CETA Study Guide with correct Answers, Exams of Advanced Education

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CETA Study Guide with correct 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 How often, at a minimum, should Ante Room Counters be cleaned? A. Daily B. Weekly C. Hourly D. Yearly - Answer - A. Daily How often, at a minimum, should ISO Classification 5 environments be cleaned? A. Beginning of each shift B. Every 30 minutes when compounding C. After Spills D. All of the above - Answer - D. All of the above How are Risk Levels Classified? A. Red, Yellow, Blue B. Low, Medium, High C. Sterile, Non-Sterile, Hazardous D. None of the above - Answer - B. Low, Medium, High Who determines Risk Level? A. Certification Technician/Professional B. Pharmacy Director / Manager C. USP D. None of the above - Answer - B. Pharmacy Director / Manager Two Types of Air Sampling Include? A. Sterile, Non-Sterile B. Pre-Compounding, Post-Compounding C. Active, Passive D. None of the above - Answer - C. Active, Passive Which Type of Air Sampling is NOT Complaint with USP 797? A. Passive B. Active

C. Impaction D. Dual Method - Answer - A. Passive What Type of sampling requires plates to contain neutralizers for cleaning chemicals? A. Air B. Control C. Surface D. None of the Above - Answer - C. Surface When doing environmental air sampling, what are the lower and upper limits for air volume? A. 600 - 1100 CFM B. 500 - 1000 M^ C. 400 - 1000 L D. Must be 1000L - Answer - C. 400 - 1000L Environmental Monitoring Reports must report down to? A. Genus Level B. Speciation Level C. Colony Level D. Genius Level - Answer - A. Genus Level When, at a minimum, must your gloves be disinfected when performing environmental air sampling? A. Once every 3x Samples B. Once every 10 Minutes C. Once ever 6x Samples D. Once every Sample - Answer - D. Once every Sample When, at a minimum, must your gloved be disinfected when performing environmental surface sampling? A. Once every Sample B. Once every 5-6 Samples C. Once every 10 Minutes D. Once every 3x Samples - Answer - B. Once every 5-6 samples Which type of sampling plate MUST be used when using the Single Plate Method? A. GMA B. SDA C. TSA

D. MDA - Answer - C. TSA How many cfu are allowed during Finger Tip Gowning Validation? A. < B. 1 - 3 C. 0 D. <5 - Answer - C. 0 cfu limit for environmental AIR samples taken from an ISO 5 environment? A. <3 cfu/m^ B. 0 cfu/m^ C. <1 cfu/m^ D. None of the above - Answer - C. <1 cfu/m^ cfu limit for environmental SURFACE samples taken from an ISO 5 environment is? A. <3 cfu B. 0 cfu C. <1 cfu D. None of the above - Answer - A. <3 cfu cfu limit for environmental SURFACE samples taken from an ISO 8 environment is? A. <1 cfu B. <10 cfu C. <100 cfu D. None of the above - Answer - C. <100 cfu cfu limit for environmental SURFACE samples taken from an ISO 7 environment is? A. <5 cfu B. <1 cfu C. <50 cfu D. None of the above - Answer - A. <5 cfu cfu limit for environmental AIR samples taken from an ISO 7 environment is? A. <1 cfu/m^ B. <10 cfu/m^ C. <100 cfu/m^ D. None of the above - Answer - B. <10 cfu/m^ cfu limit for environmental AIR samples taken from an ISO 8 environment is?

A. <1 cfu/m^ B. <10 cfu/m^ C. <100 cfu/m^ D. None of the above - Answer - C. <100 cfu/m^ Environmental samples taken using the single plate method, should be incubated at 30 celsius - 35 celsius for how long? A. 48 - 72 hours B. 2 - 4 days C. 24 hours D. 7 days - Answer - A. 48 - 72 hours Environmental samples taken using the single plate method, should be incubated at 26 celsius - 30 celsius for how long? A. 24 - 48 hours B. 3 - 5 days C. 72 hours D. 5 - 7 days - Answer - D. 5 - 7 days Environmental samples taken using the duplicate plate method, when looking for bacterial growth, should be incubated under which of the following conditions? A. 30 celsius - 35 celsius for 48 - 72 hours B. 0 celsius - 10 celsius for 2 days C. 30 celsius - 35 celsius for 3 - 5 days D. Slightly above room temperature for 7 days - Answer - A. 30 celsius - 35 celsius for 48 - 72 hours How must all sampling plates be packaged, shipped, and incubated? A. Frozen B. Concaved C. Inverted D. Sterile - Answer - C. Inverted Viable air samples are expressed in? A. Ft^3/Minute B. FPM C. cfu D. cfu/M^3 - Answer - D. cfu/M^ Viable surface samples are expressed in?

