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Hand Washing, Hygiene, CGMP, and Science
Author: Scott Sutton

“Microbiology Topics” discusses various topics in microbiology of practical use in validation and compliance. We intend this column to be a useful resource for daily work applications.

Reader comments, questions, and suggestions are needed to help us fulfill our objective for this column. Please send your comments and suggestions to column coordinator Scott Sutton at scott.sutton@microbiol.org or journal coordinating editor Susan Haigney at shaigney@advanstar.com.

KEY POINTS
The following key points are discussed in this article:
• Good personal hygiene is a requirement of all pharmaceutical activities, from operating on the line through laboratory good manufacturing practice (GMP) studies. However, studies show poor hand washing compliance is the rule in a variety of occupations.
• Poor hand washing technique may result in increased absenteeism, particularly in time of a potential H1N1 pandemic.
• Limited availability to adequate facilities may lead to poor compliance or poor efficacy of washing if performed. These facilities include appropriately constructed and sourced water supply, soap supply and, perhaps most importantly, adequate provisions for thorough drying of hands. This is the basis for the current good manufacturing practice (CGMP) requirement for adequate facilities.
• While “antibacterial” label claims do no harm, they should not be relied upon to protect against poor practice.
• Jewelry can interfere with adequate cleansing and should be removed before washing. Jewelry should be discouraged in areas where hand cleanliness is important.
• Training for compliance in hand washing is difficult. There have been numerous reports of the difficulty in training and the subsequent monitoring of healthcare workers for compliance with hand washing requirements. Suggestions for training and a potentially useful monitoring tool are provided.
• Many studies use extended periods of time during the wash (1.5-2 minutes in some). This is not a practical regimen. A hand washing regiment is suggested for pharmaceutical industry workers based on Centers for Disease Control (CDC) hand washing protocol.
• Personnel should carefully evaluate common practices when microbial control is required. It is likely that simple processes, such as hand washing, are generally assumed to be under control. They may, however, be an undetected source of product or sample contamination.
• Hand scrubs are not currently covered by GXP, but there may be a role for their use in a compliant facility in addition to hand washing.

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