(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
N.J.A.C.
13:39-11.8;
2. Compounding in a laminar airflow workbench
in an institutional pharmacy pursuant to
N.J.A.C.
13:39-11.10; and
3. Compounding immediate use compounded
sterile preparations in an institutional pharmacy pursuant to
N.J.A.C.
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
N.J.A.C.
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
N.J.A.C.
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
N.J.A.C.
13:39-11.5, Information required to appear on
prescription label, was recodified to
N.J.A.C.
13:39-11.11.
Recodified from
N.J.A.C.
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
N.J.A.C.
13:39-11.4 subsequent to its recodification
from N.J.A.C. 13:39-11.16 by R.2013
d.084:
Recodified from
N.J.A.C.
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
N.J.A.C.
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
N.J.A.C.
13:39-11.16, Patient profile records,
recodified to
N.J.A.C.
13:39-11.15.
Recodified from
N.J.A.C.
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
N.J.A.C.
13:39-11.4, General requirement for
compounded sterile preparations; pre-approval, repealed.
Administrative correction.
See: 45 N.J.R. 1658(d).
