Guidance for Industry - Sterile Drug Products Produced by Aseptic Processing : Current Good
K
Manufacturing Process - ANS U.S. Department of Health and Human Services
A. Acronym: NIOSH
C
B. Used for: __________ - ANS A. National Institute of Occupational Safety and Health
B. Hazardous Drugs List
LO
IEST-RP-CC001.5 - ANS HEPA & ULPA Filters
IEST-RP-CC002.3 - ANS Unidirectional-Flow & Clean-Air Devices
YC
IEST-RP-CC006.3 - ANS Testing Cleanrooms
IEST-RP-CC013.2 - ANS Calibration Procedures and Guidelines for Select Equipment Used in
Testing Cleanrooms and Other Controlled Environments
IEST-RP-CC034.3 - ANS HEPA and ULPA Filter Leak Tests
D
ISO 14644-1 - ANS Cleanroom and Associated Controlled Environments - Classification of Air
Cleanliness by Particle Concentration
U
ISO 14644-2 - ANS Cleanroom and Associated Controlled Environments - Monitoring to
Provide Evidence of Cleanroom Performance Related to Air Cleanliness by Particle
ST
Concentration
ISO 14644-3 - ANS Cleanroom and Associated Controlled Environments - Test Methods
ISO 14644-4 - ANS Cleanroom and Associated Controlled Environments - Design,
Construction and Start-up
ISO - ANS International Organization of Standards
CETA - ANS Controlled Environment Testing Association
, CAG - ANS Certification Application Guide
IEST - ANS Institute of Environmental Sciences and Technology
USP - ANS United States Pharmacopeia
FDA - ANS Food and Drug Administration
HEPA - ANS High Efficiency Particulate Air
K
PEC - ANS Primary Engineering Control
DCA - ANS Direct Compounding Area
C
SOP - ANS Standard Operating Procedure
LO
LAFW - ANS Laminar Air Flow Workbench
cfu - ANS Colony-forming Unit(s)
BUD - ANS Beyond-Use Date
YC
ACPH - ANS Air Changes per Hour
BSC - ANS Biological Safety Cabinet
TSA - ANS Trypticase Soy Argar
D
FPM - ANS Feet per Minute
U
CFM - ANS Cubit Feet per Minute
ug/L - ANS Micro-Grams per Liter
ST
µm - ANS Micron
dB - ANS Decibel
DP - ANS Differential Pressure
CACI - ANS Compounding Aseptic Containment Isolator
CAI - ANS Compounding Aseptic Isolator
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