XiltriX_Lab_Equipment_Monitoring_ebook_011922 (1)
24/7 LAB MONITORING-AS-A-SERVICE
Lab Equipment Monitoring
The Ultimate Guide to Ensuring Lab Assets are Secured and Properly Monitored
xiltrixusa.com Equipment Monitoring | 1
Following best practices for monitoring lab equipment means more than just responding to alarms when something goes wrong.
For instance, if a freezer is opened several times throughout the day, how does that affect the unit’s temperature and how long does it take before the required temperature is recovered? As importantly, how do you track how often it’s opened? How do you ensure it’s closed properly each time?
If a new piece of equipment (lab, business, or other) is introduced, how does it affect security and/or compliance with CLIA, CAP, GxP, and other standards? How do you ensure it’s being used properly after “go live?”
With constant developments of new technologies, changing regulations and standards, and pressure to ensure you pass audits, it’s often overwhelming
simply to keep pace, let alone get ahead of the curve. Which is why implementing a monitoring platform that can scale with your organization’s evolving needs is absolutely critical.
Following is our ultimate guide to everything there is to know related to laboratory equipment monitoring.
xiltrixusa.com
Equipment Monitoring | 2
INDEX
Cold Storage 4
Incubators 7
Bioreactors 10
Flow Hoods and Biosafety Cabinets 13
Water Baths 15
Autoclaves 16
“Everything else” 18
Conclusion 19
Cold Storage
xiltrixusa.com Equipment Monitoring | 3
Cold Storage
Monitoring cold storage units is a critical aspect of any laboratory monitoring program as cold storage devices typically hold hundreds of thousands of dollars worth of valuable lab assets. It’s imperative to put in place a comprehensive cold storage monitoring system that protects your investments and limits unnecessary risks to your organization.
Among the myriad features to look for in cold storage monitoring are:
Notification if a unit’s temperature drifts outside the normal scope
Alerts if a unit loses power
Reporting on recovery times for any unit
Predictive analytics to help reduce likelihood of future failures
Customized reporting (based on business needs, project time frames, etc.).
Read our white paper
“When Freezers Fail” to learn more about cold storage monitoring.
This last bullet is often overlooked, but accurate reporting and insight can provide your facility with “machine fingerprints” of all your cold storage units
and be used to create SOPs, optimize maintenance schedules, and identify troublesome units before they fail. This ensures your lab is always operating at the highest standard.
REFRIGERATORS, FREEZERS, AND ULTRA-LOW-FREEZERS
Whether you need to monitor units storing samples in 4°C, -20°C, or -80°C, there are several factors to consider:
Are your units regularly temperature mapped to ensure reproducibility of research?
Are SOPs followed in regards to the duration of door openings?
Are safeguards in place to ensure the right personnel get notified in the event of an equipment failure?
Regarding safeguards, for example, the consequences of an erroneous alarm system can be severe if not caught on time. In 2012, the Harvard Brain Tissue Resource Center lost the third largest collection in the world of autism brain tissue samples for this exact reason, setting research in the field back by over a decade.
XiltriX uses industrial grade, high sensitivity temperature probes to help clients respond to issues before they become severe and provide users with scientifically significant data on sample storage conditions.
Temperature mapping: Did you know that how a unit is packed can affect results and security? E.g., something as small as putting sensitive samples slightly closer to the door can have a noticeable difference on end-results and sample degradation.
xiltrixusa.com
Equipment Monitoring | 4
Due to issues like this and more, it’s common and recommended for life science organizations to do temperature mappings of their cold storage
devices and cold rooms before receiving operational qualification.
These mappings can then be performed at regular intervals to ensure equipment stability over the course of a unit’s lifetime, and thereby ensure storage conditions are within regulation and your science
is protected. (Learn more: Real-time Temperature Mapping for Your Facility.)
Temperature Probes: Hardware is always critical in successfully monitoring your cold storage devices (you don’t simply want to rely on readouts from the storage devices themselves: not always accurate enough).
Choose your temperature probes carefully. Look for independently calibrated sensors, and don’t skimp on either quality (i.e., quality = reliability. The last thing a lab needs are false alarms from “cost-saving” sensors), or quantity (as most cold rooms require multiple
probes throughout, depending on the size and types of samples stored therein). Temperature mapping often plays a critical role in determining the optimal number of probes in larger storage units.
Door Contacts: Having door contacts installed on your cold storage units provides an extra layer of protection and valuable insight into equipment health and usage.
How long can the door be opened before the temperature increases to a critical level? How long does it take for a unit’s temperature to recover after a door opening? Can the door send you an alert in the event it’s left open? Will an audible alarm remind scientists when they’ve held the door open for too long as they search for their samples?
