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)(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: Phar 15.31(3)(mm)1.1. The buffer and ante areas shall be designated with a line of demarcation. Phar 15.31(3)(mm)2.2. 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. Phar 15.31(3)(n)(n) Devices and objects essential to compounding shall be located at an appropriate distance from the primary engineering control. Phar 15.31(3)(q)(q) The buffer area shall meet all of the following requirements: Phar 15.31(3)(q)2.a.a. Items, including furniture, equipment, and supplies, that are required for the tasks to be performed in the buffer area. Phar 15.31(3)(q)2.b.b. Items that are smooth, impervious, free from cracks and crevices, nonshedding, and easily cleaned and disinfected. Phar 15.31(3)(q)2.c.c. Items that have been cleaned and disinfected immediately prior to their being placed in the buffer area. Phar 15.31(3)(q)4.4. Does not contain any course cardboard, external shipping containers, and nonessential paper. Phar 15.31(4)(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: