Global compliance and validation

Your Passport to Global Markets

The Hybrid Advantage

At AIRKEY, validation is embedded throughout the project lifecycle—from design and procurement to manufacturing and construction. By aligning BIM design and project execution with applicable international standards from the outset, we help reduce regulatory risks and accelerate time to market.
The Hybrid Advantage

Comprehensive Factory Quality Assurance

Comprehensive Factory Quality Assurance

HEPA Testing Center

Every FFU and filter undergoes rigorous efficiency and leakage testing before shipment.

LAF Quality Inspection Center

Precision airflow distribution and cleanroom performance testing for laminar airflow (LAF) systems.

Quality Inspection Area

AIRKEY’s quality control center conducts final inspections to ensure all structural components meet OSM quality standards before shipment.

The V-Model Methodology

Design Qualification

Design Qualification

Ensures the design meets your process requirements.

Installation Qualification

Installation Qualification

Verifies that all equipment, piping, and systems are correctly installed according to design specifications.

Operational Qualification

Operational Qualification

Verifies that systems operate reliably under specified conditions, including airflow, pressure, and temperature and humidity.

Performance Qualification

Performance Qualification

Confirms that the controlled environment consistently meets requirements under actual production conditions.

Global Trust

AKRON-BIO
ASM
Artoss-Inc
BAIN
BGI
BYD
Canon
DELTA
Design-Biologix
EVE
GE-HealthCare
HUAWEI
INVT
LISNEN
MGI
NXP
OU-PONT
PENTAX
SELBY
SIDAPHARM
SNS
SONY
SQUARE
SonoScape
TE
Unimed-UniHealth
Vazyme
WORLO-MEDICNE
XYG
amcor
dy
faeder
kerecis
opentrons
safecare
winner
中国科学院物理研究所
复旦大学
大族激光
奥比中光
暨南大学
诺禾

Cleanroom Global Compliance & Validation Project Cases