Cleanroom Commissioning & Validation
Backed by UKAS accreditation and decades of contamination-control expertise, we rigorously test and certify cleanrooms for pharmaceutical, laboratory, and defence applications.
Cleanroom Commissioning & Validation You Can Trust
UKAS ISO 17025-accredited testing and independent verification delivering compliant, audit-ready cleanrooms across pharmaceutical, laboratory, and high-containment environments.
Total Clean Air delivers expert cleanroom commissioning and validation services, ensuring your controlled environments meet the highest standards of compliance, safety, and performance. From pharmaceutical manufacturing suites to high-containment laboratories and advanced manufacturing cleanrooms, we provide end-to-end support for operational reliability and audit-ready certification.
Every aspect of your facility is rigorously tested, measured, and verified to ensure it performs exactly as designed. As a UKAS ISO 17025-accredited company, our work carries independent scientific credibility, giving you confidence in compliance with ISO 14644, EU GMP Annex 1, MHRA, FDA, and other regulatory standards.
At Total Clean Air, commissioning and validation is where design intent becomes real performance. Every project, from GMP-certified pharmaceutical suites to high-containment laboratories and defence-grade facilities, undergoes meticulous testing, independent verification, and full validation under our UKAS accreditation.
Our engineers bring decades of contamination control and pharmaceutical experience, overseeing projects from sterile drug production suites to CL2/CL3 labs and advanced defence facilities. Every cleanroom receives the same precise attention to compliance, reliability, and long-term performance.
Comprehensive Commissioning & Validation, Delivered with Precision
Our commissioning and validation approach is structured, evidence-based, and fully aligned with regulatory expectations. We apply rigorous testing methodologies and independent verification to confirm that every cleanroom system operates exactly as intended—supporting compliance, audit readiness, and long-term operational confidence.
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UKAS ISO 17025-Accredited Testing
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Full Regulatory Compliance Assurance
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End-to-End Lifecycle Support
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Experienced, Sector-Specific Engineers
Our validation process typically encompasses:
Installation
Qualification (IQ):
Verifying that all systems and equipment are installed correctly, to specification.
Operational
Qualification (OQ):
Confirming that under operating conditions, systems perform within predefined parameters (airflow, pressure, filtration, etc.).
Performance
Qualification (PQ):
Demonstrating over time (or under simulated production/operational conditions) that the cleanroom maintains performance, stability, safety and compliance.
Installation
Qualification (IQ):
Verifying that all systems and equipment are installed correctly, to specification.
Operational
Qualification (OQ):
Confirming that under operating conditions, systems perform within predefined parameters (airflow, pressure, filtration, etc.).
Performance
Qualification (PQ):
Demonstrating over time (or under simulated production/operational conditions) that the cleanroom maintains performance, stability, safety and compliance.
Total Clean Air offers a complete turnkey package for all your cleanroom requirements
View more services:
Cleanroom
Consultancy
Providing expert guidance on design, compliance, and operation to ensure controlled environments meet regulatory standards and perform efficiently.
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Cleanroom
Decontamination Solutions
SteraMist® is an advanced decontamination system using ionised hydrogen peroxide to deliver rapid, residue-free sterilisation of air and surfaces.
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Cleanroom
Design & Construction
We create tailored cleanroom solutions, engineered to your exact specifications, ensuring performance, compliance and efficiency from the ground up.
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Cleanroom
Furniture
From modular to fully customisable solutions, our cleanrooms are built to meet the strictest standards for quality, compliance and operational excellence.
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Cleanroom
Maintenance & Servicing
Keep your cleanroom performing at its best with our expert maintenance and servicing solutions, designed to minimise downtime and maximise reliability and efficiency.
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Cleanroom
Testing & Validation
We provide precise testing and validation services to guarantee your cleanroom meets all regulatory and performance standards.
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Environmental
Monitoring
Providing real-time environmental monitoring, delivering accurate, continuous data on air quality and critical conditions to support compliance and optimise controlled environments.
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Cleanroom Commissioning & Validation
What Our Commissioning & Validation Involves
When we commission and validate a cleanroom, we systematically confirm that every component and environmental parameter works as intended. That includes measuring airflow, verifying air-change rates, checking pressure cascades and ensuring filter integrity. All results are independently verified to provide traceable and audit-ready documentation.
We follow internationally recognised standards, including ISO 14644, EU GMP Annex 1, and, where relevant, guidance from MHRA, FDA and other regulatory bodies.
Cleanroom Commissioning & Validation
Why Choose Total Clean Air for Commissioning & Validation?
As a UKAS ISO 17025-accredited organisation, our testing and results carry independent scientific credibility. This ensures that you receive not merely a certificate, but comprehensive assurance that your facility complies with the highest international standards.
We are not simply a contractor delivering a completed facility; we are a long-term partner. From commissioning and validation to planned preventative maintenance, requalification, and revalidation throughout the lifecycle of your cleanroom, we support sustained compliance, operational stability, and confidence in performance.
With extensive experience across multiple sectors—including pharmaceuticals, biotechnology, high-containment laboratories, and advanced manufacturing—we understand the specific requirements of each industry. This enables us to deliver a commissioning and validation programme tailored to your unique operational workflows and regulatory obligations.
