Environment: it’s a HUGE word. But in today’s clinical laboratories, when we talk about “environment,” we’re focusing on some very specific facets. In particular, mostly those connected to what we can call the internal atmosphere of a lab, such as temperature, humidity, volatile organic compounds (VOCs), CO2/O2 levels, and the like.
So, how do you ensure an environment remains controlled at all times? What parameters must be monitored to ensure scientific assets are free of the threat of contamination? Going more granular, how do you ensure environment-related data reported from various sensors is accurate and in accordance with standards and regulations such as ISO, CAP, CLIA, and GxP?
The answers for these questions and others vary as every lab is different. The nature of the facility itself, as well as the equipment and environments it contains and maintains, are unique and tied to unique scientific processes and goals. An environmental monitoring solution that might work well for Clinical Lab A rarely works for Clinical Lab B, C… Z.
But solutions are available. It simply must be customized to your lab and your needs. This eBook can help you find the right answer for your lab by presenting a broad spectrum of environmental lab parameters to monitor and help guide you in deciding what will work best for your facility. Including:
The heating, venting, and air conditioning (HVAC) system plays a fundamental role in any laboratory requiring a controlled environment. A fundamental fact about HVAC systems is that they are known as being difficult to regulate and maintain.
There’s the human element (technicians manually adjusting HVAC settings), but so much more. For instance, how do you know an HVAC’s built-in sensors are reporting accurate ambient conditions? (If it has sensors at all?) What happens to temperature and humidity during the night when no one is in the lab?
The key is ensuring your HVAC system is not standalone by integrating it with an environmental monitoring system (EMS), which enables you to receive independent, accurate insight into every ambient parameter in your facility. Using a robust real-time EMS eliminates the “blind spots” left by most HVAC’s built-in monitoring tools, tools that typically only report on larger, system-wide failures. As examples of these blind spots, let’s dig into temperature and humidity.
One example of a common practice for commercial properties is to turn down the HVAC system late at night to reduce energy costs.
While this measure doesn’t tend to have any impact on regular office space, even the mildest temperature fluctuations can have massive negative impacts for a facility storing critical pieces of equipment and assets. For instance, if room temperature increases, cold storage devices have to work harder to maintain set temperatures, which can increase the risk of equipment failure.
There are also consequences associated with drops in ambient temperatures — the space surrounding an incubator, for example. Incubators are commonly set to temperatures higher than ambient temperatures. But if the room’s ambient temperatures are too cold, incubators must work harder (i.e., run hotter), which can cause fluctuations in the incubator’s internal temperature and stress-sensitive biological samples.
Ambient temperature fluctuations easily and often go undetected when only relying on an HVAC reporting system as that system is neither tracking nor reporting ambient temperature data continuously. Having a robust third-party lab monitoring system can provide a facility with a 360-degree insight into what’s going on with temperatures inside and around sensitive equipment 24/7.
Humidity can be a lab’s worst enemy. Humid environments foster mold and mildew, and can cause rapid and massive damage to samples or equipment. From rust building up on equipment, to humidity issues or cold spots within incubators or stability chambers, humidity left unchecked can wreak havoc on a lab. And if your HVACs or dehumidifiers are not running properly, something as simple as the outside weather can quickly impact laboratory conditions.
The key to avoiding these risks and more is monitoring relative humidity (Rh). By measuring the ratio of the mass of moisture in the air, high-quality Rh sensors provide a critical data point for any lab concerned with controlling its environment. And integrating Rh sensors with a real-time environmental monitoring system ensures that you or someone on your team is immediately alerted to changes in humidity, whether fueled by external factors or HVAC failures. To learn more about how relative humidity can impact a laboratory, read Monitoring Relative Humidity & Temperature in Real-time for Your Lab.
When it comes to air quality in a laboratory environment, many factors — external and internal — must be measured and controlled. External events, such as a construction site or a wildfire miles away, as well as internal events, such as excessive cologne or prolonged door openings, can all have a direct impact on your lab environment.
