Published: 16th Jun 2025, 18:06

Aseptic conditions have to be maintained at all costs in Pharmaceutical Cleanrooms. And this is where Environmental Monitoring comes in. One of the most vital parts of environmental monitoring is Air Sampling, a process crucial for identifying microbial airborne contaminants. Active Air Sampling has been a turnaround point against increasing regulatory scrutiny and changing good manufacturing practices (GMP), ensuring product safety, patient health, and process adhesion.

What is an Air Sampler?

An Air Sampler is a microbiological tool used to actively sample airborne microorganisms on Culture Media like Soya Casein Digest Medium. Hence, it is also called as Microbial Air Monitoring System. Unlike passive settle plates, Air Samplers draw a measured volume of air through a microbial growth medium—usually agar plates—enabling the viable particle detection and quantification. 

Why Air Monitoring is Crucial in Pharmaceuticals

Airborne contamination in sensitive zones like ISO 5–8 Cleanrooms, Sterile Filling Areas, and Formulation Zones can jeopardize product sterility. Air quality monitoring ensures:

• Early alerts of microbial excursions
• HVAC system performance validation
• Adherence to international standards (EU GMP Annex 1, ISO 14698, and USP <797>)

Air Samplers based on Various technologies

• Impaction Air Samplers: Pull air through tiny holes, impacting particles on an agar surface (e.g., TME 003, TME 004, & TME 005).
• Centrifugal Samplers: Employ centrifugal force to place microorganisms onto the media.
• Filtration Samplers: Pass air through a sterile filter, which is subsequently placed on media for incubation.
• Liquid Impingers: Capture airborne microbes in a Liquid medium.

Out of these, Impaction Air Samplers are commonly applied because of their effectiveness, portability, and simplicity to use within controlled environments.

Presenting TM Media’s Microbial Air Monitoring System (TME-005)

For addressing the requirements of today’s cleanrooms, TM Media provides the TME-005 Air Monitoring System, a strong and compliant viable air sampling solution. Its most important features are:

• Stainless steel housing: Disinfectable and autoclavable parts
• HEPA-filtered exhaust to avoid cross-contamination of the environment
• Touchscreen for programmable sample volume
• ISO 14698-compliant design for validated performance
• Support for 90 mm standard petri plates

This Air Sampler provides precise quantification of microbial burden in air to facilitate reliable environmental control and record-keeping in production areas.

Best Practices for Applying Air Samplers in Cleanrooms

1. Proof sampler function prior to regular use.
2. Employ sterile pre-prepared agar plates like TSA, SDA, or R2A, as required by the cleanroom category and sampling application.
3. Place the sampler at representative sites: operator’s working space, close to HEPA filters, and equipment surfaces.
4. Implement ISO 14698 guidelines for air volume sampling (e.g., 1,000 liters per sample).
5. Incubate plates received on sample collections under proper conditions (e.g., 30–35°C for bacteria, 20–25°C for fungi).
6. Trend and inspect data regularly to detect deviations and institute preventive measures.

Regulatory Guidelines Supporting Air Sampling

Regulatory agencies such as the European Medicines Agency (EMA), U.S. FDA, and World Health Organization (WHO) place stress upon air monitoring under GMP directives. The updated Annex 1 (2022) demands real-time and regular viable monitoring particularly during critical activities.

Conclusion

In the high-stakes environment of sterile production, Air Samplers are not just instruments—critical tools for assurance. With properly validated tools like TM Media’s TME-005, pharmaceutical microbiologists can enhance their contamination control programs and meet global compliance requirements with confidence.

For advanced microbiological analysis, discover our entire line of Pre-Prepared Agar Plates, Dehydrated Culture Media, and Lab Consumables engineered for accuracy and performance.

Frequently Asked Questions (FAQs)