BPS Sterile Compounding Practice Exam

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• What does an MFR stand for in sterile compounding?
• What are the key characteristics of storage shelving in a buffer room?
• How often should personnel be re-evaluated for competency in sterile compounding?
• What type of air filtration is not required in a Segregated Compounding Area (SCA)?
• What is the significance of using a "closed system transfer device" (CSTD)?
• What volume defines a large volume parenteral?
• What is the maximum allowable humidity in a Sterile Product Complex?
• What is the required pressure for the ISO 7 Negative Pressure Buffer Room?
• What is one of the main areas prone to contamination during compounding activities?
• What is the consequence of using non-sterile water in the preparation of high risk CSPs?
• What relative humidity should be maintained within a C-SCA?
• What is a characteristic of an environment suitable for the preparation of medium risk compounded sterile preparations (CSPs)?
• Which temperature is considered acceptable for storing low-risk CSPs when frozen?
• Non-viable airborne particle testing directly measures what aspect?
• What must be done in a segregated compounding area (SCA) for low-risk CSPs?
• Which of the following is a requirement for the immediate use provision?
• What is one example of a medium risk compounded sterile preparation?
• Which of these methods is suitable for sterilization in a Compounding Environment?
• What type of equipment can be used for a low-risk level CSP?
• What is a "master formulation record"?
• Which chapter of USP deals primarily with radiopharmaceuticals?
• What document outlines the sterile compounding policies in a pharmacy?
• What is the longest allowed storage time for high risk CSPs when frozen?
• What is the maximum storage period for low-risk CSPs stored at controlled room temperature?
• Why is double-checking calculations critical during compounding?
• Why is it important to calculate the correct diluent volume when compounding a parenteral solution?
• What do the terms "beyond-use date" and "expiration date" signify?
• What is a common bacteriostatic agent used in compounding?
• Why is maintaining proper temperature control essential for compounded preparations?
• In which situations is it appropriate to use compounded sterile preparations?
• Describe the function of environmental monitoring in sterile compounding.
• Which retention capacity requirement is crucial for filters during CSP sterilization?
• Which type of flooring is recommended for a buffer room in sterile compounding?
• What is the purpose of a validation process in sterile compounding?
• What is the primary purpose of a compounding record in sterile compounding?
• When performing manipulations of low-risk CSPs, what is permitted?
• Which types of items must be limited in a buffer room?
• In sterile compounding, how long is the depyrogenation process typically done at 250 degrees C?
• If contamination is suspected during compounding, what steps should be taken?
• What does the term "sterility assurance level" (SAL) refer to?
• What is the incubation temperature for fungi growth using malt extract agar?
• What should the environment be for compounding radiopharmaceuticals?
• How is unidirectional air verified in the Primary Engineering Controls (PEC)?
• What type of air quality does a Clean Room (Buffer Room) need to achieve?
• What is the beyond-use date (BUD) for opened or needle-punctured single-dose containers in ISO 5 air?
• At what temperature is depyrogenation achieved using dry heat?
• What type of compounded sterile products (CSPs) should never utilize bacteriostatic diluents?
• What is one component of personnel training for high risk compounding?
• What is the incubation temperature for media fill tests for high risk CSPs?
• What does "first air" refer to in laminar airflow hoods?
• What is the required temperature in a Containment Segregated Compounding Area (C-SCA)?
• Which of the following is NOT a requirement for low-risk level CSPs?
• Which method is NOT typically used for achieving sterility in high risk CSPs?
• Terminal filtration is primarily used for what purpose in compounding sterile products?
• Which aspect directly relates to the patient's safety in sterile compounding?
• Which best describes the BUD for low-risk CSPs prepared in a segregated compounding area?
• For low-risk CSPs, what type of PECs are permitted?
• What is the maximum number of sterile products that can be pooled together for medium risk CSPs?
• What are the characteristics of the furniture used in the buffer room?
• When is a Master Formulation Record (MFR) necessary?
• When should the Sterile Compounding area (SPC) be certified?
