Study with the several resources on Docsity
Earn points by helping other students or get them with a premium plan
Prepare for your exams
Study with the several resources on Docsity
Earn points to download
Earn points by helping other students or get them with a premium plan
Community
Ask the community for help and clear up your study doubts
Discover the best universities in your country according to Docsity users
Free resources
Download our free guides on studying techniques, anxiety management strategies, and thesis advice from Docsity tutors
CETA EXAM 2024/2025 WITH 100% ACCURATE SOLUTIONS
Typology: Exams
1 / 75
If a segregated radiopharma processing area is used to elute radionuclides generators - Precise Answer ✔✔it must have ISO Class 8 particle count non-viable particle count air quality Category 1 CSP - Precise Answer ✔✔A CSP assigned a BUD of 12 hours or less at controlled room temperature or 24 hours or less refrigerated. Category 2 CSP - Precise Answer ✔✔A CSP assigned in a BUD of greater than 12 hours room temperature or greater than 24 hours refrigerated. Immediate use CSP - Precise Answer ✔✔Administration begins within 4 hrs following the start of the preparation. Must not involve more that 3 sterile products. Glove Fingertip Sampling - Precise Answer ✔✔One plate per hand, TSA to support bacterial and fungal growth, label each device, do not spray hands with IPA, Incubate 30-35 for 48 H and 20-25 for 5 days, record CFU, Determine if CFU action level is exceeded by counting the total number of CFU from both hands Media Fill Testing Procedure - Precise Answer ✔✔Simulate compounding activities if sterile to sterile use soybean-casein digest media, if non sterile use commerically available nonsterile soybean-
casein digest powder to make a 3% non-sterile solution. Preparer at least 1 container as a positive control. Once compounding simulations are completed perform gloved fingertip and thumb sampling on each hand and surface sample of DCA inside the PEC. Take samples prior to disinfecting. Incubate 20-25 and 30-35 for a minimum of 7 days at each temperature. Failure is indicated by visible turbidity or other growth in one more containers on or before 14 days. Action Level for Gloved fingertip and thumb sampling - Precise Answer ✔✔After Garbing greater than 0 CFU After media-fill testing greater than 3 CFU Action levels based on total CFU count from both hands Compounder - ongoing training and competency - Precise Answer ✔✔Training and Competency in compounding sterile principles - at least every 12 months Garbing Competency - Category 1 and 2 at least every 6 months, Category 3 every months Media Fill with Post GFT and Surface sampling - Category 1 and 2 at least every 6 months, Category 3 at least every 3 months
Designated Persons - ongoing training and competency - Precise Answer ✔✔Training and Competency in compounding sterile principles - at least every 12 months unless compounding Garbing Competency - At least every 12 months unless compounding Media Fill with Post GFT and Surface sampling -at least every 12 months unless compounding Personnel who restock or clean and disinfect the sterile compounding area- ongoing training and competency - Precise Answer ✔✔Defined by facilities SOP Handwashing procedures - Precise Answer ✔✔Clean under fingernails under warm running water using nail cleaner Wash hands and forearms up to elbows for 30 s. Dry hands and forearms up to elbows completely with low-lint disposable towels. Apply an alcohol-based hand rub to dry skin Apply product to one hand and rub hands together Allow hands to dry before donning sterile gloves
Minimum Garb requirements in category 2 and 3 - Precise Answer ✔✔Low Lint garment with sleves Low Lint shoe covers Low Lint cover for head and facial hair Low Lint face mask Sterile powder free gloves If using a RABS disposable gloves should be worn inside the RABS sleeves. Additional garbing requirements for category 3 - Precise Answer ✔✔No exposed skin in the buffer room (face/neck) All lo-lint outer garb must be sterile, including use of over gauntlet sleeves in the RABS Disposable garbing items must not be reused, laundered garb must not be reused without being laundered and re-sterilized with a validated cycle
Facilities SOPs must describe procedures for using goggles, respirators, and other reusable equipment ISO 7 Classification - Precise Answer ✔✔352,000 particle per cubic meter. Limits measured at greater than 0.5 micrometers under dynamic operating conditions ISO 5 Classification - Precise Answer ✔✔3,520 particle count per cubic meter. Limits measured at greater than 0.5 micrometers under dynamic conditions ISO 8 Classification - Precise Answer ✔✔3,520,000 particle count per cubic meter. Limits measured at greater than 0.5 micrometers under dynamic conditions Design Requirements to maintain air quality <USP 797> - Precise Answer ✔✔Anterooms providing access to positive-pressure buffer room must meet at least ISO Class 8 Anterooms providing access to negative-pressure buffer rooms must meet at least an ISO Class 7. A buffer room must meet at least ISO Class 7 air quality. Activities in the buffer room must be controlled to minimize any effect on air quality in the are where CSP are prepared
