Air Sampling with EMTEK’s Products

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The EMTEK Microbial Air Sampler, such as the EMTEK V100 Controller and RAS Sampler, is an active air sampler used to monitor Bulk production Suites, ISO 7-9 Areas, such as Media Prep, Fermentation, Buffer Preparation, Purification, etc. ISO 5, LAF Hoods. Final Filtration and Filling in ISO 5 Filling Lines, Barrier Isolators need microbial air samplers. Aseptic Connections, ISO 5-9, Vessels and Transfer Panels are supported. The ISO 6-9 support areas adjacent to ISO 5 Hoods, Rooms, Zones, Hallways, Material – Personnel Air Locks use microbiological air samplers. QC Product Testing in Sterility Testing Chambers, LAF Hoods and Bio-Safety Cabinets also need fungal, bacterial and microbial monitoring. Bulk Filtration and Filling with ISO 5 LAF Hoods are supported. In addition, the R&D and Product Development Labs need microbiological air sampling.

The most common types of ACTIVE microbiological air samplers are Sieve Impactors, Slit-to-Agar, Centrifugal, Liquid Impinger and Filter samplers. Air is actively drawn into the device via a vacuum source and the particles within the sampled air volume is captured on, or within the test media employed. The test media is incubated, Colony Forming Units (CFU) recovered, counted and then the number of CFU per volume of air sampled is determined. The density of microorganisms per volume of air can be determined, as well as determination of settling rates in product containers (vials). The EMTEK Microbial Air Sampler is designed to provide superb versatility in the monitoring, dynamic control and data feedback that you need. Air Flow dynamics are well controlled compared to other similar products and the capture rate is higher and more uniform across the sample. In addition, the sample can be rotated over a specified period of time to describe the microbial sample results as a function of time.

The EMTEK Slit-to-Agar technology relies on placing an agar plate beneath a collection slit, drawing a specified volume of air through an appropriately sized slit inlet, and accelerating the air to a desired capture speed for consistent viable organism capture. When the air hits the collection surface it makes a tangential change of direction and any suspended particles are thrown out of the air flow by inertia, impacting onto the agar surface. The test plate is rotated beneath the slit to separate any recovery events. The test plate also serves as a time mapping feature of the sampled bacteria, fungus and fungal microorganisms. EMTEK Microbial Air Samplers have taken this technology to a higher level of functionality and usability with the combination of the V100 Controller paired with a Remote Slit Sampler(R2S) and Remote Compressed Gas/Confined Space (RCG) Sampler.

In addition to EMTEK’s Slit to Agar Sampler, their RAS Sieve Sampler has grown to be very popular in its use. It is, as is the Slit to Agar sampler, an impaction device, which utilizes the acceleration of the air through 300 small inlets in a perforated inlet cover to impact suspended particles in the air onto the surface of the agar based test media, which is maintained on a height adjustable stage to assure the proper inlet to media surface distance is achieved. Through its unique design, EMTEK LLC, has taken this technology to a higher level as well, increasing recovery capabilities of their RAS sieve samplers over other sieve impaction devices, while being versatile in combination with the V100 Controller. To note, EMTEK’s V100 Controller may operate up to four (4) R2S, or RAS air samplers at the same time to create a “mini” FMS system for clean room monitoring.

Following air sample collection, samples are transferred back to a testing lab for processing. Processing includes incubation in controlled temperature units (CTU) followed by plate reads (CFU counts). Incubation of Test Plates follows the Air Sampling. Test plates are commonly incubated for periods of 48-hours to 7-days with incubation temperatures ranging from 20-25 C, 28-32 C, and 30-35 C. Bi-Phasic Incubation may also be used, example 2 days of 20-25 C (mold) or 3-5 days at 30-35 C. EMTEK Microbial Air Samplers provide a user friendly approach to your monitoring and test requirements. If you want your biological and production areas monitored to prevent bacterial and fungal microorganisms, the EMTEK Air Samplers provide the most accurate air flow control, the highest capture rate, i.e the most efficient sampler, plus the most user friendly interface and data control. Over 35 years of actual EMTEK Pharmaceutical Manufacturing experience drives the product design to focus on what Pharma and BioPharma Environmental Engineers need.

EMTEK Microbial and Microbiological Air Samplers

  1. EMTEK V100 Controller Simultaneously Supports 1-4 Downstream R2S or RAS Air Samplers
  2. Media Prep, Fermentation, Buffer Preparation, Purification, etc.
  3. Key Intermediate steps ISO 5 (LAF Hoods)
  4. Aseptic Connections, ISO 5-9 (Vessels, Transfer Panels)
  5. Bulk Filtration/Filling, ISO 5 (LAF Hoods)
  6. Final Filtration/Filling, ISO 5 (Filling Lines, Barrier Isolators,
  7. Support areas ISO 6-9, Adjacent to ISO 5 Hoods, Hallways and Personnel Air Locks
  8. QC Product Testing, Sterility Testing Chambers, LAF Hoods, Biosafety Cabinets
  9. R&D and Product Development Labs/Facilities