It is of critical importance that Pharmaceutical facility process air and gas lines are monitored for microbial contaminants. While air sampling and other quality procedures are obviously required, regulatory standards demand that process air/gas systems used for production activities (e.g., product pushes, overlays, material blow down, etc.) receive routine quality testing, with the same level of quality oversight. The best tool for microbial testing of a compressed air/gas system is a properly designed microbial air sampler.
The RCG Confined Space Sampler
At Emtek, we have a long history of designing easy-to-use, accurate, and reliable air sampling equipment. We know that air monitoring is a key and vital component of your Quality Systems, and that it can impact your production of quality product on a daily basis. Without the right equipment, your tests could be compromised or worse, your product could be at risk of contamination.
That’s why we’ve developed the RCG Compressed Air and Gas sampler. It’s a compressed air/gas monitoring system designed to recover microbial organisms from these critical production systems, and it provides results that you can count on. The RCG is a remote Slit-to-Agar Impaction device that is so compact it can also serve as an ambient air sampler (e.g., as the R2S, or RCG Confined Space Sampler) in areas where most air sampler can’t, or shouldn’t be placed.
A few of the RCG specs include:
• Solid construction: Aluminum/316 stainless steel materials
• Simple cleaning and durability: Clear polycarbonate dome with inlet assembly
• Portable and convenient: 4 lb. weight, 7.5” by 5” diameter
• Flexible sampling: 0-40 minutes of monitoring per cycle
• Quick sampling: Operates at at 50 and 100 LPM for compressed air/gas testing
• Works in conjunction with the EMTEK Microbial High Pressure Diffuser
Compressed Air monitoring is a delicate science that requires only the best equipment. Our air sampling equipment is the best in the industry, and is backed by our incredible support staff and our guarantee that every product we make will exceed your expectations. At EMTEK, we know that manufacturing great equipment is just one small part of keeping clients satisfied. We’re happy to answer any questions you might have to help you find the right microbial air sampler. For more information please visit www.emtekair.com.
There are two primary types of microbial air sampling: Active air sampling, and passive air sampling. In passive air sampling, a nutrient media test plate is placed in a desired location and allowed to collect particulates (both viable and non viable) for a desired amount of time. Active air sampling, on the other hand, requires air to be drawn into the device through a vacuum source and the particles within the sampled air volume are then captured on, or within the nutrient test media employed.
If you’re considering an active air sampling solution for your work environment, there are some things you need to take into account before deciding on a specific model:
Because an active microbial air sampler requires equipment to generate air vacuum and gather samples, they’re much larger than a simple sample test plate. Still, active air monitoring equipment comes in a variety of sizes, giving you the ability to find a solution that fits both your budget and your physical workspace. Ideally, your air sampling equipment won’t be cumbersome, take up space, or impact your environment or operations in a negative way.
Active air sampling equipment presents a variety of advantages, which includes the allowance to monitor smaller microbial particulates, less than 1 micron in size. Active air sampling can meet the requirements for capture of 1m3 of air in critical zones and the density of microorganisms per volume of air can be determined. You’ll need to regularly sterilize and sanitize the equipment to ensure the sampling process isn’t corrupted by previous collections.
A sample plate used for passive air sampling is generally less expensive than an active air sampler. Combined with the maintenance costs, an active sampler can represent quite an investment. Regardless, active air sampling can be a beneficial asset and is the best method of testing in certain environments and circumstances. At EMTEK, we provide our clients with several varieties of samplers available for varying types of labs as well as budgets.
The right air sampling solution is the one that gives you the results you need without negatively impacting your environment and workspace. For more information about which air sampler may work best for your facilities and process please visit www.emtekair.com or contact us at 877.850.4244.
One of the most important factors in the world of microbial air sampling is the sample rate. In simple terms, the sample rate refers to how quickly an air sampler gathers a specific volume of air for testing — different air sampling methods are recommended for different purposes.
Because there are a myriad of uses for air sampling, it’s vital to understand which air sampling rate is best for your workspace needs.
High Sampling Rates
High air sampling rates are generally considered to be between 50-100 LPM. Sampling at a high rate is recommended when the goal is collecting a large volume of air, such as a cubic meter, in a short period of time. High sampling rates work well for shorter processing or testing events, non-process or routine facility monitoring of ISO 7 – ISO 9 areas such as production support zones, labs, and bulk production spaces.
