Phar 15.30(16) (16) “Restricted access barrier system (RABS)” means an enclosure that provides HEPA-filtered ISO Class 5 unidirectional air that allows for the ingress or egress of materials through defined openings that have been designed and validated to preclude the transfer of contamination, and that generally are not to be opened during operations. RABS include compounding aseptic isolators and compounding aseptic containment isolators.

Phar 15.30(17) (17) “Sterility assurance level of 10-6” means an equivalent to a probability that one unit in a million is nonsterile.

Phar 15.30(18) (18) “Segregated compounding area” means a designated, unclassified space, area, or room that contains a primary engineering control.

Phar 15.30(19) (19) “Urgent use compounded sterile preparation” means a preparation needed urgently for a single patient and preparation of the compounded sterile preparation under Category 1 or Category 2 requirements would subject the patient to additional risk due to delays.

Phar 15.30 History History: CR 16-085: cr. Register April 2018 No. 748 eff. 11-1-18; CR 22-007: cr. (10m), (14g), (14r) Register July 2022 No. 799, eff. 8-1-22.

Phar 15.31 Phar 15.31 Facility design and environmental controls.

Phar 15.31(1) (1) General. Facilities shall meet all of the following requirements:

Phar 15.31(1)(a) (a) Be physically designed and environmentally controlled to minimize airborne contamination from contacting critical sites.

Phar 15.31(1)(b) (b) Be accessible only to designated personnel.

Phar 15.31(1)(c) (c) Have a heating, ventilation, and air conditioning system controlling the temperature and humidity.

Phar 15.31(2) (2) Segregated compounding area. A segregated compounding area shall meet all of the following requirements:

Phar 15.31(2)(a) (a) Be located in an area away from unsealed windows and doors that connect to the outdoors, or significant traffic flow.

Phar 15.31(2)(b) (b) Be located in an area which is not adjacent to construction sites, warehouses, and food preparation areas.

Phar 15.31(2)(c) (c) Have a defined perimeter.

Phar 15.31(2)(d) (d) Locate the primary engineering control at least one meter from any sink.

Phar 15.31(3) (3) Classified area. A classified area shall meet all of the following:

Phar 15.31(3)(a) (a) The surfaces of ceilings, walls, floors, fixtures, shelving, counters, and cabinets shall be smooth, impervious, free from cracks and crevices, and nonshedding.

Phar 15.31(3)(b) (b) Work surfaces shall be constructed of smooth, impervious materials. All work surfaces shall be resistant to damage from cleaning and sanitizing agents.

Phar 15.31(3)(c) (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.

Phar 15.31(3)(d) (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.

Phar 15.31(3)(e) (e) Walls shall be constructed of a durable material, panels locked together and sealed or of epoxy-coated gypsum board.

Phar 15.31(3)(f) (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.

Phar 15.31(3)(h) (h) Ceiling lighting fixtures shall have exterior lens surfaces which are smooth, mounted flush, and sealed.

Phar 15.31(3)(i) (i) Carts shall be constructed of stainless steel wire, nonporous plastic or sheet metal with cleanable casters.

Phar 15.31(3)(j) (j) Tacky mats may not be used in a classified area.

Phar 15.31(3)(k) (k) HEPA filters and unidirectional airflow shall be used to maintain the appropriate airborne particulate classification.

Phar 15.31(3)(L) (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.

Phar 15.31(3)(m) (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.

Phar 15.31(3)(mm) (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: