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Clean Room Validation Services

ISO 14644-compliant clean room classification, validation, and monitoring — ensuring your controlled environments meet pharmaceutical and manufacturing standards.

NCECNCEC Licensed
ISOISO Certified
500+Projects Delivered
24/7Expert Support

Certified Clean Room Validation & Classification

OzoneCo provides clean room validation and classification services for pharmaceutical, semiconductor, healthcare, and precision manufacturing facilities across Saudi Arabia. Properly validated clean rooms are essential for product quality, regulatory compliance, and patient safety.

Our validation services include ISO 14644 particle count classification, air change rate verification, HEPA filter integrity testing, pressure differential monitoring, temperature/humidity mapping, and comprehensive documentation for regulatory submissions.

Our Capabilities

01ISO 14644 classification testing
02Particle count monitoring
03HEPA filter integrity testing (DOP/PAO)
04Air change rate verification
05Pressure differential testing
06Temperature & humidity mapping
07Recovery rate testing
08Airflow visualization (smoke studies)
09Clean room monitoring systems
10Annual requalification

NCEC Regulatory Alignment

Supports NCEC indoor environmental quality requirements and SFDA pharmaceutical manufacturing standards.

Industries We Serve

PharmaceuticalSemiconductorMedical DevicesBiotechnologyFood ProcessingAerospaceHealthcareCosmetics
How We Work

Our Proven 4-Step Delivery Process

From discovery to long-term support — engineered for compliance, speed, and ROI.

STEP01

Consult & Scope

Free expert consultation to understand your facility, NCEC obligations, and project goals.

STEP02

Audit & Design

On-site audit, gap analysis, and tailored engineering aligned with KSA regulations.

STEP03

Deploy & Commission

Turnkey installation, calibration, and commissioning with full documentation.

STEP04

Monitor & Support

Ongoing maintenance, real-time monitoring, and 24/7 technical support.

Our Advantage

Why Choose OzoneCo?

01

ISO 14644 Certified

Testing and classification performed per ISO 14644-1, -2, and -3 standards.

02

Calibrated Equipment

NIST-traceable particle counters and calibrated instruments.

03

Regulatory Expertise

Reports accepted by SFDA, FDA, EU GMP, and other regulatory bodies.

04

Comprehensive Testing

Full validation packages including all required test protocols.

05

Monitoring Solutions

Continuous particle monitoring systems for ongoing compliance.

06

Annual Requalification

Scheduled annual requalification to maintain clean room certification.

Frequently Asked Questions

01What is clean room classification?
Clean room classification per ISO 14644-1 determines the class (ISO 1-9) based on the number and size of airborne particles per cubic meter, with ISO 5 being typical for pharmaceutical manufacturing.
02How often must clean rooms be revalidated?
ISO 14644-2 recommends revalidation every 6-12 months depending on the clean room class and regulatory requirements.
03What tests are included in validation?
Full validation includes particle count classification, HEPA filter integrity, airflow velocity/uniformity, pressure differential, temperature/humidity mapping, and recovery rate testing.
04Do you provide continuous monitoring?
Yes. We install continuous particle monitoring systems with real-time alerting and data logging for ongoing clean room compliance.

Get a Free Consultation

Speak with our experts about Clean Room Validation Services in Saudi Arabia.

NCEC-licensed experts • Response within 24 hours

Validate Your Clean Room

ISO 14644 clean room classification and validation.

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