There are several ways of monitoring air quality, such as air sampling or, even better, continuous air monitoring. If you have cleanrooms — areas used for biosafety, semiconductor production, or electron microscope labs (EML) — it’s important to have a proper system in place to ensure a controlled environment and quality consistency.
Air sampling is a common method but provides very limited information on the actual overall environment of a lab as it’s only a single point in time with minimal insight into how levels change throughout the day. A better option is to use a system that takes multiple data points throughout the day of both static conditions (when the lab is empty) and dynamic conditions (when a lab is actively in-use). This data gives facilities and operations teams more valuable insight into how parameters deviate over time.
The most effective way of monitoring air quality is a real-time environmental monitoring system (EMS) that can integrate with your particle counters and VOC sensors. This platform can also automate record-keeping around air quality, improve accuracy in overall reporting, and allow personnel to pull specific, custom reports in accordance with compliance and regulations.
An EMS not only gives staff time back to focus on the actual science: it also helps make quality control a breeze.
With an EMS in mind, several parameters should be considered: air flow, air velocity, air filtration, air particle counts, and VOCs.
Air flow measures the volume of air moving in a room. If the room contains flow hoods or biosafety cabinets, it’s important to have flow sensors integrated with your EMS to ensure minimum air flow requirements are met. Understanding the relationship between flow sensors in equipment and HVAC systems of the facility helps better control air flow throughout the lab.
Measuring how fast air flows by foot per minute, or fpm, air velocity provides more in-depth information than just whether or not air flows through an area. Why does this matter? Myriad reasons.
For example, biosafety cabinets are notorious for having inaccurate control systems when it comes to whether or not air is flowing fast enough through filters and exhaust systems. If storing hazardous substances, and air velocity isn’t strong enough, harmful aerosols can enter a laboratory environment and cause a health concern for lab personnel, destroy samples, and so on.
With air velocity sensors in place, a lab has an additional safeguard against a typically unseen threat.
Having filtration systems in place to remove air particles from flow hoods, areas used for biosafety, and/or cleanrooms are essential to ensure a controlled environment. A monitoring system must therefore be flexible enough to monitor a multitude of different filtration methods. Examples of filters are:
Particulate contaminants can be identified as viable (live microorganisms such as mold or yeast) or non-viable (non-living matter such as dust, fibers, or smoke). Viable particles, such as bacteria, fungi, and fungal spores, vary in size and, if left unchecked in the lab, they will continue to grow. Non-viable particles on the other hand can become a host for viable particles to grow on.
Learn more about particle counting here.
While there are some differences between the two, both must be tracked and accounted for. Particle counting may be built-in to an overarching lab monitoring system, help you capture and understand data for both viable and nonviable particles in your environment, and give you the information you need to act when and if necessary.
Particle counting must adhere to specific standards as well. For ISO 14644 compliance (the ISO classifications for cleanrooms and associated controlled environments), all particle counting equipment must have a calibration certificate and be tested every 6-12 months, depending on the application. It also defines 9 different classifications based on total allowable particulates in the air:
Finally, in regards to air quality, we have VOCs: organic chemicals that can harm biological samples, threaten valuable IP, and pose a danger to lab personnel.
Spikes in VOCs can be linked to various events, such as samples not being stored properly and leaking out gasses (e.g. organic acids, carbon disulfide, ethanol, alcohol, formaldehyde, and methylene chloride), but they can also be caused by lab personnel. Wearing heavy colognes and perfumes, or smoking before entering the building, can cause VOC spikes, which can destroy sensitive samples if not detected in time.
Having clear SOPs in place that set procedures for how lab personnel should prepare prior to entering highly controlled areas is the bare minimum way to combat the problem. For a more comprehensive solution, a real-time monitoring system that tracks VOC particulates ensures parameters are always within range.
Furthermore, to respond to unacceptable shifts in those parameters, a monitoring system should be equipped with audible and visual alarms to provide prompt notifications to on-site scientists and staff.
Differential pressure is a means of monitoring flow and filtration. Differential pressure is used to determine if a line (gas, air, water, etc.) has any clogs or contaminates as particles flow through openings and filters.