Category 1, Category 2, and Category 3 CSPs must be compounded in an ISO Class 5 or better PEC. If compounding only Category 1 CSP, the PEC may be placed in a Segregated Compounding Area What temperature and humidity level does the cleanroom suite need to be maintained? - Precise Answer ✔✔The cleanroom suite should be maintained at a temperature of 20 degrees or cooler and a relative humidity of 60% or below to minimize the risk of microbial proliferation and provide comfortable conditions for compounding personnel attired in required garb. How often must the temperature and humidity be monitored? - Precise Answer ✔✔The temp and humidity must be monitored each day that compounding is performed, either manually or by a continuous recording device. How often do temperature and humidity devices in the cleanroom suites need to be verified for accuracy? - Precise Answer ✔✔Every 12 months or verified by the mfg. Who at the facilities is responsible for ensuring that each area related to CSP preparations meets the classified air quality standard appropriate for the activities to be conducted in that area? - Precise Answer ✔✔Designated Person Where can a PEC be located? - Precise Answer ✔✔The PEC must be located in the buffer room or SCA in an a manner that minimizes conditions that could increase the risk of microbial contamination.
Describe a cleanroom suite <USP 797> - Precise Answer ✔✔The ISO classified anteroom and buffer must be separated from the surrounding unclassified areas of the facility by fixed walls and doors, and controls must be in place to minimize the flow of lower quality air into more controlled areas. The classified rooms must be equipped with pressure-differential monitoring systems. Air supplied to the cleanroom suite must be introduced through HEPA filters that are located in the ceiling of the buffer room and anteroom. Air returns must be low on the wall unless visual smoke study demonstrates an absence of stagnant airflow. The anteroom must have a line of demarcation to separate clean side from the dirty side. The anteroom is entered from dirty side and the clean side is closest to the buffer room. It is critical to control materials as they move from classified areas of lower quality to those of higher quality to minimize the influx of contaminants. Consider the placement of doors closures, door surfaces, and the movement of the doors, all of which can affect airflow.
Should seals and sweeps be installed at the doors between buffer rooms and anterooms? - Precise Answer ✔✔No Can tacky mats be placed within ISO classified areas? - Precise Answer ✔✔No If PECs used for sterile and non-sterile compounding are places in the same room, what is the distance they need to be apart? - Precise Answer ✔✔1 m apart, and particle generating activities must not be performed while sterile compounding is in process Do sterile and non-sterile PECs need to be in separate rooms? - Precise Answer ✔✔They must be in separate rooms unless those PECs are sufficiently effective that the room can continuously maintain ISO 7 SCA - Precise Answer ✔✔Segregated compounding area Describe a SCA according to USP <797> - Precise Answer ✔✔A PEC may be located within an unclassified area without an anteroom or buffer room Only Category 1 CSP may be compounded in an SCA The SCA must be located away from unsealed windows, doors that connect to the outdoors, and traffic flow, all of which may adversely affect air quality in the PEC
SCA must not be located where environmental control challenges could negatively affect air quality in the PEC. The impact of activities what will be conducted around or adjacent to the SCA must be considered when signing the area. The area within 1 m of the PEC should be dedicated only for sterile compounding activities. (not storage, hand hygiene, donning/doffing garb, or other particle generating activities) CSP Compounding Environment - Precise Answer ✔✔The PEC must be certified to meet ISO Class 5 or better conditions during dynamic operating conditions and must be designed to minimize risk of contamination during compounding of CSPs. Unidirectional airflow must e maintained in the PEC. HEPA filtered air must be supplied by the PEC at a velocity sufficient to sweep particles away from the critical sites and maintain unidirectional airflow during operations. Laminar airflow system - Precise Answer ✔✔An LAFS provides an ISO Class 5 or better environment for sterile compounding. The LAFS provides unidirectional HEPA-filtered airflow that is designed to minimize the risk of contamination of a sterile compounding environment. The unidirectional airflow within the LAFS helps protect the direct compounding area (DCA) from process-generated contaminatio
