1.
Aseptic technique refers to which of the following descriptions?
Correct Answer
E. All of the above
Explanation
Aseptic technique refers to carrying out a procedure under controlled conditions, minimizing the chance of contamination, and producing a product without microorganisms or their by-products. This means that all of the given descriptions are correct and encompass different aspects of aseptic technique.
2.
Which one of the following classifies as a "pyrogen"?
Correct Answer
E. All of the above
Explanation
All of the options listed, including an agent that causes a rise in temperature, metabolic products of a living organism, the dead organism itself, and the constituents of the cell wall of gram-negative bacteria, can be classified as pyrogens. Pyrogens are substances that can induce fever or an increase in body temperature.
3.
Exposure to a pyrogen, as described previously, causes which of the following reactions? (Check all that apply)
Correct Answer(s)
A. Fever
B. Chills
D. Malaise
Explanation
Exposure to a pyrogen, which is a substance that causes fever, can lead to various reactions in the body. Fever is a common reaction that occurs in response to pyrogen exposure, as it is the body's way of fighting off infection or inflammation. Chills can also occur as the body tries to raise its temperature. Malaise, a general feeling of discomfort or uneasiness, can also be a reaction to pyrogen exposure. Diarrhea, however, is not typically associated with pyrogen exposure and is not a common reaction. Therefore, the correct answers are fever, chills, and malaise.
4.
What does the acronym "CSP" stand for?
Correct Answer
C. Compounded Sterile Product
Explanation
The acronym "CSP" stands for Compounded Sterile Product. This refers to a pharmaceutical product that is prepared by a pharmacist or a licensed compounding facility, which involves combining, mixing, or altering ingredients to meet the specific needs of an individual patient. These products are prepared in a sterile environment to ensure safety and efficacy.
5.
Which of the following actions can be performed by pharmacy personnel, using an aseptic technique and other quality assurance procedures to a drug or nutritional substance that is free from living organisms in order for the product to be considered a "CSP"?
Correct Answer
E. All of the above
Explanation
All of the above actions can be performed by pharmacy personnel, using an aseptic technique and other quality assurance procedures to a drug or nutritional substance that is free from living organisms in order for the product to be considered a "CSP". Repackaging involves transferring the product into a different container, compounding involves mixing or preparing the product according to specific requirements, and manipulating involves altering the product in some way. All of these actions can be done while maintaining aseptic conditions and following quality assurance procedures to ensure the product is free from living organisms.
6.
Which of the following is NOT an example of a sterile product?
Correct Answer
D. Antibiotic suspensions for a child
Explanation
Antibiotic suspensions for a child are not an example of a sterile product because suspensions are not required to be sterile. Sterile products are those that are free from any living microorganisms, while antibiotic suspensions for a child may contain inactive ingredients or preservatives that do not meet the criteria for sterility. Inhalation products, parenteral products, ophthalmic products, and nasal products, on the other hand, need to be sterile to ensure safety and effectiveness.
7.
What is the CURRENT chapter that is used to describe conditions and practices that outline how to prevent harm, including death, to patients that could result from CSPs?
Correct Answer
C. Chapter 797
Explanation
Chapter 1206 is the OLD chapter, which was actually considered a guideline, NOT enforceable by the FDA.
8.
Events that are considered potentially harmful to a patient in Chapter 797 include all of the following EXCEPT:
Correct Answer
A. Consistency in the intended strength of correct ingredients
Explanation
In Chapter 797, consistency in the intended strength of correct ingredients is not considered potentially harmful to a patient. The other options listed (microbial contamination, excessive bacterial endotoxins, unintended chemical and physical contaminant) are all considered potentially harmful to a patient.
9.
Which of the following facilities is considered International Organization for Standardization (ISO) Class 5?
Correct Answer
C. Primary engineering control (PEC)
Explanation
ISO Class 5 refers to a cleanroom classification that specifies the maximum allowable concentration of airborne particles. Primary engineering control (PEC) is a facility that meets this ISO Class 5 standard. The other options, ante-area and buffer area, may or may not meet this standard depending on their specific design and cleanliness requirements. Therefore, PEC is the only option that is definitely considered ISO Class 5.
