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Exam (elaborations)

CETA Study Guide Exam Questions With Answers

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CETA Study Guide Exam Questions 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

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Institution
CETA
Course
CETA

Content preview

CETA Study Guide Exam Questions
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

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Institution
CETA
Course
CETA

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Uploaded on
October 3, 2023
Number of pages
16
Written in
2023/2024
Type
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Questions & answers

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