Phar 15.32(2)(d)1. 1. Low-lint, disposable shoe covers.

Phar 15.32(2)(d)2. 2. Low-lint, disposable covers for head and facial hair that cover the ears and forehead and face masks.

Phar 15.32(2)(d)3. 3. Eye shields, if required due to working with irritants or hazardous drugs.

Phar 15.32(2)(d)4. 4. Wash hands and forearms up to the elbows with unscented soap and water for at least 30 seconds. Hands and forearms to the elbows shall be completely dried using either lint-free disposable towels or wipes.

Phar 15.32(2)(d)5. 5. Don low lint disposable gown or overalls.

Phar 15.32(2)(d)6. 6. Prior to donning sterile gloves, hand antisepsis shall be performed using an alcohol-based hand rub with sustained antimicrobial activity following the manufacturers labeled instructions and application times.

Phar 15.32(3) (3) Gloves on hands and gauntlet sleeves on RABS shall be routinely inspected for holes, punctures, or tears and shall be replaced immediately if any are detected. Sterile gloves shall be donned over the RABS gloves.

Phar 15.32(4) (4) Disinfection of contaminated gloved hands shall be accomplished by wiping or rubbing sterile 70% isopropyl alcohol on all contact surface areas of the gloves and letting the gloved hands dry thoroughly. Routine application of sterile 70% isopropyl alcohol shall occur throughout the compounding process and whenever non-sterile surfaces, including vials, counter tops, chairs, and carts, are touched.

Phar 15.32(5) (5) When compounding personnel exit the buffer or segregated compounding area, a gown may be removed and retained in the ante area or segregated compounding area if not visibly soiled, to be worn again during the same work shift. Coveralls, shoe covers, hair and facial hair covers, face masks, eye shields, and gloves shall be replaced with new ones before re-entering the compounding area.

Phar 15.32(6) (6) Garbing items, including gowns, shall be segregated and stored before use in an enclosure to prevent contamination.

Phar 15.32(7) (7) Visibly soiled gowns shall be changed immediately.

Phar 15.32(8) (8) Gloves shall be sterile and powder free and tested by the manufacturer for compatibility with alcohol disinfection.

Phar 15.32 History History: CR 16-085: cr. Register April 2018 No. 748 eff. 11-1-18.

Phar 15.33 Phar 15.33 Cleaning and Disinfecting the Compounding Area and Supplies.

Phar 15.33(1) (1) Compounding personnel are responsible determining the cleaning and disinfecting products to be used and for ensuring that the frequency of cleaning and disinfecting compounding area is done.

Phar 15.33(2) (2) Compounding personnel shall clean in accordance with the following:

Phar 15.33(2)(a) (a) Primary engineering control work surfaces, counters, floors and work surfaces in the buffer zone area, ante room and segregated compounding areas daily.

Phar 15.33(2)(b) (b) Walls, ceilings and storage shelving monthly.

Phar 15.33(2)(c) (c) When a spill occurs or the surface is visibly soiled.

Phar 15.33(2)(d) (d) Sporicidal agents shall be used at least weekly to clean compounding areas.

Phar 15.33(3) (3) Compounding personnel shall disinfect in accordance with the following:

Phar 15.33(3)(a) (a) Primary engineering control work surfaces at the beginning and end of each compounding business day and before each batch, but not longer than 4 hours following the previous disinfection when ongoing compounding activities are occurring.

Phar 15.33(3)(b) (b) When microbial contamination is known to have been or is suspected of having been introduced into the compounding area.

Phar 15.33(4) (4) All cleaning and disinfecting practices and policies for the compounding area shall be included in written standard operating procedures and shall be followed by all compounding and environmental services personnel.

Phar 15.33(5) (5) Cleaning, detergents and disinfection agents shall be selected and used with consideration of compatibilities, effectiveness, and inappropriate or toxic residues. The selection and use of disinfectants shall be guided by microbicidal activities, inactivation by organic matter, residue, and shelf life. Disinfectants shall have antifungal, antibacterial and antiviral activity. Sporicidal agents shall be used at least weekly to clean compounding areas.

Phar 15.33(6) (6) Storage sites for compounding ingredients and supplies shall remain free from dust and debris.

Phar 15.33(7) (7) Floors, walls, ceiling, and shelving in the classified and segregated compounding areas are cleaned when no aseptic operations are in progress. Cleaning shall be performed in the direction from cleanest to dirtiest areas.

Phar 15.33(8) (8) All cleaning tools and materials shall be low-lint and dedicated for use in the buffer room, ante room and segregated compounding areas. If cleaning tools and materials are reused, procedures shall be developed based on manufacturer recommendations that ensure that the effectiveness of the cleaning device is maintained and that repeated use does not add to the bioburden of the area being cleaned.

Phar 15.33(9) (9) Supplies and equipment removed from shipping cartons shall be wiped with a suitable disinfecting agent delivered from a spray bottle or other suitable delivery method. After the disinfectant is wiped on a surface to be disinfected, the disinfectant shall be allowed to dry, during which time the item shall not be used for compounding purposes.