In a standard office building, the concept of “clean” is relatively simple. Your office is clean if the floor has been swept, the carpet has been vacuumed, the trash cans are emptied, and the area looks overall neat and free of dirt and debris. In a cleanroom setting, however, that concept is far, far from what regulations consider “clean.” In such a room, whether it’s in a semiconductor fabrication plant or a pharmaceutical lab, “clean” surfaces contain no microscopic particles that can damage products or cause vital research to fail.
This means that cleanroom cleaning isn’t a luxury you can skip out of. It’s a fundamental requirement for your work. When your industry requires you to maintain a cleanroom to ISO standards, you need to work with a partner who understands those standards. Here at SourceONE, we have years of experience and are ISO-certified. This means that whether you’re doing research into life-saving medications or creating microchips for the next generation of computers, your space is not compromised. Let’s take a deeper look at what cleanroom cleaning requires such specialized expertise and what SourceONE brings to the table.
The Science of Contamination Control
In the controlled environment of a cleanroom, the concentration of airborne particles must be kept within the specified limits for your particular environment. For example, in an ISO 5 cleanroom, which is typical for sterile drug compounding, there can be no more than 3,520 particles that are 0.5 microns or larger. If there are, the area is compromised and none of the medication created in it can be used. This is why meeting these requirements can’t be done with a simple mop and bucket.
While many lab workers believe that various chemicals and other factors are the biggest source of contamination in a cleanroom, that’s actually not the case. Human workers are the largest source of contamination. A person who is doing nothing but sitting perfectly still will sheed around 100,000 particles every minute. If they’re walking, they’re shedding upwards of 1,000,000 particles every sixty seconds.
This means contamination experts have to understand how to deal with these contaminants as well as dirt and other types of debris. This often includes the following:
- Gowning – Gowning procedures reduce the amount of particles a technician sheds when in a clean space. These procedures take a top-down approach, ensuring that particles don’t fall onto cleaned areas.
- Airflow – Understanding how airflow stirs up particles is vital to understanding how to deal how contamination moves through a space.
- Material Selection – Using specialized wipes and chemicals that leave behind no residue or lint ensure that new contaminants aren’t introduced while removing the old ones.
Navigating the Regulatory Landscape
One of the biggest reasons why you should partner with a professional cleaning service like SourceONE is due to regulations and the fines and other penalties that come with not following those regulations. Cleanrooms have a number of standards that must be followed, including ISO 14644 and USP <797> and <800>. In almost all industries were cleanrooms are required, audits aren’t a matter of “if” but of “when,” and when one occurs, you want to be ready.
During one of these audits, there’s no forgiveness or wiggle room. If you don’t have something documented, an auditor will assume it never happened. Issues like this are the leading cause of sterile drug recalls. In fact, between 2012 and 2023, over 90% of these recalls were due to sterile facility failures. On top of that, in 2024, the FDA issued over 500 “Inspectional Observations” forms, many of which cited environmental monitoring and contamination control as one of the “objectionable conditions” found by the auditor.
Our specialized expertise ensures that you’re always ready for an audit at all times by implementing the following:
- Detailed logs – It’s vital that you have precise records of every chemical used, technician involved, type of cleaning done, and other details of every cleaning cycle.
- SOP alignment – We align our cleaning methods and schedules with your specific Standard Operating Procedures.
- Good documentation practices – We ensure that all of our documents are organized and recorded in a way that meets both your internal quality assurance standards and external regulatory requirements.
The SourceONE Edge: Specialized Equipment and Chemicals
In order to correctly clean a high-tech sterile environment, you have to have the right tools. A mop and a broom simply won’t do it. Even something like a standard vacuum would be a disaster because of how many particles it would expel back into the air. The team at SourceONE uses professional cleanroom tools such as Ultra-Low Penetration Air (ULPA) filtered vacuums that were designed not just to remove dirt, debris and particles but also to avoid bringing in their own contaminants. The goal is to remove particles, not simply spread them around, and for that, you have to have these tools.
But you don’t simply need a specialized vacuum. You also have to use chemical cleaning agents that were designed for use in cleanrooms. This is especially important in biotech and pharmaceutical cleanrooms where biological agents may be present. Specific types of disinfectants have to be used that neutralize and clean these agents as well as leave instruments without any type of resident or film on them. It’s also important that your cleaning team recognizes the correct contact time for agents in your labs. If chemical cleaners are wiped away too soon, traces of these agents can remain. When it comes to specific medications and other products, a small contaminated corner can be just as bad as a fully contaminated table.
Protecting Your Bottom Line
Failing to properly clean a sterile space isn’t just an error that leads to a strongly worded letter following an audit—it has real costs associated with it. A single contaminated batch of medication, for example, can cost you upwards of $2 million in lost product, not to mention leaving you open to lawsuits, regulatory fines, and damage to your reputation.
This is why investing in a partner with cleanroom expertise is vital. You’re not just working with a cleaning company, you’re bringing in another layer of protection for your bottom line. We bring ISO-certified quality management to the table, creating a consistent, documented cleaning procedure that will ensure success. Our teams undergo rigorous training not just to meet our standards but also to meet yours. We know you have specific facility needs, and we will work closely with you to understand and implement solutions that meet them.
Why SourceONE is the Right Choice
SourceONE has more than 20 years of experience serving industries in the Bay Area, and we’re ready to put that experience to work for you. We understand the nuance of cleanroom care and its importance on your budget and your reputation. Whether it’s a BSL-2 lab or a high-volume medication manufacturing plant, we’re equipped to maintain your environment to both your and the industry’s highest standards.
When you work with us, you’re not just bringing in someone to keep your labs sterile, you’re gaining a partner who understands your needs, your hardware, and industry compliance. If you’re ready to entrust your cleanroom facilities to an expert, it’s time to reach out to SourceONE.