A. FPM

B. cfu/plate C. cfu/lot D. cfu/column - Answer - B. cfu/plate When creating a viable environmental monitoring sampling plan, where should samples be taken? A. Critical Areas B. Direct Compounding Areas C. Backwash Areas D. All of the above - Answer - D. All of the above Viable environmental sampling shall be taken in all PEC? A. True B. False - Answer - A. True Selected sampling sites shall include locations within each ISO class 5 environment, ISO class 7 environment, ISO 8 environment, segregated compounding areas at greatest risk of contamination, counters near doors, & pass-through boxes. A. True B. False - Answer - A. True When conducting viable environmental sampling in an isolator, samples shall be taken in the following locations: A. Main Chamber, Ante Chamber B. Just Main Chamber C. Main Chamber, Ante Chamber, Outside the Isolator D. Only on Isolator Glove Finger Tips - Answer - C. Main Chamber, Ante Chamber, Outside the Isolator Recovery of any mold, yeast, coagulase positive staphylococcus or gram negative rods in any area in considered to not be in compliance with USP 797. A. True B. False C. None of the above - Answer - A. True How often, at a minimum, should control samples be supplied during viable environmental monitoring if all samples are taken within the same day? A. Once for each type/lot number B. Once per client

C. Once per Room D. None of the above - Answer - A. Once for each type/ lot number At a minimum, how often should viable environmental monitoring be performed in a USP 797 environment? A. Annually B. Semi- Annually C. Monthly D. Daily - Answer - B. Semi-Annually Viable, AIR , environmental monitoring may take place while pharmacy competency testing is being performed? A. True B. False - Answer - A. True Viable, SURFACE , environmental monitoring may take place while pharmacy competency testing is being performed? A. True B. False - Answer - B. False All of the following are generally included in the Chain of Custody or Sample Plan for viable environmental monitoring, EXCEPT? A. Date & Time of sampling B. ISO Classification C. Media Type, Lot Number, Expiration Date D. Barometric Pressure at time of testing - Answer - D. Barometric Pressure at time of testing Test Reports for viable environmental monitoring must include all of the following, EXCEPT? A. Total Microbial Count B. Results showing Mold, Yeast, Gram Negative Rods, or Coagulase Positive Staphylococcus C. Photo of control plates D. ID of organisms to Genus Level - Answer - C. Photo of control plates Jewelry, Hats, & Make-Up are allowed in all ISO Classified environments, EXCEPT for ISO-Class 5. A. True B. False - Answer - B. False

Except for new construction of cleanrooms, viable sampling should be conducted prior to other testing criteria. A. True B. False - Answer - A. True Viable samples should be taken from least clean to the cleanest. A. True B. False - Answer - B. False ISO Classification 5 environments should be cleaned and disinfected at the beginning of each shift, before each batch, no longer than 30 minutes from previous disinfection when ongoing compounding activities are occurring, after spills, and when surface contamination is known or suspected. A. True B. False - Answer - A. True What is the required minimum ACPH, as specified by USP 797, in a non-hazardous, non-sterile, ISO Class 8, Ante-Room? A. 10 ACPH B. 20 ACPH C. 30 ACPH D. None of the above - Answer - D. None of the above (FDA Recommendation is 20 ACPH) What is the required minimum ACPH, as specified by USP 797, in a hazardous, sterile, ISO Class 7 Ante-Room, serving a negative pressure Buffer Room? A. 35 ACPH B. 30 ACPH C. 25 ACPH D. 20 ACPH - Answer - B. 30 ACPH What is the required minimum ACPH, as specified by USP 797, in a non-hazardous, sterile, ISO Class 7, Buffer Room? A. 5 ACPH B. 12 ACPH C. 20 ACPH D. 30 ACPH - Answer - D. 30 ACPH A room containing a CACI, per USP 797, must have a minimum ACPH of?

