N.J. Admin. Code § 13:39-11.5 - Cleanroom requirements
(a) The surfaces of
ceilings, walls, floors, fixtures, shelving, counters, and cabinets in the
cleanroom shall be smooth, impervious, free from cracks and crevices, and
nonshedding, thereby minimizing spaces in which microorganisms and other
contaminants may accumulate.
(b)
Work surfaces shall be constructed of smooth, impervious materials, such as
stainless steel or molded plastic, so that the work surfaces may be readily
cleaned and sanitized. 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 contaminates 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 flexible material (for example, heavy gauge polymer), 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.
(g) There shall
be no dust-collection overhangs (such as ceiling utility pipes) and ledges
(such as window sills) shall be avoided. All sprinkler heads shall be flush
with the ceiling.
(h) Ceiling
lighting fixtures shall have exterior lens surfaces which are smooth, mounted
flush, and air tight.
(i) Carts
shall be of stainless steel wire, nonporous plastic, or sheet metal
construction with good quality, cleanable casters to promote
mobility.
(j) Refrigerators shall
be within, or reasonably accessible to, the cleanroom in order to ensure the
integrity of the compounded sterile preparations, consistent with the
requirements of
N.J.A.C.
13:39-11.12(b)3.
Notes
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