Wyoming Administrative Code › Agency 059 - Pharmacy, Board of › Sub-Agency 0001 - Pharmacy, Board of › Chapter 17 - STERILE COMPOUNDING › Section 17-5 - Facilities and Engineering Controls

Current through July 13, 2024
(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.