N.J. Admin. Code § 13:39-11.15

Current through Register Vol. 56, No. 24, December 18, 2024

Section 13:39-11.15 - Cleaning and disinfection requirements for cleanroom, buffer area, and ante area

(a) The cleanroom, buffer area, and ante area shall be cleaned and disinfected consistent with the following requirements:

1. All surfaces in laminar airflow workbenches, biological safety cabinets, compounding aseptic isolators, and compounding aseptic containment isolators shall be cleaned and disinfected at the beginning of each work shift, before each batch preparation is started, after spills, and when surface contamination is known or suspected;

2. All counters, work surfaces, and floors shall be cleaned and disinfected daily; and

3. All walls, ceilings, and storage shelving shall be cleaned monthly.

(b) All cleaning and disinfection shall be performed consistent with the standards established in USP 797 Appendix II, which is incorporated herein by reference, as amended and supplemented, and which is available for purchase at the United States Pharmacopeia website, http://www.usp.org.

N.J. Admin. Code § 13:39-11.15

Recodified from N.J.A.C. 13:39-11.10 and amended by R.1998 d.297, effective 6/15/1998.
See: 29 N.J.R. 2246(a), 30 N.J.R. 2255(a).
Rewrote (a) and (b) and inserted a new (c). Former N.J.A.C. 13:39-11.16, Anteroom, was recodified to N.J.A.C. 13:39-11.21.
Recodified from N.J.A.C. 13:39-11.16 and amended by R.2005 d.25, effective 1/18/2005.
See: 36 N.J.R. 3345(a), 37 N.J.R. 295(a).
In (a), amended the N.J.A.C. reference in 1. Former N.J.A.C. 13:3911.15, Quality assurance program, recodified to N.J.A.C. 13:39-11.14.
Repeal and New Rule, R.2013 d.084, effective 6/3/2013.
See: 45 N.J.R. 439(a), 45 N.J.R. 1400(b).
Section was "Patient profile records for compounded sterile preparations".
Administrative correction.
See: 45 N.J.R. 1658(d).