Common Myths About Cleanrooms Debunked
Cleanrooms play a crucial role in industries such as pharmaceuticals, biotechnology, aerospace, and electronics. Despite their importance, many misconceptions exist about cleanrooms and how they operate. These myths can lead to confusion, inefficiencies, or even non-compliance with critical standards. In this blog, we’ll debunk some of the most common cleanroom myths and provide accurate insights into these highly controlled environments.
Myth #1: Cleanrooms Are 100% Sterile
Reality:
While cleanrooms are designed to minimize contamination, they are not completely sterile environments. Cleanrooms are classified based on the number of particles allowed per cubic meter of air, as defined by ISO standards. For example, an ISO Class 5 cleanroom permits up to 3,520 particles per cubic meter (≥0.5 microns in size). These controlled conditions significantly reduce contamination risks but do not eliminate all particles or microorganisms.
Myth #2: Cleanrooms Only Need to Be Cleaned Occasionally
Reality:
Cleanrooms require frequent and rigorous cleaning to maintain their classification. Dust, particles, and microbes can accumulate from personnel, equipment, and even the air filtration systems. Cleaning schedules often include daily, weekly, and monthly protocols for surfaces, equipment, and flooring using approved cleaning agents. Neglecting proper cleaning can lead to contamination and non-compliance with regulatory standards.
Myth #3: All Cleanrooms Are the Same
Reality:
Cleanrooms vary significantly depending on their classification and purpose. An ISO Class 5 cleanroom used for pharmaceutical manufacturing has stricter contamination controls compared to an ISO Class 8 cleanroom used for assembly processes. Cleanrooms can also differ in their design, airflow patterns (laminar or turbulent), and environmental controls based on industry requirements.
Myth #4: Gowning Isn’t Always Necessary
Reality:
Personnel are one of the largest sources of contamination in cleanrooms. Skin cells, hair, and respiratory droplets can introduce particles and microbes into the environment. Proper gowning, including gloves, masks, and full-body suits, is essential even in less-stringent cleanrooms. Failing to follow gowning protocols can compromise the integrity of the cleanroom.
Myth #5: Cleanrooms Are Expensive and Only for Big Companies
Reality:
While constructing a cleanroom can be a significant investment, modular and shared cleanroom facilities offer cost-effective solutions for startups and smaller businesses. These options allow companies to access cleanroom environments without the upfront costs of building their own facility. Flexible leasing arrangements also make cleanrooms more accessible than ever.
Myth #6: Cleanrooms Don’t Require Regular Monitoring
Reality:
Environmental monitoring is a critical aspect of cleanroom maintenance. Parameters such as particle counts, temperature, humidity, and pressure differentials must be continuously tracked to ensure compliance with ISO or cGMP standards. Real-time monitoring systems provide data that helps identify potential contamination risks before they become major issues.
Myth #7: You Can Bring Any Equipment Into a Cleanroom
Reality:
Not all equipment is suitable for cleanroom environments. Tools and devices must meet cleanroom standards to prevent particle shedding or outgassing. Non-compliant equipment can introduce contaminants, disrupting operations and affecting product quality. It’s essential to use cleanroom-approved materials and follow strict decontamination protocols for all items brought into the cleanroom.
Myth #8: Cleanrooms Are Only Necessary for Medical and Pharmaceutical Applications
Reality:
While cleanrooms are essential in the medical and pharmaceutical industries, they are equally critical in fields like aerospace, electronics, food production, and nanotechnology. Any industry requiring controlled environments to prevent contamination, ensure product quality, or meet regulatory standards benefits from cleanroom technology.
Myth #9: Air Filtration Alone Keeps a Cleanroom Contamination-Free
Reality:
Air filtration, including HEPA or ULPA filters, is a vital component of cleanroom design, but it’s not sufficient on its own. Contamination can still occur through personnel, improper cleaning, or equipment. Maintaining a contamination-free environment requires a holistic approach, combining filtration with strict protocols for cleaning, gowning, and environmental monitoring.
Conclusion
Cleanrooms are highly specialized environments that require careful design, operation, and maintenance to function effectively. By debunking these common myths, businesses can better understand the importance of cleanrooms and how to utilize them efficiently. Whether you’re a startup entering the world of controlled environments or a seasoned professional, staying informed about cleanroom best practices is essential for maintaining compliance and ensuring product quality.
At ReadyStart CleanRooms, we provide state-of-the-art cleanroom solutions tailored to your industry needs. Contact us to learn more about how we can support your operations with cleanroom expertise and resources.
About The Author
Darrell Drysen has over 25 years of experience in the Medical Device, Life Science, and Bio-Tech industries. As a technical leader, he holds patents in several fields including Brachytherapy, Electrophysiology, and Neurovascular implants. His outstanding ability to lead projects is evident from the numerous products he has taken from from concept through commercialization for both large companies and starts-ups. He joined ThermoGenesis in 2019 and is currently the Vice President of Operations.
Darrell holds certificates and degrees in Plastics Engineering Technology, Project Management, and Business Administration from California State University Sacramento and Cal Poly Pomona.
At ThermoGenesis CleanRooms, we provide ISO-compliant cleanroom solutions tailored to your industry. Contact us today to learn how we can help you build a cleanroom that supports your operational and compliance goals.
