Texas Register, Volume 37, Number 35, Pages 6819-7008, August 31, 2012 Page: 6,931
6819-7008 p. ; 28 cm.View a full description of this periodical.
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(IV) have non-porous and washable floors or
floor covering to enable regular disinfection;
(V) be ventilated in a manner to avoid disruption
from the HVAC system and room cross-drafts;
(VI) have walls, ceilings, floors, fixtures, shelv-
ing, counters, and cabinets that are smooth, impervious, free from
cracks and crevices (e.g., coved), nonshedding and resistant to damage
by disinfectant agents;
(VII) have junctures of ceilings to walls coved or
caulked to avoid cracks and crevices;
(VIII) have drugs and supplies stored on shelving
areas above the floor to permit adequate floor cleaning;
(IX) contain only the appropriate compounding
supplies and not be used for bulk storage for supplies and materials.
Objects that shed particles shall not be brought into the controlled area;
(X) contain an anteroom/ante-zone that provides
at least an ISO class 8 air quality and may contain a sink that enables
hands-free use with a closed system of soap dispensing to minimize the
risk of extrinsic contamination; and
(XI) contain a buffer zone or buffer room de-
signed to maintain at least ISO Class 7 conditions. The following is
applicable for the buffer area.
(-a-) There shall be some demarcation desig-
nation that delineates the anteroom or area from the buffer area. The
demarcation shall be such that it does not create conditions that could
adversely affect the cleanliness of the area.
(-b-) The buffer area shall be segregated from
surrounding, unclassified spaces to reduce the risk of contaminants be-
ing blown, dragged, or otherwise introduced into the filtered unidi-
rectional airflow environment, and this segregation should be continu-
ously monitored.
(-c-) A buffer zone that is not physically sep-
arated from the anteroom shall employ the principle of displacement
airflow as defined in Chapter 797, Pharmaceutical Compounding--Ster-
ile Preparations, of the USP/NF, with limited access to personnel.
(-d-) The buffer area shall not contain sources
of water (i.e., sinks) or floor drains.
(ii) The pharmacy shall prepare sterile pharmaceuti-
cals in a primary engineering control device, such as a laminar air flow
hood, biological safety cabinet, compounding aseptic isolator, com-
pounding aseptic containment isolator which is capable of maintaining
at least ISO Class 5 conditions during normal activity.
(I) The primary engineering control shall:
(-a-) be located in the buffer area or room and
placed in the buffer area in a manner as to avoid conditions that could
adversely affect its operation such as strong air currents from opened
doors, personnel traffic, or air streams from the heating, ventilating and
air condition system.
(-b-) be certified by an independent contrac-
tor according to the International Organization of Standardization
(ISO) Classification of Particulate Matter in Room Air (ISO 14644-1)
for operational efficiency at least every six months and when it is
relocated, in accordance with the manufacturer's specifications; and
(-c-) have pre-filters inspected periodically
and replaced as needed, in accordance with written policies and
procedures and the manufacturer's specification, and the inspection
and/or replacement date documented.(II) The compounding aseptic isolator or com-
pounding aseptic containment isolator must be placed in an ISO Class
7 buffer area unless the isolator meets all of the following conditions.
(-a-) The isolator must provide isolation from
the room and maintain ISO Class 5 during dynamic operating condi-
tions including transferring ingredients, components, and devices into
and out of the isolator and during preparation of compounded sterile
preparations.
(-b-) Particle counts sampled approximately
6 to 12 inches upstream of the critical exposure site must maintain ISO
Class 5 levels during compounding operations.
(-c-) The pharmacy shall maintain documen-
tation from the manufacturer that the isolator meets this standard when
located in worse than ISO Class 7 environments.
(B) High-risk Preparations. In addition to the require-
ments in subparagraph (A) of this paragraph, when high-risk prepara-
tions are compounded, the primary engineering control shall be located
in a buffer room that provides a physical separation, through the use of
walls, doors and pass-throughs and has a minimum differential positive
pressure of 0.02 to 0.05 inches water column.
(C) Automated compounding device. If automated
compounding devices are used, the pharmacy shall have a method to
calibrate and verify the accuracy of automated compounding devices
used in aseptic processing and document the calibration and verifica-
tion on a routine basis, based on the manufacturer's recommendations.
(D) Cytotoxic drugs. If the preparation is cytotoxic, the
following is also applicable.
(i) General.
(I) All personnel involved in the compounding
of cytotoxic products shall wear appropriate protective apparel, such
as gowns, face masks, eye protection, hair covers, shoe covers or ded-
icated shoes, and appropriate gloving.
(II) Appropriate safety and containment tech-
niques for compounding cytotoxic drugs shall be used in conjunction
with aseptic techniques required for preparing sterile preparations.
(III) Disposal of cytotoxic waste shall comply
with all applicable local, state, and federal requirements.
(IV) Prepared doses of cytotoxic drugs must be
dispensed, labeled with proper precautions inside and outside, and dis-
tributed in a manner to minimize patient contact with cytotoxic agents.
(ii) Primary engineering control device. Cytotoxic
drugs shall be prepared in a Class II or III vertical flow biological safety
cabinet or compounding aseptic containment isolator located in an ISO
Class 7 area that is physically separated from other preparation areas.
The area for preparation of sterile chemotherapeutic preparations shall:
(I) have not less than 0.01 inches water column
negative pressure to the adjacent positive pressure ISO Class 7 or better
antearea; and
(II) have a pressure indicator that can be readily
monitored for correct room pressurization.
(iii) Facilities that prepare a low volume of cytotoxic
drugs. Pharmacies that prepare a low volume of cytotoxic drugs, are
not required to comply with the provisions of clause (ii) of this subpara-
graph if the pharmacy uses a device that provides two tiers of contain-
ment (e.g., closed-system vial transfer device within a BSC or CACI
that is located in a non-negative pressure room).
(E) Cleaning and disinfecting the sterile compounding
areas. The following cleaning and disinfecting practices and frequen-ADOPTED RULES August 31, 2012 37 TexReg 6931
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Texas. Secretary of State. Texas Register, Volume 37, Number 35, Pages 6819-7008, August 31, 2012, periodical, August 31, 2012; Austin, Texas. (https://texashistory.unt.edu/ark:/67531/metapth253227/m1/112/: accessed April 30, 2024), University of North Texas Libraries, The Portal to Texas History, https://texashistory.unt.edu; crediting UNT Libraries Government Documents Department.