Why Expertise in Environmental Monitoring Systems is Critical in Preventing Research Problems
Success in science hinges on monitoring lab equipment and their environments. Monitoring-as-a-Service plays a key role
Complete monitoring of a lab environment is critical to data integrity and the ongoing success of any research, but it is also highly complex. Many labs are familiar with the benefits of around-the-clock monitoring of cold storage equipment. Yet a complete, effective lab monitoring system encompasses people, equipment, and ambient conditions to cover the major risks to operations.
A modern environmental monitoring system (EMS) affords organizations quality control, predictable results, improved operational oversight, and detailed records. Real-time performance data for equipment helps labs mitigate risk and improve standard operating procedures. Data on environmental conditions can identify sources of variation. Incorporation of independent sensors adds a new level of quality control and assurance that is often overlooked.
Even though monitoring is critical to operations, environmental monitoring systems and disparate sensors frequently bring new challenges to lab management. Extensive experience, knowledge, and expertise is needed to understand and correctly interpret data collected from multiple types of sensors or even ensure the deployment is adequately covering the lab’s parameters.
Monitoring-as-a-Service brings leading industry expertise to lab monitoring that cannot be matched by AI or machine learning. It brings in-depth technical knowledge of sensors, equipment, best practices, and limitations, as well as extensive troubleshooting experience. It empowers managers to make informed decisions based on correct data interpretation. Services also introduce redundancy to ensure any problems in the lab are swiftly caught and addressed by subject matter experts.
Considerations for establishing environmental monitoring systems
Lab environments, equipment, and systems are complex. There are numerous considerations in implementing monitoring solutions, from choices on sensor technology, to what should be monitored where, to calibration requirements. This section touches on a few common factors to be considered.
Monitoring the many variables across the lab relies on a variety of sensor types. Measuring temperature, humidity, light intensity, pH, differential pressure, gas levels, ammonia levels, volatile organic compounds (VOC), or particulates all require different technologies. Additional sensor technologies are used to detect or quantify movement, water quality indicators, door openings, building access, or even backup power supplies. Specific variables often have multiple options around base technology that differ in accuracy. For example, temperature can be measured by thermocouples or resistance temperature detector probes like the Pt100. Adding another layer of complexity, sensor performance can be affected by other variables, e.g., humidity levels on temperature sensor readings.
Monitoring and controlling air quality according to regulatory and internal standards is a top concern for many labs and manufacturing facilities. Even in the most tightly controlled lab environments, internal air quality is affected by external factors ranging from staff clothing to distant wildfires or local building activity. Environmental controls must account for temporal and geographical differences, like seasonal changes and the effect of regional climate between facilities. Air quality is also impacted by adjustments to HVAC operation during off-hours or by staff introducing particulates or bacteria from personal products, perfume, or jewelry. While adequate HEPA systems can filter external air pollutants, monitoring is required to immediately catch any drops in air quality. It can also reveal trends that help lab managers identify underlying issues, such as problems with the lab pressure regime or SOP adherence.
Lab temperature and humidity parameters are important in experimental or manufacturing processes, highly variable through the year, and controlled through HVAC systems. Because of this, independently monitoring HVAC systems provides valuable insight into maintaining conditions and optimization potential. Fume hoods and biosafety cabinets vent large volumes of air that must be balanced with HVAC systems, potentially adding considerable strain. In one case, XiltriX assisted with an overworked HVAC system that was driving large temperature changes in the lab. Independent sensors placed through the room provided the data needed to optimize the HVAC cycles, stabilizing conditions and even cutting energy costs.
While O2 and CO2 tracking is important for activities like cell culturing, monitoring and alarming for ambient O2 and CO2 levels are also important for workplace safety. CO2 levels can rise quickly and cause cognitive impairment. Oxygen levels must be monitored in all labs storing cryogenic gases as any deviations can be problematic—low levels can cause loss of consciousness or death and high levels are toxic and increase combustion risks.
The extreme conditions frequently present in labs introduce additional challenges, from liquid nitrogen in cryotanks to extreme heat and pressure in autoclaves, or highly corrosive environments like those generated with H2O2 gas sanitization. Any monitoring equipment subjected to these environments must be tailored in their design and engineering.
Sensors require calibration, which can be conducted in place or off-site. Off-site calibration requires a replacement sensor, relevant amendments to the data trail, and typically a large amount of manual paperwork. The calibration can also be affected during shipping. On-site calibration performed by any qualified calibration vendor within the sensor’s operating environment ensures measurement accuracy. Calibration equipment needs to be traceable to international standards (such as NIST or ISO-17025).
Establishing an effective environmental monitoring system with accurate, appropriate monitoring and recording of all relevant parameters requires detailed planning and forethought—though labs may share many common concerns, there is no one-size-fits-all approach. As with any other scientific endeavor, understanding the underlying technology and how sensors and parameters are impacted by other variables is critical to interpreting data.
