Phar 15.31(3)(p)2. 2. Have a sink with running hot and cold running water.

Phar 15.31(3)(q) (q) The buffer area shall meet all of the following requirements:

Phar 15.31(3)(q)1. 1. Be capable of maintaining an ISO Class 7 air or better.

Phar 15.31(3)(q)2. 2. Only contain any of the following:

Phar 15.31(3)(q)2.a. a. Items, including furniture, equipment, and supplies, that are required for the tasks to be performed in the buffer area.

Phar 15.31(3)(q)2.b. b. Items that are smooth, impervious, free from cracks and crevices, nonshedding, and easily cleaned and disinfected.

Phar 15.31(3)(q)2.c. c. Items that have been cleaned and disinfected immediately prior to their being placed in the buffer area.

Phar 15.31(3)(q)3. 3. Does not contain any sinks.

Phar 15.31(3)(q)4. 4. Does not contain any course cardboard, external shipping containers, and nonessential paper.

Phar 15.31(4) (4) Primary engineering control. The primary engineering control shall be certified by an independent, qualified individual certified by the Controlled Environment Testing Association’s National Board of Testing or another Board approved entity prior to initial use and then every six months. It shall also be certified when any of the following occurs:

Phar 15.31(4)(a) (a) Redesign of the facility.

Phar 15.31(4)(b) (b) Replacement of the primary engineering control.

Phar 15.31(4)(c) (c) Relocation of the primary engineering control.

Phar 15.31 History History: CR 16-085: cr. Register April 2018 No. 748 eff. 11-1-18.

Phar 15.32 Phar 15.32 Personnel hygiene, garbing and protective gear.

Phar 15.32(1) (1) Personnel suffering from rashes, sunburn, oozing tattoos or sores, conjunctivitis, active respiratory infection, or other active communicable disease shall be excluded from working in compounding areas until the condition is resolved.

Phar 15.32(2) (2) All personnel who engage in compounding sterile preparations shall comply with all of the following requirements before entering the compounding area:

Phar 15.32(2)(a) (a) Remove personal outer garments, all cosmetics, exposed jewelry and piercings, headphones, ear buds, and cell phones.

Phar 15.32(2)(b) (b) Abstain from eating, chewing gum or drinking in the compounding area or bringing food, gum, or drink into the compounding area.

Phar 15.32(2)(c) (c) Artificial nails, nail extenders or nail polish may not be worn while working in the compounding area. Nails shall be neat and trim.

Phar 15.32(2)(d) (d) Don personnel protective equipment and perform hand hygiene in the following order:

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.