C. DEFINITIONS:
1. According to ISO, a clean room is defined as "a room in which the concentration of airborne
particles is controlled, and which is constructed and used in a manner to minimize the
introduction, generation, and retention of particles inside the room, and in which other
relevant parameters, e.g., temperature, humidity, and pressure, are controlled as necessary."
Refer to USP<797> Pharmaceutical Compounding Sterile Preparations, Pharmacy Design
Briefing Document for this definition.
2. Refer to USP 797 Pharmacy Design Briefing Document @ http://vaww.ceosh.med.va.gov,
for helpful information listed under Pharmacy Safety for ISO Class 5, Class 7 and Class 8
Clean rooms.
3. Air lock: A small room or space ("pass-through" chamber or window) between two rooms of
different air pressure, with interlocked doors (one tightly closed at all times) to prevent loss of
pressure in the higher pressure room.
D. DISCUSSION:
USP 797 issued in January 2004 describes three risk levels defined by the complexity of the
compounding process, namely Low, Medium and High risk level compounding, all of which
require that work involving the sterile compounding shall take place under International
Organization for Standardization (ISO) Class 5 conditions within a buffer area that should be
ISO Class 7 with appropriate air conditioning and humidity controls in place in the buffer area
environment. These standards are to be exemplified in every category. Class 5 environments
require hundreds of air changes of HEPA filtered air, stringent gowning and masking
requirements, Anteroom etc. The Class 5 environment is achievable in four ways:
Option 1: Provide a Class 5 Clean room.
Option 2: Provide a Class 5 critical area (laminar flow hood area) within a Class 7 Clean buffer
room (deals with much lower standard of air particulates), in which all sterile compounding
work takes place within a laminar airflow work station (LAFW). The LAFW is a biological safety
cabinet with HEPA air supplied over the working surface. The anteroom or support area, which
is outside the buffer area, should be ISO Class 8.
Option 3: Perform all sterile compounding within Primary Air Flow Barriers (PAFBs). PAFBs
are glove-box enclosures similar to totally enclosed biological safety cabinets.
Option 4: Consider use of a portable clean room.
E. RECOMMENDATIONS:
1. Determine the risk level of compounding typically performed within the pharmacy (Low,
Medium or High) and the volume of work to be accomplished at peak periods. The medical
centers can perform this essential task with guidance from the Workgroup and Chief of
Pharmacy. Consider Options 1-4 for their impact on ventilation and architectural issues.
2. Review material shown under `REFERENCES' below.
3. Option 1, Class 5 clean rooms will be a very difficult option to follow, primarily due to the
severe operational difficulties associated with gowning, masking, scrubbing, very high rate of
air changes and the high cost of the HVAC and architectural features. More importantly, if the
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