Cleanrooms are specially designed areas that provide various cleanliness levels, prevent particle contamination, and filter air. However, the design alone is not enough to keep these rooms clean as contaminants accumulate as the room is used. Having a cleaning protocol is vital to maintaining the pristine conditions of a cleanroom.
It is essential that your cleanroom stays clean to ensure that everything handled in the room is free of contamination. A dirty cleanroom exposes you to several risks. To begin with, your cleanroom will fail to meet quality checks and compliance tests. Since the room will have contaminants such as bacteria, dust, cosmetics, and fungi, your products can easily get contaminated as well. Contaminated product leads to losses down the chain because you cannot sell the goods while having to foot the costs of supplies, labor, and other overhead expenses. If contaminated products get into the market, your business risks court action if users get the bad product.
To stay cleanroom compliant, you’ll need a clear, comprehensive cleaning protocol strictly and regularly adhered to by all using the cleanroom. Cleaning once you notice contaminants will often not be enough to keep the room clean and neither will a regular cleaning schedule. Having a proper protocol will ensure that every time you clean, all contaminants are removed, and your cleanroom stays compliant.
Cleanroom compliance is governed by the International Organization for Standardization’s (ISO) standard for the use of cleanrooms, ISO Standard 14644-1. The standard classifies cleanrooms according to the levels of cleanliness required for the room, determined by the number of contaminants present per cubic meter. The standard has nine classifications, with ISO Class 1 being the ‘cleanest’ and 9 being the ‘dirtiest’. Every room must be maintained according to its classification’s specifications for cleanliness, temperature, number of air changes per hour, flow rate, and more.
Your cleaning protocol begins before entering the cleaning room. A few pre-cleaning practices include:
Assembling and using the recommended cleaning materials and avoiding non-cleanroom cleaning agents are essential to clean properly. Cleanroom mops are specially designed with materials such as woven polyester to limit tearing or shredding during the cleaning process, unlike other rags. The mopping system should also separate dirty from clean water to avoid contaminating cleaned areas with dirty water.
Deionized and distilled water is also the recommended type for cleaning these rooms. The cleaning products should also be sterilized before using the room to minimize contaminant infiltration.
To minimize the risk of contamination further, collect all the materials you need as you enter the cleanroom to only enter and exit once.
Just as cleanrooms vary widely in use, your cleaning requirements and schedule will also be different. Regardless of your cleanroom type, however, you’ll have to diligently follow a cleaning routine daily, weekly, and as the need arises to keep your room clean and usable. A general cleaning schedule includes the following tasks:
The floor, walls, and work surfaces have to be cleaned daily before the shifts begin. Mop the floor with distilled or deionized water and vacuum them dry. The walls and ceiling are vacuumed using a HEPA filter vacuum, and the windows are all washed and wiped dry.
Wipe all the work surfaces at the end of the shift or as per the recommended frequency of your ISO class.
The cleanroom should be mopped with distilled or deionized water and a cleanroom detergent and vacuumed dry with a HEPA filter vacuum. The walls should also be wiped down and vacuumed dry at least once a week.
The tacky mats should be changed out as soon as they wear out. The ceiling should also be washed with distilled water and detergent from time to time to clean out any deposits.
Cleaners should avoid making fast motions to reduce air turbulence in the room. If a staff member is sick, they should not be allowed into the cleanroom. It is also recommended to wipe any spills immediately and change garments if any splashes on them.
Getting your cleanroom clean and maintaining it that way can be quite challenging. Following these protocols, however, should get you on the way to having proper cleanroom compliance. Concerned you’re missing something in your current protocol? Contact us today!