Monitoring-as-a-Service provides requisite expertise
Most labs do not have internal expertise in EMS, and tasking scientists and researchers with learning enough to make good decisions diverts considerable lab resources. Partnering with a service provider for lab monitoring can provide the experience and expertise required to safeguard your lab, ensuring a more precise, stable, and measured environment.
Many of the monitoring-related questions that arise are quickly and easily resolved with industry expertise, like: Is the CO2 overshoot in my incubator adjusted correctly? What’s the advantage of continuous particle counting? How do I know if my fume hood has an acceptable airflow rate? How do I know that my gas manifold switched tanks? How do I integrate a backup generator into my EMS? How should I monitor my HVAC? What’s the difference between a BMS (building management system) and an EMS?
Data interpretation is accomplished much faster and easier with knowledge of the many factors affecting parameters across the lab. Problems that often take researchers considerable time and resources to troubleshoot can be rapidly characterized, and predictive analysis can forestall disruptions or loss. Trends that signal impending failure, like deviations in compressor cycles in ultra-low temperature freezers, flag the need for preventative maintenance. A service provider can also spot problems often overlooked, like identifying refrigerators that run too cold using minimum temperature tracking and recommending a safer set-point for samples. Experience in analyzing data trends helps quickly identify common behavioral causes like a chamber door being opened too frequently or held too long, doors in pressure environments being propped open and causing the pressure regime to fail, or badly placed or routed sensors, for example, temperature probes that cross a door seal.
A partnership for monitoring provides advantages in developing and implementing optimized monitoring systems. Monitoring-as-a-Service incorporates an in-depth understanding of the lab’s challenges and goals, the connections between departments, and how each is affected by the system. Custom design plans unique to each lab or business are developed in consultation, along with custom software configuration. Implementation planning accommodates the usual lab activity, ensuring a smooth rollout with daily check-ins and amendments to work around the current needs of the lab. System validation, as approved by lab QA dept, incorporates mature, tested protocols and full qualification documentation.
This type of collaborative monitoring partnership focuses on creating the best protection for sensitive lab operations, as shown by the ORM Fertility Laboratory’s experience with XiltriX. Alison Coates, Ph.D., the embryology laboratory director, chose to partner with XiltriX on a lab monitoring system for new facilities in development. A custom system infrastructure configured in close collaboration with the lab ensured all operational standards and specifications were met with around-the-clock monitoring. Some of the custom solutions deployed included specially designed probes monitoring the liquid nitrogen fill level in cryotanks and custom CO2 monitoring for the incubators that sample small air volumes without risk of contamination and that calibrate automatically. Additionally, XiltriX monitors O2 levels, cold storage temperatures, door openings, and lab conditions like temperature, humidity, particles, VOCs, and backup generators for the facility.
Air quality monitoring particularly benefits from a custom approach, as needs vary by lab or even by room. A custom solution based on compliance needs, workflows, and sensitivity of projects and IP is typically best. Using a lab monitoring service provider can provide reporting integrated in business and security systems, helping to automate response and contingency plans.
A major benefit of Monitoring-as-a-Service is the live, trained monitoring team that watches over clients' systems around the clock to ensure the system is always working and alarms are never missed. The monitoring team provides redundancies and support, including unlimited training for end users. All calls generate tickets for organizing supporting information, like audit logs and graphical readouts, facilitating detailed, accurate reporting.
Major lab catastrophes can and do occur, unfortunately, and a rapid understanding of the situation and quick response is critical. A San Diego biotech company working with XiltriX, experienced this firsthand when a major power outage blew the two main breakers late at night on the Friday of a three-day weekend. Escalating alerts reached the facilities and operations manager with a follow-up call shortly after to ensure the manager was aware of the criticality and extent. XiltriX was able to determine that the backup generator, though running, was not supplying power to the building due to the breaker issue.
A monitoring partner with knowledge and experience can also assist with GxP audits, eliminating mistakes and drastically reducing workload for the lab. This is typically a very time-consuming (and stressful) process, with audits for pharmaceutical production labs taking up to three months. It is also an extremely detailed, sensitive, and critical process requiring additional considerations, and not all systems can be validated. XiltriX carries ISO 9001:2015 quality management system certification—the environmental monitoring system can be fully validated and is compliant with all applicable quality and regulatory standards including GxP, FDA 21 CFR part 11, CAP, HACCP, JCAHO, and USP 797.
Management of software, firmware, and hardware updates is another time-saving benefit of working with a service, who can help ensure documentation remains up to date for validated systems. Managing these updates can include hardware repairs, replacements, and troubleshooting, or software bug fixes and patches, with addendum paperwork provided for approval prior to rollout.
Monitoring-as-a-Service partners with labs to provide the knowledge and expertise managers need to inform decision-making and improve peace of mind through ensuring a safe and secure lab environment. The expertise provided helps to ensure best practices are in place and enable a proactive approach to protecting samples, experiments, and product by identifying deviations and patterns that predict equipment failure. Researchers and scientists are in turn free to focus on their areas of expertise, returning resources to the lab and accelerating progress. XiltriX’s monitoring service provides the best solution to a complex demand.
To learn more, visit xiltrixusa.com.