10.
Compared to an ISO class 5 area for compounding, how much more particulate matter in room air of particles 0.5 microns and larger per cubic meter does an ISO class 8 area have?
Correct Answer
D. 1000-fold
Explanation
ISO Class 8: 3520000 ISO Class 5: 3520 = 1000-fold difference
11.
If pharmacy personnel needs to perform the following activities: hand hygiene and garbing procedures, staging of components, order entry, CSP labeling, and removal of packaging. Which area should they be in?
Correct Answer
A. Ante-area
Explanation
The pharmacy personnel should be in the ante-area to perform the mentioned activities. The ante-area is the designated space where hand hygiene and garbing procedures are performed before entering the cleanroom or buffer area. It is the transition zone between the non-sterile and sterile areas, ensuring that proper cleanliness and aseptic techniques are followed before entering the controlled environment. The other areas mentioned, such as the buffer area, primary engineering control (PEC), and laminar airflow hood, have specific functions within the cleanroom but are not suitable for all the mentioned activities.
12.
All of the following activities and requirements are unique to the buffer area EXCEPT?
Correct Answer
E. May perform ante-room activities if a positive-pressure differential exists.
Explanation
The given answer is the only activity or requirement that is not unique to the buffer area. The other options mention specific characteristics or activities that are unique to the buffer area, such as ISO Class 7 air quality, containing necessary equipment and supplies, using nonpermeable and cleanable items, and having a laminar airflow hood ISO class 5. However, the option "May perform ante-room activities if a positive-pressure differential exists" does not mention any unique characteristic or requirement of the buffer area.
13.
From ASHP's video Guide to Chapter <797>, in order to implement a range of quality assurance indicators, all of the following are put into practice at every facility compounding CSPs EXCEPT:
Correct Answer
C. UA screening of all potential employees
Explanation
In order to implement a range of quality assurance indicators, several practices are put into place at every facility compounding CSPs. These practices include initial and ongoing training of personnel, competency evaluation, process validation testing, and other quality assurance measures. However, UA screening of all potential employees is not included as a practice. This means that while all the other options are necessary for ensuring quality assurance, UA screening is not required in this context.
14.
A laminar airflow workbench (LAFW) sends a constant of filtered air across a work surface at a precisely controlled rate, using specialized high-efficiency particular air (HEPA) filters to remove many of the tiny particles found in the air. How many times is the air inside of a LAFW filtered?
Correct Answer
B. Twice
Explanation
The air inside a laminar airflow workbench (LAFW) is filtered twice. This is because the LAFW uses specialized high-efficiency particular air (HEPA) filters to remove tiny particles from the air. The filtered air is then sent across the work surface at a precisely controlled rate. By filtering the air twice, the LAFW ensures a high level of cleanliness and reduces the presence of contaminants, making it suitable for various applications that require a sterile environment.
15.
True or False: HEPA filters remove 100% of particles that are 0.3 microns or larger and, as a result, most airborne microorganisms.
Correct Answer
B. False
Explanation
99.9%!
16.
Which of the following pairs of precautions that must be taken when working in the specific laminar flow hoods are correctly matched? (Check all that apply)
Correct Answer(s)
A. Horizontal airflow -- Never allow anything to pass behind a sterile object
D. Vertical airflow -- Never allow anything to pass above a sterile object
Explanation
When working in a specific laminar flow hood with horizontal airflow, it is important to never allow anything to pass behind a sterile object. This is because the horizontal airflow is designed to create a barrier that prevents contaminants from entering the sterile area. Similarly, when working with vertical airflow, it is crucial to never allow anything to pass above a sterile object to maintain the integrity of the sterile environment. This is because the vertical airflow is designed to direct contaminants away from the sterile area.
17.
Which of the following defines the "principle of first air"?
Correct Answer
D. Keeping the airflow between the HEPA filter and the sterile object unobstructed
Explanation
All these statements are true, but only D defines the principle of first air.
18.
True or False: Aseptic manipulations should be performed at least 6 inches inside the workbench to prevent reflected contamination from compounding personnel or contamination from particles carried in turbulent air patterns.
