Pharmaceutical Cleanroom Maintenance Tips

If you work in the pharmaceutical industry, you know that even the slightest bit of contamination could drastically disrupt your production line and affect the safety of consumers. Because of this, it’s not only important to perform operations within a cleanroom, but it’s also important to keep that cleanroom well-maintained.

You should think of your cleanroom just like any other piece of equipment. It needs a little tuning up here and there to keep it running as it’s intended. Let’s take a closer look into what regular maintenance looks like for pharmaceutical cleanrooms.

Looking for examples of our work with pharmaceutical cleanrooms at Angstrom Technology? Check out this case study on a pharmaceutical cleanroom we designed and installed for our client, Praxis.

Pharmaceutical Cleanroom Maintenance Tips

When it comes to pharmaceutical cleanrooms, there’s one main category of contaminants that could disrupt your operations: process- or human-related contaminants, such as dirt, skin, hair, clothing fibers, etc.

In order to combat these contaminants, most facilities have their own unique method and schedule for cleanroom maintenance. But if you’re new to the cleanroom world and you’re wondering where to start, the following sections outline some of the most basic cleanroom maintenance tips to keep in mind.

Day-to-Day Cleanroom Maintenance

The most tried-and-true method of keeping your cleanroom in good operating condition is to diligently adhere to daily cleaning tasks. You’ll want to do the following at least once per shift:

Wet mop floors with an ISO-recommended mop, cleaning solution, and deionized water
Change sticky mats (if applicable)
Wipe walls with an ISO-recommended mop and cleaning solution
Wipe furniture, tables, and work surfaces with ISO-recommended wipes and cleaning solution
Clean pass-through chambers and other additional features with ISO-recommended wipes and cleaning solution (if applicable)
Remove trash, soiled garments/PPE, and waste

Something to keep in mind — while accomplishing each of these tasks, it’s best to think of your cleanroom divided into four sections: ceilings, walls, surfaces, and floors. Then, clean each area following that particular order, from the highest point of your room (ceilings) to the lowest point (floors). This helps to reduce the risk of transferring contaminants from one area to another or counterproductively dirtying a workspace you’ve just cleaned.

Filter Maintenance

Your filtration system is responsible for filtering the air that is constantly circulated in and out of your cleanroom. Since they’re usually operating on a 24/7 basis, these filters need to be serviced and changed with some sort of frequency. There are two main components of your filters that require regular servicing:

Pre-filters are the outermost filters and, in most cases, are located in the return air grilles. They are easily accessed from within the cleanroom, and should be checked on a quarterly basis to see if they need to be replaced. By changing out the pre-filters with some sort of frequency you will extend the life of your HEPA/ULPA filter.
HEPA/ULPA filters do the heavy lifting in the filtration process and therefore are more of an investment — in terms of both labor and finances. ULPA filters remove 99.9995% of particles 0.12 microns or larger. HEPA filters remove 99.99% of particles 0.3 microns or larger. These filters typically sit inside the fan filter housing which is installed in the ceiling grid. But with proper pre-filter maintenance and replacements, HEPA/ULPA filters can last up to 8-10 years, depending on the cleanliness of the surrounding facility.

Additional Equipment Maintenance

From glove boxes to pill packaging conveyor systems, whatever equipment your cleanroom holds should be serviced according to manufacturer recommendations. Any malfunctioning machines could release contaminants or gases that pose a threat to the sensitive materials you’re handling. Always make sure your equipment is working normally before starting daily operations. Equipment typically requires bi-annual or annual servicing, calibration, and certification.

Cleanroom Maintenance Reporting

Our final cleanroom maintenance tip is to keep a thorough, detailed record of all your cleanroom maintenance efforts. We recommend setting up cleanroom maintenance protocols, documenting and outlining the following:

The person responsible for each maintenance task
A schedule for accomplishing each maintenance task
Contamination levels before and after cleaning and/or maintenance
Any “good-to-know” items or maintenance tasks that require follow-up

By using these protocols, you’ll help to ensure that your team sticks to all required maintenance, that your facility remains compliant with all ISO classification standards, and that your business remains profitable.

If your company doesn’t have the capacity and/or resources to stick to regular cleanroom maintenance, don’t worry! There are plenty of resources out there for contracting maintenance and cleanroom cleaning work. Check with your cleanroom manufacturer to see if they have their own maintenance services, or if they can refer you to someone they trust.

Looking for someone to service your cleanroom and get it back into top shape? Give Angstrom Technology a call! As experienced cleanroom experts, we’re happy to talk through your needs and find the right solutions.