Confidence in cleanrooms and controlled manufacturing environments
Normec supports organisations with cleanroom validation, environmental monitoring and hygiene monitoring for controlled manufacturing environments. Using a cGMP-compliant approach, we help organisations control contamination risks and maintain compliance with international guidelines such as ISO 14644, USP and EU GMP.
In accordance with international guidelines
We support the entire lifecycle of cleanrooms and controlled environments through commissioning, qualification and validation (CQV). Our focus is on ensuring the reliable performance of cleanrooms, HVAC systems and critical utilities.
Our services include:
- Initial qualification and periodic requalification of cleanrooms
- Validation of HVAC systems and airflow patterns
- Particle counting and differential pressure measurements
- Filter integrity testing and airflow visualisation
- Thermal validation and temperature and humidity mapping
- Qualification of process equipment and supporting systems
Microbiological monitoring and particle counting
Routine monitoring of manufacturing environments enables deviations to be detected at an early stage. Normec provides cGMP-compliant environmental monitoring programmes tailored to the specific requirements of your facility.
Our monitoring services include:
- Microbiological monitoring of bacteria, yeasts and moulds
- Particle counting in cleanrooms and controlled environments
- Air monitoring and surface sampling
- Hygiene monitoring of personnel, gloves and cleanroom garments
- Microbiological and chemical analysis of water and compressed air systems
- Trend analysis and support for contamination investigations
With our support, you can:
- Detect and control contamination risks more effectively
- Strengthen compliance with GMP and ISO guidelines
- Demonstrate the reliability of your cleanrooms
- Be well prepared for audits and inspections
- Improve product quality and process safety
Future-ready manufacturing environments
We support organisations with both initial validation and ongoing environmental monitoring programmes. Through our cGMP-compliant approach and in-depth knowledge of international regulations, we help organisations keep their cleanrooms and controlled environments safe, reliable and compliant.
Together, we build manufacturing environments that are ready for future growth.
Would you like to know more about cleanroom validation and environmental monitoring?
Frequently Asked Questions
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Cleanroom validation is the qualification and validation of cleanrooms, HVAC systems, equipment and utilities to verify that they meet predefined requirements.
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Environmental monitoring is the routine monitoring of air, surfaces, personnel and utilities to identify contamination risks at an early stage.
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Microbiological monitoring focuses on detecting viable microorganisms, such as bacteria, yeasts and moulds, within controlled manufacturing environments.
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Particle counting measures the concentration of airborne particles in controlled environments to verify cleanroom performance.
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Hygiene monitoring assesses the microbiological status of personnel, gloves, garments and surfaces within cleanrooms.
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We work in accordance with international standards and guidelines, including ISO 14644, USP and EU GMP.
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We support organisations operating in the pharmaceutical, biotechnology, medical device and high-tech industries.