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 4 of 8 Siemens Industry, Inc.
Document No. A6V11520001
If facilities are designed with ante-areas and buffer
areas, those areas must be separate from the
general pharmacy and must control for these
environmental conditions:
• Particle count
• Temperature
• Humidity
• Differential pressure (D/P)
• Air changes
Buffer and Ante-Area Requirements
The environment is designed to have the C-PEC
located in the buffer area (negative pressure). An
anteroom (positive pressure) adjacent to the buffer
area provides a clean area for donning personnel
barriers, such as hair covers, gloves, gowns, shoe
coverings, or other cleanroom attire.
The compounding area must be designed to
facilitate the safe movement of personnel,
equipment, and components without disruption of
the air flow or air quality.
The temperature must not exceed 68°F (20°C) and
humidity must not exceed 60% in the buffer area.
Access to the area must be controlled.
The C-PEC must be located so that it is not affected
by air currents or streams from HVAC, personnel, or
doors.
The ISO-class rooms must be physically separated,
with walls and doors between them and with controls
to prevent the flow of lower-quality air into the
controlled area.
ISO 7 areas must have at least 30 ACPH, and at
least 15 ACPH must be HEPA-filtered fresh air.
There must be a D/P of negative 0.01 to 0.03 inches
wc between the buffer and all adjacent spaces.
There must be a D/P of at least 0.02 inches wc
between the ante-room and the pharmacy or
unclassified area.
D/P shall be recorded daily (every shift
recommended).
Surfaces must be smooth, impervious, free of cracks
and crevices, and non-shedding. Walls must be
constructed of durable material.
Supply Air
Supply air is provided to the space through HEPA
filters which make the supply air virtually free from
contaminants. While HEPA filters are effective in
removing most particulate contamination, they are
not effective in removing gases and vapors. For this
reason, the National Institute for Occupational
Safety and Health (NIOSH) requires that BSCs and
isolators used for volatile drugs be externally vented.