CETA QUESTIONS WITH VERIFIED ANSWERS

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