NMBOP:16.19.36 COMPOUNDED STERILE PREPARATIONS Flashcards
Q: What does “Air changes per hour” (ACPH) mean?
A: “Air changes per hour” (ACPH) means the number of times a volume of air equivalent to the room passes through the room each hour.
Q: What is an “Anteroom”?
A: An “Anteroom” means an ISO Class 8 or cleaner area where personnel hand hygiene and garbing procedures, staging of components, order entry, CSP labeling, and other high-particulate generating activities are performed. It is also a transition area that:
(1) provides assurance that pressure relationships are constantly maintained so that air flows from clean to dirty areas; and
(2) contains a line of demarcation which is a visible line on the floor that separates the clean and dirty sides of the anteroom.
Q: What does “Aseptic processing” refer to?
A: “Aseptic processing” refers to a method by which separate, sterile components (e.g., drugs, containers, or closures) are brought together under conditions that maintain their sterility. The components can either be purchased as sterile or, when starting with nonsterile components, can be separately sterilized prior to combining (e.g., by membrane filtration or by autoclave).
Q: What is meant by “Aseptic technique”?
A: “Aseptic technique” means proper manipulation of preparations to maintain sterility.
Q: Define “Batch” in the context of CSPs.
A: “Batch” refers to more than one CSP prepared as described in the MFR in a single, discrete process, and expected to have uniform character and quality, within specified limits.
Q: What is a “Beyond-use date” (BUD)?
A: A “Beyond-use date” (BUD) means the date, or as appropriate, date and time, after which a compounded preparation is not to be used and is determined from the date and time the preparation is compounded.
Q: What is a “Biological safety cabinet (BSC), Class II”?
A: A “Biological safety cabinet (BSC), Class II” is a ventilated cabinet with an open front and inward and downward unidirectional HEPA-filtered airflow and HEPA-filtered exhaust. A BSC used to prepare a CSP must be capable of providing an ISO Class 5 or better environment for preparation of the CSPs.
Q: What does “Biological safety cabinet” (BSC) refer to?
A: “Biological safety cabinet” (BSC) is a ventilated cabinet that may be used for compounding. These cabinets are divided into three general classes (Class I, Class II, and Class III). Class II BSCs are further divided into types (Type A1, Type A2, Type B1, Type B2, and Type C1).
Q: Define “Buffer room”.
A: A “Buffer room” is an ISO Class 7 or cleaner room with fixed walls and doors where PEC(s) that generate and maintain an ISO Class 5 environment are physically located. The buffer room may only be accessed through the anteroom or another buffer room.
Q: Define “Category 2 CSP”.
A: A “Category 2 CSP” is a CSP that may be assigned a BUD of greater than 12 h at controlled room temperature or greater than 24 h refrigerated that is compounded in accordance with all applicable requirements for Category 2 CSPs in USP/NF <797>.
Q: What is a “Category 3 CSP”?
Q: What is a “Category 3 CSP”?
A: A “Category 3 CSP” is a CSP that may be assigned a BUD exceeding the limits in for Category 2 CSPs and is compounded in accordance with all applicable requirements for Category 3 CSPs in USP/NF <797>.
Q: What does “Certification” mean in this context?
A: “Certification” means independent third party documentation declaring that the specific requirements of USP/NF <797> (USP General Chapters: <797> Pharmaceutical Compounding-Sterile Preparations) have been met.
Q: What is a “Category 1 CSP”?
A: A “Category 1 CSP” is a CSP that is assigned a BUD of 12 h or less at controlled room temperature or 24 h or less refrigerated that is compounded in accordance with all applicable requirements for Category 1 CSPs in USP/NF <797>.
Q: What is a “Cleaning agent”?
A: A “Cleaning agent” is an agent, usually containing a surfactant, used for the removal of substances (e.g., dirt, debris, microbes, and residual drugs or chemicals) from surfaces.
Q: Define “Cleaning”.
A: “Cleaning” is the process of removing substances (e.g., organic and inorganic material) from objects and surfaces, normally accomplished by manually or mechanically using water with detergents or enzymatic products.
Q: What does “Cleanroom suite” refer to?
A: A “Cleanroom suite” is a classified area that consists of both an anteroom and buffer room.
Q: What is a “Closed system vial-transfer device”?
A: A “Closed system vial-transfer device” is a vial-transfer system that allows no venting or exposure of substances to the environment.
Q: Define “Component” in the context of compounding.
A: A “Component” is any ingredient used in the compounding of a preparation, including any active ingredient, added substance, or conventionally manufactured product.
Q: What are “Compounded sterile preparations” (CSPs)?
A: “Compounded sterile preparations” (CSPs) include, but are not limited to, the following dosage forms which must be sterile when administered to patients:
(1) parenteral preparations;
(2) aqueous bronchial and nasal inhalations;
(3) baths and soaks for live organs and tissues;
(4) injections (e.g. colloidal dispersions, emulsions, solutions, suspensions);
(5) irrigations for wounds and internal body cavities;
(6) ophthalmic drops and ointments; and
(7) implants.
Q: What is a “Compounding aseptic containment isolator” (CACI)?
A: A “Compounding aseptic containment isolator” (CACI) is a type of RABS that uses HEPA filtration to provide an ISO Class 5 unidirectional air environment designed for the compounding of sterile HDs.
Q: Define “Compounding record” (CR).
A: A “Compounding record” (CR) documents the compounding of each CSP.
Q: What is a “Compounding aseptic isolator” (CAI)?
A: A “Compounding aseptic isolator” (CAI) is a type of RABS that uses HEPA filtration to provide an ISO Class 5 unidirectional air environment designed for compounding of sterile non-HDs.
