Cleanroom Air Monitoring
We offer complete air monitoring for cleanrooms – from particle counting and microbiological sampling to cleanroom classification. All in accordance with ISO 14644, EU GMP Annex 1 and the industry's most stringent requirements.
What is cleanroom air monitoring?
In short: Cleanroom air monitoring involves systematic measurement of airborne particles and microorganisms in controlled environments. The purpose is to verify that the cleanroom meets classification requirements according to ISO 14644 and GMP.
When do you need to monitor cleanroom air?
In short: Regular monitoring is required under EU GMP Annex 1 for pharmaceutical production, during cleanroom classification, after installation of new HEPA filters, during process changes and as part of validation.
Which standards apply to cleanroom monitoring?
In short: The key standards are ISO 14644 (cleanroom classification), EU GMP Annex 1 (pharmaceutical production), EN 17141 (microbiological control) and 21 CFR Part 11 (data integrity).
How quickly can you carry out cleanroom monitoring?
In short: We can schedule monitoring shortly after a needs analysis. The timeline is adapted to your production schedule to minimise disruption.
When is this relevant?
- Cleanroom classification according to ISO 14644
- Ongoing GMP monitoring in pharmaceutical production
- Validation of HEPA filters and ventilation systems
- Microbiological control in aseptic manufacturing
- Inspection after installation or remodelling of cleanrooms
- Documentation for regulatory inspections and audits
What is included
- Needs analysis and planning of sampling points
- Particle counting with calibrated instruments
- Microbiological air sampling as needed
- Documentation according to applicable standards
- Report with classification results and recommendations
- Support with interpretation and action planning
How it works
Contact
Describe your cleanroom and monitoring needs. We help you identify the right measurement programme.
Planning
We plan sampling points and methodology according to ISO 14644 and your specific requirements.
Measurement
Particle counting and microbiological sampling is carried out on-site with calibrated equipment.
Analysis
Results are evaluated against classification requirements and relevant limit values.
Report
Complete report with measurement data, classification results and recommendations.
What you receive
- Cleanroom classification report according to ISO 14644
- Particle counting protocol
- Microbiological results summary
- Recommendations for deviations
- Documentation for GMP audit
Industries we serve
Hospitals & Clinics
Air sampling in operating theatres, sterilisation units and cleanroom environmen...
Pharmaceuticals & Biotech
Microbiological air monitoring in cleanrooms, aseptic production and sterility t...
Food & QC
Monitor air quality in food production lines. Microbiological monitoring and par...
Research & Universities
Air monitoring in research laboratories, aerobiology and controlled environments...
Equipment
Related instruments
We sell and calibrate instruments used for this type of sampling.
ZR-1630
Portable 6-channel particle counter – 28.3 L/min
ZR-1640
Portable 6-channel particle counter – 100 L/min
ZR-2052
Portable microbial air sampler with touchscreen and audit trail
ZR-6012
Portable aerosol photometer for HEPA/ULPA filter integrity testing
Frequently asked questions about cleanroom
We can measure and classify cleanrooms from ISO Class 1 to 9. The choice of instrument and method is adapted to the applicable class and standard.
The frequency depends on cleanroom class, usage and regulatory requirements. EU GMP Annex 1 specifies particular requirements for pharmaceutical production.
Yes, we offer sampling and documentation that supports your Annex 1 compliance, including microbiological monitoring and particle counting.
We use calibrated particle counters (Junray ZR series) and microbiological sampling equipment that meets ISO 21501-4.
Yes, we plan monitoring to minimise disruption to your production. In-operation measurement provides representative results for ongoing monitoring.
Contact
Book a free assessment
Describe your situation and we will carry out an assessment and get back to you with a proposal and quote.
What happens next?
Quick response
We get back to you within 1 business day
3-5 questions
We ask questions to find the right approach
Proposal + quote
You receive a tailored proposal
Get a Quote Within 48 Hours
Tell us about your facility and requirements — we'll respond with a detailed proposal within two business days.