Micro-organisms 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 sterilised 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.
Points to Ponder:
[b][COLOR=“blue”]One square inch of hand surface has an average of 10,000 micro-organisms.
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 0.3µm or greater. On the move, this rises to approximately 5 million. [/color][/b]
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.
[b][COLOR=“darkred”]The sterile cleanroom gowning process takes between 5 and 10 minutes for the vast majority of cleanroom operators.
Almost one-third of cleanroom operators indicate that cleanroom coveralls are the most difficult part of the six-step gowning process, and that donning coveralls takes an average of 30% of the entire gowning process time.
Cleanroom operators are disposing of an average of 10% of their sterile cleanroom garments every week due to exterior contamination during the gowning process.
Most new cleanroom operators need 30 hours of initial training on cGMP donning procedures before they are allowed in the cleanroom itself, and an average of 6 hours of ongoing training each week.
More than 50% of cleanroom operators reported garments ripping out or billowing due to poor fit.
One-third of cleanroom operators report being unsure of their garment’s sterility due to the appearance of its packaging.
Approximately 87% of cleanroom operators would consider switching to a new garment if it was more comfortable and offered less risk of contamination. [/color][/b]
The issue of garment comfort was also addressed. Scientific research in the workplace has revealed that a moderate variation in body temperature can greatly reduce concentration and increase risk-inducing behavior.Workers unable to maintain a thermo-neutral zone, or comfort zone, have a higher tendency to become injured and need time off from work, thus reducing productivity.