Monitoring differential room pressure is commonly done in areas requiring a sterile environment, such as cleanrooms, vivariums, operating theaters, or pharmaceutical manufacturing, ensuring the area is free from dust particles and airborne contaminants. It’s an extension, in some ways, of ensuring air quality but can also apply to liquids and gasses.
To ensure the safety of highly sensitive and valuable scientific assets, sterile environments should have a controlled pressure program. In some instances, overpressure is required to create outward motion of filtered air – pushing away contaminated air rather than introducing it into the environment. In other instances, it’s important to make sure the controlled environment has less pressure to help keep contaminants within the area. Monitoring differential pressure is a means of protecting the lab and its assets.
Air pressure, for example, can be easily compromised for myriad reasons. For instance, if a door isn’t properly closed, the pressure balance will become disrupted and air pollutants are no longer pushed out.
NOTE: Door contact sensors can play a major role in providing critical information on events that impact air pressure. While these contact sensors don’t do anything directly to mitigate or report on differential pressure, the data they provide on, for example, the comings and goings of staff, can help clinical lab managers create improved SOPs that do directly mitigate pressure.
With differential pressure sensors integrated into an EMS, lab personnel can have peace of mind that their clean environments are properly pressurized and in compliance with relevant regulations. Learn more about how to ensure a secure environment for critical life science assets in this white paper
The oxygen level in an area, or ambient O2 is measured to ensure a stable and safe environment for lab staff and scientific assets. It’s particularly important to monitor O2 levels in areas where gas tanks are stored.
Inert gasses, such as argon, helium, neon, and nitrogen, can cause a drop in oxygen (leading to unconsciousness if O2 drops below 18%, or even fatalities if it drops further). Gas that reacts with oxygen — e.g., carbon dioxide, hydrogen, methane, or propane — can not only be potential fire hazards, but can be immediately toxic to staff, resulting in nerve and brain damage.
Using an O2 gas detector with audio and visual cues, as well as integrating such detectors with an alarm sequence that promptly alerts the right people, you can ensure the safety of your staff and the integrity of your biological samples.
Learn more in our Lab Equipment Monitoring eBook.
You have likely heard the term “sun-bleached” and seen what too much light can do. In the lab, too much light or too intensely focused light beams can do quick damage to your work. This is why many labs use light sensors, or photoelectric devices, to measure light intensity in a given area. These sensors are common in facilities storing light-sensitive materials and in vivariums.
For organizations that perform light-sensitive chemical or biological processes, it will be important to work with an expert to determine the placement of light intensity sensors specific to their applications. For vivariums, strategically placing light sensors around the rooms (rather than on each enclosure), ensures the circadian rhythm of the animals can be monitored and controlled. Learn more about vivarium monitoring in our case study.
As with air quality, HVAC system, and air pressure, it’s critical to have a system in place to provide prompt alerts of any kind of deviations in light intensity.
Temperature. Humidity. Air quality. Differential pressure… There are many conditions affecting the stability of a laboratory environment.
Having a robust environmental monitoring system (EMS) in place is vital for more reasons than what we’ve listed here. By integrating multiple sensors with a 24/7 real-time lab monitoring service, it’s a safeguard that ensures quality control, proper record-keeping, audit readiness, and the safety of your laboratory personnel. Not only that, an EMS enables you to more easily spot problem areas in your lab environment, report on them to stakeholders, and optimize the equipment, facilities, and workflows in your labs to ensure a more secure and productive lab environment.
As a laboratory monitoring-as-a-service provider for 30+ years, XiltriX has a deep knowledge and understanding of how to protect and monitor lab equipment, facilities, and environmental conditions. We focus solely on lab monitoring and create custom service offerings based on every client’s unique needs. As an all-encompassing service provider, our customers benefit from a professional installation of industrial-grade hardware, cloud-based software, customizable quality reports, as well as full 24/7 service and support.
To learn more about how XiltriX can help ensure peace of mind for you and your team, simply contact us.