Absolute Confidence in Microbial Air Sampling
Sterile and biopharmaceutical manufacturing requires biocontamination control through careful process design, monitoring systems, and swift remedial actions. Contamination risks increase with routine interventions. Therefore, microbial monitoring programs, including volumetric air sampling, are crucial for assessing biocontamination prevention measures.
A microbial air monitoring program in cleanrooms is essential to meet stringent cleanliness standards in various industries. Its primary goal is to detect and quantify airborne microbial contamination, preventing product contamination and ensuring compliance with international standards, such as the EU-GMP Annex 1, ISO 14698, EN 17141, FDA Aseptic Guidance and the USP <1116>.
Airborne microbial contaminants are measured by active sampling, using devices to draw defined air volumes and measure microbes in colony forming units (CFU) per cubic meter. Methods include impaction, impingement, and filtration-based sampling, where air is either impacted onto a culture medium plate or filtered through a membrane. The culture medium plates are incubated for 3-5 days to grow microorganisms, then examined, counted, and recorded. Quality Risk Management (QRM) involves statistical analysis to identify trends and deviations. If microbial counts exceed alert/ action limits, a root cause analysis is initiated.
The Sartorius MD8 Airscan® and gelatin membrane filters, used since the 1970s, have set the benchmark for continuous, intervention-free environmental monitoring in Grade A pharmaceutical environments.
- Accurately detects even the smallest presence of airborne microorganisms and viruses
- Reduces the risk of contamination and demand on personnel
- Utilized by leading pharmaceutical manufacturers for true continuous monitoring
Microbial Air Monitoring Products
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Gelatine Membrane Filters for Air Monitoring
Absolute Reliability in Environmental Monitoring
Microbial air monitoring in aseptic processing systems like RABS, isolators, and cleanrooms is enhanced by our unique gelatine filters.
These filters, similar to HEPA H14, retain airborne microbes and viruses through sieving and diffusion. Gamma-sterilized and hygroscopic, they prevent desiccation of microorganisms by continuously drawing residual moisture, allowing for up to 8 hours of continuous sampling without compromising microbial recovery. Post-sampling, the filters can be transferred onto agar plates completely touch-free, where they dissolve for easy microbial recovery and incubation.
Our gelatine filters address challenges of traditional methods, avoiding open nutrient media in isolators, preventing media dehydration, and reducing routine intervention. Designed to detect airborne contaminants, they mitigate the risks of contamination, operational stress, and patient exposure to microbially contaminated therapeutics.
Explore our comprehensive portfolio and specialized features tailored to enhance confidence in your cleanroom monitoring program.
Gelatine Membranes Key Features and Benefits
- Retentive capacity of a HEPA-Filter
- Retention rates of 99.995% for Bacillus subtilis spores
- Near complete retention of even airborne viruses – widely used for airborne virus monitoring in the MERs outbreak in 2012 and the SARS-CoV-2/ COVID-19 pandemic
- Easy microbial recovery from pore structure
- Limited water loss during sampling due to replenishment
- Protective capsid for microbes during sampling
- Tested period of 8 hours; 16 cubic meters of air, no loss of microbial viability
- Avoid frequent interventions to replace conventional impaction plates
- Multiple packaging configurations including filters in aseptic rapid transfer port (RTP) single-use bags
- EN 17141- membrane filtration method as reference in sampler qualification
- Compliant with USP<116>, ISO 14698 and EU GMP Annex 1
- Used in real-time monitoring devices to support microbial sampling and identification
- Pair with polymerase chain reaction (PCR)
- Secure your critical processes with gelatin filters, offering a 5-year shelf life
Gelatine Membrane Disposables
Gelatine membrane disposables are single- or triple-bagged in VHP/gas-impermeable packaging and delivered pre-sterilized via gamma irradiation. Both variants are routinely used for environmental monitoring in Grade A / Grade B cleanrooms and in advanced aseptic processing systems like isolators and restricted access barrier systems.
