Turnkey Cleanroom Projects, Validation & AMC

Turnkey Cleanroom Projects

Six stages. One accountable partner.

Click a stage to see what our team delivers.

Stage 1 of 6

Validation & Qualification

Our validation engineers qualify new and existing cleanrooms, clean-air equipment and HVAC systems to ISO 14644-3 methods and your own SOPs.

HEPA filter integrityPAO / DOP aerosol challenge and scan testing

Particle countsNon-viable classification to ISO 14644-1

Airflow & air changesVelocity, volume and ACPH measurement

Pressure cascadeDifferential pressure and containment checks

Recovery testsClean-up time after particle challenge

Smoke studies & IQ/OQ/PQAirflow visualisation, protocols and reports

AMC & Facility Upgrades

Regulations tighten and facilities age. Our annual maintenance contracts and upgrade services keep your rooms performing as validated.

Planned preventive maintenance and periodic requalification
HEPA and pre-filter replacement with integrity testing
Priority breakdown response for production-critical areas
Gap assessments for revised Schedule M, EU GMP Annex 1 and USFDA inspections
Upgrades of finishes, doors, pass boxes and pressure cascades without long shutdowns

Engineering Tool

Select a class to see its particle limits, the matching EU GMP grade and typical applications, then estimate the airflow for your room.

ISO 7

Maximum particles per m³ of air, equal to or larger than the size shown
Particle size	0.1 µm	0.2 µm	0.3 µm	0.5 µm	1 µm	5 µm
Limit

Limits from ISO 14644-1:2015, Table 1. A dash means the size is not specified for that class.

Length (m) Width (m) Height (m)

Room volume–

Air changes / hour–

Supply airflow–

HEPA filters (approx.)–

Industry rule-of-thumb ranges for an early budget discussion. Final design depends on heat load, process and occupancy.