Correct Answer
A. True
Explanation
Aseptic manipulations should be performed at least 6 inches inside the workbench to prevent reflected contamination from compounding personnel or contamination from particles carried in turbulent air patterns. This is because the area closer to the workbench is considered a cleaner zone with less chance of contamination. By performing manipulations at least 6 inches inside the workbench, the risk of contamination from outside sources is minimized, ensuring aseptic conditions are maintained.
19.
Arrange the following clean and disinfect all interior work surfaces before use:I. Allow sterile 70% isopropyl alcohol to dry before compoundingII. Clean top to bottom, back to front -- whichever direction is AWAY from the HEPA filterIII. Clean with sterile water.IV. Clean with sterile 70% isopropyl alcohol
Correct Answer
C. II, III, IV, I
Explanation
The correct order for cleaning and disinfecting all interior work surfaces before use is as follows: II - Clean top to bottom, back to front -- whichever direction is AWAY from the HEPA filter, III - Clean with sterile water, IV - Clean with sterile 70% isopropyl alcohol, I - Allow sterile 70% isopropyl alcohol to dry before compounding. This order ensures that the surfaces are cleaned properly and disinfected effectively before use.
20.
Which of the following situations calls for a re-certification of the laminar airflow workbench (LAFW)?
Correct Answer
E. All of the above
Explanation
The laminar airflow workbench (LAFW) should be re-certified every six months to ensure its proper functioning and adherence to safety standards. Additionally, re-certification is necessary whenever the LAFW is moved to ensure that it has not been damaged or compromised during the relocation process. Lastly, if there is suspicion of filter damage, re-certification is required to assess and address any potential issues with the filtration system. Therefore, all of the given situations call for a re-certification of the LAFW.
21.
Which of the following is ALLOWED inside the LAFW?
Correct Answer
E. None of the above are allowed inside the LAFW.
Explanation
The LAFW (Los Angeles Fashion Week) does not allow any of the mentioned activities or items inside. This means that eating, drinking, gum chewing, smoking, visible jewelry, makeup, artificial nails, and extenders are all prohibited within the LAFW.
22.
True or False: Personnel with rashes, sunburn, weeping sores, conjunctivitis, or active respiratory infection should not compound sterile products.
Correct Answer
A. True
Explanation
Ew. Weeping sores.
23.
"Any opening in a direct path between a CSP and the environment, or any surface coming in direct contact with the preparation and the environment" defines which of the following terms?
Correct Answer
D. Critical site
Explanation
The term "critical site" refers to any opening in a direct path between a CSP (Compounded Sterile Preparation) and the environment, or any surface that comes in direct contact with the preparation and the environment. This means that a critical site is a vulnerable point in the system where contamination can occur, and it is crucial to maintain the integrity of these sites to ensure the safety and sterility of the compounded preparations.
24.
The degree of exposure is defined by all of the following EXCEPT:
Correct Answer
B. ISO air quality rating
Explanation
B is false because CSPs are compounded inside the LAFW, which SHOULD all be ISO 5 air quality.
25.
Primary engineering controls (PECs) maintain ISO 5 air quality and include all of the following EXCEPT:
Correct Answer
C. Hand hygiene and garbing stations
Explanation
Hand hygiene and garbing should be done in the anteroom, ISO 8 air quality.
26.
Which of the following parameters are inspected to obtain a contamination-free environment?
Correct Answer
E. All of the above
Explanation
All of the parameters mentioned in the options are inspected to obtain a contamination-free environment. The quality of components is important as any contamination in the components can lead to a contaminated environment. The compounding process needs to be monitored to ensure that there are no contaminants introduced during the manufacturing process. Environmental conditions such as air quality, temperature, and humidity also need to be controlled to prevent contamination. Additionally, personnel performance is crucial as human actions can introduce contaminants, so proper training and adherence to protocols are necessary. Therefore, all of the mentioned parameters are inspected to achieve a contamination-free environment.
27.
True or False: A "clean room" is the buffer area that meets specific air quality, HEPA filtration, air changes per hour, and room pressure differentiation criteria.