| Item # | # of bags | Outer bag | Middle bag | Inner bag | |
|---|---|---|---|---|---|
| 17528--80----ACD (10 units) pre-sterilized | 1 |
| Shop Now | ||
| 17528--80----BZD (10 units) pre-sterilized | 3 |
| Zip-lock bag |
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| 17528--80----VPD (10 units) pre-sterilized | 3 |
| Zip-lock bag |
| Shop Now |
| 17528--------BFV (2 units pre-sterilized. For use with the Sartorius Biosafe® Rapid Transfer Port) | 2 |
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The Gelatine membrane filter discs are used in SKC samplers and the BioTrak® Real-Time Viable Particle Counter. Each bag of 5 is sterile.
| Diameter ∅ | Pieces (in bags of 5) | ||
|---|---|---|---|
| 12602--37----ALK | 37 | 50x | Shop Now |
| 12602--47----ALK | 47 | 50x | Shop Now |
| 12602--47----ALN | 47 | 100x | Shop Now |
| 12602--50----ALK | 50 | 50x | Shop Now |
| 12602--50----ALN | 50 | 100x | Shop Now |
| 12602--80----ALK | 80 | 50x | Shop Now |
MD8 Airscan® Air Sampler
Precision in Airborne Contamination Control
The MD8 Airscan® ensures isokinetic sampling, matching the velocity of incoming air with surrounding airflow to prevent turbulence and particle loss. This is critical for compliance with regulations requiring at least 1 cubic meter of air to be sampled during environmental monitoring, and for continuous sampling during both operation and rest periods.
Positioned near critical areas, the MD8 Airscan® meets EU-GMP Annex 1 standards, avoiding risks from monitoring interventions. When used with Gelatine membrane filters, it enables continuous monitoring without the frequent interventions needed for traditional methods. The sampling head supports in-line decontamination or sterilization using vaporized hydrogen peroxide and is made of electropolished stainless steel, compatible with all common sterilants.
The innovative design includes a separate command unit and operational sampling head, controllable from 3 to 30 meters away, allowing for flexible facility design and operation via a programmable logic controller (PLC).
Explore both versions of the MD8 Airscan®.
Airscan® Key Features and Benefits
- Innovative design featuring a separate command unit and operational sampling head
- Remote control of the sampling head from 3 to 30 meters away
- PLC connectivity
- Seamless integration into any facility layout
- Maintains 300 records of monitoring activities
- Matches surrounding airflow velocity
- Avoids turbulence
- Minimizes particle loss or contamination through deflection
- Built from electropolished stainless steel
- Compatible with commonly used sterilants
- Complete flow path VHP compatible
Specification | In increments of | |
| Adjustable volume | 0.01 - 9.99 m³ | 0.01 m³ |
Adjustable air flow (flowrate) | 1.8 – 7 m³/h | 0.1 m³/h |
Frequently Asked Questions
Microbial air monitoring in cleanrooms is the process of sampling and analyzing the air to detect and quantify the presence of microorganisms such as bacteria, fungi, and other microbes. This is a crucial requirement in cleanrooms and cleanroom-associated areas in various industries, such as the pharmaceutical industry, medical device, healthcare and the food & beverage industry.
Sterile products are manufactured in advanced aseptic processing systems and typically Grade A/B clean rooms. Cleanrooms are classified based on the level of airborne particulate and microbial contamination allowed. Regular monitoring helps ensure that the cleanroom remains within its designated classification limits, such as the ISO 14644-1 / cGMP standards. It ensures the consistency and reliability of the manufacturing process by detecting any deviations that could impact product quality. By monitoring the microbial load in the air, it is possible to identify and mitigate sources of contamination, such as personnel, equipment, or processes, thereby improving overall cleanroom practices. This ensures that the air is free from harmful microorganisms and is critical to protecting patient health and preventing infections. Regulatory bodies such as the FDA, EMA, and WHO have strict guidelines and standards for environmental monitoring in cleanrooms. Adhering to these regulations is essential for the approval and continued operation of manufacturing facilities.
- Volumetric/active air sampling: Air samplers actively draw air and capture airborne microorganisms on a nutrient medium or filter for subsequent analysis.
