With Answers
CAG-002-2006 - ANSWER- Compounding Isolator Testing Guide
CAG-005-2007 - ANSWER- Servicing Hazardous Drug Compounding Primary
Engineering Controls
CAG-008-2010 - ANSWER- Secondaring Engineering Controls - Matrix for Sterile
Compounding Facilities
CAG-009-00 - ANSWER- USP 797 Viable Environmental Sampling & Gowning
Evaluation
Guidance for Industry - Sterile Drug Products Produced by Aseptic Processing : Current
Good Manufacturing Process - ANSWER- U.S. Department of Health and Human
Services
A. Acronym: NIOSH
B. Used for: __________ - ANSWER- A. National Institute of Occupational Safety and
Health
B. Hazardous Drugs List
IEST-RP-CC001.5 - ANSWER- HEPA & ULPA Filters
IEST-RP-CC002.3 - ANSWER- Unidirectional-Flow & Clean-Air Devices
IEST-RP-CC006.3 - ANSWER- Testing Cleanrooms
IEST-RP-CC013.2 - ANSWER- Calibration Procedures and Guidelines for Select
Equipment Used in Testing Cleanrooms and Other Controlled Environments
IEST-RP-CC034.3 - ANSWER- HEPA and ULPA Filter Leak Tests
ISO 14644-1 - ANSWER- Cleanroom and Associated Controlled Environments -
Classification of Air Cleanliness by Particle Concentration
ISO 14644-2 - ANSWER- Cleanroom and Associated Controlled Environments -
Monitoring to Provide Evidence of Cleanroom Performance Related to Air Cleanliness
by Particle Concentration
ISO 14644-3 - ANSWER- Cleanroom and Associated Controlled Environments - Test
Methods
,ISO 14644-4 - ANSWER- Cleanroom and Associated Controlled Environments -
Design, Construction and Start-up
ISO - ANSWER- International Organization of Standards
CETA - ANSWER- Controlled Environment Testing Association
CAG - ANSWER- Certification Application Guide
IEST - ANSWER- Institute of Environmental Sciences and Technology
USP - ANSWER- United States Pharmacopeia
FDA - ANSWER- Food and Drug Administration
HEPA - ANSWER- High Efficiency Particulate Air
PEC - ANSWER- Primary Engineering Control
DCA - ANSWER- Direct Compounding Area
SOP - ANSWER- Standard Operating Procedure
LAFW - ANSWER- Laminar Air Flow Workbench
cfu - ANSWER- Colony-forming Unit(s)
BUD - ANSWER- Beyond-Use Date
ACPH - ANSWER- Air Changes per Hour
BSC - ANSWER- Biological Safety Cabinet
TSA - ANSWER- Trypticase Soy Argar
FPM - ANSWER- Feet per Minute
CFM - ANSWER- Cubit Feet per Minute
ug/L - ANSWER- Micro-Grams per Liter
µm - ANSWER- Micron
dB - ANSWER- Decibel
, DP - ANSWER- Differential Pressure
CACI - ANSWER- Compounding Aseptic Containment Isolator
CAI - ANSWER- Compounding Aseptic Isolator
OSHA - ANSWER- Occupational Safety and Health Administration
ASHP - ANSWER- American Society of Hospital Pharmacists
Critical Area - ANSWER- ISO 5 Environment
How often, at a minimum, should Buffer Room floors be cleaned?
A. Daily
B. Weekly
C. Hourly
D. Yearly - ANSWER- A. Daily
How often, at a minimum, should Ante Room floors be cleaned?
A. Daily
B. Weekly
C. Hourly
D. Yearly - ANSWER- A. Daily
How often, at a minimum, should Buffer Room Shelves be cleaned?
A. Daily
B. Weekly
C. Monthly
D. Yearly - ANSWER- C. Monthly
How often, at a minimum, should Buffer Room ceilings be cleaned?
A. Daily
B. Monthly
C. Hourly
D. Yearly - ANSWER- B. Monthly
How often, at a minimum, should Buffer Room walls be cleaned?
A. Daily
B. Weekly
C. Hourly
D. Monthly - ANSWER- D. Monthly