| (i) If the pharmacy is using a biological safety cabinet
(BSC) as its PEC for the preparation of hazardous sterile compounded
preparations, the biological safety cabinet shall be a Class II or
III vertical flow biological safety cabinet 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 ante-area;
and
(II) have a pressure indicator that can be readily
monitored for correct room pressurization.
(ii) Pharmacies that prepare a low volume of hazardous
drugs, are not required to comply with the provisions of clause (i)
of this subparagraph if the pharmacy uses a device that provides two
tiers of containment (e.g., closed-system vial transfer device within
a BSC).
(iii) If the pharmacy is using a biological safety
cabinet as its PEC for the preparation of non-hazardous sterile compounded
preparations, the biological safety cabinet shall:
(I) be located in the buffer area 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;
(II) be certified for operational efficiency using
certification procedures, such as those outlined in the Certification
Guide for Sterile Compounding Facilities (CAG-003-2006), which shall
be performed by a qualified independent individual no less than every
six months and whenever the device or room is relocated or altered
or major service to the facility is performed;
(III) 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; and
(IV) be located in a buffer area that has a minimum
differential positive pressure of 0.02 to 0.05 inches water column.
(C) Compounding aseptic isolator.
(i) If the pharmacy is using a compounding aseptic
isolator (CAI) as its PEC, the CAI shall provide unidirectional airflow
within the main processing and antechambers, and be placed in an ISO
Class 7 buffer area unless the isolator meets all of the following
conditions:
(I) The isolator must provide isolation from the room
and maintain ISO Class 5 during dynamic operating conditions including
transferring ingredients, components, and devices into and out of
the isolator and during preparation of compounded sterile preparations;
(II) Particle counts sampled approximately 6 to 12
inches upstream of the critical exposure site must maintain ISO Class
5 levels during compounding operations;
(III) The CAI must be certified for operational efficiency
using certification procedures, such as those outlined in the Certification
Guide for Sterile Compounding Facilities (CAG-003-2006), which shall
be performed by a qualified independent individual no less than every
six months and whenever the device or room is relocated or altered
or major service to the facility is performed; and
(IV) The pharmacy shall maintain documentation from
the manufacturer that the isolator meets this standard when located
in worse than ISO Class 7 environments.
(ii) If the isolator meets the requirements in clause
(i) of this subparagraph, the CAI may be placed in a non-ISO classified
area of the pharmacy; however, the area shall be segregated from other
areas of the pharmacy and shall:
(I) be clean, well lit, and of sufficient size;
(II) be used only for the compounding of low- and medium-risk,
non-hazardous sterile preparations;
(III) be located in an area of the pharmacy with non-porous
and washable floors or floor covering to enable regular disinfection;
and
(IV) be an area in which the CAI is placed in a manner
as to avoid conditions that could adversely affect its operation.
(iii) In addition to the requirements specified in
clauses (i) and (ii) of this subparagraph, if the CAI is used in the
compounding of high-risk non-hazardous preparations, the CAI shall
be placed in an area or room with at least ISO 8 quality air so that
high-risk powders weighed in at least ISO-8 air quality conditions,
compounding utensils for measuring and other compounding equipment
are not exposed to lesser air quality prior to the completion of compounding
and packaging of the high-risk preparation.
(D) Compounding aseptic containment isolator.
(i) If the pharmacy is using a compounding aseptic
containment isolator (CACI) as its PEC for the preparation of low-
and medium-risk hazardous drugs, the CACI shall be located in a separate
room away from other areas of the pharmacy and shall:
(I) provide at least 0.01 inches water column negative
pressure compared to the other areas of the pharmacy;
(II) provide unidirectional airflow within the main
processing and antechambers, and be placed in an ISO Class 7 buffer
area, unless the CACI meets all of the following conditions;
(-a-) The isolator must provide isolation from the
room and maintain ISO Class 5 during dynamic operating conditions
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 CACI must be certified for operational efficiency
using certification procedures, such as those outlined in the Certification
Guide for Sterile Compounding Facilities (CAG-003-2006), which shall
be performed by a qualified independent individual no less than every
six months and whenever the device or room is relocated or altered
or major service to the facility is performed; and
(-d-) The pharmacy shall maintain documentation from
the manufacturer that the isolator meets this standard when located
in worse than ISO Class 7 environments.
(ii) If the CACI meets all conditions specified in
clause (i) of this subparagraph, the CACI shall not be located in
the same room as a CAI, but shall be located in a separate room in
the pharmacy, that is not required to maintain ISO classified air.
The room in which the CACI is located shall provide a minimum of 0.01
inches water column negative pressure compared with the other areas
of the pharmacy and shall meet the following requirements:
(I) be clean, well lit, and of sufficient size;
(II) be maintained at a temperature of 20 degrees Celsius
or cooler and a humidity below 60%;
(III) be used only for the compounding of hazardous
sterile preparations;
(IV) be located in an area of the pharmacy with walls,
ceilings, floors, fixtures, shelving, counters, and cabinets that
are smooth, impervious, free from cracks and crevices, non-shedding
and resistant to damage by disinfectant agents; and
(V) have non-porous and washable floors or floor covering
to enable regular disinfection.
(iii) If the CACI is used in the compounding of high-risk
hazardous preparations, the CACI shall be placed in an area or room
with at least ISO 8 quality air so that high-risk powders, weighed
in at least ISO-8 air quality conditions, are not exposed to lesser
air quality prior to the completion of compounding and packaging of
the high-risk preparation.
(iv) Pharmacies that prepare a low volume of hazardous
drugs, are not required to comply with the provisions of clauses (i)
and (iii) of this subparagraph if the pharmacy uses a device that
provides two tiers of containment (e.g., CACI that is located in a
non-negative pressure room).
(8) Additional Equipment and Supplies. Pharmacies compounding
sterile preparations shall have the following equipment and supplies:
(A) a calibrated system or device (i.e., thermometer)
to monitor the temperature to ensure that proper storage requirements
are met, if sterile preparations are stored in the refrigerator;
(B) a calibrated system or device to monitor the temperature
where bulk chemicals are stored;
(C) a temperature-sensing mechanism suitably placed
in the controlled temperature storage space to reflect accurately
the true temperature;
(D) if applicable, a Class A prescription balance,
or analytical balance and weights. Such balance shall be properly
maintained and subject to periodic inspection by the Texas State Board
of Pharmacy;
(E) equipment and utensils necessary for the proper
compounding of sterile preparations. Such equipment and utensils used
in the compounding process shall be:
(i) of appropriate design, appropriate capacity, and
be operated within designed operational limits;
Cont'd... |
