Using shoe covers in a way that complies with USP800 is a small, but vital, detail in controlling microbial contamination in your critical environment. Proper use of shoe covers also protects cleanroom workers and others outside the cleanroom when hazardous drugs (HDs) are handled.
USP800 specifically addresses the use of shoe covers. This includes a wide variety of types of facilities and roles such as pharmacists, pharmacy technicians, physicians, physician assistants, nurses, home health care workers, veterinarians, and veterinary technicians. Also, any facility involved in the storage, transport, preparation, or administration of HDs should comply including pharmacies, hospitals, patient treatments clinics, physicians’ offices, other healthcare facilities, and veterinary clinics.
In addition to utilization of shoe covers, each cleanroom SOP should establish guidelines that define acceptable shoes used compounding and ISO-rated areas. For example:
- The shoe should cover the entire foot meaning no sandals or peep-toe shoes.
- Spike heels that can pierce the shoe covers should not be worn.
- Shoes must be free of visible dirt, lint, grease, and grime prior to donning shoe covers. If visible dirt and debris are an ongoing problem in compounding facilities, consider using dedicated footwear.
- Shoes must be dry prior to donning shoe covers taking special care on rainy, snowy, or icy days.
- Low-linting socks or hosiery should be worn to minimize skin exposure in ISO-rated areas.
- To make it easier for cleanroom workers to safely don shoe covers, include a bench in the garbing area.
- In a USP800-compliant cleanroom, shoe covers should fully encase the shoe to prevent any shedding of particulates from the shoes and to protect the workers from dangerous exposure to chemicals including splash and spills.
- Ensure the needed sizes of shoe covers are available to completely cover all the workers’ varying shoe sizes while being snug for walking comfort and safety.
- Match the shoe cover height to the other apparel worn to ensure that no skin or street clothes are exposed. Shoe covers come in a variety of vertical lengths: shoe-only, shoe and ankle, and knee-high boot cover. To minimize incidental migration of HD residue from the designated compounding area to outside areas of the facility,
- USP800 requires the use of a second pair of shoe covers over the first pair when crossing over the demarcation line entering the HD compounding area. The outer pair must be removed prior to exiting leaving the inner pair in place.
- Staff should be educated about shoe cover use and theri materials and taught to frequently examine the shoe covers during use:
- Shoe covers with a polycoated, non-skid, or foam anti-skid feature may have a tendency to flake if worn too long.
- Most disposable shoe covers are made of thin polypropylene or polyethylene and have a tendency to wear, thus exposing the shoe. Shoe covers made from poly-coated material that are tested against blood and bodily fluids per ASTM 1670 are often more durable.
- Shoe covers should not be allowed to get wet and should be replaced immediately if exposed to a spill, splash, or other wet situation. Wet shoe covers tear more easily and create the potential for residues on the shoe bottom to liquefy.
- Staff should never leave ISO-rated areas with shoe covers on and then enter other ISO-rated areas. A fresh pair should be donned when preparing to enter an ISO-rated area.
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