LAFW - Laminar Airflow Workbench - Precise Answer ✔✔Laminar airflow workbench (LAFW): An LAFW is a device that provides an ISO Class 5 or better environment for sterile compounding. The LAFW provides either horizontal or vertical unidirectional HEPA-filtered airflow IVLFZ - Precise Answer ✔✔Integrated Vertical Laminar Flow Zone Integrated Vertical Laminar Flow Zone (IVLFZ) - Precise Answer ✔✔An IVLFZ is a designated ISO Class 5 area serving as the PEC within an ISO Class 7 or cleaner buffer room. In the IVLFZ, unidirectional airflow is created by placing HEPA filters over the entire surface of the worktables and by effective placement of air returns. The unidirectional HEPA-filtered zone must be separated from the ISO Class 7 area with a physical barrier to direct the airflow downward over the work area to separate the DCA from potential sources of contamination. Strategic location of air returns in addition to full coverage of HEPA filters above the work surface is required. Both static and dynamic smoke studies verifying a continuous flow of HEPA-filtered air void of turbulence, dead air zones, and refluxing from the HEPA filters to and across the entire work area and to the air returns must be documented (e.g., with video). [NOTE—Dynamic airflow smoke pattern tests have shown that it is difficult to achieve this type of design and also achieve and maintain unidirectional airflow under dynamic operating conditions.] Class II biological safety cabinet (BSC) - Precise Answer ✔✔A Class II BSC is a ventilated cabinet with an open front and inward and
downward unidirectional HEPA-filtered airflow and HEPA-filtered exhaust. The BSC is designed to provide worker protection from exposure to airborne drugs and to provide an ISO Class 5 or better environment for preparing CSPs. [NOTE—The exhaust air from the BSC must be externally vented for preparation of antineoplastic and/or API HDs (see á800ñ).] Placement of LAFS - Precise Answer ✔✔The LAFS must be located out of traffic patterns and away from room air currents that could disrupt the intended airflow patterns inside the PEC. If used to prepare only Category 1 CSPs, the ISO Class 5 PEC may be located in an unclassified SCA. If used to prepare Category 2 or Category 3 CSPs, the LAFS must be located within a cleanroom suite with an ISO Class 7 or better buffer room with an ISO Class 8 or better anteroom. A dynamic airflow smoke pattern test must be performed in the PEC initially and at least every 6 months to ensure that 1) the LAFS is properly placed into the facility and 2) compounders understand how to utilize the unidirectional airflow to maintain first air in the DCA. RABS - Precise Answer ✔✔restricted access barrier system What is a Restricted-access barrier system? - Precise Answer ✔✔A RABS is an enclosure that provides HEPA-filtered ISO Class 5 unidirectional air. It allows for the ingress and/or egress of materials through defined openings that have been designed and validated to preclude the transfer of environmental air contamination and are generally not to be opened during compounding operations. RABS include compounding aseptic isolators (CAIs) and compounding aseptic containment isolators (CACIs). In a CAI or CACI, glove ports are used
to provide physical separation between the surrounding area and the aseptic manipulations. Compounding Aseptic Isolator (CAI) - Precise Answer ✔✔A CAI is designed for compounding non-HD CSPs. It is designed to maintain an ISO Class 5 environment throughout the compounding and material transfer processes. Air exchange into the CAI from the surrounding environment must not occur unless the air has first passed through a HEPA filter. Compounding Aseptic Containment Isolator (CACI) - Precise Answer ✔✔A CACI is designed to provide worker protection from exposure to undesirable levels of airborne drug throughout the compounding and material transfer processes and to maintain an ISO Class 5 environment for compounding sterile HD preparations Placement of RABS - Precise Answer ✔✔If used to prepare only Category 1 CSPs, the ISO Class 5 environment may be achieved by placing the RABS in an unclassified SCA. If used to prepare Category 2 or Category 3 CSPs, the RABS must be located within a cleanroom suite with an ISO Class 7 or better buffer room with an ISO Class 8 or better anteroom. For placement of a CACI used for the preparation of antineoplastic and/or API HDs, see á800ñ Pharmaceutical isolator - Precise Answer ✔✔A pharmaceutical isolator provides isolation from the surrounding area and maintains ISO Class 5 air quality during dynamic operating conditions. [NOTE—A CAI or CACI is not a pharmaceutical isolator.]
