Cleanroom measurements are an essential part of quality assurance and risk management in pharmaceutical, hospital, laboratory, and food industry environments. Carefully executed measurements help identify and prevent deviations in time, minimize production downtime, and ensure compliance with regulatory requirements .
Cleanroom conditions directly affect product quality as well as patient safety. We use precise, modern measuring equipment and experienced specialists who understand the requirements of your industry.
Contact us and let’s ensure the compliance of your facilities – now and in the future.
Cleanroom classification is based on the concentration of airborne particles. Classification measurements are performed in accordance with the international ISO 14644 standard, which defines precise limit values for different cleanliness classes.
In the pharmaceutical industry and hospital environments, we specifically follow the EU GMP Annex 1 guidelines, which categorize facilities into Grade A, B, C, and D based on their criticality. With certified measurements, we ensure that your facilities meet the strict cleanliness requirements set by authorities under all conditions.
Cleanroom compliance must be verified at every stage of a project to ensure reliable operation in all intended use situations. The best results are achieved when measurement needs are considered already during the design or procurement phase. This ensures that layouts and measurement points support later validation and help prevent delays during commissioning.
Compliance of cleanrooms and equipment with their quality requirements must be regularly established. We perform all required measurements with professional expertise. The measurement scope is always defined based on the intended use of the facility, cleanroom classification, and applicable standards.
Our services include:
Every cleanroom measurement we perform is thoroughly documented to demonstrate cleanliness levels and operational reliability. We produce standard-compliant reports detailing the measurement methods used, calibrated equipment, and precise point-by-point results.
Accurate reporting is an essential part of cleanroom maintenance and serves as key evidence during regulatory inspections. Measurement results are often integrated into broader cleanroom validation, but they also serve as independent documentation of regular maintenance and continuous compliance.
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.
The frequency depends on the cleanroom classification and criticality. According to the latest EU GMP Annex 1 requirements, Grade A and B areas must be requalified (including measurements) at least every 6 months. For Grade C and D areas, the maximum interval is 12 months. Measurements must also be performed after any major changes.
The scope is tailored to requirements but typically includes particle measurements, HEPA filter leak testing, pressure differentials, airflow rates, air change rates, temperature and humidity measurements, and recovery time testing.
The best results are achieved when contact is made already during the design or procurement phase. This ensures that layouts, HVAC systems, and measurement points support later validation and helps avoid costly retroactive modifications.
In regulated GMP environments, cleanroom compliance must be demonstrated to authorities through documented evidence. Validation and regular measurements are essential to ensure safe and compliant pharmaceutical, research, and hospital operations.
Yes. Cleanroom measurements can be performed as a standalone service or combined with equipment, system, or utility validation, allowing the entire environment to be verified as one compliant whole.
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