Cleanroom Commissioning Services
From commissioning a new-build cleanroom to service, maintenance, testing & validation of existing controlled environments, the Guardtech Service Department support ongoing compliance in all cGMP & ISO14644 classified cleanrooms.
ISO14644:1-15 Validation: Airborne Particle Counts, Airflow Volume Measurements, Pressure Differential Testing, Temperature, Humidity & Lux Level Recording, ISO Certification and Full Validation Report.
Environment Qualification: Design Qualification (DQ) conducted by in-house Design Team, Installation Qualification (IQ) and Operational Qualification (OQ) conducted by the Services Department.
Facility Decontamination: Builders’ Cleans, Pre-Validation Cleans, Biocidal / Sporicidal Cleans. Range of contract options: annual, quarterly, monthly, weekly or daily. Cleanliness Verification tests conducted and full reporting.
Maintenance: Service Visits and Maintenance Contracts for cleanroom plant including Filtration, HVAC, Compressed Air, Extraction and other Mechanical Services.
All work conducted is followed by detailed reporting in line with ISO14644-1:2015 standards and cGMP guidelines, ensuring client facilities are audit-ready and compliant with the requirements of regulatory bodies.