Having an integrated monitoring solution that can measure temperature in real-time, along with door contacts, provides important data and ensures your SOPs are working well to protect your frozen samples.
CRYOTANKS
Cryogenic tanks offer several unique benefits compared to other cold storage units. They’re ideal for storing samples sensitive to temperature fluctuations, as liquified or vaporized gasses — some labs use both, and each requires a specific monitoring system
— are used as coolants, rather than electricity, and the tanks therefore aren’t at risk for power outages.
Liquefied gasses also quickly restore the interior temperature of -150°C between openings which makes them ideal for storing sensitive biological samples such as blood and biological cell cultures.
If using liquid nitrogen, it’s imperative to not just monitor the tank’s LN2 levels and temperature, but also ambient O2 levels and provide both local audible and visual alarms to keep personnel safe from potential leaks. The issue often faced is that many
sensors on the market are simply unreliable due to connectivity issues or short life spans, or simply aren’t robust enough to capture the necessary information.
Measuring the subtle change in temperature from liquid nitrogen to vapor phase (liquid nitrogen is
-196C, vapor phase is -195C) is an incredibly effective, and reliable way to get a notification when LN2 levels drop below a certain level. It’s imperative you have the sensors and reporting systems in place to capture and relay these measurements.
XiltriX can automatically log and record temperature, gas concentrations, and tank openings in real-time, all data that’s easily accessed via our cloud-based platform. More information about cryotank storage can be found in our blog post “How to Mitigate Risks in Your Cryotank Storage”.
xiltrixusa.com
Equipment Monitoring | 5
Incubators
xiltrixusa.com Equipment Monitoring | 6
Incubators
Used to grow and maintain microbiological samples, incubators come in a variety of shapes and sizes with third party monitoring of these devices varying greatly. They are the backbone of any fertility clinic or life science facility handling cell cultures.
These biological materials are often highly sensitive and require perfect balance between conditions such as humidity, temperature, and CO2/O2
concentrations. Real-time monitoring and reporting is vital to ensure an incubator’s stability.
Humidity: The level of humidity in an incubator often depends on cell culture, but is usually in a range between 50-60%. If the humidity drops below that, samples could die and valuable research could be lost. Reporting and early warning signs of failure is again central to success. (Read our blog on the topic:
Monitoring relative humidity in real-time for your laboratory)
Temperature: Just as with cold storage units, temperature is a critical parameter to measure in any incubator, and with large box types the placement
of the probe can also play a critical role in getting accurate measurements.
Understanding location, temperature fluctuations, identifying cold spots (which can cause condensation), getting data on the recovery time after door-opening, and understanding how consistent fluctuation ranges are over time can help ensure the integrity of your resources and samples.
Equipment invariably degrades over time and fluctuations may increase, making it important to track trending stability data for these devices to know when it’s time for maintenance or a new unit.
CO2/O2: Monitoring CO2 levels is very important as it’s not possible to cultivate cells if the levels aren’t
between specific concentrations. In addition to monitoring the levels inside the incubator, it’s just as
important to also set up CO2 sensors and monitor the areas in close proximity to the tanks.
These gases have been classified as “substances hazardous to health” due to the risks associated with them if a leak were to occur. If a leak is not discovered in a timely manner, the consequences could be a matter of life and death.
Having both audible and visual alarms to notify if the CO2 level rises to above the recommended 1,000 parts per million (ppm) is therefore key to ensure safety of the lab personnel. In addition to these
alarms, XiltriX also has an alarm sequence that sends out notifications in real-time to select employees to resolve the problem as promptly as possible.
pH: Ideal environments for cell cultures are usually slightly acidic (often between 7.2 and 7.4 in pH level). In contrast to temperature, pH is a difficult condition to monitor and control, and is directly affected by the previously stated conditions.
By maintaining CO2 levels at around a
5% concentration, a chemical reaction takes place inside of the incubator and controls the pH
of the system. pH is notoriously difficult to calibrate and reliable sensors are incredibly important to achieve uniformity.
Shaking: Shaking incubators are mainly used for mass-cultivation of bacterial cultures and require monitoring of motion. Sensors for these are usually based around a magnet to measure RPMs (or at least dry contacts — detailed below — to ensure the unit is still functioning).
Door sensor: Measure how often, and how long, an incubator is open with door contacts. When connected to an integrated software, like XilitrX,
reporting can compare door usage to other conditions in the incubator to analyze the effects it has on the overall environment.
xiltrixusa.com
Equipment Monitoring | 7
Learn more about ideal incubator environments in the white paper What is Your CO2
Incubator Telling You?
For example, in the event the door is held (or left) open too long, incubators will often spike in
temperature (as a heating coil kicks into overdrive to keep the temperature stable). A simple door sensor can be used to report usage and set SOPs (and then monitor that SOPs are being properly followed).
