Wis. Admin. Code Pharmacy Examining Board Phar 15.33 - Cleaning and Disinfecting the Compounding Area and Supplies

(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.

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

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

(b) Walls, ceilings and storage shelving monthly.

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

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

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

(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.

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

(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.

(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.

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

(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.

(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.

(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.

(10) Entry points on bags and vials shall be wiped with small sterile 70% isopropyl alcohol swabs or comparable method for disinfecting, allowing the isopropyl alcohol to dry before piercing stoppers with sterile needles and breaking necks of ampules. The surface of the sterile 70% isopropyl alcohol swabs used for disinfecting entry points of sterile package and devices may not contact any other object before contacting the surface of the entry point. Particle generating material may not be used to disinfect the sterile entry points of packages and devices.

(11) When sterile supplies are received in sealed pouches designed to keep them sterile until opening, the sterile supplies may be removed from the covering pouches as the supplies are introduced into the ISO Class 5 primary engineering control without the need to disinfect the individual sterile supply items.

Notes

Wis. Admin. Code Pharmacy Examining Board Phar 15.33

Adopted by, CR 16-085: cr. Register April 2018 No. 748, eff. 11/1/2018 Amended by, CR 22-007: am. (10) Register July 2022 No. 799, eff. 8/1/2022.