This paper addresses the importance of process protection in cleanrooms via the appropriate cleanroom suit. It provides an overview of the sterile cleanroom apparel category and defines key areas for improvement. It introduces a new concept for sterile cleanroom gowning to help minimize the problems associated with current technologies. Kimberly-Clark Professional did just that, spending the better part of two years interviewing cleanroom operators, visiting them in their workplaces and evaluating the features and functions of traditional sterile cleanroom gowns to identify areas in which there was potential room for improvement. Key findings of the research were that: 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.

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• Cleanroom Technology Magazine

• Kimberly-Clark

• Cleanroom

• Garment

• Sterile Manufacturing

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