Garbing and Hand Hygiene

Sterile compounding requires that the compounder adhere to additional rules and requirements. Those regulations describe additional facilities and specialized equipment needed for this level of compounding. Special clothing is required. This garb can consist of aprons, sleeves, gloves, hoods, shoe covers, coveralls, head coverings, lab coats, smocks, shirts/pants, hats/caps, facemasks, and beard covers. The entire process of garbing is designed to reduce the particle shedding count from personnel.

The garb worn during aseptic compounding also provides some level of microbial containment, but complete containment is not possible. Personnel cleansing and hygiene also play an important role in reducing the microbial burden. Hands must be cleansed carefully and personnel protective equipment worn correctly in order to minimize the microbial contamination of CSPs. Infected skin (e.g., rashes, cuts, sunburn, and weeping sores) or people with active respiratory infections shed particles at higher rates. When individuals wear cosmetics or makeup, more particles are shed.

There is an appropriate order of garbing that can be remembered as covering or clothing from the "dirtiest"� to the "cleanest"� areas of a person's outside clothing. This order is given in the table below

Appropriate Order of Garbing

Hand Hygiene

Hand hygiene, which is the most effective method of preventing the transmission of pathogens that cause infection in the community and in health-care settings, is an essential component of good compounding practices. Waterless, alcohol-based hand sanitizers that exhibit persistent activity (that is, effectiveness for six hours) and comply with guidelines and/or criteria from the USP, the FDA, and the Centers for Disease Control and Prevention (CDC), are among the most effective products that ensure an appropriate level of hand hygiene during compounding. In studies of antimicrobial-resistant organisms, alcohol-based products reduce the number of multidrug-resistant pathogens recovered from the hands of health-care workers more effectively than hand washing with soap and water.

Most alcohol-based hand antiseptics contain isopropanol, ethanol, N-propanol, or combination of two of those agents. The antimicrobial activity of alcohols results from their ability to denature proteins and disrupt bacterial and fungal cell membranes and viral capsids. The resulting cell lysis causes intercellular material to enter the cell and cause cell death. Alcohols solutions that contain 60% to 95% alcohol are most effective; the higher concentrations are less potent because proteins need water for the denaturation process.

Alcohols demonstrate excellent in vitro germicidal activity against gram-positive and gram-negative bacteria, including multidrug resistant pathogens such as methicillin-resistant Staphylococcus aureus, vancomycin-resistant enterococci, Mycobacterium tuberculosis, and various fungi. Some enveloped (lipophilic) viruses such as herpes simplex, human immunodeficiency, influenza, respiratory syncytial, and vaccinia have demonstrated susceptibility to alcohols when tested in vitro. However alcohols exhibit very poor activity against protozoan oocysts, bacterial spores, and some non-enveloped (non-lipophilic) viruses. Alcohols are not effective against bacilli of the genus Clostridium, including those of Clostridium difficile.

A hand washing procedure is given in Appendix II of the USP-NF Chapter <797>. Below is a process validation check-off sheet that could be used alternatively.