List of Common Cleanroom Acronyms
This page provides definitions and explanations for key cleanroom-related terms and acronyms. Whether you're looking for industry standards, equipment definitions, or regulatory terms, this glossary will help you navigate the cleanroom environment.
ACPH - Air Changes Per Hour
API - Active Pharmaceutical Ingredient
AHCA - Agency of Health Care Administration
BI - Barrier Isolator
AHU - Air Handling Unit
BI - Barrier Isolator
BSC - Biological Safety Cabinet
BUD - Beyond Use Date
CAI - Compounding Aseptic Isolator
CACI - Compounding Aseptic Containment Isolator
C PEC - Containment Primary Engineering Control
C SEC - Containment Secondary Engineering Control
CDC - Centers for Disease Control and Prevention
CSP - Compound Sterile Preparation
CVE - Containment Ventilated Enclosure
DCA - Direct Compounding Area
FDA - Food and Drug Administration
HD - Hazardous Drug
HEPA - High-Efficiency Particulate Air
HVAC - Heating Ventilation and Air Conditioning
IPA - Isopropyl Alcohol
ISO - International Organization of Standardization
ISO# - Particle Count Rating
LAFW - Laminar Air Flow Workbench
LOD - Line of Demarcation
NIOSH - National Institute for Occupational Safety and Health
NIST - National Institute for Standards and Technology
PPE - Personnel Protective Equipment
SAR - Small Acrylic Room
SOP - Standard Operating Procedure
USP - United States Pharmacopeia
Cleanroom Glossary
This section defines key terms related to cleanroom environments, air control, and regulatory compliance.
Air Lock
A space of separation between two different air pressures; may be a pass-through chamber or room; a door must be present to prevent loss of pressure in the high pressured room.
Air Pressure
Can be either positive or negative; positive air pressure environments may only be used for nonhazardous sterile preparations. Negative pressure environments can be used to prepare both hazardous and non-hazardous sterile preparations.
Acrylic Return
Takes air from room and recycles it back through HEPA filters to reduce the demand/ size of air handling unit (AHU) needed by almost half.
Ante-Area
An ISO Class 8 or better area where personnel hand hygiene and garbing procedures, staging of components, order entry, CSP labeling, and other high particulate generating activities are performed. It is also a transition area that provides assurance that pressure relationships are constantly maintained so that air flows from clean to dirty areas and reduced the need for the HVAC control system to respond to large disturbances.
Buffer Area
An area where the primary engineering control (PEC) is physically located. Activities that occur in this area include the preparation and staging of components and supplies used when compounding CSP’s.
Cleanroom
(also see definition of buffer area) a room in which the concentration of airborne particles is controlled to meet a specified airborne particulate cleanliness class. Microorganisms in the environment are monitored so that a microbial level for air, surface, and personnel gear are not exceeded for a specified cleanliness class.
Critical Area
An ISO Class 5 environment
Externally Vented
Exhausted to the outside
Negative Pressure Room
A room that is at a lower pressure than the adjacent spaces, and therefore, the net airflow is into the room
Passthru
An enclosure with interlocking doors that is positioned between two spaces for the purpose of reducing particulate transfer while moving materials from one space to another. A passthru serving negative-pressure rooms needs to be equipped with sealed doors.
Positive Pressure Room
A room that is at a higher pressure than the adjacent spaces, and therefore, the net airflow is out of the room
Segregated Compounding Area
A designated space, either a demarcated area or room, that is restricted to preparing low-risk level CSP’s with 12-hour or less BUD.
