The primary purpose of cleanroom gowning is to protect the products and the processing environment from human contamination. Cleanroom gowning greatly reduces the microorganisms released by personnel. All personnel should be properly gowning qualified before entering the cleanroom, and the qualification should be performed by a trained analyst. The degree of gowning should get more complex as the cleanroom grades increase.
In addition to being properly gowning qualified, personnel entering the cleanroom should practice good hygiene (i.e., daily showering, removing makeup and jewelry, washing hands prior to gowning, and not entering the cleanroom in the event of illness or compromised skin). Non-linting cleanroom scrubs that cover as much skin as possible should be used as the inner-suit before gowning. All uniform components should be sterile and nonshedding. Aseptic gowning practices should be used to don the uniform components, including the nonpowdered, sterile gloves. Once properly gowned, no skin or hair should be exposed in the cleanroom.
Thorough training in aseptic techniques is required for ISO 5 areas. Personnel must maintain high standards each time they deal with sterile product. Some aseptic technique concepts include:
- Never breaking “first air”
- Not touching sterile items with nonsterile items
- Not exposing sterile items to nonsterile environments
- Using clean/sterile equipment and components
- Using sterile gloves and frequently sanitizing hands
- Using slow, deliberate movements
- Not talking excessively or shouting
- Not interfering or blocking the ISO 5 airflow
We have done short courses, that largely involves lecture only in as little as one day on-site.
Depending on the number of people, a full training and testing class can take as long as two weeks. Usually, prior to actual training, we like to set aside the first day to do a full engineering controls and certification reports of valuation. This gives us the ability to prioritize and Tailor the training specifically to your facility.