• What is a key difference between a Segregated Compounding Area (SCA) and a Buffer Room?
• What pressure differential should exist between the ISO 7 buffer room and the ante room?
• What is the required testing frequency for media fill in low-risk CSPs?
• What determines the exposure duration for critical sites to worse than ISO 5 air?
• Which practice is essential for handling hazardous drugs?
• What distinguishes terminal sterilization from aseptic processing?
• Why is regular equipment maintenance important in sterile compounding?
• What is the preferred temperature range for storing compounded sterile preparations?
• For low and medium risk CSPs, what is the recommended frequency of Active (Viable) Air Sampling?
• Which components are essential on a sterile product label?
• What type of growth medium is used for surface sampling in Active (Viable) Air Sampling?
• What is the function of benzyl alcohol in some sterile compounded preparations?
• What materials are suitable for work surfaces in a buffer room?
• Carts in a buffer room should be constructed from which of the following materials?
• What is the pressure setting when using an autoclave for steam sterilization?
• How should hazardous drugs be disposed of in a pharmacy?
• What element should NOT be included on a sterile product label?
• Why is documentation critical in the compounding process?
• What is the typical beyond-use date for a needle-punctured multiple-dose container?
• How often should environmental sampling be performed according to best practices?
• What must junctions between ceilings and walls in the buffer room be designed to avoid?
• What characteristic should the exterior lens of lights in a buffer room have?
• Where must hazardous drugs (HDs) be stored according to USP 797?
• What is the main purpose of USP 797?
• What is the recommended integrity test for sterilization filters?
• What is a necessary feature for all HD compounding areas?
• Which sterilization method requires higher temperatures and longer duration than steam?
• How long should items be sterilized using dry heat at 160 degrees C?
• What is the classification of the air in a Compounding Aseptic Isolator (CAI)?
• What is the volume range for a small volume parenteral?
• What is an essential element of effective environmental monitoring in a compounding area?
• What is the function of a smoke study in a PEC?
• What is the recommended temperature and pressure for steam sterilization using an autoclave?
• What additional personal protective equipment (PPE) is required for hazardous compounding?
• How often must media fill testing be conducted for high risk compounded sterile preparations?
• What is the main consequence of failing to verify drug compatibility during compounding?
• Which type of risk level is associated with sterilization by filtration?
• How often should wipe sampling be performed for hazardous drugs?
• Which type of injection is included in the restriction against using bacteriostatic diluents?
• What is the highest priority when considering critical sites in sterile compounding?
• Is it necessary to identify Active (Viable) Air Sampling CFUs?
• What is the preferred method for introducing HEPA filtered air into the SEC?
• What is the correct action when highly pathogenic microbes are identified in air sampling?
• Which of the following is an appropriate method of sterility testing during compounding?
• At what temperature should TSA be incubated for Active (Viable) Air Sampling?
• Which factors must be taken into account when determining the stability of a compounded sterile preparation?
• Which of the following tests can confirm the sterility of a compounded preparation?
• What is the recommended growth medium for Active (Viable) Air Sampling to promote bacteria growth?
• What is a requirement for surfaces in the Sterile Product Complex (SPC)?
• What is the definition of a "compounding pharmacy"?
• What is the osmolality threshold for a drug administered via a central line?
• Which ISO class is typically required for areas where sterile compounding occurs?
• What is a compounding record?
• What aspect of automated compounding devices increases their utility in sterile compounding?
• What defines critical sites in sterile compounding?
• What should be done for allergen extracts prior to compounding?
• What materials are preferred for constructing the walls of a buffer room in sterile compounding practice?
• What should be the maximum temperature for a Sterile Product Complex?
• Which element is NOT part of the stability evaluation for compounded sterile preparations?
• Why is proper hand hygiene critical in sterile compounding?
• What typical cycle is used for depyrogenation using dry heat?
• Which type of risk level is allowed under the immediate use provision?
• What are "the six rights" of medication administration?
• What is a requirement regarding cleaning and disinfection in low-risk CSP preparation?
