Basic Documentation
Table Of Contents
- Hospital Pharmacy–USP Compounding Standards for Hazardous Drugs
- Environmental Requirements for USP <800 >Compliance
- Current USP Guidelines
- Center for Medicare and Medicaid Services (CMS) Compliance Date
- USP Chapter Overviews
- Receipt of HDs
- Compounding of HDs
- Compounding Nonsterile HDs
- Compounding Sterile HDs
- Equipment (Primary Controls)
- Design Requirements for HD Compounding Areas
- Building Exhaust Design Considerations
- Cleanroom Design Considerations
- HVAC Design Considerations
- Certification and Recertification
- Controlled Storage Areas
Page 6 of 8 Siemens Industry, Inc.
Document No. A6V11520001
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
4
.
• 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).
4. AIA Guidelines 2001, section 7.31.D3, p.69
Cleanroom Design Considerations
The following list describes important design criteria
for cleanrooms
5
:
• 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.
• 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.
5. USP<797> Pharmaceutical Compounding - Sterile
Preparations, Proposed Revision – September 2015.