Low Sampling Rates
Microbial air sampling at a lower rate, commonly at 28.3 LPM, or 1 CFM, has its own benefits. This air sampling method is desirable for extended sampling periods when continuous monitoring for the entire product exposure window is required. Low sampling rates are ideal for ISO 5 – ISO 6 environments such as fill lines, sterility champers, BFS, biological safety cabinets, Laminar flow hoods, and barrier isolators. Any event that needs to be tested for longer than 30 minutes and up to a day or more should probably rely on low sampling rates. The longer the sampling period, the fewer times personnel are required to enter the critical area to collect and replace test plates. And, it is well known, that personnel are the number one source of contaminants in a clean room environment!
Exact recommendations for air sampling rates depend heavily on your specific needs and the environment in which you work. If you need assistance in sorting out which air sampling setup would be best for your environment, or simply have questions about our air samplers and their many options, please contact us at 877.850.4244 or visit www.emtekair.com for more information.
Air sampling equipment is designed with a specific purpose in mind, but many purchasers do not realize that the differences between different air samplers can be major factors in the appropriate testing and control of their environments. Simply put, some air monitoring equipment are not fit for operation in certain environments, and using the wrong device could end up creating negative consequences for the environment that surrounds it. For this reason, it is critical to understand the differences between devices.
Some device traits make specific pieces of air monitoring equipment undesirable in a cleanroom, or lab environment. Problems such as material shedding by the device, sample volumes exhausted at test locations, unfiltered exhaust, and airflow disruption can arise when using the wrong air sampling equipment. Additionally, cumbersome or large devices are not easily placed or located for the sake of testing.
The right air sampling design skips the major design problems of lesser units. Look for HEPA filtered exhausts, the exhaust of particles outside of critical zones, a device that is easily sterilized or sanitized, and something with a small footprint and low profile that’s easy to place. Also desirable: Remote operation controls that make it easier to manage your sampling protocols from a location, outside, or away from the critical environment being tested.
When considering a new piece of air sampling equipment, you should think about the following: Type and size of microbial particles being sampled, sensitivity of those microbial organisms to the testing parameters, concentration of those microbial particles, and the ability to detect high or low levels of microbial contamination. Also to be considered: Appropriate culture media for detection of the desired microbes being collected, and the time and duration of sampling.
The wrong air sampling devices can compromise everything you do. But, choosing the right air sampler helps you keep your critical environments in an appropriate state of control, by ensuring that the device itself does not negatively impact your environnment, while the samples and data you collect are accurate.
Microbial Air samplers are used in a variety of environments, in a wide array of industries, ranging from food production lines, surgical amphitheaters, to pharmaceutical cleanrooms. Each application and environment may require differing sampling parameters (e.g., sampling periods, sampling rates, etc.), and understanding the difference between various sample rates, and associated particulate capture velocities, can help you better determine which type of air sampling you need and which devices will give you the best possible results.
Capture velocity is a deciding factor in your sample rate. The combination of a device’s flow rate and its inlet size, in conjunction with the distance of the inlet to the media surface, result in specific capture velocities, and capabilities, of particulates and microbial organisms. Air sampling devices offer capture velocities as low as 5 meters per second to over 135 meters per second; the ideal range is around 25-80 MPS.
The Importance of Capture Velocity
A microbial air sampler’s capture velocity is more than just a line item on a devices specifications — it is a critical component of the device’s functionality that has a big impact on its overall effectiveness. If the velocity is too low, smaller organisms and spores will not be retained. If it is too high, the force of hitting the media could render microbes non-viable.
High sample rates are best for short sampling periods and low sampling rates are best for long sampling periods. But, it is important to assure whether you have a high or low sampling rate, that your capture velocity remains consistent, for a consistent and comparable data set of your environments. Your required sampling periods will be dictated by the work you do and the environment in which you do it.
There is much to learn when it comes to microbial air samplers. Each individual device provides a specific list of features that may or may not be appropriate for your requirements. Knowledge in the basic specifications that set these devices apart helps you make the right decisions for your work environment, and ensures you do not compromise samples with an inappropriate sampling device.
For more information about the technical details of our samplers or the best sampler for your needs please visit www.emtekair.com.