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CETA Study Guide Incomplete

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CETA Study Guide (Incomplete) Servicing Hazardous Drug Compounding Primary Engineering Controls Compounding Isolator Testing Guide Secondaring Engineering Controls - Matrix for Sterile Compounding Facilities USP 797 Viable Environmental Sampling & Gowning Evaluation U.S. Department of Health and Human Services A. National Institute of Occupational Safety and Health B. Hazardous Drugs List HEPA & ULPA Filters Unidirectional-Flow & Clean-Air Devices Testing Cleanrooms Calibration Procedures and Guidelines for Select Equipment Used in Testing Cleanrooms and Other Controlled Environments HEPA and ULPA Filter Leak Tests Cleanroom and Associated Controlled Environments - Classification of Air Cleanliness by Particle Concentration Cleanroom and Associated Controlled Environments - Monitoring to Provide Evidence of Cleanroom Performance Related to Air Cleanliness by Particle Concentration Cleanroom and Associated Controlled Environments - Test Methods Cleanroom and Associated Controlled Environments - Design, Construction and Start-up International Organization of Standards Controlled Environment Testing Association Certification Application Guide Institute of Environmental Sciences and Technology United States Pharmacopeia Food and Drug Administration High Efficiency Particulate Air Primary Engineering Control Direct Compounding Area Standard Operating Procedure Laminar Air Flow Workbench Colony-forming Unit(s) Beyond-Use Date Air Changes per Hour Biological Safety Cabinet

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CETA Study Guide (Incomplete)

1). Servicing hazardous drug compounding primary engineering controls

 Ans: CAG-005-2007


2). Compounding isolator testing guide

 Ans: CAG-002-2006


3). Secondaring engineering controls - matrix for sterile compounding facilities

 Ans: CAG-008-2010


4). Usp 797 viable environmental sampling & gowning evaluation

 Ans: CAG-009-00


5). U.s. department of health and human services

 Ans: Guidance for Industry - Sterile Drug Products Produced by Aseptic Processing :
Current Good Manufacturing Process


6). A. national institute of occupational safety and health

b. hazardous drugs list

 Ans: A. Acronym: NIOSH
B. Used for: __________


7). Hepa & ulpa filters

 Ans: IEST-RP-CC001.5




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, 8). Unidirectional-flow & clean-air devices

 Ans: IEST-RP-CC002.3


9). Testing cleanrooms

 Ans: IEST-RP-CC006.3


10). Calibration procedures and guidelines for select equipment used in testing cleanrooms
and other controlled environments

 Ans: IEST-RP-CC013.2


11). Hepa and ulpa filter leak tests

 Ans: IEST-RP-CC034.3


12). Cleanroom and associated controlled environments - classification of air cleanliness by
particle concentration

 Ans: ISO 14644-1


13). Cleanroom and associated controlled environments - monitoring to provide evidence of
cleanroom performance related to air cleanliness by particle concentration

 Ans: ISO 14644-2


14). Cleanroom and associated controlled environments - test methods

 Ans: ISO 14644-3


15). Cleanroom and associated controlled environments - design, construction and start-up

 Ans: ISO 14644-4


16). International organization of standards

 Ans: ISO


17). Controlled environment testing association



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,  Ans: CETA


18). Certification application guide

 Ans: CAG


19). Institute of environmental sciences and technology

 Ans: IEST


20). United states pharmacopeia

 Ans: USP


21). Food and drug administration

 Ans: FDA


22). High efficiency particulate air

 Ans: HEPA


23). Primary engineering control

 Ans: PEC


24). Direct compounding area

 Ans: DCA


25). Standard operating procedure

 Ans: SOP


26). Laminar air flow workbench

 Ans: LAFW


27). Colony-forming unit(s)



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