Q: What is a “Container closure system”?
A: A “Container closure system” is packaging components that together contain and protect the dosage form. This includes primary packaging components and secondary packaging components, if the latter are intended to provide additional protection.
Q: What is a “Containment ventilated enclosure” (CVE)?
A: A “Containment ventilated enclosure” (CVE) is a non-ISO classified full or partial enclosure that uses ventilation principles to capture, contain, and remove airborne contaminants through HEPA filtration and prevent their release into the work environment.
Q: What is a “Critical area”?
A: A “Critical area” means an ISO Class 5 environment.
Q: Who is a “Designated person”?
A: A “Designated person” is an individual assigned to be responsible and accountable for the performance and operation of the facility and personnel as related to the preparation of CSPs. For pharmacies, the designated person must be the pharmacist-in-charge. For clinic facilities, the designated person must be the consultant pharmacist.
Q: Define “Critical site”.
A: A “Critical site” means a location that includes any component or fluid pathway surfaces (e.g., vial septa, injection ports, beakers) or openings (e.g., opened ampules, 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.
Q: What is a “Direct compounding area” (DCA)?
A: A “Direct compounding area” (DCA) means a critical area within the ISO Class 5 primary engineering control (PEC) where critical sites are exposed to unidirectional HEPA-filtered air, also known as first air.
Q: What does “Disinfectant” mean?
A: A “Disinfectant” is a chemical or physical agent used on inanimate surfaces and objects to destroy fungi, viruses, and bacteria. Sporicidal disinfectants are considered a special class of disinfectants that also are effective against bacterial and fungal spores.
Q: Define “Dynamic operating conditions”.
A: “Dynamic operating conditions” are conditions in the compounding area in which operating personnel are present and simulating or performing compounding. The conditions should reflect the largest number of personnel and highest complexity of compounding expected during routine operations as determined by the designated person(s).
Q: What is a “Dynamic airflow smoke pattern test”?
A: A “Dynamic airflow smoke pattern test
” is a PEC test in which a visible source of smoke, which is neutrally buoyant, is used to observe air patterns within the unidirectional space (i.e., the DCA) under dynamic operating conditions (see the entry for Dynamic operating conditions). This test is not appropriate for ISO Class 7 or ISO Class 8 cleanrooms that do not have unidirectional airflow (see the entry for Visual smoke study).
Q: What is “Home care”?
A: “Home care” means health care provided in the patient’s home (not a hospital or skilled nursing facility) by either licensed health professionals or trained caregivers. It may include hospice care.
Q: What does “Garb” include?
A: “Garb” includes items such as gloves, garments (e.g., gowns), shoe covers, head and facial hair covers, masks, and other items designed to reduce particle-shedding from personnel and minimize the risk of contamination of CSP(s).
Q: What is a “Hazardous drug” (HD)?
A: A “Hazardous drug” (HD) is any drug identified by at least one of the following six criteria: carcinogenicity, teratogenicity or developmental toxicity, reproductive toxicity in humans, organ toxicity at low dose in humans or animals, genotoxicity, or new drugs that mimic existing HDs in structure or toxicity. (Reference current NIOSH publications).
Q: What does “High-efficiency particulate air (HEPA) filtration” refer to?
A: “High-efficiency particulate air (HEPA) filtration” refers to being, using, or containing a filter designed to remove ninety-nine and ninety-seven one-hundredths percent of airborne particles measuring zero and three-micron or greater in diameter passing through it.
Q: What does “ISO class” refer to?
A: “ISO class” refers to an air-quality classification from the International Organization for Standardization.
Q: What does “Laminar airflow” mean?
A: “Laminar airflow” means a non-turbulent, non-mixing streamline flow of air in parallel layers.
Q: What is an “Integrated vertical laminar flow zone” (IVLFZ)?
A: An “Integrated vertical laminar flow zone” (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.
Q: What is a “Laminar airflow system” (LAFS)?
A: A “Laminar airflow system” (LAFS) is a device or zone within a buffer room that provides an ISO Class 5 or better air quality environment for sterile compounding. The system provides a unidirectional HEPA filtered airflow.
Q: Define “Laminar airflow workbench” (LAFW).
A: A “Laminar airflow workbench” (LAFW) is a device that is a type of LAFS that provides an ISO Class 5 or better air quality environment for sterile compounding. The device provides a unidirectional HEPA-filtered airflow.
Q: What is a “Line of demarcation”?
A: A “Line of demarcation” is a visible line on the floor that separates the clean and dirty sides of the anteroom.
Q: What is a “Master formulation record” (MFR)?
A: A “Master formulation record” (MFR) is a detailed record of procedures that describes how the CSP is to be prepared.
Q: What is a “Media-fill test”?
A: A “Media-fill test” is a simulation used to qualify processes and personnel engaged in sterile compounding to ensure that the processes and personnel are able to prepare CSPs without contamination.
Q: Define “Multiple-dose container”.
A: A “Multiple-dose container” is a multiple-unit container for articles or preparations intended for parenteral administration only and usually containing antimicrobial preservatives. Once opened or entered, a multiple-dose container with antimicrobial preservative has a BUD of 28 days unless otherwise specified by the manufacturer.
Q: What is a “One-step disinfectant cleaner”?
A: A “One-step disinfectant cleaner” is a product with an EPA-registered (or equivalent) claim that it can clean and disinfect a nonporous surface in the presence of light to moderate organic soiling without a separate cleaning step
Q: What is a “Negative pressure room”?
A: A “Negative pressure room” is a room that is at a lower pressure than the adjacent spaces and therefore, the net flow of air is into the room.
