The personnel understand how a cleanroom works. Everybody knows that there are things from the outside environment that need to stay outside of the cleanroom. The staff is qualified and capable of donning gowning apparel. This should take care of all of the contamination, right? Wrong. No matter how well people are trained, and how well they follow gowning procedures, external contamination will always enter the cleanroom.
As it is impossible to prevent all contaminates from entering the cleanroom, it is the goal of a cleaning program to remove as many of the contaminating particles as possible. Thus the first step in the cleaning process should be to vacuum all accessible surfaces from the cleanest part of the room to the dirtiest part of the room.
The second step in the cleaning process is to wipe all surfaces with an approved cleaning solution. The cleaning should be done in a right to left or left to right manner. The wipe should be inspected and re-folded after each pass to make sure that the wipe is not soiled and a fresh surface of the wipe is always used on a new cleaning pass.
After the surfaces have been vacuumed and wiped, the final step in the cleaning process is mopping. Lint free polyester or PVA mops attached to stainless steel handles are required. A two bucket system allows for the safe isolation of the contaminants that have been mopped from the surface of the clean-room.
All three cleaning methods, HEPA vacuuming, unidirectional wiping, and pull and lift mopping have been validated at the ISO level. Therefore, the clean-room operators do not have to validate the cleaning methods, only the ability to clean the cleanroom must be validated.
Until there is no human traffic in a cleanroom, there will always be the need for a contamination control program. The contamination control goal is to keep the outside world from entering the cleanroom, and to efficiently remove whatever does enter the room. All contamination control programs will depend on the population of the room, the amount of air and air filtration, and the level of cleanliness that is desired. With proper training, cleaning equipment, and cleaning methodology, the desired level of cleanliness can be achieved and maintained to keep the outside world out.
From: “Implementing A Contamination Control Program”
