Basic Documentation

Page 2 of 8 Siemens Industry, Inc.
Document No. 149-224
USP <797> divides CSPs into two classifications:
Category 1 and Category 2 preparations. The
definition and requirements are as follows:
Category 1:
• Category 1 CSPs are those with an assigned
beyond-use date (BUD) of 12 hours or less at
controlled room temperature or 24 hours or less
if refrigerated.
• Category 1 CSPs must be prepared in a primary
engineering control (PEC) which provides an
ISO Class 5 environment. The PEC may be
located in an ISO Class 7 buffer area (see
category 2 requirements) or in a segregated
compounding area (SCA).
• An SCA is a designated, unclassified space,
area, or room in which a PEC is located for the
purpose of preparing category 1 CSPs.
Category 2:
• Category 2 CSPs are those with an assigned
BUD of greater than 12 hours at controlled room
temperature or greater than 24 hours if
refrigerated.
• Category 2 CSPs must be prepared in a PEC
which provides an ISO Class 5 environment.
The PEC must be located in a designated
operational clean area which includes an ante-
area and a buffer area.
Equipment (Primary Controls)
Although the ventilation system designer does not
normally select the type of ventilated cabinets that
are used within the compounding area, the designer
must know the type of protection (personnel,
product, and/or environment) provided by the units.
This knowledge ensures that the ventilation system
design will address the exhaust and makeup air
requirements of these cabinets.
Cabinets provide a constant, even airflow that
creates a barrier across the face of the work area
while also maintaining a constant flow inside the
cabinet.
ISO Class 5 Environment
2
–USP <797> requires
that CSP preparation take place in an ISO Class 5
PEC. This requirement means that airflow within the
PEC uses HEPA filters to remove any particles.
PEC Types Description
BioSafety
Cabinet
(BSC)
A ventilated cabinet with unidirectional
HEPA-filtered airflow and HEPA-filtered
exhaust to protect the worker from
hazardous drugs
Compounding
Aseptic
Isolator (CAI)
A type of restricted-access barrier
system (RABS) that uses HEPA
filtration to provide an ISO Class 5
clean-air environment designed for the
compounding of sterile non-hazardous
drugs
Compounding
Aseptic
Containment
Isolator
(CACI)
A type of RABS that uses HEPA
filtration to provide an ISO Class 5
clean-air environment designed for the
compounding of sterile hazardous
drugs
Isolator An enclosure that provides HEPA-
filtered ISO Class 5 unidirectional air
operated at a continuously higher
pressure than its surrounding
environment and decontaminated using
an automated system
Laminar
Airflow
System
(LAFS)
A device or zone within a buffer area
that provides an ISO Class 5 or better
environment for sterile compounding;
the system provides a unidirectional
HEPA-filtered airflow
Laminar
Airflow
Workbench
(LAFW)
A device that is a type of LAFS that
provides an ISO Class 5 or better
environment for sterile compounding;
the device provides a unidirectional
HEPA-filtered airflow
Restricted-
Access
Barrier
System
(RABS)
An enclosure that provides HEPA-
filtered ISO Class 5 unidirectional air
and that allows for the ingress and/or
egress of materials through defined
openings that have been designed and
validated to preclude the transfer of
contamination and that generally are
not to be opened during operations
2. Classification of air cleanliness; ISO Class 5 is equivalent to
100 particles per ft
3
or 3520 particles per m
3
of 0.5 µm per
m
3
or larger.