Cleanroom Monitoring

Cleanroom Monitoring

Cleanrooms are dedicated spaces in which the environment is monitored and carefully controlled to maintain optimal air conditions. Important conditions to monitor in a cleanroom include temperature, humidity, air pressure, airborne particle count, and more.

Monitoring and maintaining cleanroom conditions is an important task in a wide variety of industries and usually requires the use of some specialized tools.

Examples of industries that commonly use cleanrooms include the pharmaceutical, biotech,  automotive, aerospace, medical device, and life sciences industries.

For many of these industries, one of the primary uses for cleanrooms is to prevent very small particles in the air from negatively affecting manufacturing processes, contaminating research samples, or interfering with other kinds of sensitive assets or operations.

Contaminants that travel through the air are present all around us — and even though most of them may be little threat in most scenarios, they can potentially spell disaster for processes that must be carried out in sterile environments or assets that must be stored under specific conditions.

For example, if certain kinds of airborne particles land on sensitive parts for medical devices while they’re being assembled, it could ultimately cause those products to fail at a higher rate, leading to lost time and revenue — not to mention wasted parts that may be very expensive in some cases.

To understand cleanroom monitoring, it’s essential to understand viable and non-viable cells. The difference between viable vs. non-viable particles is that viable particles are live microorganisms, while non-viable particles are non-living particulate matter. Viable particles examples include:

• Bacteria
• Mold
• Yeast and fungi

Some examples of non-viable particles include:

• Pollen
• Dust
• Dead skin cells
• Clothing particles 

Non-viable particles sometimes act as carriers of viable particles. Viable and non-viable particle counts can be monitored using tools for testing cleanroom environmental conditions.

It’s also important to understand the difference between viable vs. non-viable air sampling. You can use a particle counter to measure the presence of particles in the air, but a particle counter will not differentiate between viable vs. non-viable particles. There are other kinds of tools that are designed specifically for viable particle sampling.

One variable that is among the most difficult to control in cleanroom environments is the human variable. While cleanrooms can be closely monitored and kept sterile using the appropriate technology and due diligence, people are not so easy to sterilize. This is why many kinds of personnel “suit up” in gear like lab coats, gloves, or hair nets before they enter cleanrooms and perform their work.

To monitor cleanroom conditions like particle count, air pressure, humidity, temperature, and more, you need the right tools. Environmental conditions monitoring tools like Sonicu’s SoniShield Duo can enable more accurate cleanroom monitoring, more reliable alerts, and more consistent reporting.

You can learn more about how our software helps compliance professionals in these case studies: 

Ohio University Innovation Center

Problem: Tech and tech-enabled startups at the Innovation Center needed reliable support systems for temperature and environmental monitoring due to the requirements of grant-funded projects.

Solution: Implement Sonicu for comprehensive monitoring of temperature, ambient humidity, and air pressure differential, ensuring necessary protection and compliance.

Hancock Regional Health: Enterprise Monitoring from Sound to Environmental

Problem: Disparate monitoring systems were taxing the staff with many manual processes, leading to inefficiencies and reduced asset protection.

Solution: CEO Steve Long initiated the adoption of a consolidated monitoring program for temperature, environmental, and sound, which automated compliance and reduced manual logging.

Xytex Sperm Bank: Ultra Low Temperature Monitoring

Problem: Frequent false alerts were causing alarm fatigue, threatening the operations at Xytex Sperm Bank.

Solution: Partnered with Sonicu to develop a custom temperature monitoring solution for ULT and cryo temperatures, including probes inside and outside the preservation chambers.

Cleanroom Monitoring Equipment

In many industries, it’s extremely important to maintain very specific room conditions for a variety of reasons. This is where cleanrooms come in. Here are a few of the reasons that it’s important to monitor critical environments for even small environmental changes:

Safer conditions

Obviously, one of the main advantages of having highly-effective room condition monitoring solutions in place is that it greatly improves the stability of your cleanroom’s conditions. Without accurate monitoring technology, you may not be alerted in time to a dangerous fluctuation in a room’s particle count, humidity level, air pressure, temperature, or other environmental conditions. You can use cleanroom monitoring equipment like Sonicu’s room conditions monitoring solutions to improve monitoring capabilities at your organization.

Regulatory compliance

An effective lab monitoring system for room condition management is also essential for ensuring compliance. Regulatory agencies like the FDA have set various standards and laws to guarantee best practices in environmentally-sensitive cases. For example, Good Manufacturing Processes (GMP) is the FDA regulation that requires manufacturers to proactively test that their products are both effective and safe. Top-quality room conditions monitoring technology can make it easier to achieve and maintain GMP environmental monitoring compliance.

Effective reporting

Regulatory agencies require most kinds of organizations to keep detailed records of room environment monitoring data. Aside from meeting compliance requirements, accurately and consistently logging room conditions data can help organizations complete audits or system maintenance more efficiently. Sonicu’s room condition monitoring tools include advanced reporting features that enable highly-accurate automated logging.

Clean Room Temperature And Humidity Sensor

One environmental condition that’s often necessary to monitor in cleanrooms is relative humidity. Relative humidity (RH) measures the water vapor content in the air and expresses it as a percentage.

Organizations that need to control the relative humidity of their cleanrooms can use a cleanroom temperature and humidity sensor to monitor humidity levels in the air.

Relative humidity is closely linked with temperature. Relatively, humidity typically moves up and down in inverse proportion to the temperature of the cleanroom, and it is very sensitive to even minor temperature changes.

