Basic Documentation

Page 6 of 8 Siemens Industry, Inc.
Document No. 149-224
• Ceilings with inlaid panels should be
impregnated with a polymer to render them
impervious and hydrophobic. Caulk around each
perimeter to seal the panels to the frame.
• Walls may be constructed of panels locked
together and sealed or can be made of epoxy-
coated gypsum board.
• Floors should be overlaid with wide sheet vinyl
flooring with heat-welded seams and coving at
the sidewall.
• Avoid dust-collecting overhangs and ledges,
such as ceiling utility pipes and windowsills.
• The exterior lens of ceiling light fixtures should
be smooth, mounted flush, and sealed.
• The buffer area should not contain a sink or floor
drain. The anteroom should contain a hands-
free sink for hand-washing and no floor drain.
• Hand-sanitizing and gowning occur in the
anteroom area adjacent to the buffer area.
Faucet handles should be designed to be
hands-free.
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
Compounded Nonsterile Preparations
Before a CVE can be used to prepare CNSPs, it
must be certified in accordance with current
guidelines from the American Society of Heating,
Refrigerating and Air-Conditioning Engineers
(ASHRAE).
The CVE must be certified regularly thereafter:
• A CVE that is equipped with an exhaust alarm
must be certified annually.
• A CVE that is not equipped with an exhaust
alarm must be certified semi-annually.
Temperature and Humidity monitoring equipment
must be calibrated or verified for accuracy at least
every 12 months or as recommended by the
manufacturer.
Differential pressure monitoring equipment must be
tested for accuracy and performance at least every 6
months
Compounded Sterile Preparations
Before an area is used to compound either
Category 1 or Category 2 CSPs, it must be certified
using procedures in the current Controlled
Environment Testing Association (CETA)
certification guide for Sterile Compounding Facilities
or equivalent guideline.
Environmental quality is evaluated as follows:
• Certification that each 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 8) 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 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.
• 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 every 6 months.