy consumption trade-offs between air change rate and contamination control performance.
02Contamination Control and Monitoring
2 sessions · 8 points
Session 1Particle and Microbial Monitoring
- Conduct airborne particle counting using calibrated instruments aligned with ISO 14644-1 test methods.
- Design environmental monitoring programmes covering viable and non-viable particle sampling locations.
- Interpret settle plate, active air sampling and surface contact plate results against alert and action limits.
- Investigate monitoring excursions to determine root cause and corrective action requirements.
Session 2Gowning, Behaviour and Material Transfer Control
- Specify gowning protocols and garment material selection appropriate to cleanroom classification.
- Train personnel behaviour practices that minimise particle and microbial shedding during operations.
- Design material and equipment transfer procedures through pass-throughs and airlocks to prevent contamination ingress.
- Audit gowning qualification and personnel monitoring programmes for compliance with facility procedures.
03Cleaning, Disinfection and Validation
2 sessions · 8 points
Session 1Cleaning and Disinfection Programme Design
- Select cleaning agents and disinfectant rotation schedules effective against the facility's microbial risk profile.
- Design cleaning procedures and frequencies for walls, floors, equipment and hard-to-reach cleanroom surfaces.
- Validate disinfectant efficacy and contact time against qualified microorganisms relevant to the facility.
- Manage sporicidal treatment programmes for areas with elevated bioburden risk.
Session 2Facility Qualification and Requalification
- Plan cleanroom qualification testing including airflow visualisation, filter integrity and recovery time tests.
- Schedule periodic requalification aligned with classification standards and regulatory expectations.
- Document qualification protocols, acceptance criteria and deviation handling for facility certification.
- Coordinate requalification activities with production schedules to minimise facility downtime.
04Facilities Engineering and Continuous Improvement
2 sessions · 8 points
Session 1Building Management and Facility Monitoring Systems
- Configure building management systems to trend pressure differentials, temperature, humidity and filter status continuously.
- Set alarm thresholds and escalation procedures for excursions affecting contamination control parameters.
- Integrate facility monitoring data with quality systems to support batch release and audit trails.
- Plan preventive maintenance for HVAC components without compromising cleanroom operational status.
Session 2Facility Upgrades and Continuous Improvement
- Evaluate facility upgrade options when process changes require higher classification or additional zones.
- Plan phased construction or renovation activities that maintain contamination control in adjacent operating areas.
- Benchmark facility performance data to identify opportunities for energy or contamination control improvement.
- Present facility performance and improvement recommendations to quality and operations stakeholders.
What the participant receives
4 course modules
A structured syllabus
8 training sessions
across 5 days
32 detailed points
Applied, detailed content
Accredited attendance certificate
On completing the programme
Complete your registration
We will contact you within one business day to confirm.
Ready to start?
Reserve your seat and start building the skill.