When the temperature increases, the humidity level goes down (the air becomes drier); when the temperature decreases, the humidity level goes up (the air becomes wetter). It’s usually much easier to keep the relative humidity of a cleanroom stable when you keep the temperature stable as well.

Tools like humidity and temperature transmitters or RH sensors can facilitate RH monitoring. Investing in a high-quality cleanroom temperature sensor, like the ones available from Sonicu, can also make it easier to monitor cleanroom RH and allow you to react quickly if there’s a problem that needs to be rectified.

Cleanroom Air Quality Monitor

Air particles are tiny bits of matter that travel through the air and are usually nearly or completely invisible to the human eye. There are two types of air particles that pertain to cleanroom sterilization: viable and non-viable particles. 

Viable particles consist of living organic matter, while non-viable particles contain no living microorganisms. Viable particles can compromise many kinds of controlled critical environments if not kept under control.

Non-viable particles do not have the same direct potential for harm, but they are capable of transporting viable particles, so they usually need to be monitored as well.

Most organizations use specialized air particle counters to measure cleanroom air quality. Monitors are essential for ensuring the stability of critical environments and for maintaining legal compliance (depending on the industry).

There are many different kinds of cleanroom particle counters that can meet a wide variety of needs across different industries — examples include handheld particle counters and remote particle counters. 

Sonicu provides tools for remotely monitoring cleanroom air conditions that can make it easier to log data and remain in the know about changes in air quality.

Humidity Monitoring System

The humidity of cleanrooms is another important factor to monitor in many cases. Organizations can use humidity monitoring systems to track and report changes in humidity in controlled environments like cleanrooms.

You can also use an industrial temperature monitoring system to measure humidity changes since temperature and relative humidity share an inversely proportional relationship.

A remote temperature and humidity monitoring system provides one of the best kinds of temperature and humidity monitoring in the pharmaceutical industry and many other industries.

Monitoring humidity remotely allows you to be quickly alerted if any issues arise, such as unexpected changes in temperature or humidity. 

Remote temperature monitoring tools like Sonicu’s solutions make it possible to stay continuously informed about cleanroom humidity conditions.

There are several different types of cleanroom monitoring systems that you can use to measure humidity levels in a variety of industries; one example is a temperature and humidity monitoring system for warehouses.

You can learn more about how our software helps compliance professionals in these case studies: 

Nomi Health: Fast installation, simple deployment

Problem: A rapidly growing healthcare technology startup needed to scale quickly and monitor cold chain storage devices nationwide.

Solution: Implement Sonicu's temperature probes with a central command center for enterprise visibility, allowing fast and easy training for reps across the country.

CleanSlate: Addiction Treatment Centers

Problem: A Boston-based addiction treatment center needed an affordable and simple monitoring solution for their facilities across the United States.

Solution: Choose Sonicu for its affordability and ease of self-installation, supporting the center's mission to manage growth and improve service delivery nationwide.

UHS: South Texas Health System, Edinburg

Problem: Fire alarm testing disrupted the environmental conditions in Operating Rooms, causing compliance and operational challenges.

Solution: Implemented Sonicu's environmental monitoring system, which allowed the facility manager to monitor conditions via a mobile app and resolve issues with the HVAC system triggered by fire alarms.

Viable And Non-viable Environmental Monitoring

One of the most crucial purposes of a room monitoring system is viable and non-viable environmental monitoring, which measures the concentration of particles in the air.

As briefly mentioned earlier in this article, there are two kinds of particles: viable and non-viable (meaning living, organic matter, and non-living particles with no microorganisms present). 

While the importance of testing for viable particles may be apparent due to their organic nature, who performs non-viable air monitoring, and for what does it test? Non-viable air monitoring is performed in a variety of industries, from healthcare to manufacturing, to ensure that critical environments remain properly sterilized.

Non-viable particles pose no inherent risk the way viable particles do, but non-viable particles are often responsible for transporting harmful viable particles through the air.

Temperature Monitoring

Temperature monitoring is another critical task for organizations that maintain cleanrooms. Temperature-sensitive environments need to be carefully monitored for even slight fluctuations in temperature.

Certain kinds of assets, like vaccines or lab samples, can easily be ruined if they’re not stored at the proper temperatures.

In addition, monitoring temperature is a critical part of ensuring stable humidity levels in cleanrooms and other sensitive environments.

To keep temperature levels within the ideal range, organizations typically lean on specialized room condition monitoring tools, like Sonicu’s wireless temperature monitoring systems.

A proper temperature monitoring procedure ensures that your organization does not have to suffer the negative repercussions of failing to keep room conditions optimized or neglecting to properly log room conditions data.

Using temperature monitoring PC tools or other advanced room condition monitoring technology is one of the best ways to keep room conditions under control.

American-based Customer Support: Robust & Reliable High Touch Service 

Software and technology is only as good as the people who stand behind it. 

At Sonicu, that means our team of American-based customer success managers who are never more than a phone call away to help field and fix any service issues. 

Our probes and sensors are placed in demanding frozen environments and our software literally sends billions bits of data monthly, meaning there’s alway the potential for a hiccup on either the hardware or software. 

We are committed to fielding every customer service request promptly and addressing our customer’s concerns promptly and professionally.

“I like to say that every refrigerator or freezer is like a car in that they all behave a bit differently,
and then every now and then you just get a bad boy who doesn’t want to perform as we need it to,”
Martha Rardin, Director, Nutrition and Dietetics, Hendricks Regional Hospital.