N.J. Admin. Code § 13:39-11.4

Current through Register Vol. 56, No. 21, November 4, 2024

Section 13:39-11.4 - Cleanroom: use, access, location; temperature; air pressure

(a) The pharmacy shall have a designated area for sterile preparation compounding, known as the "cleanroom." A cleanroom shall be physically designed and environmentally controlled to minimize airborne contamination from contacting critical sites. Critical sites are locations that include any component or fluid pathway surfaces (for example, vial septa, injection ports, beakers), openings (for example, opened ampules, needle hubs), exposed and at risk of direct contact with air (for example, ambient room or HEPA-filtered), moisture (for example, oral and mucosal secretions), or touch contamination. A cleanroom shall include a buffer area and an ante area. The buffer area shall contain an ISO class 5 or better primary engineering control, such as a laminar airflow workbench, biological safety cabinet, compounding aseptic isolator, and/or compounding aseptic containment isolator, unless the buffer area has ISO class 5 or better air quality.

(b) All sterile compounding shall take place within the confines of the buffer area, except for the following:

1. Compounding in a compounding aseptic isolator or a compounding aseptic containment isolator pursuant to 13:39-11.8;

2. Compounding in a laminar airflow workbench in an institutional pharmacy pursuant to 13:39-11.10; and

3. Compounding immediate use compounded sterile preparations in an institutional pharmacy pursuant to 13:39-11.11.

(c) A cleanroom shall be:

1. Accessible only to designated personnel;

2. Used only for the compounding of sterile preparations or such other tasks that require a cleanroom;

3. Structurally isolated from other areas within the pharmacy by means of restricted entry or access; and

4. Air conditioned to maintain a temperature of 59 to 77 degrees Fahrenheit with an ideal temperature of 66 degrees Fahrenheit.

(d) A pressure indicator or air velocity meter shall be installed that can be readily monitored for correct room pressurization or air velocity, respectively, consistent with the following:

1. For compounding of non-hazardous drugs, if the buffer area and the ante area are physically separated through the use of walls, doors, and pass-throughs, a minimum differential positive pressure of 0.02 inch to 0.05 inch water column shall be required. For buffer areas not physically separated from the ante area, the principle of displacement airflow shall be employed. Using displacement airflow, an air velocity of 40 feet per minute or more from the buffer area across the line of demarcation into the ante area is required.

2. For compounding of antineoplastic agents and other hazardous substances, the standards set forth in N.J.A.C. 13:39-11B.

3. For compounding of antineoplastic agents and other hazardous substances outside of a cleanroom pursuant to 13:39-11.8, if a compounding aseptic containment isolator is used outside of a buffer area, the compounding area shall be physically separated from other areas and shall maintain a minimum negative pressure of 0.01 inch water column and have a minimum of 12 air exchanges per hour.

(e) No chewing gum, drinks, candy, or food items shall be brought into the cleanroom.The following annotations apply to 13:39-11.4 prior to its repeal by R.2013 d.084:

New Rule, R.1998 d.297, effective June 15, 1998.

See: 29 N.J.R. 2246(a), 30 N.J.R. 2255(a).

Former 13:39-11.5, Information required to appear on prescription label, was recodified to 13:39-11.11.

Recodified from 13:39-11.5 and amended by R.2005 d.25, effective January 18, 2005.

See: 36 N.J.R. 3345(a), 37 N.J.R. 295(a).

Rewrote the section. Former N.J.A.C. 11:39-11.4, Compliance, repealed.

The following annotations apply to 13:39-11.4 subsequent to its recodification from 13:39-11.16 by R.2013 d.084:

Recodified from 13:39-11.11 and amended by R.1998 d.297, effective June 15, 1998.

See: 29 N.J.R. 2246(a), 30 N.J.R. 2255(a).

Rewrote (a); and in (b), substituted "sterile" for "parenteral" in 2 and added a new 4.

Recodified from 13:39-11.17 and amended by R.2005 d.25, effective January 18, 2005.

See: 36 N.J.R. 3345(a), 37 N.J.R. 295(a).

In (a), substituted "sterile preparation compounding, known" for "sterile product preparation, known" and amended the N.J.A.C. references in the introductory paragraph, and substituted "for the compounding of sterile preparations" for "for the preparation of sterile products" in 2. Former 13:39-11.16, Patient profile records, recodified to 13:39-11.15.

Recodified from 13:39-11.16 and amended by R.2013 d.084, effective June 3, 2013.

See: 45 N.J.R. 439(a), 45 N.J.R. 1400(b).

Section was "Controlled environment for compounded sterile preparations: use, access, location; temperature". Rewrote (a); added new (b); recodified former (b) as (c); in the introductory paragraph of (c), and in (c)2, substituted "cleanroom" for "controlled environment"; in (c)2, deleted a comma following "preparations"; in (c)4, inserted "with an ideal temperature of 66 degrees Fahrenheit"; and added (d) and (e). Former 13:39-11.4, General requirement for compounded sterile preparations; pre-approval, repealed.

Administrative correction.

See: 45 N.J.R. 1658(d).

N.J. Admin. Code § 13:39-11.4

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