A pharmaceutical isolator comprises four elements:
What are factors that may require higher ACPH to maintain the ISO requirements? - Precise Answer ✔✔Number of personnel permitted to work in the area Number of particles that may be generated from activities and processes in the area Equipment located in the room Room pressure How many air changes per hour for ISO 7 Class rooms? - Precise Answer ✔✔Minimum of 30 HEPA Filtered air changes per hour The total HEPA filtered ACPH must be adequate to maintain ISO 7 during dynamic operations conditions. At least 15 ACPH of the total air changes rate in a room must come from the HVAC HEPA filters located in the ceiling The HEPA-filtered air from the PEC, when added to the HVAC- supplied HEPA-filtered air, must increase the total HEPA-filtered ACPH to at least 30 ACPH If the PEC is used to meet the minimum total ACPH requirements, the PEC must not be turned off except for maintenance
Rooms where activity levels are high may require more HEPA-filtered ACPH to maintain ISO Class 7 air quality under dynamic operating conditions The ACPH from HVAC, ACPH contributed from the PEC, and the total ACPH must be documented on the certification report How many air changes per hour for ISO 8 Class Rooms? - Precise Answer ✔✔The total HEPA-filtered air change rate must be adequate to maintain ISO Class 8 under dynamic operating conditions considering the factors listed above At least 15 ACPH of the total air change rate in a room must come from the HVAC through HEPA filters located in the ceiling Rooms where activity levels are high may require more HEPA-filtered ACPH to maintain ISO Class 8 air quality under dynamic operating conditions The total ACPH must be documented on the certification report How many air changes per hour in an Unclassified SCA? - Precise Answer ✔✔No requirement
What is the pressure differential requirement for a SCA for non- hazardous drug compounding? - Precise Answer ✔✔No requirement Certification of the classified areas including the PEC must be performed initially, and recertification must be performed at least every 6 months and must include <USP 797> - Precise Answer ✔✔Airflow testing: Airflow testing is performed to determine acceptability of the air velocity, the room air exchange rate, and the room pressure differential in doorways between adjacent rooms to ensure consistent airflow and that the appropriate quality of air is maintained under dynamic operating conditions. The ACPH from HVAC, ACPH contributed from the PEC, and the total ACPH must be documented on the certification report. HEPA filter integrity testing: HEPA filters must be leak tested at the factory and then leak tested again after installation and as part of recertification. Total particle count testing: (See 5.1 Total Airborne Particle Sampling.) Total particle count testing must be performed under dynamic operating conditions using calibrated electronic equipment. Dynamic airflow smoke pattern test: Smoke pattern tests must be performed for each PEC during dynamic operating conditions to demonstrate unidirectional airflow and sweeping action over and away from the preparation(s).
Does the number of personnel present in each PEC and SEC during total particle-count tests and dynamic airflow smoke-pattern test need to be documented? - Precise Answer ✔✔Yes The microbiological air and surface monitoring program must include - Precise Answer ✔✔1 - viable impact volumetric airborne particulate sampling 2- surface sampling What are the goals of microbiological air and surface morning program?
B. Incubate each media device in a separate incubator. Incubate one media device at 30°-35° for no less than 48 h, and incubate the other media device at 20°-25° for no less than 5 days. If fungal media are used as one of the samples, incubate the fungal media sample at 20°-25° for no less than 5 days. C. Count the total number of discrete colonies of microorganisms on each media What are the action levels for Viable Airborne Particle Air Sampling? - Precise Answer ✔✔Iso Class 5 - Greater than 1 Iso Class 7 - Greater than 10 Iso Class 8 - Greater than 100 Action Levels - Precise Answer ✔✔The quantity of colony forming units (CFU) at which the state of contamination control is lost, warranting investigation and mitigation of cause. Aseptic - Precise Answer ✔✔A state of control, void of unwanted microbial contamination CFU - Precise Answer ✔✔A measure of the total number of microorganisms present on a sampling device after incubation to estimate the total viable microbial inhabitance of an area sample Don - Precise Answer ✔✔to put on garbing materials
Detection Level - Precise Answer ✔✔The lowest qty or concentration that can be reliably recovered with a given analytical method Growth Promotion - Precise Answer ✔✔A study where an unexposed sampling device is inoculated with specific microorganisms in specific qty and compared to the expected number of colony forming units after incubation. Irradiated - Precise Answer ✔✔A method of sterilization through controlled exposure to gamma wave radiation. This is commonly used for sterilizing microbial growth media. TSA - Precise Answer ✔✔Tryptic Soy Agar This is suitable for recovery of both bacterial and fungal organisms What neutralizers are in TSA media? - Precise Answer ✔✔Lecithin and polysorbate 80, they can neutralize a wide range of chemicals used for cleaning controlled areas. Media Considerations for GFT - Precise Answer ✔✔Each lot of media requires a certificate of analysis Media must be stored according to mfg specifications.
