Does your business plan include the development of an area in your plant or laboratory for clean manufacturing or other procedures? Are you concerned that you make the right purchase? Do you want to make sure you consider the right factors when you evaluate different models?

There are numerous considerations when evaluating a cleanroom. The goal of this article is to touch on the basics. You may very well need to employ the services of a cleanroom consultant to help you. Here are a few things to keep in mind as you start to consider cleanrooms and controlled environments.

1. What’s the application?
Better quality or better yield is the primary reason for investing in a cleanroom space. It goes straight to your bottom line.

You need to know the requirement for your specific product or process. If the product you are manufacturing is regulated by a government agency, or you are contracting with a private firm that requires a certain level of clean manufacturing, they should have the cleanroom standards already documented. Check with them first.

There are different levels of cleanrooms. ISO, the International Standards Organization, ranks cleanrooms ISO Class 1 (the cleanest) through ISO Class 9. The lower the ISO rating the cleaner the environment. Measurement of contamination is done in “parts-percubic- meter.” An ISO Class 6 cleanroom, for example, is rated at 35,200 parts per cubic meter. That means the room can have no more than 35,200 particles greater than .5 micron in size per cubic meter. These are particles that are not visible to the human eye. (As a comparison, a particle of cigarette smoke is between .5 and 2 micron in size. The end of a piece of human hair is about 60 to 100 microns in size).