Dry contact: A very simple type of alarm that can only perform two actions: it detects if a condition has gone out of parameters, and it triggers an alarm in response.
Dry contacts are directly connected with the device’s built-in sensor and are often therefore not properly calibrated. They also do not provide actual readings of device conditions, only if it’s in alarm or not.
Additionally, some devices offer multiple dry contact alarms - for example, the K-System G210 incubator offers dry contact alarms for temperature, gas concentrations, or pressure. So while you don’t gather any data, it does point you in the direction of what is going wrong.
xiltrixusa.com
Equipment Monitoring | 8
Bioreactors
xiltrixusa.com Equipment Monitoring | 9
Bioreactors
Built to store and grow biological samples in an active and protected environment. Common use cases are for growth of phototrophic organisms such as algae or cyanobacteria, high volumes of specialized tissues, and growth of yeast and bacteria. Larger reactors
can be more cost-effective, but also come with the increased risk of higher potential losses if something goes wrong.
Additionally, bioreactors often include software programs that capture critical process data in a 21CFR11 format.
Connecting this data to an environmental monitoring system (EMS), like XiltriX, brings up the question on
pH: Monitoring pH levels is immensely hard due to several factors, such as these sensors requiring
significant maintenance and calibration routines to ensure accurate data is being captured. If these are missed or performed incorrectly, pH sensors can easily produce erroneous results. One example of a sensor producing faulty readings is as small as if a sensor has been cleaned, but a small film remains on it. To ensure you’re generating accurate readings, it’s therefore recommended to monitor parameters that have a direct impact on the pH levels, such as temperature and CO2/O2 levels. While pH sensors do exist, activities such as calibration and regular
maintenance can be more of a burden than a benefit.
whether the EMS will act as a dry contact alarm for
CO /O
levels: As with any cultivation, balanced
different parameters, or be the actual intelligence 2 2
hub and extract data from the device. (Another driver behind why monitoring-as-a-service is almost always a customized deliverable, as ensuing use cases will demonstrate.)
The advantage of storing data in the EMS is that everything is in one system for future analysis, eliminating data silos and making it easier to view manufacturing operations holistically. However, the disadvantage is that it’s very difficult to do these integrations and often requires working directly with the manufacturer to determine integrations or customize devices.
Also, in bioreactors, process parameters change over time, making creating limits on the device difficult as the acceptable ranges will also change over time. Real-time monitoring of vital conditions is crucial to ensure the safety of the science as well as reproducibility.
Depending on the use case, facilities will have different needs for what should be monitored in the bioreactor. Here are some examples:
levels between CO2 and O2 can help ensure cell growth and product quality, and is key for desired
growth. It’s also the easiest way to ensure pH remains at a healthy level. As with all types of hazardous
liquid gases, monitoring of these should also be done in the tank storage area to better ensure the safety
of lab personnel.
Temperature: Regardless of type of bioreactor, temperature monitoring is an essential parameter to monitor for bioreactors. Depending on use case and growth phase, temperature is usually set between 25- 40°C. (We recognize this is a broad range, but — the more data you capture — the more the range may be refined over time.)
Having a monitoring software that can integrate multiple sensors will give you a better understanding of how different events, such as door openings and changes to ambient parameters, influence different conditions and have an impact on your critical life science assets.
xiltrixusa.com
Equipment Monitoring | 10
Light sensitivity: Monitored for photobioreactors. In order for phototrophic organisms to grow, or ferment, photosynthesis is required. This can either be done with artificial illumination or by sunlight.
Light monitoring measures the light intensity (watt), wavelength (lux), and brightness (lumens) the bioreactor is exposed to over a course of time to ensure successful photosynthesis and scientific reproducibility.
Dry contacts: As with incubators, this is a simple alarm that does two things: it detects if a condition has gone out of parameters, and it triggers an alarm in response. Dry contacts don’t supply data on the cause of an alarm.
xiltrixusa.com
Equipment Monitoring | 11
Flow Hoods and Biosafety Cabinets
xiltrixusa.com
Equipment Monitoring | 12
Flow Hoods and Biosafety Cabinets
Flow hoods and biosafety cabinets (BSC) both require filtration systems. Flow hoods are enclosed workbenches designed to draw air through a filtration system. There are several different types of flow hoods, but the most common ones are horizontal and vertical. Horizontal airflow hoods project ambient air through a blower towards the HEPA filter to then exhaust the purified air horizontally into the cabinet.
Flow hoods and biosafety cabinets are mainly used for industrial purposes, such as semiconductor wafers, and when handling sensitive biological samples. To ensure the safety of these materials, and depending on classification requirements, there are several parameters that need to be monitored, such as:
Source: www.lamsys.com/products/vertical_laminar_flow/
Air Flow: The primary purposes of a flow hood are 1) ensuring the safety of personnel and 2) maintaining the quality of materials contained within a BSC. Air flow is therefore a vital parameter to monitor and report on. Several monitoring systems have visual and audible alarms to ensure any potential drop in flow rate is discovered early and can be promptly resolved.
