GMP and ISO cleanroom qualification, requalification, classification and certification, supported by design review and risk assessment.
Cleanrooms are among the most tightly regulated environments in pharmaceutical manufacturing. Classification, airflow performance and environmental control must be demonstrated under both static and dynamic conditions, and sustained over time. Demonstrating that consistently across a global footprint calls for a documented, risk-based approach to contamination control and reliable environmental data.
Our cleanroom validation services cover qualification, requalification, performance testing and ongoing monitoring against GMP and ISO 14644 requirements. We help you demonstrate compliance consistently across sites, reduce contamination risk in critical environments and maintain audit-ready environmental data throughout the cleanroom lifecycle.
Maintain compliant, high-performance cleanrooms across your global footprint
- Demonstrate regulatory complianceQualify and requalify cleanrooms against GMP, ISO 14644 and applicable regional requirements.
- Reduce contamination riskVerify microbial and particulate control in critical environments through risk-based testing and monitoring.
- Verify cleanroom performanceConfirm HVAC performance, airflow patterns, pressure differentials and HEPA filter integrity under representative conditions.
- Support inspection readinessGenerate traceable environmental data and documentation that stands up to regulatory inspection and customer audit.
- Strengthen contamination controlBring environmental monitoring, microbial and particulate control together under a documented, risk-based approach.
- Optimize cleanroom lifecycle managementMaintain the validated state through periodic requalification, trending and change impact assessment.
Discover our cleanroom validation services
HVAC and cleanroom performance testing, airflow visualization, pressure differential checks, HEPA filter integrity testing and recovery studies.
Environmental monitoring programs, microbial and particulate control, and risk-based contamination control, including contamination control strategy alignment under EU GMP Annex 1 for sterile manufacturing.
Periodic requalification and trending, change management and impact assessment, performance monitoring and audit readiness support.
Why SGS?
As the world’s leading testing, inspection and certification company, we deliver cleanroom validation as part of an integrated assurance offering that also spans commissioning, qualification and validation, calibration and asset integrity. Our specialists work across GMP manufacturing areas, clean utilities and computerized monitoring systems, applying standardized, audit-ready methodologies.
With technical teams in key pharmaceutical manufacturing hubs, we support consistent execution across multi-site and multi-country programs, combining global mobilization capability with local regulatory knowledge.