A. 3 ACPH

B. 10 ACPH

C. 12 ACPH

D. 15 ACPH - Answer - C. 12 ACPH Hazardous Sterile Compounding Rooms must have _____ ACPH, but are allowed to include a maximum of ______ ACPH from PEC. A. 25 ACPH, 5 ACPH B. 15 ACPH, 7 ACPH C. 30 ACPH, 15 ACPH D. 15 ACPH, 30 ACPH - Answer - C. 30 ACPH, 15 ACPH Is there a minimum requirement on how many ACPH must come from outside the room in a Non-Hazardous Sterile Buffer Room? If so, how many are required? A. No B. Yes, 5 ACPH C. Yes, 15 ACPH D. Yes, 20 ACPH - Answer - C. Yes, 15 ACPH What is the formula for determining ACPH of HEPA filtered air? A. Total FPM x 60 / Ft^ B. Total CFM x 60 / Ft^ C. Avg. CFM x 60 / Ft^ D. Total CFM x 60 / Ft^3 - Answer - D. Total CFM x 60 / Ft^ What is the minimum differential pressure requirement between a positive pressure buffer room and its associated ante room? A. +0.001 wc B. - 0.010 wc C. +0.020 wc D. None of the above - Answer - C. +0.020 wc What is the minimum differential pressure requirement between a negative pressure buffer room and its associated ante room? A. - 0.009 wc B. - 0.010 wc C. - 0.020 wc D. None of the above - Answer - B. - 0.010 wc

What is the minimum differential pressure requirement between a non-hazardous ante room and its associated unclassified space? A. +0.001 wc B. +0.010 wc C. +0.020 wc D. None of the above - Answer - C. +0.020 wc What is the minimum differential pressure requirement between a hazardous ante room and its associated unclassified space? A. - 0.020 wc B. +0.020 wc C. +0.010 wc D. None of the above - Answer - B. +0.020 wc What is the minimum displacement velocity in a door opening between a hazardous buffer room and its associated ante room? A. 10 FPM B. 20 FPM C. 40 FPM D. None of the above - Answer - D. None of the above What is the minimum displacement velocity in a door opening between a high risk non- hazardous buffer room and its associated ante room? A. 10 FPM B. 20 FPM C. 40 FPM D. None of the above - Answer - D. None of the above What is the minimum displacement velocity in a door opening between a low-medium risk non-hazardous buffer room and its associated ante room? A. 10 FPM B. 20 FPM C. 40 FPM D. None of the above - Answer - C. 40 FPM All velocity readings taken during a displacement velocity test, must meet the following requirement: A. Greater than or equal to 40 FPM B. 40 FPM, +/- 10% of average velocity C. 25 FPM, 20 FPM Min. - 100 FPM Max.

D. None of the above - Answer - A. Greater than or equal to 40 FPM How many test methods are there for visual airflow characterization testing? A. 4 B. 2 C. 3 D. 1 - Answer - B. 2 The name for one method of visual airflow characterization testing is? A. Constant Flow B. Dispersion String Test C. Turbulent Theory Test D. None of the above - Answer - B. Dispersion String Test Dispersion String Test is suitable for horizontal unidirectional airflow situations. A. True B. False - Answer - B. False (Only vertical unidirectional situations) The name for the other method of visual airflow characterization testing is? A. Constant Flow B. Aerosol Dispersion Test C. Turbulent Theory Test D. None of the above - Answer - B. Aerosol Dispersion Test The visual airflow characterization test is acceptable to both non-unidirectional and unidirectional airflow situations. A. True B. False - Answer - B. False All readings in excess of 14 degrees offset are a matter between customer and supplier. A. True B. False - Answer - A. True A hazardous buffer room that measures 40 ft x 100ft x 9 ft has how many particle count locations per ISO 14644:2015? A. 16 B. 25 C. 20 D. 11 - Answer - B. 25

