01 / COMPLIANCE
The standards, and the paperwork that proves them.
A logo on a website has never passed an inspection. What passes one is a dossier where every number traces to a calibrated instrument and a named engineer.
ISO 9001:2015
Quality management across design, procurement, installation, and service.
ISO 14644-1
Classification and monitoring methodology applied on every project.
FDA cGMP
Facility design and qualification aligned to FDA cGMP expectations.
EU GMP Annex 1
Sterile design principles including contamination control strategy.
02 / THE DOSSIER
Five documents, and none of them optional.
DQDesign qualificationURS traceability matrix, GA drawings, HVAC load calculations, and P&IDs signed before fabrication.
IQInstallation qualificationAs-built verification against drawings, material certificates, and instrument calibration records.
OQOperational qualificationAir changes, velocity, DOP filter integrity, recovery time, and pressure cascade under real conditions.
PQPerformance qualificationAt-rest and in-operation particle counts plus microbial monitoring across a defined campaign.
HOHandover packO&M manuals, spare parts list, training records, and the requalification schedule for the next three years.
03 / INSTRUMENTATION
Owned, calibrated, and operated by us.
Testing is never subcontracted. Every instrument below is ours, calibrated annually against traceable standards, and operated by the validation engineer whose name goes on the report.
Laser particle counters
Aerosol photometers
Thermal anemometers
Balometer capture hoods
Differential pressure meters
T/RH mapping loggers
04 / AUDIT SUPPORT
Our validation lead attends your regulatory inspection at no extra cost for the first twelve months after handover.