Media should be double bagged and should be irradiated to ensure testing with a sterile product. Media can be either terminally sterilized and aspectically filled. (aspectically filled is not recommended) GFT samples only need to be collected with TSA plus neutralizers Single plate method Describe Glove Finger Tip testing - Precise Answer ✔✔Do not spray hands with IPA, use a separate sampling device for each hand, compounding personnel must gently roll fingertip then thumbs over surface of agar with not over lapping. Carefully place lid or cover using aseptic technique and seal with parafilm or approved cleanroom tape. What are the action levels for glove finger tip testing? - Precise Answer ✔✔>0 after garbing
3 after media fill How often do compounders need to perform garbing competency (including GFT) - Precise Answer ✔✔Category 1 and 2 every 6 months, category 3 every 3 months
What type of labeling needs to be on the GFT sample? - Precise Answer ✔✔Label on the base of the plate, Label with personnel identifier, right or left hand, date of testing, and any additional relevant identifiers. What is a negative control media? - Precise Answer ✔✔Negative controls is media that is not opened and incubated along with the other media samples. The media is suitable if there is no growth of organisms. What is positive control media? - Precise Answer ✔✔Positive control media is media that is unopened that will be inoculated with microbes at the lab. Positive controls is not the equivalent to the growth promotion studies. How long and what temperatures are required for the GFT and Media fill testing? - Precise Answer ✔✔Incubate for no less than 48 hrs at 30- 35 degreed C and then 20-25 degrees C for no less than 5 days How do you calculate CFU on media fill and gft testing? - Precise Answer ✔✔the total count of CFU from both hands. if no colonies are recovered the results are listed as less than detection level. <1CFU/both hands CSTD - Precise Answer ✔✔closed-system transfer device TSB - Precise Answer ✔✔tryptic soy broth
MFU - Precise Answer ✔✔Media Fill Units What is the purpose of a media fill test? - Precise Answer ✔✔Media Fill testing is used to measure the aseptic skill of compounding personnel. What type of media should be used if the organization performs non- sterile to sterile compounding? - Precise Answer ✔✔dehydrated media must be used as part of he media fill How long does a MFU need to be incubated? - Precise Answer ✔✔20- 25 degrees for 7 days, then gently swirl i 30-35 for an additional 7 days. The order of temperature must be described by the facility SOP. Does do you express results of a MFU? - Precise Answer ✔✔either clear or turbid Activity Level - Precise Answer ✔✔The current operational condition in the area where the viable environmental monitoring is being performed Dual Plate Method - Precise Answer ✔✔Two devices, at least one is TSA collected at the same sample location. Each device is incubated at different time and temp conditions Growth Promotion - Precise Answer ✔✔A study where an unexposed sampling device is inoculated with specific microoganisms in specific
quantities and compared to an expected number of CFU after incubation, normally performed by the mfg for the certificate of analysis IVLFZ - Precise Answer ✔✔integrated vertical laminar flow zone What are the 3 different type of operating conditions - Precise Answer ✔✔As Built, At Rest, Operational/dynamic SDA - Precise Answer ✔✔Sabouraud dextrose agar What are two examples of fungal media? - Precise Answer ✔✔MEA (Malt Extract Agar) and SDA Sabouraud Dextrose Agar Why does media used for sampling need to incorporate neutralizers? - Precise Answer ✔✔Lecithin and polysorbate 80 can neutralize a wide range of chemicals used to cleaning controlled areas. What tests are performed on the media for quality control? - Precise Answer ✔✔growth promotion, pH, and sterlization, and is done by the mfg. How many liters of air should you collect for viable air samples? - Precise Answer ✔✔1000 L
What is the probe size for aerosol photometer? - Precise Answer ✔✔Probe area shall have a maximum opening of 1.7 in2 and a minimum dimension of .50 inches. What is the FDA guidance range for LAFW air velocity? - Precise Answer ✔✔72-108 FPM What is the rate of speed to perform the HEPA leak test with the photometer probe? - Precise Answer ✔✔2inches per second with overlapping strokes. The probe should be no more than in inch from the area being tested. Environmental Monitoring - Precise Answer ✔✔Semi-quantitative evaluation to assess the continued control of contamination NIOSH - Precise Answer ✔✔National Institute for Occupational Safety and Health refrigerators used for HD storage - Precise Answer ✔✔exhaust located adjacent to the refrigerator's compressor and behind the refrigerator should be considered. API - Precise Answer ✔✔Active Pharmaceutical Ingredient What are requirements of a C-SEC - Precise Answer ✔✔externally vented, be physically separated, have appropriate acph, must have a