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Air Sampling with EMTEK’s Products

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. www.emtekair.com

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

Air Sampling – How to do it the Right Way

Air sampling is a critical function of any Quality Control (QC) laboratory associated with a Pharmaceutical, Biotech, or healthcare facility, yet many QC personnel are unaware of the best methods of microbial air sampling for their particular needs. There are several mechanisms for sampling viable particulates out of the air, and different mechanisms benefit different testing requirements. One must first determine the type of sampling device and scheme, which fits their specific needs, then work with the available technologies that best suits them to meet their testing requirements.

If one is unclear on how to most effectively use a microbial air sampler or compressed gas monitoring system to ensure the safety and health of your employees and customers, it’s important to understand the types of microbial air sampling devices and their individual benefits.

Passive vs. Active
There are two primary methods for microbial air sampling: Active and Passive monitoring. In active monitoring, a microbial air sampler is used to force air into, or onto its collection medium (e.g., Petri Dish with nutrient agar based test media) over a specified period of time. The collected culture can then be incubated and analyzed (ie., count bacterial and/or fungal, colony forming units (CFU), and identify if required). In passive monitoring, settle plates (Petri dishes) are opened and exposed to the air for specified periods of time to determine what microbiological particles may be present in the environment, as they may settle out of the ambient air, and onto the media surface of the Petri Dish.. These plates are then incubated and analyzed.

Both passive and active monitoring have their own strengths and weaknesses. Passive monitoring is not aggressive and may miss critical microbes, but offers a lengthy (4-hour) sampling period, and a very low cost associated with it. Active monitoring requires equipment purchases, additional training, device qualification, and most devices offer a shorter sampling period (e.g., 10-minutes), which can be both a benefit, or a burden. But, active monitoring devices are more ideal for situations with low microbial concentration, which includes most clean rooms, since microbial contaminants will be less likely detected by passive monitoring.

With both Passive and Active monitoring, personel are required to physically start the process, set up the settling plate, or device, and remember to check samples in process, label, and submit the test plates for incubation and analysis. With the analysis, active monitoring will allow for both a quantitative and qualitative analyses of the sample, by allow the determination of contamination levels per volume of air sample, while with passive monitoring one can only obtain a qualitative analysis.
Because there is no standardized protocol for collecting air samples, it is difficult to determine whether one method is “better” than the other. However, knowing the difference can help you determine which solution will work best in your work environment. It is also important to note that microbial air samplers will turn up different results within the same area, or room based on the time and activity of the room. As such, both “Dynamic” and “Static” condition monitoring data should be collected in an area, or room. If a sample is taken during a surgery, for example, it will likely show more microbial elements than air sampling done in the same room with fewer factors, such as personnel and equipment, contributing to the microbial population.

When it comes to air sampling, the best method is one that works best for you and suits your specific needs while keeping your employees and clients safe. www.emtekair.com

What Microbial Air Sampling Solutions are Best for You?

A microbial air sampler is a critical component of any Quality Control (QC) lab associated with Pharmaceutical, Biotech, and Healthcare facilities. Not only do samplers protect your work environment and ensure that there is no contamination in your processes and products, they are absolutely required in order to meet most mandatory regulatory requirements.

You cannot run a QC lab without a microbial air sampler. The real question isn’t whether you need one, but which one will work best for your specific requirements.

Here’s a quick overview of a few key elements:

  • Sample Rate
    Sample rates in air samplers are somewhat self-explanatory. This element refers to the speed at which your air sampler can collect a specific volume of air, along with the particles (viable and non-viable) within that air volume, and is commonly measured in liters per minute. On the low end, you’ll find samplers that collect at about 28.3 liters per minute, while the high end offers units that can collect up to 180 liters. The nature of your work will determine the importance of sample rate.
  • Sample Period
    The maximum sample period of a microbial air sampler determines how long the device can be left to perform its task. Much like sample rates, you’ll find a wide range of options here with allowed sampling periods as low as 1 minute and as high as four hours. If one is looking to take quick samples in general facility areas one of the most common sample rates is 100 lpm, which allow s for capture of a 1 cubic meter sample in 10-minutes. But, if one is looking to monitor a lengthy process, such as a pharmaceutical filling operation, or a lengthy surgery, one would opt to have an extended sampling period such as testing at 28.3 LPM for 2-hours. This minimizes required personnel interactions with the sampling device for test medium changes Again, the nature of your testing requirements will drive the required sampling period.
  • Volume Collected
    Volume collected determines how much is sampled over the course of the device’s maximum sample period, and its set, or allowable sample rate, and is measured in liters, cubic meters or cubic feet. Results vary widely from device to device, with standard total volumes running from 1,000 liters to 6,800.

Overall, the specific microbial air sampling solution that works best for you will be the one that gives you the sample rate you need over the right period of time, along with enough volume for you to actually get readings on the factors you consider important. Every test has different requirements; thus, it’s up to you to decide the selection of your device.

For more information about air samplers, compressed air samplers or sampling in general, please visit www.emtekair.com