- Passive air sampling: Petri dishes/ or settle plates with nutrient media are left open to the environment for a specified period, allowing airborne microorganisms to settle on the surface for subsequent analysis.
Surface sampling and personnel monitoring is performed in conjunction with microbial air monitoring to assess potential sources of contamination within cleanrooms.
Impaction sampling: Air is drawn through an inlet (either a sieve or a slit) and directed onto a semi/solid nutrient/culture media plate, where microorganisms adhere to the surface on impaction. The method is conventionally adopted in the pharmaceutical industry and is typically suited for environments with high microbial loads.
Filtration sampling: Air is drawn through a membrane filter that traps microorganisms. The filter is then transferred to a nutrient media or analyzed using methods such as PCR. This facilitates the sampling of large volumes of air and is extremely suitable for environments with low microbial loads/contamination, such as cleanrooms in the pharmaceutical industry and surgical rooms (cleanroom-associated areas) in a healthcare setting.
Liquid Impingement sampling: Air is directed through a liquid medium and microorganisms are captured/suspended in the liquid matrix. This method is largely used in laboratory/research settings.
Centrifugal sampling: Air is drawn into a chamber where centrifugal forces cause particles to collect on/impact nutrient agar strips or a collection liquid. Due to the shearing forces generated, and the additional processing steps required, this method is seldom adopted in cleanroom monitoring.
Passive air monitoring is traditionally favored for its simplicity and lower cost due to minimal equipment requirements. It does not typically interfere with the normal operation within a cleanroom as it does not disrupt the airflow or processes but is typically more effective in environments with high microbial loads. The fact that it captures microorganisms that settle out of the air is deemed representative of what might potentially contribute to product contamination.
Active air monitoring/sampling is more effective at detecting low levels of contamination since air is actively drawn through the sampler. It provides quantitative data on the concentration of airborne microorganisms (CFU/cubic meter) making it easier to compare results over time and between locations.
In practice, both passive and active air monitoring are often used together to provide a comprehensive picture and combinatorial use is recommended in guidelines such as the EU-GMP Annex 1. monitoring.
EU-GMP Annex 1 specifies that any risk caused by interventions in monitoring operations be avoided. Interventions increase product safety risks and pose a threat to patients. By minimizing interventions, manufacturers reduce the overall risk profile of their operations, improve product quality, and decrease the likelihood of batch failures or recalls.
Examples of interventions include resupplying stoppers and vials, conducting weight-volume checks, and changing plates during environmental monitoring (which may also involve handling the sieve/ slit plate/lid on an impaction sampler). The latter operation may require personnel to enter and exit a Grade B cleanroom, necessitating increased monitoring and potentially increasing the number of microbiological samples for analysis.
The EU-GMP annex 1 recommends that process simulations be repeated twice a year and that it should take into account interventions known to occur during normal production. Given the aim of achieving zero growth in media fills, more interventions pose higher risks of contamination.
The EU-GMP Annex 1 specifies alert and action limits for microbial environmental monitoring in one cubic meter of air. It mandates continuous monitoring during both operational periods (the full duration of critical processing, including equipment aseptic set-up, assembly, and critical processing) and non-operational periods in grade A and grade B cleanrooms, based on the risk of impact on aseptic processing. However, there is ambiguity regarding the required volume of air to be sampled within a defined timeframe. This has led to various interpretations, with traditional solutions providers defining the upper limits of their sampling technologies as the benchmark for continuous monitoring.
Ensuring the sampled volume of air is representative is crucial. In our study, we conducted sampling of a total of 16 cubic meters of air over an 8-hour period without adversely impacting the viability of the sampled microorganisms. This equates to a sampling rate of 2 cubic meters per hour. Additionally, we are aware of data where gelatin filters have been validated for extended sampling durations, beyond the tested 8 hours.
Resources for Microbial Air Monitoring
Product Documents
Gelatine Filter Disposables — for Quantification and Differentiation of Airborne Organisms
PDF | 376.3 KB
