059-17 Wyo. Code R. §§ 17-5 - Facilities and Engineering Controls

(a) The cleanroom suite shall be designed as follows:

(i) The ante-room and buffer rooms shall be separated from areas not directly related to compounding by fixed walls and doors;

(ii) The ante-room shall have a line of demarcation separating the dirty side and the clean side. Alternatively, the facility can have two (2) separate ante-rooms, one dirty and one clean;

(iii) Buffer rooms shall maintain a minimum differential positive presser of 0.02-inch water column between the buffer and ante-rooms;

(iv) Ante-rooms shall maintain a minimum differential positive pressure of 0.02-inch water column between the ante-room and unclassified areas;

(v) A pressure differential monitoring device shall be used to continuously monitor pressure differentials. Results from the pressure monitoring device shall be reviewed and documented at least daily on the days when compounding is occurring;

(vi) Ante-rooms shall maintain ISO Class 8 or better quality of air and maintain a minimum of 20 to HEPA-filtered air changes per hour (ACPH);

(vii) Buffer rooms shall maintain ISO Class 7 or better air quality and maintain a minimum of 30 total HEPA-filtered ACPH. At least 15 ACPH shall be supplied through the buffer room's heating, ventilation, and air-conditioning (HVAC) system;

(viii) Air supplied to the cleanroom suite shall be introduced through HEPA filters located in the ceiling. Air returns shall be located low in the wall, unless a visual smoke study demonstrates the absence of stagnant flow where particles can accumulate;

(ix) Temperature and humidity shall be controlled through a HVAC system. Free-standing humidifiers/dehumidifiers and air conditioners shall not be used within the classified area;

(A) The cleanroom suite should be maintained at a temperature of 20° C (68° F) or cooler and a relative humidity below 60% to minimize the risk for microbial proliferation and provide comfortable conditions for compounding pharmacy staff;

(B) The designated person shall monitor temperature and humidity and each room of the cleanroom suite each day that compounding is performed, either manually or by a continuous recording device;

(C) The designated person shall verify the accuracy of temperature and humidity monitoring devices at least every twelve (12) months or as required by the manufacturer.

(x) The cleanroom suite shall provide a well-lighted working environment;

(xi) The cleanroom suite shall be designed to allow for easily cleanable conditions:

(A) The surfaces of ceilings, walls, floors, doors, door frames, fixtures, shelving, work surfaces, counters, and cabinets shall be smooth, impervious, free from cracks and crevices, and non-shedding. These surfaces should be resistant to damage by cleaning agents, disinfectants, sporicidal agents and tools used to clean them;

(B) Overhangs and ledges should be limited, but easily cleanable, if present;

(C) Floors shall include coving to the sidewall, or the juncture between the floor and wall shall be sealed. The junctures between the ceiling and the walls shall be sealed. All penetrations through the ceiling or walls shall be sealed;

(D) If ceilings consist of inlaid panels, the panels shall be caulked around each panel to seal them to the support frame;

(E) The exterior lens surface of all ceiling light fixtures shall be smooth, mounted flush, and sealed;

(F) The walls shall be either constructed of or covered with durable material including but not limited to epoxy painted walls or heavy-gauge polymer. The integrity if the surfaces shall be maintained. Panels shall be joined together and sealed to each other and the support structure;

(G) All furniture, equipment, and other materials necessary for compounding activities should be low-shedding and easily cleaned and disinfected; and

(H) Carts used to transport components or equipment into classified areas shall be constructed from nonporous material with cleanable casters and wheels to allow for cleaning and disinfection. Carts shall not be moved from the dirty side to the clean side of the ante-room unless the entire cart, including casters, is cleaned and disinfected.

(xii) Water supplied to the cleanroom suite shall meet the following requirements:

(A) The sink used for hand hygiene may be placed either inside or outside the ante-room. If placed outside the ante-room, it shall be located in a clean space. If the sink is located inside the ante-room, it may be placed on either the clean side or dirty side of the ante-room;

(B) The sink should allow for hand-free use;

(C) The ante-room shall not contain floor drains;

(D) The buffer room shall not contain plumbed water sources; and

(E) Sprinkler systems shall be recessed, covered, and easily cleanable.

(b) The SCA shall meet the following requirements:

(i) The SCA shall be separated from general pharmacy areas not directly related to compounding by fixed doors and walls;

(ii) The SCA shall be located away from unsealed windows, doors that connect to the outdoors, traffic flow, and other environmental control challenges that could affect the air quality of the PEC within the SCA;

(iii) A visible perimeter shall be established to mark the boundaries of the SCA;

(iv) The SCA shall provide a well-lighted working environment.

(v) Free-standing humidifiers/dehumidifiers and air conditioners shall not be used within the perimeter of the SCA;

(vi) All surfaces shall be clean, uncluttered, and dedicated to compounding;

(vii) All surfaces shall be smooth, impervious, free from cracks and crevices, and non-shedding;

(viii) All surfaces should be resistant to damage by cleaning agents; disinfectants, sporicidal agents, and tools used to clean them;

(ix) Dust-collecting overhangs and ledges should be limited, but shall be easily cleanable if present; and

(x) The sink shall be at least one (1) meter away from the PEC and shall not be placed inside the perimeter of the SCA. The sink should allow for hands free use.

Notes

059-17 Wyo. Code R. §§ 17-5

Amended, Eff. 5/13/2021.