Section Phar 15.31 - Facility design and environmental controls(1) GENERAL. Facilities shall meet all of the following requirements: (a) Be physically designed and environmentally controlled to minimize airborne contamination from contacting critical sites.(b) Be accessible only to designated personnel.(c) Have a heating, ventilation, and air conditioning system controlling the temperature and humidity.(2) SEGREGATED COMPOUNDING AREA. A segregated compounding area shall meet all of the following requirements: (a) Be located in an area away from unsealed windows and doors that connect to the outdoors, or significant traffic flow.(b) Be located in an area which is not adjacent to construction sites, warehouses, and food preparation areas.(c) Have a defined perimeter.(d) Locate the primary engineering control at least one meter from any sink.(3) CLASSIFIED area. A classified area shall meet all of the following:(a) The surfaces of ceilings, walls, floors, fixtures, shelving, counters, and cabinets shall be smooth, impervious, free from cracks and crevices, and nonshedding.(b) Work surfaces shall be constructed of smooth, impervious materials. All work surfaces shall be resistant to damage from cleaning and sanitizing agents.(c) Junctures where ceilings meet walls shall be covered, caulked, or sealed to avoid cracks and crevices in which microorganisms and other contaminate can accumulate. All areas in ceilings and walls where the surface has been penetrated shall be sealed.(d) Ceilings that consist of inlaid panels shall be impregnated with a polymer to render them impervious and hydrophobic and shall either be caulked or weighted and clipped.(e) Walls shall be constructed of a durable material, panels locked together and sealed or of epoxy-coated gypsum board.(f) Floors shall have a covering that shall be seamless or have heat-welded seams and coving to the sidewall. There shall be no floor drains.(h) Ceiling lighting fixtures shall have exterior lens surfaces which are smooth, mounted flush, and sealed.(i) Carts shall be constructed of stainless steel wire, nonporous plastic or sheet metal with cleanable casters.(j) Tacky mats may not be used in a classified area.(k) HEPA filters and unidirectional airflow shall be used to maintain the appropriate airborne particulate classification. (L) The classified area shall measure not less than 30 air changes per hour of which at least half shall be HEPA-filtered fresh air.(m) For classified areas physically separated through the use of walls, doors, and pass-throughs, a minimum differential positive pressure of 0.02-inch water column is required to separate each classified area. If a pass-through is used, only one door shall be opened at a time. A pressure gauge or velocity meter shall be used to monitor the pressure differential or airflow between classified areas with results documented at least daily.(mm) For classified areas not physically separated, no sterile compounded preparation may be compounded using any ingredient that was at any time non-sterile in a classified area not physically separated and all of the following shall be met: 1. The buffer and ante areas shall be designated with a line of demarcation.2. The principle of displacement airflow shall be used with an air velocity of 40 feet per minute or more from the buffer area across the entire plane of the line of demarcation.(n) Devices and objects essential to compounding shall be located at an appropriate distance from the primary engineering control.(p) The ante area shall meet all of the following requirements: 1. Be capable of maintaining an ISO Class 8 air or higher.2. Have a sink with running hot and cold running water.(q) The buffer area shall meet all of the following requirements:1. Be capable of maintaining an ISO Class 7 air or better.2. Only contain any of the following: a. Items, including furniture, equipment, and supplies, that are required for the tasks to be performed in the buffer area.b. Items that are smooth, impervious, free from cracks and crevices, nonshedding, and easily cleaned and disinfected.c. Items that have been cleaned and disinfected immediately prior to their being placed in the buffer area.3. Does not contain any sinks.4. Does not contain any course cardboard, external shipping containers, and nonessential paper.(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: (a) Redesign of the facility.(b) Replacement of the primary engineering control.(c) Relocation of the primary engineering control.Wis. Admin. Code Pharmacy Examining Board Phar 15.31
Adopted by, CR 16-085: cr. Register April 2018 No. 748, eff. 11/1/2018