Cleanrooms have to meet all relevant regulatory requirements that are mandated for the products being manufactured. These are agencies like the Institute of Environmental Sciences and Technology (IEST) and the International Organization for Standardization (ISO).
In order to ensure continued compliance, manufacturers need to understand what environmental factors cause contaminates, and they need the proper equipment to test for them. Here are a few reminders for your cleanroom plan.
First and foremost, remember that personnel produce the most contaminates in a controlled environment. In addition to covering people with proper garments, keep in mind:
- Personnel should practice good personal hygiene
- If anyone has a skin or respiratory condition, he or she should not work in the cleanroom until it clears up
- The risk of human flora contamination increases when people perspire, so ensure that the temperature is not too hot
- Shivering releases microbes into the air, so the temperature can also not be too cold
To ensure that surfaces meet sterility requirements, they need to be tested for environmental flora. There are two methods to accomplish this:
- Contact plates. These are used on flat surfaces. The media filling the plates creates a dome. The surface of the media is pressed against the surface being tested. The plates are incubated, and any colonies present are counted.
- Swabbing. Swabs can easily reach nooks, crevices, and other irregular surfaces. They are typically made of cotton, synthetics, or calcium alginate materials. The sterile swab is moistened with a non-nutritive medium and swiped in several directions over the test area. The swab is placed in a rinse solution and then agitated. The collection medium is then tested for its microorganisms.
Proper cleaning materials are also necessary to maintain an environment that meets all regulatory standards. Be sure that you have chosen cleaning supplies that work with the class of your cleanroom. Some supplies include:
- Mops and buckets
- Vacuum cleaners
- Wipes
- Brooms
- Sponges
- Squeegees
- Disinfectants
- Cleansers
- Shoe cleaners
Once a cleanroom is built, it still needs to be maintained to ensure that manufactured materials are not compromised. It is the manufacturer’s responsibility to monitor the cleanroom environment and provide proper training for workers.
Need certification or validation for your cleanroom? Gerbig Cleanrooms does both. Contact us today.