A non-hazardous ante room has 11 particle count locations, per ISO 14644:2015, what is the area of the room? A. 30 Ft^ B. 56 M^ C. 97 M^ D. 400 Ft^2 - Answer - B. 56 M^ The number of particle count locations for an area exceeding 1000M^2 can be found on the ISO 14644:2015 Particle Count Location Chart A.1. A. True B. False - Answer - B. False What is the technical name of the device used to sample particles? A. Light Scattering Discrete Airborne Particle Counter B. Mass Volume Particle Counter C. Laser Emitting Particle Separating Counter D. None of the above - Answer - A. Light Scattering Discrete Airborne Particle Counter What is the limit of 0.5um particles in an ISO Classification 5 environment? A. 35 B. 3520 C. 3525 D. 325 - Answer - B. 3520 What is the limit of 0.5um particles in an ISO Classification 7 environment? A. 3520 B. 352000 C. 352500 D. 30000 - Answer - B. 352000 What is the limit of 0.5um particles in an ISO Classification 8 environment? A. 35200 B. 3520000 C. 3525000 D. 300000 - Answer - B. 3520000 Minimum sampling volume of air during particle counting shall be? A. 10 CFM

B. 2 Liter C. 6M^ D. None of the above - Answer - B. 2 Liter Minimum time per sample per location during particle counting shall be? A. 2 Minutes B. 90 Seconds C. 1 Minute D. 59 Seconds - Answer - C. 1 minute Particle Counter Probe shall be where when testing? A. Work Plane B. 26" above floor C. Shoulder Height D. 3 " Above Particle Counter - Answer - A. Work Plane Particle Counting Sampling Probe shall be oriented in which direction, when airflow direction is known? A. Perpendicular to Airflow B. Downward C. Vertically Upward D. Into Airflow - Answer - D. Into Airflow When airflow direction is unknown or not controlled, which orientation shall the particle counting probe be positioned? A. Perpendicular to Airflow B. Downward C. Vertically Upward D. None of the above - Answer - C. Vertically Upward If an out-of-specification count is found at a location due to an identified abnormal occurrence, then that count can be discarded and noted as such on the test report and new sample taken. A. True B. False - Answer - A. True How old is Mike, Really? A. 4 B. 15 C. 51

D. 137

E. None of the above, Mike forgot - Answer - E. None of the above, Mike forgot Critical Site is defined as: "A location that includes any component or fluid pathway surfaces (e.g. vial septa, injection ports, beakers) or openings (e.g. opened ampule. needle hubs) exposed and at risk of direct contact with air (e.g. ambient room or HEPA filtered), moisture (e.g. oral and mucosal secretions), or touch contamination. Risk of microbial particulate contamination of the critical site increases with the size of the openings and exposure time" A. True B. False - Answer - A. True Unidirectional Airflow is defined as: " An airflow moving in a single direction in a robust and uniform manner and at a sufficient speed to reproducibly sweep particles away from the critical processing or testing area" A. True B. False - Answer - A. True A thermal Anemometer is required to have an accuracy of what percentage? A. 2% or +/- 2 FPM whichever is greater B. 1% or +/- 1 FPM whichever is greater C. 3% or +/- 3 FPM whichever is greater D. 5% or +/- 5 FPM whichever is greater - Answer - C. 3% or +/- 3 FPM whichever is greater An Aerosol Photometer, as per CETA, should have the following parameters: " A calibrated Aerosol Photometer capable of indicting 100% upstream concentration with an aerosol of between 10 and 90 μg/L of polydispersed diotylphthalate (DOP), polyalphaolefin (PAO) or an equivalent fluid. Unit must have a threshold sensitivity of at least 10 μg/L and be capable of measuring concentrations over a range of 10^5 times the threshold sensitivity. The sampling rate shall be 1 CFM (28.3 lpm) (+/-100%) with an inlet probe having sufficient area (1.7 in^2) (11.0cm^2) as to maintain a probe inlet velocity of 90 fpm (0.46 m/s) or slightly higher." A. True B. Falsehood - Answer - A. True