N.J. Admin. Code § 13:39-11.5

Current through Register Vol. 56, No. 11, June 3, 2024

Section 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 13:39-11.12(b)3.

N.J. Admin. Code § 13:39-11.5

Amended by 49 N.J.R. 3761(a), effective 12/4/2017