In-house CQV team
Commissioning, qualification and validation
A lifecycle approach with quality risk management at its core, from early process mapping to final validation and ongoing monitoring.
ISO 14644cGMPPIC/SVCCNEudraLex
A lifecycle approach with quality risk management at its core, from early process mapping to final validation and ongoing monitoring.
ISO 14644cGMPPIC/SVCCNEudraLex
Engineer-to-Order creates project-specific design risks that delay CQV. With CTO+ we verify a proven product, built from the ADAPTUS library of pre-engineered, validated modules.
Start from systems that are already tested and confirmed.
No lengthy documentation and testing for bespoke components.
Repeatable, predictable performance.
Bridges construction and qualification. Verifies correct installation, operation as designed and defined performance. Risk-based and integrated with qualification for a faster handover.
Confirms the cleanroom meets the URS. IQ as-built against the ADAPTUS configuration, OQ at rest, PQ in operation. Guided by a validation master plan and GAMP 5.
Process, equipment and utility sterility, including autoclave cycles. Aligned with EU GMP Annex 15, FDA process validation guidance and ICH Q9.
Ongoing monitoring in line with 21 CFR Part 11, ICH Q7, ISO 14644 and ISO 8573, combining the VIX concept with GMPConnect.
HEPA/ULPA filter integrity testingLight-scattering airborne particle counter (LSAPC)Non-viable airborne particle monitoringMicrobial samplingRecovery testingParticle deposition testingTemperature and humidity mappingAir tightness testing (RL 10 VCCN)Aerosol photometer methodAir change effectiveness (ACE)Unidirectional airflow velocityAirflow volume and air change ratesAirflow visualisation
Gas purity and system performance: particles in gases, microbiological monitoring, dew point, hydrocarbon analysis and more.
From design to installation and long-term support: cGMP compliance, environmental monitoring and full validation, for new facilities and upgrades.
Pre-engineered building blocks, circular design, validation, GMP monitoring, commissioning or remodelling: our team answers quickly and to the point.