The good news? Business is booming. Your customer base is expanding and orders are rolling in.
The bad news? Some of your new clients are from an entirely new market sector with requirements your business has never had to worry about before.
Case in point: The specs you just received from an important new customer state that your product must be certified as cleanroom-ready.
After a quick Google search, you are wading through terms like “particulate” and “particles per cubic meter”. The vocabulary alone is daunting, never mind actually proving that the product is clean enough for the customer to accept delivery.
But don’t throw in the towel and turn down the business just yet! Consider outsourcing the cleaning and packing steps to an industrial packaging company with cleanroom expertise. This primer can help you build a base of knowledge and choose a reputable cleanroom packager.
Products that will be deployed in a cleanroom need to be thoroughly cleaned prior to packing, so they don’t bring contaminants into the delivery site. The best way to accomplish that level of cleanliness is to perform the packing operation in a cleanroom.
A cleanroom is a contained area with a very low level of the environmental pollutants found in everyday air, such as dust, aerosol particles, and chemical vapors. Microscopic pollutants, such as dead skin cells, paper fibers, and the droplets of moisture that are expelled when someone coughs, are all contaminants.
Cleanrooms are classified by how clean the air is. For example, a “class 100 cleanroom” would never allow more than 100 particles sized 0.5 mm or larger per cubic foot of air. (For comparison, a human hair is approximately 100 microns in diameter.)
Key features of a proper cleanroom packaging facility include:
Air lock: Just like the air locks that keep astronauts safe as they transition from outer space to the spaceship, this serves as a buffer between the clean room and the rest of the world. The goal is to prevent any contaminants in the regular room air from entering the clean room along with the workers. Flowing air helps knock any stray contaminants off anything or anyone entering the air lock. Those airborne pollutants are then trapped by the air lock’s filters. A tacky mat, which employees walk on as they cross through the air lock, collects contaminants from the bottoms of shoes and booties.
Filtration: The air inside of the cleanroom is filtered to remove potential contaminants that are present in the air you would find in an office, factory, or warehouse. Particulates in the environment, such as dust, airborne microbes, aerosol particles, and chemical vapors, could cause serious damage to the delicate machine parts being manufactured or assembled. So all air delivered to a cleanroom is filtered through a High Efficiency Particulate Air (HEPA) or Ultra Low Particulate Air (ULPA) filter.
Air flow: The flow of air within the cleanroom helps contain the spread of any incidental contaminants. Usually air will flow from the ceiling down toward the work surface and, eventually, the floor. Air exits the cleanroom at the floor level and is pumped back toward the ceiling where it is filtered before re-entering the cleanroom.
Positive pressure: Cleanrooms usually maintain positive pressure, so that whenever a door is opened, air rushes from the cleanroom out into the surroundings. That proactive strategy prevents the surrounding environment from contributing any unfiltered, potentially polluted, air.
The Dress Code
There is no such thing as Casual Friday in the cleanroom. In fact, humans release an immense quantity of microscopic debris, such as dead skin cells, hair, and droplets of saliva, which can contaminate the product before it is packed. So “gowning up” in protective clothing is required before entering the cleanroom.
Depending on the cleanroom classification, the packaging team might be in a full-body “bunny suit”, complete with a hood and face mask. Or they might be sporting some combination of hair net, smock, gloves, and booties.
Questions to Ask Your Cleanroom Packager
Before you hire a cleanroom packager, do a little research to determine if they will be a good fit.
What class of cleanroom do you operate?
Make sure that the cleanroom where your product will be packaged meets or exceeds the specifications provided by your customer.
When can I take a tour of the facility?
Schedule an appointment to tour the facility where your product will be packaged. But then, arrive at the site 24-48 hours in advance of your appointment time. Visiting unannounced will give you a far more accurate impression of the standards of operation. On your tour, pay special attention to the cleanroom, of course, but don’t ignore the cleanliness of the reception area, the manufacturing floor, and the warehouse. The entire facility should be clean and organized to earn your confidence.
How will you clean my product prior to shipment?
Preparing equipment for use in a cleanroom requires a real “deep clean”. Stray particulate can contaminate delicate surfaces or lodge in the crevices of moving parts during transit. So the cleanroom packagers use a variety of tools to give your product a real “spa day” before packing begins. A tacky roller collects surface debris just like a lint roller would. An air knife blasts filtered air into all the nooks and crannies to dislodge any microscopic stowaways. And alcohol wipes provide a quick-drying, static-free wipe-down.
What packing supplies will you use?
Ask for a preview of the materials that will be used to protect your product from harm during its journey. Standard packing supplies, such as cardboard boxes and styrofoam peanuts are a no-no in the cleanroom setting because they generate particulate with every touch. Instead, your cleanroom packager is likely to use corrugated plastic boxes and cleanroom-certified polyethylene bags to contain your product and prevent contamination during transit. Closed cell clenroom foam is a good choice to prevent damage from shock and vibration.
How are the packaging supplies stored?
Keep your eyes open to see how the packing supplies are stored. The items that are cleanroom-certified should be kept in their original packaging until needed. Since they have arrived on-site free of contaminants, the best way to keep them ultra-clean is to leave them unopened. Other packing supplies are simply cleanroom-compatible, in that they won’t generate particulate, but they don’t arrive pre-cleaned at the packaging site. So, a corrugated plastic box, for example, might need to be brought into the cleanroom to be cleaned before it can be used to pack anything. If a large quantity of boxes arrives at the site in a single package, they can be pre-cleaned and re-bagged in smaller quantities for storage.
Can I test a sample of your packing supplies?
You don’t have to rely on a visual inspection to determine the cleanliness of the packaging supplies. Microscopic contaminants won’t be visible on your tour, after all. Request a sample of the cleanroom packaging supplies that will be used to package your product and hire an independent tester to verify that they meet your customer’s specifications. Or test the samples in-house using an ultraviolet light and/or alcohol wash.
Trust CDC Packaging with Your Cleanroom Shipments
Preparing a product for delivery into a cleanroom setting is serious business. CDC Packaging has the specialized expertise, facility, manpower, and supplies to ensure that your product is cleanroom-ready when it arrives at your customer’s site. Contact us today to learn more about our in-house and off-site cleanroom packaging services.