What is a foundational piece of your cleanroom contamination control strategy? Your gowning protocol. Humans, by far, produce the most particles in a cleanroom and your gowning protocol can limit that number.
While we have a number of ways to improve your gowning protocol across the board, it is important to recognize that different ISO classifications require different gowning protocols and procedures. When reviewing your protocols, make sure to know your classification and the associated requirements.
But, no matter what, you can take a few crucial steps towards making sure your cleanroom users are gowning properly.
Regularly conduct gowning protocol training.
This feels like the most boring and practical way to start this list, but it is the most impactful. Because your cleanroom users will forget your gowning protocols – especially the details – without regular training.
The forgetting curve is very real. Within an hour, 50% of people will forget something they just learned. A day later, they will have forgotten 70% of what they learned, and, a week later, they will have forgotten 90%.
But if you continue to tell them the same information over and over again in the same way, they will start to tune you out and assume they know the details. So make sure to spice up your training. You can make it interactive, shock them with statistics, or follow more traditional methods, such as requiring them to take tests regularly on the details of the gowning protocol.
Make sure your feet are spotless.
No matter what level of certification your cleanroom is, your gowning protocol should require some kind of shoe cover, but it needs to be done properly.
Have your employees use a shoe cleaner and then put on booties. If you are following stricter ISO guidelines, your cleanroom users might need to wear additional boots that fit with coveralls.
An additional precaution you can have our employees take is to step on a sticky mat before entering the gowning area but after putting on the initial booties.
Follow best practices, such as gowning top down.
Your gowning protocols should start at the head. If you gown up but continue to shed hair on the outside of the gown or coveralls, you defeat the purpose of a sterile uniform. So always start by covering your head.
Properly use a bouffant cap.
A bouffant cap should completely cover your hair and ears. Put on the bouffant cap starting at the forehead to pull the hair back into the cap. If any of your cleanroom users have long hair, make sure they put it up and secure it firmly under the cap.
A typical spot missed by the bouffant cap is the nape of your neck. Make sure your employees know how to properly secure your bouffant caps at that point to minimize its impact.
Always double check sizing.
Ill-fitting boots, gowns, or cover-alls can result in exposed skin areas that shed particles. Make sure your cleanroom users know what size they should be wearing and always verify that the appropriate sizes are available.
Cut open cover-all and gown bags with scissors.
When you open a bag that contains sterile material, always use scissors. The clean cut limits particle shedding, whereas tearing open the bag can create more particles and potentially contaminate the contents. This is one step of gowning protocols that’s often overlooked but can seriously limit particles.
Properly wear a face mask.
In the age of COVID-19, it’s not a secret there is a proper way to wear a face mask: it needs to cover your nose and your mouth. As we get used to face masks and cleanrooms, it can be easy to overlook a face mask slipping or fitting improperly. So always make sure your and your employees’ face masks fit well and are being worn properly.
Double check glove handling.
How are your cleanroom users handling their gloves?
Gloves should only be touched on the gauntlet, while keeping clean of the palms and fingers. For extra security, use appropriate tape to secure the gauntlet to your sleeves.
Use a bench to denote a dirty zone.
In your gowning area, include a bench part way through to mark the “dirty zone” from the “clean zone”. Have your cleanroom users sit on the bench to put on their cover-alls and boots, to avoid letting them touch the ground. Keeping sterile material sterile is they key: it should not touch anything before entering the cleanroom, especially the floor. The bench not only creates a physical barrier but assists in this process.
Use the buddy system or a mirror.
Always have a mirror available for your cleanroom users to check their gowning before entering the cleanroom. If you cannot put up a mirror, use the buddy system so they can evaluate each other.
Is Your Cleanroom As Clean As You Think It Is?
Your gowning protocols can go a long way towards making sure particles stay out of your cleanroom, but those pesky particles will find their way in. So do you know how clean your cleanroom really is?
A reliable airborne particle counter is a fundamental component of your cleanroom contamination control strategy. It is what will let you know if something is wrong in the rest of your strategy to keep your cleanroom clean while limiting yield loss.
Do you trust your current airborne particle counter to tell you the moment something goes wrong in your cleanroom? If you don’t, it might be time to evaluate your particle counter needs. We’d be happy to walk you through what would be best for your situation based on industry standards and ISO classification. Let us help you find your solution today.
