Basic Documentation

Siemens Industry, Inc. Page 7 of 8
Document No. A6V11520001
HVAC Design Considerations
Before developing the project design, assess the
pharmacy HVAC system for the following:
 Does the air handler serving the pharmacy have
enough cooling capacity to meet the cooling
requirements for the cleanroom?
 Does the air handler serving the pharmacy have
enough static pressure to meet the static
pressure requirements of the HEPA-filtered
diffusers?
 Can the HVAC terminal equipment be located in
an area adjacent to the pharmacy to facilitate
good maintenance practices?
Certification and Recertification
Nonsterile HD Preparations
Before a C-PEC can be used to prepare CNSPs, it
must be certified in accordance with current industry
guidelines.
The C-PEC must be certified regularly thereafter:
• A C-PEC that is equipped with an exhaust alarm
must be certified annually.
• A C-PEC that is not equipped with an exhaust
alarm must be certified semi-annually.
Environmental wipe sampling for HD surface residue
should be performed at least every six months.
Monitoring equipment must be calibrated or verified
for accuracy at least every 12 months or as
recommended by the manufacturer.
Sterile HD Preparations
Before an area is used to compound either
Category 1 or Category 2 CSPs, it must be certified.
Environmental quality is evaluated as follows:
• Certification that each C-PEC is functioning
properly and meets the air quality requirement of
ISO Class 5. Certification must include the
following tests:
• Airflow testing
• HEPA filter integrity testing
• Total particle counts testing
• Smoke studies
• Certification of the buffer area (ISO Class 7) and
ante-area (ISO Class 7) must include:
• Air velocity and volume measurements
• ACPH verifications
• Room pressure cascade verification to
ensure proper airflow
• Air quality measurements
• Qualified Operator(s) must certify both C-PECs
and the room environments at least every six
months and when renovations occur. These
records should be maintained and reviewed by
the supervising pharmacist or other designated
employee.
• Environmental wipe sampling for HD surface
residue should be performed at least every six
months.
• Total (non-viable) particle counts on ISO areas
must be conducted during operations every six
months.
• Active air sampling (viable) of all ISO-classified
areas must be conducted during typical
operating conditions at least monthly.
• Monitoring equipment must be calibrated or
verified for accuracy at least every 12 months or
as recommended by the manufacturer.
Controlled Storage Areas
HDs must be stored separately from non-HDs in a
manner that prevents contamination and personnel
exposure.
HDs must be stored in an externally ventilated,
negative-pressure room with at least 12 ACPH.
Sterile and non-sterile HDs may be stored together,
but non-sterile HDs should not be stored in areas
designated for sterile compounding.
Refrigerated HDs must be stored in a dedicated
refrigerator in a negative-pressure area with at least
12 ACPH (for example, a storage room, buffer room,
or C-SCA).
If a refrigerator is located in the buffer room, then
consider installing a local exhaust for the
refrigerator’s compressor.
USP <797> and <795> require documentation that
medications are stored under conditions necessary
to ensure stability.