Basic Documentation

Page 2 of 8 Siemens Industry, Inc.
Document No. A6V11520001
controlled room temperature or 24 hours or less
if refrigerated.
• Category 2 CSPs are those with an assigned
BUD of greater than 12 hours at controlled room
temperature or greater than 24 hours if
refrigerated.
Receipt of HDs
HDs must be unpacked in an area that has neutral
or negative pressure relative to the surrounding
area. HDs must not be unpacked in the sterile
compounding area or in any positive-pressure area.
Compounding of HDs
Engineering controls for containment are divided into
three categories representing primary, secondary,
and supplementary levels of control:
• A containment primary engineering control
(C-PEC) is a ventilated device designed to
minimize worker and environmental HD
exposure.
• A containment secondary engineering control
(C-SEC) is the room in which the C-PEC is
located.
• Supplemental engineering controls are adjunct
controls that offer additional levels of protection
(for example, a closed-system drug-transfer
device).
Sterile and nonsterile HDs are required to be
compounded within a C-PEC located within a
C-SEC.
The C-SEC used for either sterile or nonsterile
compounding must:
• Be externally vented
• Be physically separated (different room from the
preparation area)
• Have an appropriate number of air changes per
hour (ACPH)
• Have a negative pressure between 0.01 and
0.03 inches water column (wc) relative to
adjacent space
If a C-PEC is used for sterile compounding, then it
must remain in operation continuously.
Nonsterile and sterile C-PECs must be in separate
rooms unless it is possible to maintain ISO 7
classification continuously throughout the nonsterile
compounding. Nonsterile and sterile C-PECs that
are located in the same room must be at least
3.28 feet (1 meter) apart.
Compounding Nonsterile HDs
Compounding must meet the requirements of
USP <795>.
C-PECs must be externally vented or must have
redundant high-efficiency particulate air (HEPA)
filters in series.
Compounding must be performed in a C-PEC that
provides personnel and environmental protections,
such as a Class I biological safety cabinet (BSC),
Class II BSC, containment ventilated enclosure
(CVE), or a compounding aseptic containment
isolator (CACI).
A C-PEC must be located in a C-SEC. The C-SEC
must have at least 12 ACPH.
Compounding Sterile HDs
Compounding must meet the requirements of
USP <797>.
All C-PECs must be externally vented.
Compounding must be performed in a C-PEC that
provides an ISO Class 5 or better environment, such
as a Class II BSC, a Class III BSC, or a CACI.
A C-PEC must be located in a C-SEC. The C-SEC
must be either an ISO Class 7 buffer room with an
ISO Class 7 ante-room or an unclassified
containment segregated compounding area
(C-SCA).
Only HDs that meet the requirements of USP <797>
category 1 CSPs may be compounded within a
C-SCA.