Minimizing contamination risks in sterile gowning

Strict cleanroom cleanliness and sterility is a priority in some lifesciences industries like pharmaceutical manufacturing. If contaminated with microorganisms, products manufactured in sterile cleanrooms must be scrapped — a costly proposition in any economy.

Microorganisms introduced into a cleanroom environment need only three things to grow: moisture, food, and temperature — all of which exist in a cleanroom. Consequently, all incoming air, water, chemicals, and materials must be filtered or sterilized to meet high standards of purity and microbiological control, so as not to contaminate processes or products in production. Also to be “filtered,” in a sense, is the cleanroom operator, who, most will agree, is the dirtiest thing to enter a cleanroom.

Consider the following:

• One square inch of hand surface has an average of 10,000 microorganisms.
• Every square inch of the human body has an average of 32 million bacteria on it.
• Every minute of the day, people lose about 30,000 to 40,000 dead skin cells off the surface of their skin.
• Even when stationary, people generate approximately 100,000 particles of 0.3 microns or greater. On the move, this rises to approximately 5 million.

Keeping the operator’s dirt and germs out of the sterile cleanroom environment and away from sensitive products and processes is the main objective of the sterile cleanroom suit. The suit needs to protect the environment from viable particles such as bacteria and yeasts, and non-viable particles such as hair, dead skin cells, and dandruff. To that end, it is critical for cleanroom operators to select cleanroom suits that provide not only the highest levels of inherent sterility, but also the greatest chances of maintaining that sterility through the gowning process.