• What is the primary goal of risk assessment in sterile compounding?
• What distinguishes non-hazardous sterile compounding from hazardous sterile compounding?
• What is the purpose of maintaining a cleanroom log book?
• What document must accompany compounded sterile preparations when dispensed to patients?
• Why is training pharmacy staff on sterile compounding techniques important?
• Which populations are specifically contraindicated for the use of bacteriostatic diluents?
• Immediate remediation of Active (Viable) Air Sampling CFUs is required if which types of microbes are identified?
• How should compounded sterile preparations be labeled for patient dispensing?
• What are the advantages of using automated compounding devices?
• What should be done if a compounded sterile preparation fails sterility testing?
• Why is it critical to verify drug compatibility during compounding?
• What factors influence the standards required for environmental conditions during CSP processing?
• Which of the following is NOT a bacteriostatic agent?
• What does the right documentation in medication administration ensure?
• How long should TSA be incubated for Active (Viable) Air Sampling?
• What is the volume needed for Active (Viable) Air Sampling according to USP 797?
• Which of the following is NOT a source of exceeding CFU action levels in air sampling?
• What are potential consequences of not adhering to guidelines regarding central line PN treatment duration?
• What is the main purpose of a Laminar Air Flow Workbench (LAFW)?
• What is the recommended action level for CFU in ISO 5 air sampling?
• How should epidermal compounded sterile products be treated with respect to bacteriostatic agents?
• What can be a result of improper temperature control of compounded sterile preparations?
• What is the preferred method for terminally sterilizing aqueous CSPs?
• What is indicated by visible turbidity in the medium during a media fill test?
• What should be done with compounded sterile preparations that have exceeded their beyond-use date?
• In the context of compounded sterile preparations, why is it important to have documentation of the compounding procedure?
• What does USP 800 focus on in healthcare settings?
• What is the significance of the sterile compounding policy and procedure manual?
• What type of training should staff receive regarding hazardous drugs?
• What is the objective of determining the sterility assurance level (SAL)?
• What role does visual inspection serve in quality assurance for compounded preparations?
• How can compounding accuracy be verified?
• What is meant by "ISO class" in the context of cleanrooms?
• Which method of sterility testing is favored to extend beyond-use dates (BUD)?
• Which of the following describes Secondary Engineering Controls (SECs)?
• What percentage of dextrose is typically recommended for central line parenteral nutrition due to phlebitis concerns?
• Why is terminal filtration by membrane filtration preferred over direct inoculation?
• What procedures are essential for verifying the accuracy of a compounded sterile preparation?
• How should opened single-dose ampules be handled?
• What is the minimum air change per hour (ACPH) required in a buffer area?
• What should be included in the training documentation for sterile compounding personnel?
• What are the allowed total particle counts for ISO 5 classification?
• Which of the following methods could potentially reduce CFU counts?
• What is the recommended incubation period for media fill tests at both low and medium risk levels?
• How many entries into a sterile container are allowed for low-risk CSPs?
• Which biological indicator is used to verify steam sterilization effectiveness?
• What is the primary purpose of performing media fill tests?
• What is the recommended duration of treatment for central line parenteral nutrition (PN) due to potential complications?
• Which method is used for sterilization in a Segregated Compounding Area (SCA)?
• What environment is required for preparing low-risk CSPs?
• Which USP chapter is associated with sterilization and sterility assurance of compendial articles?
• How can the risk of contamination at critical sites increase?
• What facilities are designated for CAIs in terms of ISO classification?
• What must be true about filters used for sterilizing CSP solutions?
• What is the primary risk associated with hyperosmolality in PN treatment?
• For how long can refrigerated medium risk CSPs be stored in the absence of sterility tests?
• What is the maximum storage period for high risk CSPs at controlled room temperature in the absence of sterility tests?
• What is the primary condition under which immediate use compounding may be performed?
• What is necessary for the caulking around ceiling panels in a buffer room with inlaid panels?
• What aspect of training is crucial for maintaining standard practices in sterile compounding?