Guidance for Industry - Sterile Drug Products Produced by Aseptic Processing : Current
Good Manufacturing Process - U.S. Department of Health and Human Services
A. Acronym: NIOSH
B. Used for: __________ - A. National Institute of Occupational Safety and Health
IEST-RP-CC013.2 - Calibration Procedures and Guidelines for Select Equipment Used
in Testing Cleanrooms and Other Controlled Environments
IEST-RP-CC034.3 - HEPA and ULPA Filter Leak Tests
ISO 14644-1 - Cleanroom and Associated Controlled Environments - Classification of
Air Cleanliness by Particle Concentration
ISO 14644-2 - Cleanroom and Associated Controlled Environments - Monitoring to
Provide Evidence of Cleanroom Performance Related to Air Cleanliness by Particle
Concentration
ISO 14644-3 - Cleanroom and Associated Controlled Environments - Test Methods
,ISO 14644-4 - Cleanroom and Associated Controlled Environments - Design,
Construction and Start-up
ISO - International Organization of Standards
CETA - Controlled Environment Testing Association
CAG - Certification Application Guide
IEST - Institute of Environmental Sciences and Technology
USP - United States Pharmacopeia
FDA - Food and Drug Administration
HEPA - High Efficiency Particulate Air
PEC - Primary Engineering Control
DCA - Direct Compounding Area
SOP - Standard Operating Procedure
LAFW - Laminar Air Flow Workbench
cfu - Colony-forming Unit(s)
BUD - Beyond-Use Date
ACPH - Air Changes per Hour
BSC - Biological Safety Cabinet
TSA - Trypticase Soy Argar
FPM - Feet per Minute
CFM - Cubit Feet per Minute
ug/L - Micro-Grams per Liter
µm - Micron
dB - Decibel
DP - Differential Pressure
, CACI - Compounding Aseptic Containment Isolator
CAI - Compounding Aseptic Isolator
OSHA - Occupational Safety and Health Administration
ASHP - American Society of Hospital Pharmacists
Critical aArea a- a aISO a5 aEnvironment
How aoften, aat aa aminimum, ashould aBuffer aRoom afloors abe acleaned?
A. aDaily
B. aWeekly
C. aHourly
D. aYearly a- a aA. aDaily
How aoften, aat aa aminimum, ashould aAnte aRoom afloors abe acleaned?
A. aDaily
B. aWeekly
C. aHourly
D. aYearly a- a aA. aDaily
How aoften, aat aa aminimum, ashould aBuffer aRoom aShelves abe acleaned?
A. aDaily
B. aWeekly
C. aMonthly
D. aYearly a- a aC. aMonthly
How aoften, aat aa aminimum, ashould aBuffer aRoom aceilings abe acleaned?
A. aDaily
B. aMonthly
C. aHourly
D. aYearly a- a aB. aMonthly
How aoften, aat aa aminimum, ashould aBuffer aRoom awalls abe acleaned?
A. aDaily
B. aWeekly
C. aHourly
D. aMonthly a- a aD. aMonthly
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