Aseptic Technique MCQ Quiz Questions

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.

Ew. Weeping sores.

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.

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.

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.

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.

Just trying to force you to read definitions.

Sure, "D" might not be considered garb, since it is only recommended, is protecting the personnel member, not the CSP.

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.

Chapter 1206 is the OLD chapter, which was actually considered a guideline, NOT enforceable by the FDA.

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.

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.

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.

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.

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.

Hand hygiene and garbing should be done in the anteroom, ISO 8 air quality.

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.

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.

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.

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.

99.9%!

All these statements are true, but only D defines the principle of first air.

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.

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.

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.

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.

ISO Class 8: 3520000 ISO Class 5: 3520 = 1000-fold difference

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.

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.

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.

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.

E is incorrect because SECs only need to be ISO 7 or ISO 8.

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).

B is false because CSPs are compounded inside the LAFW, which SHOULD all be ISO 5 air quality.

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.