Basic Documentation

Siemens Industry, Inc. Page 5 of 8
Document No. 149-224
Air Changes
The required rate of air changes is dictated by the
internal generation of particles from operators and
building elements such as walls, ceiling, floor, and
so on.
The ISO 7 buffer room must maintain an ACPH
value of not less than 30. The ACPH of 30 can
include re-circulated HEPA-filtered air, but at least
half of the ACPH must be HEPA-filtered fresh air.
The ISO 8 ante-room must maintain an ACPH value
of not less than 20.
Monitoring and Alarms–The International Society
for Pharmaceutical Engineering (ISPE) Good
Practice Guide
4
states that critical parameters that
can affect end product quality must remain within
process limits and should have alerts and alarms.
USP <1079> Good Storage and Distribution states
that alarms should be used to reveal environmental
excursions during operations. The following critical
room conditions should be monitored to document
cleanroom environmental conditions:
• Room temperature
• Room humidity
• Room D/P
• (Optional) Particle count
Audible and visual indication of cleanroom alarms
should be provided for healthcare workers, and the
time of the alarm should be recorded. Integration of
HVAC controls into the BAS allows historical data,
alarms, and alarm acknowledgements to be
collected and archived to document compliance with
regulatory requirements.
4. ISPE Good Practice Guide: Heating, Ventilation, & Air
Conditioning (HVAC) Published: September 2009
Building Exhaust Design
Considerations
Care must be exercised in the system design and
particularly in the location of the exhaust air inlets.
The following list describes important design criteria
for healthcare exhaust systems
5
.
• Consult with the facility engineer before adding a
new cabinet to the building exhaust system.
• Exhaust air should be discharged away from
supply air intakes to prevent entrainment of
exhausted laboratory air back into the building
air supply system.
• Exhaust air discharge outlets should be placed
as high as practical and typically are located on
the building roof.
• The exhaust air discharge outlet must not have
a rain cap or other elements that could disrupt
the upward direction of the exhaust air stream.
• Exhaust stacks or outlets must be located at
least 25 feet (7.62 meters) from fresh air intakes.
Plumbing and vacuum vents that terminate at a
level above the top of the air intake may be
located as close as 10 feet (3.05 meters).
Cleanroom Design Considerations
The following list describes important design criteria
for cleanrooms
6
:
• Construct walls, floors, ceilings, fixtures,
shelving, counters, and cabinets so that the
surfaces are accessible for cleaning and so that
spaces in which microorganisms and other
contaminants can accumulate are minimized.
• Select materials that will not deteriorate with use
and affect particle control and contribute to
contamination.
• Reduce the number of joints, cracks, and
crevices to promote cleanliness and to minimize
spaces where microorganisms and other
contaminants can accumulate.
• Junctures of ceilings to walls should be
coved or caulked to avoid cracks and
crevices where dirt can accumulate.
• Any penetrations through the walls and
ceiling should be sealed.
5. AIA Guidelines 2001, section 7.31.D3, p.69
6. USP<797> Pharmaceutical Compounding - Sterile
Preparations, Proposed Revision – July, 2018.