When dealing with research and manufacturing in an ISO 7 and ISO 8 cleanroom environment, there’s often a very fine line between success and costly failure. Often, the causes of these failures can’t even be seen by the human eye. That’s because even very small biological hazards can impact your work in these areas. While ISO 7 and ISO 8 environments may seem a little laxer than classifications such as ISO 5, which have a much smaller particle allowance, that doesn’t mean you don’t need to be on top of your cleaning protocols. One small mistake can lead to compromised research, product recalls, and steep regulatory fines.
Contamination control is more than just cleaning; it’s about understanding how a controlled environment works and how substances act within that environment. It’s why working with a standard cleaning company isn’t enough for a biotech company. You need to partner with someone who understands ISO best practices, which SourceONE does.
Common Sources of Cleanroom Contamination
Before you can fully control contamination, you have to identify what causes it. ISO 7 and ISO 8 clean environments typically focus on three categories of contaminants.
Airborne Particles
These particles act as microscopic rafts to ferry around microorganisms through the air. In an ISO 8 room, the maximum number of these particles in the air cannot exceed 3,520,000 per cubic meter. If your cleanroom must meet ISO 7 standards, however, the number of allowed airborne particles is much smaller, with only 352,000 per cubic meter allowed. These particles can come from a variety of sources, including cardboard packaging, machinery, and other materials.
Fibers
While they may be standard outside of cleanroom environments, regular janitorial equipment and tools can easily contaminate a cleanroom. Mops, brooms, sponges, and even rags can shed millions of microscopic fibers. These fibers can get into electronics or sterile fluids, contaminating them and introducing unexpected elements into your work. Cleanroom standards require that monofilament or knitted polyester materials designed to trap particles without leaving behind fibers be used in cleanrooms.
Human Microorganisms
While airborne particles from materials and fibers from cleaning equipment can certainly impact a cleanroom, the largest number of contaminants come from your very own people who work in the space. Humans shed around 10 million skin cells every day, and basic actions such as reaching for something can leave behind biological debris. That’s why gowning protocols are so important.
Best Practices for ISO 7 and ISO 8 Cleanrooms
Maintaining your cleanroom environment cannot be an afterthought. Keeping these spaces within ISO standards requires a planned approach. Here are several ways SourceONE approaches cleanroom maintenance:
HEPA Vacuuming
Many people would assume that most biological debris accumulates on horizontal surfaces such as floors, tables, and desks. However, while these surfaces do contain a good number of these particles, debris can also cling to the walls and even the ceilings thanks to static electricity. This electrostatic attraction requires more than basic dusting, which typically just moves the particles around in the air.
A vacuum rated for use in cleanrooms and equipped with a HEPA filter is typically required to remove these particles. These vacuums are able to remove upwards of 99.97% of particles, leaving the space nearly spotless. Cleaners needs to follow a top-down approach to avoid dirtying recently cleaned areas. They should start vacuuming at the ceiling, then work their way down the walls before finishing with the floors.
Mopping
While the walls and ceiling do collect their share of particles, most of them do end up on the floor. In ISO 7 and ISO 8 cleanrooms, floors need to be mopped after every shift change. However, the standard mopping technique isn’t the right option. The industry standard is to use a two-bucket or a three-bucket method. This ensures that the dirty water is never reused on the clean floor. It’s also important to use a disinfectant that is rated for a cleanroom.
Selecting the Right Cleaning Supplies
Standard cleaners and disinfectants, even those that are listed as “green” or safe for use in sterile environments, are not rated for use in ISO cleanrooms. The chemicals used in cleaning these spaces must be low residue so they do not leave behind a film or other particles that can actually trap debris. All cleaning agents also need to be filtered to 0.2 microns before they can be used in a cleanroom. A service that does not follow these regulations can actually leave a cleanroom more contaminated than it was before they “cleaned” it.
The SourceONE Difference
At SourceONE, we’re more than just a cleaning service; we’re a team of trained technicians who understand the industry best practices for ISO-certified cleanrooms. When we partner with you, you can rest assured that your facilities will be cleaned correctly with attention to every detail.
Gowning and Training
Our team understands that the cleaning process simply cannot be effective without first effectively growing. Our team is trained to ensure that our outer garments never touch the floor or the dirty part of a bench, table, or other surface. Our team follows strict cleaning protocols for masks, gloves, coveralls, and all other requirements so we do not contaminate the space we’re there to clean.
Avoiding Cross-Contamination
One of the most common failures for an ISO certification is cross-contamination. This occurs when particles from another part of the facility or from an outside space enter your cleanroom. This can be avoided by maintaining separate inventories for each facility. Items used in one ISO 7 space won’t be used in another, resulting in a controlled, clean environment. By quarantining equipment in the space it’s used, we avoid the cross-contamination that can lead to failed inspections and audits.
Protecting Your ISO Cleanroom Certification
Your ISO 7 or ISO 8 cleanroom is a significant investment, but it’s an investment that can unfortunately be compromised very easily. A cleanroom can become useless if it’s not maintained properly. You risk contaminating costly research, damaging your production line, and failing audits if these areas are not cleaned properly.
SourceONE is here to provide the expertise necessary to ensure that your cleanroom is truly clean and complies with all appropriate ISO standards. Our highly-trained team of experts follows rigorous documentation processes and uses only the best equipment to keep your environment clean pristine.
Ready to learn more? Reach out to SourceONE today to discuss how we can help keep your cleanrooms contamination-free.