Cleanroom validation verifies that the facility meets defined cleanliness, functional and safety requirements for its intended use. Validation is based on GMP requirements and the ISO 14644 standard and demonstrates that the cleanroom operates in a controlled and repeatable manner.
Cleanroom conditions have a direct impact on product quality as well as user and patient safety. For this reason, air cleanliness, airflow patterns, pressure differentials and environmental conditions must be verified through measurements and documented evidence prior to commissioning and during routine operation.
Well-executed cleanroom validation reduces contamination risks and supports regulatory compliance throughout the entire lifecycle of the cleanroom.
Cleanroom validation applies to facilities where air cleanliness, environmental conditions and functional performance are critical to product quality, process control or user safety. The scope of validation and measurement requirements are defined based on the intended use of the facility, cleanroom classification and applicable standards.
Typical cleanroom validation targets include:
Cleanroom validation includes four stages. Depending on the client’s needs, we can perform all the validation stages:
1. Design Qualification (DQ)
Verification that cleanroom design meets user requirements, cleanroom classification and regulatory requirements. This phase includes evaluation of layout solutions, HVAC concepts and material selections.
2. Installation Qualification (IQ)
Verification that the cleanroom has been constructed and installed according to approved designs. This includes inspection of structures, HVAC systems, filters, measurement points and other critical components.
3. Operational Qualification (OQ)
Verification that the cleanroom operates within defined operating parameters. Testing includes airflow rates, pressure differentials, temperature and humidity conditions, as well as filtration performance.
4. Performance Qualification (PQ)
Verification of cleanroom performance under actual operating conditions. The PQ phase confirms that cleanroom classification requirements are consistently met during normal use.
Compliance with the cleanroom requirements must be verified at every stage of a project: As built, At rest, In operation. We perform individual cleanroom validations and measurements and control the entire validation process.
When needed, we can participate in compliance assessment even during the idea or design phase of a new plant, facility or process. We can also ensure the compliance of your cleanrooms during their entire life cycle.
By choosing Feicon, you gain a partner who offers:
Feicon ensures that validation is carried out correctly, on time, and in support of your business.
Cleanroom validation means verifying cleanroom performance and conditions through measurements and documented evidence. Validation confirms that the cleanroom meets GMP and ISO 14644 requirements and is suitable for its intended use throughout its lifecycle.
Cleanrooms are typically validated prior to commissioning and after significant changes. Compliance must also be demonstrated regularly during operation through periodic measurements and requalification.
The best results are achieved when contact is made already during the design or construction phase. This ensures that layouts, HVAC systems and measurement points support later validation and avoids corrective actions during commissioning.
In regulated GMP environments, cleanroom compliance must be demonstrated to authorities. Validation and regular measurements are essential to ensure safe and compliant pharmaceutical, research and hospital operations.
Validation documentation includes validation plans, test protocols, measurement results and a final validation report. Documentation is prepared to withstand regulatory inspections and support internal quality management systems.
Yes. Extensive experience has been gained across pharmaceutical manufacturing, hospital environments, laboratories and food industry cleanrooms.
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