Our company is shifting focus from the manufacturing of medical device components in a controlled environment to manufacturing in a certified ISO Class 8 environment. We are converting a controlled manufacturing area into a 20’ X 30’ soft wall cleanroom with fanfilter units providing the HEPA filtered air for the cleanroom. Where do I find information about cleaning of this cleanroom area, what garments our operators must wear, and personnel behavior while working in this new cleanroom? We also are concerned with static electricity accumulating inside the cleanroom area.

The primary source for the contamination control industry is the Institute of Environmental Sciences and Technology (www.iest.com). The IEST Contamination Control collection of recommended practices is the basis for certification of cleanrooms, selection and maintenance of garments used in cleanrooms, consumable supplies used in cleanrooms, cleaning of the cleanrooms, proper operations in cleanrooms, and the procedures and practices performed by personnel working in the cleanrooms.

There are four key factors that contribute to contamination in the cleanroom.

1. The furniture and/or equipment
2. The product being produced
3. The processes performed in the cleanroom
4. The people working inside the cleanroom

The people working inside the cleanroom contribute the most contamination; however, the people working inside the cleanroom exercise the most control over the environment of the cleanroom. Selecting the correct garments and performing the recommended garmenting procedures, selection of the appropriate cleanroom consumable items, proper cleaning of the cleanrooms, and the behavior of the personnel while working in the cleanrooms will increase the level of contamination control in the cleanroom.

The recommended gowning configuration for an ISO Class 8 cleanroom is:

• disposable bouffant
• shoecovers (there also are shoecovers that are static dissipative)
• gloves
• frocks