Validation and Compliance
Full validation documentation (IQ, OQ, PQ)
Compliance with ISO, GMP, and FDA standards
Expert auditing support
Reduced regulatory risk
We prove performance, not just compliance.
Validation is one of the most critical stages in any cleanroom project. Without it, even the most advanced facility cannot be brought safely into operation. At Modular Clean Air, validation is never treated as a procedural formality; it is a rigorous, evidence-led process designed to prove that your cleanroom not only meets regulatory requirements but also performs consistently under real-world conditions.
Our comprehensive validation services encompass Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) — each supported by detailed documentation capable of withstanding the most stringent audits.
Every system is meticulously tested, including airflow performance, HEPA filtration efficiency, pressure differentials, and temperature and humidity controls, to confirm that operational performance aligns precisely with design intent.
By validating your cleanroom with Modular Clean Air, you gain complete assurance that your environment is compliant, audit-ready, and engineered for long-term reliability and confidence in performance.
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Installation Qualification (IQ)
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Operational Qualification (OQ)
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Performance Qualification (PQ)
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Comprehensive documentation packages
Supporting audits with confidence
Regulatory audits can be challenging, but with Modular Clean Air by your side, you can approach them with complete confidence. Our validation packages are meticulously structured to provide the precise documentation auditors expect, minimising stress and eliminating compliance gaps before they arise.
All reports are aligned with ISO 14644 and GMP Annex 1 compliance standards, ensuring readiness for both UK and international regulatory frameworks.
Beyond documentation, our experienced engineers are available to support you throughout inspections, addressing technical queries and offering expert clarification where required. This proactive support enables your team to demonstrate competence, preparedness, and control, ensuring that audits are smooth, predictable, and successful.
With every critical element of your cleanroom validated, verified, and fully documented by Modular Clean Air, you can face each audit with the assurance that compliance and performance are already proven.
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Why cleanroom validation matters
Cleanrooms operate within some of the most tightly regulated industries, where even the smallest compliance failure can result in costly production halts, product recalls, or regulatory penalties.
Validation is the process that ensures your facility consistently maintains the environmental conditions required for safe and compliant manufacturing. Without robust validation, a cleanroom may pass its initial inspection yet fail under operational pressures — exposing your organisation to unnecessary risk.
At Modular Clean Air, we prevent this by delivering validation that is both comprehensive and practical. We not only test your cleanroom against the latest ISO and GMP standards, but also establish clear frameworks for ongoing compliance.
This proactive approach safeguards product integrity, patient safety, and brand reputation, ensuring your cleanroom continues to perform — reliably, compliantly, and without interruption.
Industry validation standards
Different industries require different levels of cleanroom validation, and MCA is equipped to deliver across all of them. For pharmaceutical and biotech companies, we ensure compliance with GMP Annex 1 and ISO 14644 particle classifications. In medical devices, we validate environments to meet stringent FDA and EU MDR standards. Semiconductor and electronics facilities require validation that focuses on airborne particle counts, electrostatic discharge control, and environmental stability. By tailoring our cleanroom validation services to your industry, MCA ensures that your cleanroom is not only compliant but also optimized for your specific production processes. Our engineers stay up to date with evolving regulations, guaranteeing your facility remains audit-ready even as standards change.
MCA cleanroom validation services
Different industries demand varying levels of cleanroom validation — and Modular Clean Air is equipped to deliver across them all.
For pharmaceutical and biotechnology facilities, we ensure full compliance with GMP Annex 1 and ISO 14644 particle classification standards. Within the medical device sector, our validation services align with EU and MDR compliance requirements, ensuring that every environment supports safe, consistent manufacturing outcomes.
In semiconductor and advanced electronics applications, our validation focuses on airborne particulate control, electrostatic discharge (ESD) protection, and environmental stability, guaranteeing optimal process reliability.
By tailoring each validation programme to your industry-specific standards and operational processes, Modular Clean Air ensures your cleanroom is not only compliant but also optimised for performance and longevity.
Our engineers remain fully abreast of evolving global regulations, ensuring your facility stays audit-ready and future-compliant as standards advance.
Cleanroom Standards Compliance & Validation Services
Ensuring cleanroom standards compliance is fundamental within highly regulated sectors such as pharmaceuticals, biotechnology, and advanced manufacturing. Robust compliance practices are essential to safeguard product integrity, protect patient safety, and satisfy stringent regulatory expectations.
Through continuous monitoring and structured validation, Modular Clean Air helps identify potential risks early, uphold operational consistency, and maintain long-term efficiency across your cleanroom facilities.
Our commitment to compliance and validation excellence ensures that every environment we deliver performs precisely as intended — reliably, safely, and in full accordance with global cleanroom standards.