Particles: To ensure the HEPA filters are functioning properly, and there are no leaks, monitoring air particles will alert lab personnel when it’s time to replace the filters to ensure a stable and secured environment.
xiltrixusa.com
Equipment Monitoring | 13
Water Baths
xiltrixusa.com Equipment Monitoring | 14
Water Baths
Used to either cool samples down or to heat up sensitive samples that risk being combusted if put over an open flame. These can have different types of motion depending on the use case. The most common things water baths are monitored for are:
Temperature: Boiling water baths normally can go up to 100°C, but if using an oil bath, temperatures can go as high as 260°C. Integrating the temperature probes with a real-time monitoring system that can generate accurate reporting will ensure accuracy and reproducibility.
Delay function: XiltriX can delay alarms to kick in once a certain temperature is reached. This means the system can delay the alarms to only trigger when the water bath is in use and prevent unnecessary alarms.
Shaking: Shaking water baths are commonly used for applications such as hybridization, cell or bacterial culturing, or thawing of blood. The average RPM ranges between 20 and 200 and can be measured with magnet-based sensors.
Source: https://www.labcompare.com/General-Laboratory-Equipment/80-Water-Baths/ https://www.labcompare.com/10-Featured-Articles/127452-Buyer-s-Guide-to-Water-Baths-and- Chillers/?ctid=1&cid=82
xiltrixusa.com
Equipment Monitoring | 15
Autoclaves
A type of chamber that uses pressurized humid heat to sterilize lab equipment. The high internal pressure makes it possible to reach a higher temperature without the water starting to boil and can therefore better sterilize.
Pressure: As the pressure is a crucial factor of the sterilization, using a differential pressure sensor to measure that vacuum is close, or slightly above,
the autoclave transducer range will ensure accurate measurements and a fully sterile environment.
Temperature: Standard temperatures for autoclaves are 121°C - 124°C and it must remain at this temperature for at least 15 minutes to ensure all of the equipment has been fully sterilized. Real-time monitoring of the temperature is a simple way to
guarantee sterilization and prevent the risks that come with using equipment where contaminants may still be present.
Water quality: Monitoring the quality of water before running the autoclave may sound counterintuitive considering the purpose of an autoclave, but it’s actually an important step as this will ensure that the water doesn’t infect or affect the contaminants that are supposed to be terminated.
Water Purification: With the aim of an autoclave being to destroy all potentially harmful elements, it’s beneficial to check the purity of the water at the end of the cycle. This ensures the sterilization was successful and provides proper documentation
for audits.
MICROSCOPE
Most specimens observed through a microscope are highly sensitive to thermal changes. Using a microscope with a thermal control system ensures a stable environment that can be set between
20°C-50°C and with temperature fluctuations of less than +/-1°C. Integrating the control system with a real- time monitoring system provides full thermal insight.
xiltrixusa.com
Equipment Monitoring | 16
“Everything Else”
xiltrixusa.com Equipment Monitoring | 17
“Everything else”
The lab is an ever-evolving place, which means the systems, software, and hardware used to ensure its integrity are always changing, and always differ from lab to lab. While we have covered many types of equipment to monitor and report on, this list is “dynamic” and growing.
Your lab may have some, all, or more of the needs detailed above. But, in most cases, the tools used to monitor and report are out there already, and XiltriX can help create a custom implementation plan for your specific equipment monitoring needs.
xiltrixusa.com
Equipment Monitoring | 18
Conclusion
Every industry has different needs and requirements in order to comply with standards and pass audits, but there are a few key factors that they all have
a need for - high quality data control, accurate monitoring, and full insight to what happens in their facilities to certify that critical life science assets are always protected.
Having a robust real-time lab monitoring system in place for your lab equipment prevents the risk of catastrophic sample losses, streamlines compliance and quality reporting processes, and provides peace- of-mind that your scientific assets are protected at all times. XiltriX’s 24/7 real-time monitoring solution
is built upon industrial grade hardware in compliance with the highest international and US standards and is capable of tracking devices from different OEMs and across multiple physical locations. Hosted in the cloud, the XiltriX software can be accessed remotely at any time or place by simply using a phone, laptop, or computer and empower lab personnel to have full insight of everything that’s going on in the lab as well as trend correlations between different parameters.
To learn more about how XiltriX can ensure your lab’s critical assets and equipment are protected 24/7/365, schedule a free lab consultation with one of our experts.
xiltrixusa.com Equipment Monitoring | 19