Correct Answer
A. True
Explanation
A "clean room" refers to a controlled environment that maintains specific air quality standards, including HEPA filtration, air changes per hour, and room pressure differentiation. This ensures that the room is free from contaminants and particles, making it suitable for sensitive processes such as scientific research, manufacturing of electronic components, and pharmaceutical production. Therefore, the statement that a "clean room" is the buffer area that meets these criteria is true.
28.
Converting an existing facility into a Secondary Engineering Control might require all of the following EXCEPT:
Correct Answer
E. Obtaining ISO 5 air quality
Explanation
E is incorrect because SECs only need to be ISO 7 or ISO 8.
29.
True or False: Sometimes, a primary engineering control (PEC) must be placed in an area that does not meet USP <797> requirements for a cleanroom or buffer area. In this case, it may be placed in a dedicated space outside of a buffer area called a "segregated compounding area."
Correct Answer
A. True
Explanation
Just trying to force you to read definitions.
30.
Protective clothing, known as garb, helps contain the particles and microorganisms produced by compounding personnel. Garb includes all of the following except:
Correct Answer
E. All of the above are considered protective clothing
Explanation
Sure, "D" might not be considered garb, since it is only recommended, is protecting the personnel member, not the CSP.
31.
Which of the following items is allowed inside the buffer area or Segregated Compounding Area?
Correct Answer
D. Hair and shoe covers
Explanation
Hair and shoe covers are allowed inside the buffer area or Segregated Compounding Area. This is because hair and shoe covers help to maintain a clean and sterile environment by preventing hair and dirt from coming into contact with the compounded medications. Wearing hair and shoe covers reduces the risk of contamination and ensures the safety and quality of the compounded products.
32.
Arrange the following preparatory steps that must be taken before entering the cleanroom:I. Put on non shedding gownII. Apply a waterless alcohol-based surgical hand scrub to bare hands and allow hands to dry.III. Put on dedicated shoes/shoe covers, hair covers, and face masks.IV. Put on sterile powder-free gloves.V. Apply a waterless alcohol-based surgical hand scrub to the gloves and allow gloves to dry.VI. Complete the proper hand hygiene process.
Correct Answer
B. III, VI, I, II, IV, VI
Explanation
The correct answer is III, VI, I, II, IV, V. Before entering the cleanroom, it is important to put on dedicated shoes/shoe covers, hair covers, and face masks (III). Then, complete the proper hand hygiene process (VI) which includes applying a waterless alcohol-based surgical hand scrub to bare hands and allowing them to dry. After that, put on a non-shedding gown (I) followed by applying a waterless alcohol-based surgical hand scrub to sterile powder-free gloves and allowing them to dry (II, IV). The last step is to apply a waterless alcohol-based surgical hand scrub to the gloves and allow them to dry (V).
33.
When personnel leaves the compounding area during a work shift, all of the following must be discarded EXCEPT (if not visibly soiled):
Correct Answer
D. Exterior gown
Explanation
When personnel leaves the compounding area during a work shift, all of the listed items (shoe covers, hair covers, masks, gloves) must be discarded except for the exterior gown. The exterior gown is not required to be discarded unless visibly soiled. This means that if the gown is still clean and not visibly soiled, it can be reused for the next shift.
34.
As shown in the quality assurance for pharmacy prepared sterile products VHS tape, regarding syringes, which parts should never be touched? (Check all that apply)
Correct Answer(s)
B. Tip
C. Plunger
Explanation
The tip and plunger of a syringe should never be touched. This is because these parts come into direct contact with the medication or sterile solution being administered. Touching these parts can introduce contaminants or bacteria, compromising the sterility of the product and potentially causing harm to the patient. The protective covering and flat end of the syringe can be touched as they do not come into contact with the medication.
35.
Arrange the following steps in the proper order to properly swab and disinfect a vial:I. Swab with 70% isopropyl alcoholII. Remove the top to reveal rubber stopperIII. Let dry
Correct Answer
E. II, I, III
Explanation
To properly swab and disinfect a vial, the correct order of steps is as follows: II, I, III. First, remove the top of the vial to reveal the rubber stopper. Then, swab the rubber stopper with 70% isopropyl alcohol. Finally, let the rubber stopper dry before using the vial.