Microbial Air Sampling for Cleanrooms, Pharmaceuticals and Healthcare
Microbial air sampling measures the concentration of viable microorganisms in the air – critical in cleanrooms, aseptic production and other controlled environments. We carry out sampling on-site with calibrated equipment and deliver a clear report with CFU results, assessment against applicable limits and recommendations. All in accordance with EU GMP Annex 1, EN 17141 and ISO 14644 – ready for audit and regulatory inspection.
What is microbial air sampling?
In short: Microbial air sampling measures the concentration of viable microorganisms in the air. With active sampling, a known volume of air is drawn through a sampler and the microorganisms are captured on an agar plate. The result is expressed as CFU/m³ and can be compared directly against the limits in EU GMP Annex 1 and EN 17141.
What is the difference from particle counting?
In short: Particle counting measures the number of particles in the air regardless of whether they are living or not. Microbial air sampling specifically measures viable microorganisms (CFU). In cleanrooms and GMP environments, both are usually required.
Which standards apply?
In short: The key standards are EU GMP Annex 1 (microbiological monitoring in Grade A–D), EN 17141 (microbiological contamination control in cleanrooms), ISO 14644 (cleanroom classification) and 21 CFR Part 11 (data integrity).
How quickly do we get results?
In short: Sampling takes place on-site. Because the samples must be incubated, microbiological analysis is normally ready within 1–2 weeks.
When is this relevant?
- Cleanroom monitoring and classification – ongoing control of microbial cleanliness in classified spaces
- EU GMP Annex 1 compliance – viable monitoring in Grade A–D during aseptic manufacturing
- Sterility assurance – verification before and during production of sterile pharmaceuticals
- Healthcare – operating theatres, sterile processing units and other sensitive environments
- Food & QC – monitoring of airborne microbial contamination in production
- Validation & investigation – for new premises, refurbishment or suspected deviations
What is included
- Needs analysis of the environment, objectives and applicable limits
- Active air sampling (impaction) with calibrated equipment
- Settle plates and contact plates as needed
- Laboratory analysis with incubation and colony counting
- CFU results with assessment against EU GMP Annex 1 and EN 17141
- Report with recommended actions, ready for audit and regulatory inspection
How it works
Needs analysis
We review the environment, objectives and which limits apply.
On-site sampling
Active air sampling is carried out with calibrated equipment according to an agreed sampling plan.
Laboratory analysis
Incubation and colony counting; analysis is normally ready within 1–2 weeks.
Report & recommendations
CFU results, assessment against limits and concrete recommendations.
What you receive
- Sampling report with CFU results per sampling point
- Assessment against limits according to EU GMP Annex 1 and EN 17141
- Documentation designed for audit and regulatory inspection
- Recommendations and corrective actions for deviations
- Input for establishing the right sampling frequency
Industries we serve
Cleanroom
Complete air monitoring for cleanrooms – particle counting, microbiological samp...
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...
Equipment
Related instruments
We sell and calibrate instruments used for this type of sampling.
Frequently asked questions about microbial air sampling
Particle counting measures the number of particles in the air regardless of whether they are living or not. Microbial air sampling specifically measures viable microorganisms (CFU). In cleanrooms and GMP environments, both are usually required.
It depends on cleanroom class and operations. Aseptic production under Annex 1 requires frequent, often continuous monitoring, while other environments can have longer intervals. We help you establish the right frequency.
Sampling takes place on-site. Because the samples must be incubated, microbiological analysis is normally ready within 1–2 weeks.
Yes. We deliver sampling, CFU analysis and documentation that supports your Annex 1 compliance, and can combine this with particle counting, calibration and IQ/OQ.
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.